01999A0204(01) — EN — 05.02.2020 — 008.001
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AGREEMENT on mutual recognition between the European Community and the United States of America (OJ L 031 4.2.1999, p. 3) |
Amended by:
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Official Journal |
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No |
page |
date |
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L 34 |
68 |
3.2.2001 |
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L 306 |
34 |
23.11.2001 |
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L 306 |
42 |
23.11.2001 |
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L 306 |
45 |
23.11.2001 |
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L 306 |
47 |
23.11.2001 |
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L 306 |
49 |
23.11.2001 |
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L 101 |
19 |
17.4.2002 |
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L 101 |
21 |
17.4.2002 |
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L 101 |
23 |
17.4.2002 |
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L 101 |
26 |
17.4.2002 |
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L 101 |
27 |
17.4.2002 |
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L 101 |
29 |
17.4.2002 |
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L 101 |
36 |
17.4.2002 |
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L 302 |
30 |
6.11.2002 |
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L 302 |
31 |
6.11.2002 |
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L 302 |
32 |
6.11.2002 |
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L 302 |
33 |
6.11.2002 |
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L 302 |
34 |
6.11.2002 |
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L 45 |
19 |
19.2.2003 |
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L 45 |
21 |
19.2.2003 |
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L 45 |
23 |
19.2.2003 |
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L 229 |
36 |
13.9.2003 |
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L 229 |
37 |
13.9.2003 |
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L 319 |
17 |
20.10.2004 |
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L 371 |
50 |
18.12.2004 |
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L 65 |
47 |
7.3.2006 |
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L 313 |
45 |
26.11.2011 |
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L 212 |
45 |
18.7.2014 |
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L 208 |
39 |
5.8.2015 |
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L 58 |
36 |
4.3.2017 |
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L 72 |
72 |
17.3.2017 |
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L 72 |
74 |
17.3.2017 |
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L 72 |
76 |
17.3.2017 |
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L 99 |
26 |
12.4.2017 |
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L 99 |
27 |
12.4.2017 |
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L 99 |
28 |
12.4.2017 |
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L 238 |
53 |
16.9.2017 |
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L 328 |
136 |
12.12.2017 |
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L 328 |
138 |
12.12.2017 |
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L 328 |
140 |
12.12.2017 |
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L 189 |
13 |
26.7.2018 |
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L 189 |
14 |
26.7.2018 |
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L 189 |
17 |
26.7.2018 |
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L 189 |
19 |
26.7.2018 |
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L 189 |
21 |
26.7.2018 |
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L 189 |
23 |
26.7.2018 |
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L 189 |
25 |
26.7.2018 |
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L 189 |
26 |
26.7.2018 |
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L 97 |
9 |
8.4.2019 |
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L 97 |
11 |
8.4.2019 |
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L 97 |
13 |
8.4.2019 |
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L 97 |
15 |
8.4.2019 |
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L 46 |
3 |
19.2.2020 |
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L 46 |
5 |
19.2.2020 |
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L 46 |
7 |
19.2.2020 |
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L 46 |
9 |
19.2.2020 |
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L 46 |
11 |
19.2.2020 |
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Corrected by:
AGREEMENT
on mutual recognition between the European Community and the United States of America
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TABLE OF CONTENTS |
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1. |
Framework |
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2. |
Telecommunication Equipment |
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3. |
Electromagnetic Compatibility (EMC) |
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4. |
Electrical Safety |
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5. |
Recreational Craft |
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6. |
Pharmaceutical Good Manufacturing Practices (GMPs) |
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7. |
Medical Devices |
The EUROPEAN COMMUNITY, and THE UNITED STATES OF AMERICA, hereinafter referred to as ‘the Parties’,
CONSIDERING the traditional links of friendship that exist between the United States of America (US) and the European Community (EC);
DESIRING to facilitate bilateral trade between them;
RECOGNISING that mutual recognition of conformity assessment activities is an important means of enhancing market access between the Parties;
RECOGNISING that an agreement providing for mutual recognition of conformity assessment activities is of particular interest to small and medium-sized businesses in the US and the EC;
RECOGNISING that any such mutual recognition also requires confidence in the continued reliability of the other Party's conformity assessments;
RECOGNISING the importance of maintaining each Party's high levels of health, safety, environmental and consumer protection;
RECOGNISING that mutual recognition agreements can positively contribute in encouraging greater international harmonisation of standards;
NOTING that this Agreement is not intended to displace private sector bilateral and multilateral arrangements among conformity assessment bodies or to affect regulatory regimes allowing for manufacturers' self-assessments and declarations of conformity;
BEARING IN MIND that the Agreement on Technical Barriers to Trade, an agreement annexed to the Agreement establishing the World Trade Organization (WTO), imposes obligations on the Parties as Contracting Parties to the WTO, and encourages such Contracting Parties to enter into negotiations for the conclusion of agreements for the mutual recognition of results of each other's conformity assessment;
RECOGNISING that any such mutual recognition needs to offer an assurance of conformity with applicable technical regulations or standards equivalent to the assurance offered by the Party's own procedures;
RECOGNISING the need to conclude an Agreement on Mutual Recognition (MRA) in the field of conformity assessment with sectoral annexes; and
BEARING in mind the respective commitments of the Parties under bilateral, regional and multilateral environment, health, safety and consumer protection agreements.
HAVE AGREED AS FOLLOWS:
Article 1
Definitions
1. The following terms and definitions shall apply to this Agreement only:
2. Other terms concerning conformity assessment used in this Agreement shall have the meaning given elsewhere in this Agreement or in the definitions contained in Guide 2 (1996 edition) of the International Organization for Standardisation (ISO) and the International Electrotechnical Commission (IEC). In the event of an inconsistency between ISO/IEC Guide 2 and definitions in this Agreement, the definitions in this Agreement shall prevail.
Article 2
Purpose of the Agreement
This Agreement specifies the conditions by which each Party will accept or recognise results of conformity assessment procedures, produced by the other Party's conformity assessment bodies or authorities, in assessing conformity to the importing Party's requirements, as specified on a sector-specific basis in the Sectoral Annexes, and to provide for other related cooperative activities. The objective of such mutual recognition is to provide effective market access throughout the territories of the Parties with regard to conformity assessment for all products covered under this Agreement. If any obstacles to such access arise, consultations will promptly be held. In the absence of a satisfactory outcome of such consultations, the Party alleging its market access has been denied, may, within 90 days of such consultation, invoke its right to terminate the Agreement in accordance with Article 21.
Article 3
General obligations
1. The United States shall, as specified in the Sectoral Annexes, accept or recognise results of specified procedures, used in assessing conformity to specified legislative, regulatory, and administrative provisions of the United States, produced by the other Party's conformity assessment bodies and/or authorities.
2. The European Community and its Member States shall, as specified in the Sectoral Annexes, accept or recognise results of specified procedures, used in assessing conformity to specified legislative, regulatory and administrative provisions of the European Community and its Member States, produced by the other Party's conformity assessment bodies and/or authorities.
3. Where sectoral transition arrangements have been specified in Sectoral Annexes, the above obligations will apply following the successful completion of those sectoral transition arrangements, with the understanding that the conformity assessment procedures utilised assure conformity to the satisfaction of the receiving Party, with applicable legislative, regulatory and administrative provisions of that Party, equivalent to the assurance offered by the receiving Party's own procedures.
Article 4
General coverage of the Agreement
1. This Agreement applies to conformity assessment procedures for products and/or processes and to other related cooperative activities as described in this Agreement.
2. Sectoral Annexes may include:
a description of the relevant legislative, regulatory and administrative provisions pertaining to the conformity assessment procedures and technical regulations;
a statement on the product scope and coverage;
a list of Designating Authorities;
a list of agreed conformity assessment bodies or authorities or a source from which to obtain a list of such bodies or authorities and a statement of the scope of the conformity assessment procedures for which each has been agreed;
the procedures and criteria for designating the conformity assessment bodies;
a description of the mutual recognition obligations;
a sectoral transition arrangement;
the identity of a sectoral contact point in each Party's territory; and
a statement regarding the establishment of a Joint Sectoral Committee.
3. This Agreement shall not be construed to entail mutual acceptance of standards or technical regulation of the Parties and, unless otherwise specified in a Sectoral Annex, shall not entail the mutual recognition of the equivalence of standards or technical regulations.
Article 5
Transitional arrangements
The Parties agree to implement the transitional commitments on confidence building as specified in the Sectoral Annexes.
1. The Parties agree that each sectoral transition arrangement shall specify a time period for completion.
2. The Parties may amend any transition arrangement by mutual agreement.
3. Passage from the transitional phase to the operational phase shall proceed as specified in each Sectoral Annex, unless either Party documents that the conditions provided in such Sectoral Annex for a successful transition are not met.
Article 6
Designating Authorities
The Parties shall ensure that the Designating Authorities specified in the Sectoral Annexes have the power and competence in their respective territories to carry out decisions under this Agreement to designate, monitor, suspend, remove suspension of, or withdraw conformity assessment bodies.
Article 7
Designation and listing procedures
The following procedures shall apply with regard to the designation of conformity assessment bodies and the inclusion of such bodies in the list of conformity assessment bodies in a Sectoral Annex:
The Designating Authority identified in a Sectoral Annex shall designate conformity assessment bodies in accordance with the procedures and criteria set forth in that Sectoral Annex;
A Party proposing to add a conformity assessment body to the list of such bodies in a Sectoral Annex shall forward its proposal of one or more designated conformity assessment bodies in writing to the other Party with a view to a decision by the Joint Committee;
Within 60 days following receipt of the proposal, the other Party shall indicate its position regarding either its confirmation or its opposition. Upon confirmation, the inclusion in the Sectoral Annex of the proposed conformity assessment body or bodies shall take effect; and
In the event that the other Party contests on the basis of documented evidence the technical competence or compliance of a proposed conformity assessment body, or indicates in writing that it requires an additional 30 days to more fully verify such evidence, such conformity assessment body shall not be included on the list of conformity assessment bodies in the applicable Sectoral Annex. In this instance, the Joint Committee may decide that the body concerned be verified. After the completion of such verification, the proposal to list the conformity assessment body in the Sectoral Annex may be resubmitted to the other Party.
Article 8
Suspension of listed conformity assessment bodies
The following procedures shall apply with regard to the suspension of a conformity assessment body listed in a Sectoral Annex:
A Party shall notify the other Party of its contestation of the technical competence or compliance of a conformity assessment body listed in a Sectoral Annex and the contesting Party's intent to suspend such conformity assessment body. Such contestation shall be exercised when justified in an objective and reasoned manner in writing to the other Party;
The conformity assessment body shall be given prompt notice by the other Party and an opportunity to present information in order to refute the contestation or to correct the deficiencies which form the basis of the contestation;
Any such contestation shall be discussed between the Parties in the relevant Joint Sectoral Committee. If there is no Joint Sectoral Committee, the contesting Party shall refer the matter directly to the Joint Committee. If agreement to suspend is reached by the Joint Sectoral Committee or, if there is no Joint Sectoral Committee, by the Joint Committee, the conformity assessment body shall be suspended;
Where the Joint Sectoral Committee or Joint Committee decides that verification of technical competence or compliance is required, it shall normally be carried out in a timely manner by the Party in whose territory the body in question is located, but may be carried out jointly by the Parties in justified cases;
If the matter has not been resolved by the Joint Sectoral Committee within 10 days of the notice of contestation, the matter shall be referred to the Joint Committee for a decision. If there is no Joint Sectoral Committee, the matter shall be referred directly to the Joint Committee. If no decision is reached by the Joint Committee within 10 days of the referral to it, the conformity assessment body shall be suspended upon the request of the contesting Party;
Upon the suspension of a conformity assessment body listed in a Sectoral Annex, a Party is no longer obligated to accept or recognise the results of conformity assessment procedures performed by that conformity assessment body subsequent to suspension. A Party shall continue to accept the results of conformity assessment procedures performed by that conformity assessment body prior to suspension, unless a Regulatory Authority of the Party decides otherwise based on health, safety or environmental considerations or failure to satisfy other requirements within the scope of the applicable Sectoral Annex; and
The suspension shall remain in effect until agreement has been reached by the Parties upon the future status of that body.
Article 9
Withdrawal of listed conformity assessment bodies
The following procedures shall apply with regard to the withdrawal from a Sectoral Annex of a conformity assessment body:
A Party proposing to withdraw a conformity assessment body listed in a Sectoral Annex shall forward its proposal in writing to the other Party;
Such conformity assessment body shall be promptly notified by the other Party and shall be provided a period of at least 30 days from receipt to provide information in order to refute or to correct the deficiencies which form the basis of the proposed withdrawal;
Within 60 days following receipt of the proposal, the other Party shall indicate its position regarding either its confirmation or its opposition. Upon confirmation, the withdrawal from the list in the Sectoral Annex of the conformity assessment body shall take effect;
In the event the other Party opposes the proposal to withdraw by supporting the technical competence and compliance of the conformity assessment body, the conformity assessment body shall not at that time be withdrawn from the list of conformity assessment bodies in the applicable Sectoral Annex. In this instance, the Joint Sectoral Committee or the Joint Committee may decide to carry out a joint verification of the body concerned. After the completion of such verification, the proposal for withdrawal of the conformity assessment body may be resubmitted to the other Party; and
Subsequent to the withdrawal of a conformity assessment body listed in a Sectoral Annex, a Party shall continue to accept the results of conformity assessment procedures performed by that conformity assessment body prior to withdrawal, unless a Regulatory Authority of the Party decides otherwise based on health, safety and environmental considerations or failure to satisfy other requirements within the scope of the applicable Sectoral Annex.
Article 10
Monitoring of conformity assessment bodies
The following shall apply with regard to the monitoring of conformity assessment bodies listed in a Sectoral Annex:
Designating Authorities shall assure that their conformity assessment bodies listed in a Sectoral Annex are capable and remain capable of properly assessing conformity of products or processes, as applicable, and as covered in the applicable Sectoral Annex. In this regard, Designating Authorities shall maintain, or cause to maintain, ongoing surveillance over their conformity assessment bodies by means of regular audit or assessment;
The Parties undertake to compare methods used to verify that the conformity assessment bodies listed in the Sectoral Annexes comply with the relevant requirements of the Sectoral Annexes. Existing systems for the evaluation of conformity assessment bodies may be used as part of such comparison procedures;
Designating Authorities shall consult as necessary with their counterparts, to ensure the maintenance of confidence in conformity assessment procedures. With the consent of both Parties, this consultation may include joint participation in audits/inspections related to conformity assessment activities or other assessments of conformity assessment bodies listed in a Sectoral Annex; and;
Designating Authorities shall consult, as necessary, with the relevant Regulatory Authorities of the other Party to ensure that all technical requirements are identified and are satisfactorily addressed.
Article 11
Conformity assessment bodies
Each Party recognises that the conformity assessment bodies listed in the Sectoral Annexes fulfil the conditions of eligibility to assess conformity in relation to its requirements as specified in the Sectoral Annexes. The Parties shall specify the scope of the conformity assessment procedures for which such bodies are listed.
Article 12
Exchange of information
1. The Parties shall exchange information concerning the implementation of the legislative, regulatory, and administrative provisions identified in the Sectoral Annexes.
2. Each Party shall notify the other Party of legislative, regulatory and administrative changes related to the subject matter of this Agreement at least 60 days before their entry into force. Where considerations of safety, health or environmental protection require more urgent action a Party shall notify the other Party as soon as practicable.
3. Each Party shall promptly notify the other Party of any changes to its Designating Authorities and/or conformity assessment bodies.
4. The Parties shall exchange information concerning the procedures used to ensure that the listed conformity assessment bodies under their responsibility comply with the legislative, regulatory, and administrative provisions outlined in the Sectoral Annexes.
5. Regulatory Authorities identified in the Sectoral Annexes shall consult as necessary with their counterparts, to ensure the maintenance of confidence in conformity assessment procedures and to ensure that all technical requirements are identified and are satisfactorily addressed.
Article 13
Sectoral contact points
Each Party shall appoint and confirm in writing contact points to be responsible for activities under each Sectoral Annex.
Article 14
Joint Committee of the Parties
1. The Parties hereby establish a Joint Committee consisting of representatives of each Party. The Joint Committee comprised shall be responsible for the effective functioning of the Agreement.
2. The Joint Committee may establish Joint Sectoral Committees comprised of appropriate Regulatory Authorities and others deemed necessary.
3. Each Party shall have one vote in the Joint Committee. The Joint Committee shall make its decisions by unanimous consent. The Joint Committee shall determine its own rules and procedures.
4. The Joint Committee may consider any matter relating to the effective functioning of this Agreement. In particular it shall be responsible for:
listing, suspension, withdrawal and verification of conformity assessment bodies in accordance with this Agreement;
amending transitional arrangements in Sectoral Annexes;
resolving any questions relating to the application of this Agreement and its Sectoral Annexes not otherwise resolved in the respective Joint Sectoral Committees;
providing a forum for discussion of issues that may arise concerning the implementation of this Agreement;
considering ways to enhance the operation of this Agreement;
coordinating the negotiation of additional Sectoral Annexes; and
considering whether to amend this Agreement or its Sectoral Annexes in accordance with Article 21.
5. When a Party introduces new or additional conformity assessment procedures affecting a Sectoral Annex, the Parties shall discuss the matter in the Joint Committee with a view to bringing such new or additional procedures within the scope of this Agreement and the relevant Sectoral Annex.
Article 15
Preservation of regulatory authority
1. Nothing in this Agreement shall be construed to limit the authority of a Party to determine, through its legislative, regulatory and administrative measures, the level of protection it considers appropriate for safety; for protection of human, animal, or plant life or health; for the environment; for consumers; and otherwise with regard to risks within the scope of the applicable Sectoral Annex.
2. Nothing in this Agreement shall be construed to limit the authority of a Regulatory Authority to take all appropriate and immediate measures whenever it ascertains that a product may: (a) compromise the health or safety of persons in its territory; (b) not meet the legislative, regulatory, or administrative provisions within the scope of the applicable Sectoral Annex; or (c) otherwise fail to satisfy a requirement within the scope of the applicable Sectoral Annex. Such measures may include withdrawing the products from the market, prohibiting their placement on the market, restricting their free movement, initiating a product recall, and preventing the recurrence of such problems, including through a prohibition on imports. If the Regulatory Authority takes such action, it shall inform its counterpart authority and the other Party within 15 days of taking such action, providing its reasons.
Article 16
Suspension of recognition obligations
Either Party may suspend its obligations under a Sectoral Annex, in whole or in part, if:
a Party suffers a loss of market access for the Party's products within the scope of the Sectoral Annex as a result of the failure of the other Party to fulfil its obligations under the Agreement;
the adoption of new or additional conformity assessment requirements as referenced in Article 14(5) results in a loss of market access for the Party's products within the scope of the Sectoral Annex because conformity assessment bodies designated by the Party in order to meet such requirements have not been recognized by the Party implementing the requirements; or;
the other Party fails to maintain legal and regulatory authorities capable of implementing the provisions of this Agreement.
Article 17
Confidentiality
1. Each Party agrees to maintain, to the extent required under its laws, the confidentiality of information exchanged under this Agreement.
2. In particular, neither Party shall disclose to the public, nor permit a conformity assessment body to disclose to the public, information exchanged under this Agreement that constitutes trade secrets, confidential commercial or financial information, or information that relates to an ongoing investigation.
3. A Party or a conformity assessment body may, upon exchanging information with the other Party or with a conformity assessment body of the other Party, designate the portions of the information that it considers to be exempt from disclosure.
4. Each Party shall take all precautions reasonably necessary to protect information exchanged under this Agreement from unauthorised disclosure.
Article 18
Fees
Each Party shall endeavour to ensure that fees imposed for services under this Agreement shall be commensurate with the services provided. Each Party shall ensure that, for the sectors and conformity assessment procedures covered under this Agreement, it shall charge no fees with respect to conformity assessment services provided by the other Party.
Article 19
Agreements with other countries
Except where there is written agreement between the Parties, obligations contained in mutual recognition agreements concluded by either Party with a party not a signatory to this Agreement (a third party) shall have no force and effect with regard to the other Party in terms of acceptance of the results of conformity assessment procedures in the third party.
Article 20
Territorial application
This Agreement shall apply, on the one hand, to the territories in which the Treaty establishing the European Community is applied, and under the conditions laid down in that Treaty and, on the other hand, to the territory of the United States.
Article 21
Entry into force, amendment and termination
1. This Agreement including its Sectoral Annexes on Telecommunication Equipment, Electromagnetic Compatibility, Electrical Safety, Recreational Craft, Pharmaceutical Good Manufacturing Practices (GMPs), and Medical Devices shall enter into force on the first day of the second month following the date on which the Parties have exchanged letters confirming the completion of their respective procedures for the entry into force of this Agreement.
2. This Agreement including any Sectoral Annex may, through the Joint Committee, be amended in writing by the Parties. The Parties may add a Sectoral Annex upon the exchange of letters. Such Annex shall enter into force 30 days following the date on which the Parties have exchanged letters confirming the completion of their respective procedures for the entry into force of the Sectoral Annex.
3. Either Party may terminate this Agreement in its entirety or any individual Sectoral Annex thereof by giving the other Party six months notice in writing. In the case of termination of one or more Sectoral Annexes, the Parties will seek to achieve by consensus to amend this Agreement, with a view to preserving the remaining Sectoral Annexes, in accordance with the procedures in this Article. Failing such consensus, the Agreement shall terminate at the end of six months from the date of notice.
4. Following termination of the Agreement in its entirety or any individual Sectoral Annex thereof, a Party shall continue to accept the results of conformity assessment procedures performed by conformity assessment bodies under this Agreement prior to termination, unless a Regulatory Authority in the Party decides otherwise based on health, safety and environmental considerations or failure to satisfy other requirements within the scope of the applicable Sectoral Annex.
Article 22
Final provisions
1. The Sectoral Annexes referred to in Article 21(1), as well as any New Sectoral Annexes added pursuant to Article 21(2), shall form an integral part of this Agreement.
2. For a given product or sector, the provisions contained in the relevant Sectoral Annexes shall apply in the first place, and the provisions of this text in addition to those provisions. In the case of any inconsistency between the provisions of a Sectoral Annex and this text, the Sectoral Annex shall prevail, to the extent of that inconsistency.
3. This Agreement shall not affect the rights and obligations of the Parties under any other international agreement.
4. In the case of the Sectoral Annex on Medical Devices, the Parties shall review the status of such Annex at the end of three years from entry into force.
This Agreement and the Sectoral Annexes are drawn up in two original in the Danish, Dutch, English, Finnish, French, German, Greek, Italian, Portuguese, Spanish and Swedish languages, each text being equally authentic. In the event of inconsistencies of interpretation, the English text shall be determinative.
Hecho en Londres, el dieciocho de mayo de mil novecientos noventa y ocho.Udfærdiget i London den attende maj nitten hundrede og otteoghalvfems.Geschehen zu London am achtzehnten Mai neunzehnhundertachtundneunzig.Έγινε στο Λονδίνο, στις δέκα οκτώ Μαϊου χίλια εννιακόσια ενενήντα οκτώ.Done at London on the eighteenth day of May in the year one thousand nine hundred and ninety-eight.Fait à Londres, le dix-huit mai mil neuf cent quatre-vingt-dix-huit.Fatto a Londra, addì diciotto maggio millenovecentonovantotto.Gedaan te Londen, de achttiende mei negentienhonderd achtennegentig.Feito em Londres, em dezoito de Maio de mil novecentos e noventa e oito.Tehty Lontoossa kahdeksantenatoista päivänä toukokuuta vuonna tuhatyhdeksänsataayhdeksänkymmentäkahdeksan.Som skedde i London den artonde maj nittonhundranittioåtta.
Por la Comunidad EuropeaFor Det Europæiske FællesskabFür die Europäische GemeinschaftΓια την Ευρωπαϊκή ΚοινότηταFor the European CommunityPour la Communauté européennePer la Comunità europeaVoor de Europese GemeenschapPela Comunidade EuropeiaEuroopan yhteisön puolestaPå Europeiska gemenskapens vägnar
Por los Estados Unidos de AméricaFor Amerikas Forenede StaterFür die Vereinigten Staaten von AmerikaΓια τις Ηνωμένες Πολιτείες της ΑμερικήςFor the United States of AmericaPour les États-Unis d'AmériquePer gli Stati Uniti d'AmericaVoor de Verenigde Staten van AmerikaPelos Estados Unidos da AméricaAmerikan yhdysvaltojen puolestaPå Amerikas förenta staternas vägnar
SECTORAL ANNEX FOR TELECOMMUNICATION EQUIPMENT
PREAMBLE
This Annex constitutes a Sectoral Annex to the Agreement on Mutual Recognition of Conformity Assessment between the United States and the European Community.
SECTION I
LEGISLATIVE, REGULATORY AND ADMINISTRATIVE PROVISIONS
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EC |
USA |
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Directive 98/13/EC of the European Parliament and of the Council of 12 February 1998 relating to telecommunications terminal equipment and satellite earth station equipment, including the mutual recognition of their conformity, and interpretation thereof; |
Communications Act of 1934, as amended by the Telecommunication Act of 1996, (Title 47 of the United States Code). The US regulatory and administrative provisions in respect of telecommunication equipment, including 47 CFR Part 68, and FCC interpretation thereof; |
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(The Parties recognize that the Handbook on the implementation of Directive 98/13/EC (ADLNB and ACTE approved), provides useful guidelines for the implementation of conformity assessment procedures falling under this Directive.); |
(The Parties recognize that the FCC Form 730 Application Guide provides useful guidelines for the implementation of conformity assessment procedures for telecommunication terminal equipment falling within these regulations.); |
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Commission Decisions (CTRs) established under Directive 98/13/EC; The EC Member States' legislation and regulations in respect of: (a) non-harmonised analogue connection to the public telecommunications network (1); (b) non-harmonised radio transmitters for which there is a civilian equipment authorization requirement; |
The US regulatory and administrative provisions in respect of all radio transmitters subject to an equipment authorisation requirement. A non-exclusive list of FCC regulations are contained in Section II; |
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For electrical safety, see Electrical Safety Sectoral Annex to the Agreement; |
For electrical safety, see Electrical Safety Sectoral Annex to the Agreement; |
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For electromagnetic compatibility aspects, see Electromagnetic Compatibility (EMC) Sectoral Annex to the Agreement. |
For electromagnetic compatibility aspects, see Electromagnetic Compatibility (EMC) Sectoral Annex to the Agreement. |
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(1) The EC agrees to seek authority to include non-harmonised digital connections; |
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SECTION II
SCOPE AND COVERAGE
This Sectoral Annex shall apply to equipment, interfaces, and services subject to Section I. In general terms the provisions of this Sectoral Annex shall apply to the following types of telecommunication terminal equipment, satellite terminal equipment, radio transmitters, and information technology equipment:
equipment intended for connection to the public telecommunications network in order to send, process or receive information, whether the equipment is to be connected directly to the ‘termination’ of the network or to inter-work with such a network, being connected directly or indirectly to the termination point. The system of connection may be wire, radio, optical or other electro-magnetic means;
equipment capable of being connected to a public telecommunications network even if it is not its intended purpose, including information technology equipment having a communication port; and
all radio transmitters subject to an equipment authorisation procedure by either Party.
The following is a non-exclusive list of the equipment, interfaces, and services included within the scope of this Sectoral Annex:
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EC |
USA |
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The following equipment categories are included: ISDN Basic Rate Access ISDN Primary Rate Access ISDN Telephony X21/V.24/V.35 Access X25 Access PSTN Non-Voice PSTN Voice Band (Analog) ONP Leased Line Terminal types: — 64 kbits/sec — 2 048 kbit/s unstructured — 2 048 kbit/s structured — 34 Mbits/s access — 140 Mbits/s access — 2 wire analogue — 4 wire analogue |
Equipment categories covered under 47 CFR, Part 68, including: ISDN Basic Access ISDN Primary Rate Access Digital Service Access: — 2.4 kbps — 3.2 kbps (2.4 kbps with Secondary Channel) — 4.8 kbps — 6.4 kbps (4.8 kbps with SC) — 9.6 kbps — 12.8 kbps (9.6 kbps with SC) — 19.2 kbps — 25.0 kbps (19.2 kbps with SC) — 56.0 kbps — 64.0 kbps (uses 72 kbps channel) — 72.0 kbps (56.0 kbps with SC) — 1.544 Mbps 2-wire analog tie trunks/ops 4-wire analog tie trunks/ops PSTN Voice Band (Analog) Access Private Line (Analog) Access |
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Radio transmitters subject to an equipment authorisation requirement, including: — Short range devices, including low power devices such as cordless telephones/microphones; — Land mobile, including: — — Private Mobile Radio (PMR/PAMR) — Mobile telecom — Paging systems — Terrestrial fixed — Satellite mobile — Satellite fixed — Broadcast — Radio determination |
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Note: A list of acronyms and a glossary is contained in Appendix I to this Sectoral Annex. |
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SECTION III
CONFORMITY ASSESSMENT PROCEDURES FOR TELECOMMUNICATION EQUIPMENT
1. Description of Mutual Recognition Obligations
In accordance with the provisions of the Agreement, the result of the conformity assessment procedures produced by a Party's conformity assessment bodies listed in Section V shall be recognised by the Regulatory Authorities of the other Party without any further conformity assessment of the products, pursuant to Section I.
2. Conformity Assessment Procedures
Taking into account the legislative, regulatory, and administrative provisions as identified in Section I, each Party recognises that the conformity assessment bodies of the other Party, listed in Section V, are authorised to perform the following procedures with regard to the importing Party's technical requirements for telecommunication terminal, satellite terminal equipment, radio transmitters or information technology equipment:
testing and issuing of test reports;
issuing certificates of conformity to the requirements of the laws and regulations applicable in the territories of the Parties for products covered under this Sectoral Annex; and
performing quality assurance certification pursuant to Directive 98/13/EC.
SECTION IV
AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V
|
EC |
USA |
|
— Belgium — Institut belge des services postaux et des télécommunications — Belgisch instituut voor postdiensten en telecommunicatie — Denmark — Telestyrelsen — Germany — Bundesministerium für Wirtschaft — Greece — Yπουργείο Μεταφορών και Επικοινωνιών — Ministry of Transport and Communications — Spain — Ministerio de Fomento — France — Ministère de l'économie, des finances et de l'industrie — Ireland — Department of Transport, Energy and Communications — Italy — Ministero delle Communicazioni — DGROS e ISETI (Radiotransmettitori) — Luxembourg — Administration des Postes et Télécommunications — Netherlands — De Minister van Verkeer en Waterstaat — Austria — Bundesministerium für Wissenschaft und Verkehr — Portugal — Instituto das Communicações de Portugal — Finland — LiikenneministeriöTrafikministeriet — TelehallintokeskusTeleförvaltningscentralen — Sweden — Under the authority of the Government of Sweden: — Styrelsen för ackreditering och teknisk kontroll (SWEDAC) — United Kingdom — Department of Trade and Industry |
National Institute of Standards and Technology (NIST) Federal Communications Commission (FCC) |
SECTION V
CONFORMITY ASSESSMENT BODIES
|
EC access to the US market |
US access to the EC market |
|
Conformity assessment bodies located in the EC shall be designated by the Authorities identified in Section IV following the procedures set out in Section VI of this Annex. |
Conformity assessment bodies located in the US shall be designated by the Authorities identified in Section IV following the procedures set out in Section VI of this Annex. |
|
►M2
|
►M2
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SECTION VI
DESIGNATING, LISTING, SUSPENDING, WITHDRAWING AND MONITORING CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V
|
EC access to the US market |
US access to the EC market |
|
EC Authorities identified in Section IV shall designate conformity assessment bodies located in the EC in accordance with the US legislative, regulatory, and administrative provisions identified in Section I that govern designation of conformity assessment bodies, based on compliance with the appropriate ISO/IEC Guides (e. g. Guide 22, 25, 28, 58, 61, 62, 65, etc.) or the comparable EN-45000 Series Standards. |
US Authorities identified in Section IV shall designate conformity assessment bodies located in the US in accordance with the EC legislative, regulatory, and administrative provisions identified in Section I that govern designation of conformity assessment bodies, based on compliance with the appropriate EN-45000 Series Standards or the comparable ISO/IEC Guides (e. g. 22, 25, 28, 58, 61, 62, 65, etc.) |
|
Procedures for designating, listing, suspending, withdrawing, and monitoring a conformity assessment body listed in Section V shall be undertaken pursuant to Articles 7, 8, 9 and 10 of the Agreement. |
Procedures for designating, listing, suspending, withdrawing, and monitoring a conformity assessment body listed in Section V shall be undertaken pursuant to Articles 7, 8, 9 and 10 of the Agreement. |
SECTION VII
ADDITIONAL PROVISIONS
1. Sub-contracting
Any sub-contracting by conformity assessment bodies shall be in accordance with the sub-contracting requirements of the other Party. Notwithstanding the use of sub-contracting, the final results of conformity assessment remain the full responsibility of the listed conformity assessment body. In the EC, these requirements are described in Council Decision 93/465/EEC.
The conformity assessment bodies shall record and retain details of their investigation of the competence and compliance of their subcontractors and maintain a register of all sub-contracting. These details will be available to the other Party on request.
2. Post-market surveillance, border measures and internal movement
For the purpose of post-market surveillance, the Parties may maintain any existing labelling and numbering requirements. The assignment of the numbers may take place in the territory of the exporting Party. The numbers will be allocated by the importing Party. Numbering and labelling systems shall not introduce additional requirements within the meaning of this Sectoral Annex.
Nothing in this Sectoral Annex shall prevent the Parties from removing products from the market that do not in fact conform to the requirements for approval.
The Parties agree that border inspections and checks of products which have been certified, labelled or marked as conforming with the importing Party's requirements specified in Section I shall be completed as expeditiously as possible. With regard to any inspections related to internal movement within their respective territories, the Parties agree that these shall be completed in no less a favourable manner than for like domestic goods.
3. Joint Sectoral Committee
A combined Joint Sectoral Committee for this Sectoral Annex and the Electromagnetic Compatibility (EMC) Sectoral Annex is hereby established (the JSC). The JSC shall operate during the transitional period and after completion of the transitional arrangement. The JSC shall meet as appropriate to discuss technical, conformity assessment and technology issues relating to this Sectoral Annex and the EMC Sectoral Annexes. The JSC shall determine its own rules of procedure.
The JSC consists of representatives of the US and the EC for telecommunications and EMC. JSC representatives may each invite manufacturers and other entities as deemed necessary. The representatives for the US shall have one vote in the JSC. The representatives of the EC shall have one vote in the JSC. Decisions of the JSC shall be made by unanimous consent. In the event of disagreement either the US or EC representative may raise the matter in the Joint Committee.
The JSC may address any matter related to the effective functioning of this Sectoral Annex, including:
providing a forum for discussion of issues and resolving problems that may arise concerning the implementation of this Sectoral Annex;
developing a mechanism for ensuring consistency of interpretations of legislation, regulations, standards, and conformity assessment procedures;
advising the Parties on matters relating to this Sectoral Annex; and
providing guidance and, if necessary, developing guidelines during the transitional period to facilitate the successful completion of the transitional period.
4. Contact point
Each Party shall establish a contact point to provide answers to all reasonable inquiries from the other Party regarding procedures, regulations, and complaints under this Sectoral Annex.
5. Regulatory changes and updating the Sectoral Annex
In the event that there are changes to the legislative, regulatory, and administrative provisions referenced in Section I or the introduction of new legislative, regulatory, and administrative provisions affecting either Party's conformity assessment procedures under the Agreement, such changes shall take effect for the purpose of this Sectoral Annex at the same time they take effect domestically within the territory of each Party. The parties shall update this Sectoral Annex to reflect the changes.
SECTION VIII
TRANSITIONAL ARRANGEMENT
There shall be a transitional period of 24 months.
The purpose of this transitional arrangement is to provide a means whereby the Parties to the Agreement can build confidence in and an understanding of each other's system for designating and listing conformity assessment bodies and in the ability of these bodies to test and certify products. Successful completion of the transitional arrangement should result in the determination that conformity assessment bodies listed in Section V comply with the applicable criteria and are competent to conduct conformity assessment activities on behalf of the other Party. Upon successful completion of the transition period, the results of conformity assessment procedures performed by the exporting Party's conformity assessment bodies listed in Section V of the exporting country shall be accepted by the importing Party.
This transitional period shall be used by the Parties:
to consider new legislative changes needed to support the objectives of the Agreement;
to initiate regulatory changes needed to support the objectives of the Agreement;
to exchange information on and develop better understanding of their respective regulatory requirements;
to develop mutually agreed mechanisms for exchanging information on changes in technical requirements or methods of designating conformity assessment bodies; and
to monitor and evaluate the performance of the listed conformity assessment bodies during the transitional period.
Parties may designate, list, suspend and withdraw conformity assessment bodies during the transitional period according to the procedures in Section VI of this Sectoral Annex.
During the transitional period each Party shall accept and evaluate test reports and related documents issued by designated conformity assessment bodies of the other Party. To this end, the Parties shall ensure that:
on receipt of tests reports, related documents and a first evaluation of conformity, the dossiers are promptly examined for completeness;
the applicant is informed in a precise and complete manner of any deficiency;
any request for additional information is limited to omissions, inconsistencies or variances from the technical regulations or standards; and
procedures for assessing the conformity for equipment, modified subsequent to a determination of compliance, are limited to procedures necessary to determine continued conformance.
Each Party ensures that issuance of approvals, certificates, or advice to the applicant shall be given no later than six weeks from receipt of the test report and evaluation from a designated conformity assessment body in the territory of the other Party.
Any proposal made during or at the end of the transitional period to limit the scope of recognition of any designated conformity assessment body or to exclude it from the list of bodies designated under this Sectoral Annex shall be based on objective criteria and documented. Any such body may apply for reconsideration once the necessary corrective action has been taken. To the extent possible, the Parties shall implement such action prior to the expiry of the transitional period.
The Parties may jointly sponsor two seminars, one in the US and one in the European Community, concerning the relevant technical and product approval requirements during the first year after this Sectoral Annex enters into force.
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Appendix 1
Lists of acronyms and glossary
|
ACTE |
Approvals Committee for Terminal Equipment |
|
ADLNB |
Association of Designated Laboratories and Notified Bodies |
|
CAB |
Conformity Assessment Body |
|
CFR |
U.S. Code of Federal Regulations, Title 47 CFR |
|
CTR |
Common Technical Regulation |
|
EC |
European Community |
|
EEC |
European Economic Community |
|
EN |
Norme Européenne (European Standard) |
|
EU |
European Union |
|
FCC |
Federal Communications Commission |
|
IEC |
International Electrotechnical Commission |
|
ISDN |
Integrated Services Digital Network |
|
ISO |
International Standards Organization |
|
ITU |
International Telecommunications Union |
|
MRA |
Mutual Recognition Agreement |
|
MS |
Member States (of the European Union) |
|
NB |
Notified Bodies |
|
NIST |
National Institute of Standards and Technology |
|
OJ |
Official Journal (of the European Union) |
|
ONP |
Open Network Provision |
|
PSTN |
Public Switched Telephone Network |
|
STG |
Sectoral Technical Group for Telecommunications |
|
TBR |
Technical Basis for Regulation |
|
X21 |
ITU-T Recommendation X21 |
|
X25 |
ITU-T Recommendation X25 |
SECTORAL ANNEX FOR ELECTROMAGNETIC COMPATIBILITY (EMC)
PREAMBLE
This Annex constitutes a Sectoral Annex to the Agreement on Mutual Recognition of Conformity Assessment between the United States and the European Community.
SECTION I
LEGISLATIVE, REGULATORY AND ADMINISTRATIVE PROVISIONS
|
EC |
USA |
|
Council Directive 89/336/EEC, as amended by Council Directive 92/31/EEC, and Directive 98/13/EC of the European Parliament and of the Council and interpretation thereof. |
Communications Act of 1934, as amended by the Telecommunication Act of 1996, (Title 47 of the United States Code), The US regulatory and administrative provisions in respect of equipment subject to electromagnetic requirements including: — 47 CFR Part 15 — 47 CFR Part 18, and FCC interpretation thereof. |
|
For electrical safety aspects see Electrical Safety Sectoral Annex to the Agreement. |
For electrical safety aspects see Electrical Safety Sectoral Annex to the Agreement. |
|
For telecommunication equipment and radio transmitters, see also Telecommunication Equipment Sectoral Annex to the Agreement. |
For telecommunication equipment and radio transmitters, see also Telecommunication Equipment Sectoral Annex to the Agreement. |
SECTION II
SCOPE AND COVERAGE
|
US access to the EC market |
EC access to the US market |
|
Any product falling under the scope of Council Directive 89/336/EEC. |
Any products falling under the scope of 47 CFR Part 15 and 18. |
SECTION III
CONFORMITY ASSESSMENT PROCEDURES FOR EQUIPMENT IDENTIFIED IN SECTION II
1. Description of Mutual Recognition Obligations
In accordance with the provisions of the Agreement, the results of the conformity assessment procedures produced by a Party's conformity assessment bodies listed in Section V, shall be recognised by the Regulatory Authorities of the other Party without any further conformity assessment of the products, pursuant to Section I.
2. Conformity Assessment Procedures
Taking into account the legislative, regulatory, and administrative provisions as identified in Section I, each Party recognises that the conformity assessment bodies of the other Party, listed in Section V, are authorised to perform the following procedures with regard to the importing Party's technical requirements for equipment identified in Section II:
testing and issuing of the test reports,
issuing certificates of conformity to the requirements of the laws and regulations applicable in the territories of the Parties for products covered under this Sectoral Annex.
SECTION IV
AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V
|
EC |
USA |
|
— Belgium — Ministère des Affaires Economiques — Ministerie van Economische Zaken — Denmark — for telecommunication equipment: — Telestyrelsen — for other equipment: — Danmarks Elektriske Materielkontrol (DEMKO) — Germany — Bundesministerium für Wirtschaft — Greece — Yπουργείο Μεταφορών και Επικοινωνιών — Ministry of Transport and Communications — Spain — for telecommunication equipment: — Ministerio de Fomento — for other equipment: — Ministerio de Industria y Energía — France — Ministère de l'économie, des finances et de l'industrie — Ireland — Department of Transport, Energy and Communications — Italy — Ministero dell'Industria, del Commercio e dell'Artigianato — Luxembourg — Ministère des Transports — Netherlands — De Minister van Verkeer en Waterstaat — Austria — for telecommunication equipment: — Bundesministerium für Wissenschaft und Verkehr — for other equipment: — Bundesministerium für wirtschaftliche Angelegenheiten — Portugal — Instituto das Comunicações de Portugal — Finland — for telecommunication equipment: — LiikennemimsteriöTrafikministeriet — for other equipment: — Kauppa- ja teollisuusministeriöHandels- och industriministeriet — Sweden — Under the authority of the Government of Sweden: — Styrelsen för ackreditering och teknisk kontroll (SWEDAC) — United Kingdom — Department of Trade and Industry |
National Institute for Standards and Technology (NIST) Federal Communications Commission (FCC) Federal Aviation Administration (FAA) |
SECTION V
CONFORMITY ASSESSMENT BODIES
|
EC access to the US market |
US access to the EC market |
|
Conformity assessment bodies located in the EC shall be designated by the Authorities identified in Section IV following the procedures set out in Section VI of this Annex. |
Conformity assessment bodies located in the US shall be designated by the Authorities identified in Section IV following the procedures set out in Section VI of this Annex. |
|
►M2
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►M2
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SECTION VI
DESIGNATING, LISTING, SUSPENDING, WITHDRAWING AND MONITORING CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V
|
EC access to the US market |
US access to the EC market |
|
EC Authorities identified in Section IV shall designate conformity assessment bodies located in the EC in accordance with the US legislative, regulatory, and administrative provisions identified in Section I that govern designation of conformity assessment bodies, based upon compliance with the appropriate ISO/IEC Guides (e.g. Guide 22, 25, 28, 58, 61, 62, 65, etc.) or the comparable EN-45000 Series Standards. |
US Authorities identified in Section IV shall designate conformity assessment bodies located in the US in accordance with the EC legislative, regulatory, and administrative provisions identified in Section I that govern designation of conformity assessment bodies, based on compliance with the appropriate EN-45000 Series Standards or the comparable ISO/IEC Guides (e.g. Guide 22, 25, 28, 58, 61, 62, 65, etc.). |
|
Procedures for designating, listing, suspending, withdrawing, and monitoring a conformity assessment body listed in Section V shall be undertaken pursuant to Articles 7, 8, 9, and 10 of the Agreement. |
Procedures for designating, listing, suspending, withdrawing, and monitoring a conformity assessment body listed in Section V shall be undertaken pursuant to Articles 7, 8, 9, and 10 of the Agreement. |
SECTION VII
ADDITIONAL PROVISIONS
1. Sub-contracting
Any sub-contracting by conformity assessment bodies shall be in accordance with the sub-contracting requirements of the other Party. Notwithstanding the use of sub-contracting, the final results of conformity assessment remain the full responsibility of the listed conformity assessment body. In the EC, these requirements are described in Council Directive 93/465/EEC.
The conformity assessment bodies shall record and retain details of its investigation of the competence and compliance of its sub-contractors and maintain a register of all sub-contracting. These details will be available to the other Party on request.
2. Post-market surveillance, border measures and internal movement
For the purpose of post-market surveillance, the Parties may maintain any existing labeling and numbering requirements. The assignment of the numbers may take place in the territory of the exporting Party. The numbers will be allocated by the importing Party. Numbering and labeling systems shall not introduce additional requirements within the meaning of this Sectoral Annex.
Nothing in this Sectoral Annex shall prevent the Parties from removing products from the market that do not in fact conform to the requirements for approval.
The Parties agree that border inspections and checks of products which have been certified, labeled or marked as conformity with the importing Party's requirements specified in Section I shall be completed as expeditiously as possible. With regard to any inspections related to internal movement within their respective territories, the Parties agree that these shall be completed in no less a favorable manner than for like domestic goods.
3. Joint Sectoral Committee
A combined Joint Sectoral Committee for this Sectoral Annex and the Telecommunications Equipment Sectoral Annex is hereby established (the JSC). The JSC shall operate during the transitional period and after completion of the transitional arrangement. The JSC shall meet as appropriate to discuss technical, conformity assessment and technology issues relating to this Sectoral Annex and the Telecommunications Equipment Sectoral Annex. The JSC shall determine its own rules of procedure.
The JSC consists of representatives of the US and the EC for telecommunications and EMC. JSC representatives may each invite manufacturers and other entities as deemed necessary. The representatives for the US shall one vote in the JSC. The representatives of the EC shall have one vote in the JSC. Decisions of the JSC shall be made by unanimous consent. In the event of disagreement either the US or EC representatives may raise the matter in the Joint Committee.
The JSC may address any matter related to the effective functioning of this Sectoral Annex, including:
providing a forum for discussion of issues and resolving problems that may arise concerning the implementation of this Sectoral Annex;
developing a mechanism for ensuring consistency of interpretations of legislation, regulations, standards, and conformity assessment procedures;
advising the Parties on matters relating to this Sectoral Annex;
providing guidance and, if necessary, developing guidelines during the transitional period to facilitate the successful completion of the transitional period.
4. Contact point
Each Party shall establish a contact point to provide answers to all reasonable inquiries from the other Party regarding procedures, regulations and complaints under this Sectoral Annex.
5. Regulatory changes and updating the Sectoral Annex
In the event that there are changes to the legislative, regulatory and administrative provisions referenced in Section I or the introduction of new legislative, regulatory and administrative provisions affecting either Party's conformity assessment procedures under the Agreement, such changes shall take effect for the purpose of this Sectoral Annex at the same time they take effect domestically within the territory of each Party. The Parties shall update this Sectoral Annex to reflect the changes.
SECTION VIII
TRANSITIONAL ARRANGEMENT
There shall a transitional period of 24 months.
The purpose of this transitional arrangement is to provide a means whereby the Parties to the Agreement can build confidence in and understanding of each others system for designating and listing conformity assessment bodies and in the ability of these bodies to test and certify products. Successful completion of the transition arrangement should result in the determination that conformity assessment bodies listed in Section V comply with the applicable criteria and are competent to conduct conformity assessment activities on behalf of the other Party. Upon completion of the transition period, the results of conformity assessment procedures performed by the exporting Party's conformity assessment bodies listed in Section V shall be accepted by the importing Party.
This transitional period shall be used by the Parties:
to consider new legislative changes needed to support the objectives of the Agreement;
to initiate regulatory changes needed to support the objectives of the Agreement;
to exchange information on and develop better understanding of their respective regulatory requirements;
to develop mutually agreed mechanisms for exchanging information on changes in technical requirements or methods of designating conformity assessment bodies; and
to monitor and evaluate the performance of the listed conformity assessment bodies during the transitional period.
Parties may designate, list, suspend and withdraw conformity assessment bodies during the transitional period according to the procedures in Section VI of this Sectoral Annex.
During the transitional period each Party shall accept and evaluate test reports and related documents issued by designated conformity assessment bodies of the other Party. To this end, the Parties shall ensure that:
on receipt of test reports, related documents and a first evaluation of conformity, the dossiers are promptly examined for completeness;
the applicant is informed in a precise and complete manner of any deficiency;
any request for additional information is limited to omissions, inconsistencies or variances from the technical regulations or standards;
procedures for assessing the conformity for equipment modified subsequent to a determination of compliance, are limited to procedures necessary to determine continued conformance.
Each Party ensures that issuance of approvals, certificates or advice to the applicant shall be given no later than six weeks from receipt of the test report and evaluation from a designated conformity assessment body in the territory of the other Party.
Any proposal made during or at the end of the transitional period to limit the scope of recognition of any designated conformity assessment body or to exclude it from the list of bodies designated under this Sectoral Annex shall be based on objective criteria and documented. Any such body may apply for reconsideration once the necessary corrective action has been taken. To the extent possible, the Parties shall implement such action prior to the expiry of the transitional period.
The Parties may jointly sponsor two seminars, one in the US and one in the European Community, concerning the relevant technical and product approval requirements during the first year after this Sectoral Annex enters into force.
▼M1 —————
SECTORAL ANNEX FOR ELECTRICAL SAFETY
PREAMBLE
This Annex constitutes a Sectoral Annex to the Agreement on Mutual Recognition between the United States and the European Community.
SECTION I
LEGISLATIVE, REGULATORY AND ADMINISTRATIVE PROVISIONS
|
US access to the EC market |
EC access to the US market |
|
Council Directive 73/23/EEC of 19 February 1973 as amended by Directive 98/13/EC of the European Parliament and of the Council. |
29 USC 651 et seq. US 29 CFR 1910.7 Products that are certified or approved under the Federal Mine Safety and Health Act (30 USC 801 et seq.) or its regulations and used in areas under the authority of the Mine Safety and Health Administration, are not covered under this Annex. Occupational Safety and Health Administration (OSHA) will consider regulatory and legislative changes needed to support the objectives of the MRA. |
|
For medical devices, see the Medical Devices Sectoral Annex to this Agreement. |
For medical devices, see the Medical Devices Sectoral Annex to this Agreement. |
|
For electromagnetic compatibility aspects, see the Electromagnetic Compatibility (EMC) Sectoral Annex to this Agreement. |
For electromagnetic compatibility aspects, see the Electromagnetic Compatibility (EMC) Sectoral Annex to this Agreement. |
|
For telecommunication equipment, see the Telecommunication Equipment Sectoral Annex to this Agreement. |
For telecommunication equipment, see the Telecommunication Equipment Sectoral Annex to this Agreement. |
SECTION II
SCOPE AND COVERAGE
|
US access to the EC market |
EC access to the US market |
|
The electrical safety requirements of products falling under the scope of Council Directive 73/23/EEC on the harmonisation of the laws of the Member States relating to electrical equipment designed or use within certain voltage limits. |
The electrical safety requirements of products falling under the scope of 29 CFR 1910 subpart S. This includes the electrical safety aspects for workplace safety of medical equipment and telecommunication terminal equipment within the scope of those Sectoral Annexes. Products that are certified or approved under the Federal Mine Safety and Health Act (30 USC 801 et seq.) or its regulations and used in areas under the authority of the Mine Safety and Health Administration, are not covered under this Annex. |
SECTION III
DESCRIPTION OF MUTUAL RECOGNITION OBLIGATIONS
In accordance with the provisions of the Agreement, EC conformity assessment bodies listed in Section V of this Annex shall be recognised to test, certify and mark products within the scope of their Nationally Recognised Testing Laboratory (NRTL) recognition for assessing conformity to US requirements.
With regard to US conformity assessment bodies listed in Section V of this Annex, in the event of a challenge within the European Community under Article 8(2) of Council Directive 73/23/EEC of 19 February 1973, test reports issued by such conformity assessment bodies shall be accepted by the European Community Authorities in the same way that reports from European Community notified bodies are accepted. That is, (listed conformity assessment bodies) in the US shall be recognised under Article 11 of Council Directive 73/23/EEC as ‘bodies which may make a report in accordance with Article 8.’
SECTION IV
AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V
|
EC access to the US market |
US access to the EC market |
|
— Belgium — Ministère des Affaires Economiques — Ministerie van Economische Zaken — Denmark — Bygge- og Boligstyrelsen — Danmarks Elektriske Materielkontrol (DEMKO) — Germany — Bundesministerium für Arbeit und Sozialordnung — Greece — Yπουργείο Ανάπτυξης — Ministry of Development — Spain — Ministerio de Industria y Energía — France — Ministère de l'économie, des finances et de l'industrie — Ireland — Department of Enterprise and Employment — Italy — Ministero dell'Industria, del Commercio e dell'Artigianato — Luxembourg — Ministère des Transports — Netherlands — De Minister van Volksgezondheid, Welzijn en Sport |
National Institute for Standards and Technology (NIST) |
|
— Austria — Bundesministerium für wirtschaftliche — Angelegenheiten — Portugal — Under the authority of the Government of Portugal: — Instituto Português da Qualidade — Finland — Kauppa- ja teollisuusministerio/Handels- och industriministeriet — Sweden — Under the authority of the Government of Sweden: — Styrelsen för ackreditering och teknisk kontroll (SWEDAC) — United Kingdom — Department of Trade and Industry |
|
SECTION V
CONFORMITY ASSESSMENT BODIES
|
EC access to the US market |
US access to the EC market |
|
The names and scope of responsibilities of Conformity Assessment Bodies located in the EC and listed in accordance with this Sectoral Annex: |
The names and scope of responsibilities of Conformity Assessment Bodies located in the US and listed in accordance with this Sectoral Annex: |
|
(to the provided by the EC) |
(to be provided by the U.S.) |
SECTION VI
DESIGNATING, LISTING, SUSPENDING AND WITHDRAWING CONFORMITY ASSESSMENT BODIES
|
EC access to the US market |
US access to the EC market |
|
Conformity assessment bodies from the EC shall be designated by the EC Authorities identified in Section IV and recognised by the Joint Committee, in accordance with the recognition procedures in the Agreement and this Annex. |
Conformity assessment bodies from the US shall be designated by the US Authority identified in Section IV and recognised by the Joint Committee, in accordance with the recognition procedures in the Agreement and Council Directive 73/23/EEC. |
|
Conformance with the appropriate ISO/IEC Guides or the corresponding EN-45000 series of standards shall be deemed consistent with US requirements identified in Section I. |
Conformance with the appropriate EN-45000 series of standards or the corresponding ISO/IEC Guides shall be deemed consistent with the requirements of Council Directive 73/23/EEC. |
|
For purposes of designation and listing, EC Designating Authorities identified in Section IV shall designate conformity assessment bodies located in the EC by filing a properly prepared proposal for listing, which includes a complete lab assessment under the US OSHA procedures. OSHA shall notify the EC Designating Authority normally within 30 days as to whether the proposal is complete or whether additional information is required. |
For purposes of designating and listing, the US Designating Authority identified in Section IV shall designate conformity assessment bodies located in the US by filing a properly prepared proposal for listing with the EC, which includes a complete lab assessment under the following EC or Member State procedures, as appropriate. |
|
OSHA shall rely on the EC Designating Authorities identified in Section IV for conducting on-site reviews at the respective Member States' conformity assessment bodies. |
The EC shall notify the US Designating Authority within 30 days as to whether the proposal is complete and shall indicate, where applicable, any additional information that is required. |
|
Upon receipt of a complete proposal, the US exercising its authority under its law shall: (a) prior to the passage from the transitional phase into the operational phase in the Telecommunication Equipment and Electromagnetic Compatibility (EMC) Sectoral Annexes, give notice of its consent or objection to a proposed conformity assessment body to the Joint Committee. The listing of an agreed conformity assessment body in Section V of this Sectoral Annex shall only occur upon such passage from the transitional phase into the operational phase of those Sectoral Annexes; (b) subsequent to passage from the transitional phase into the operational phase in the Telecommunication Equipment and Electromagnetic Compatibility (EMC) Sectoral Annexes, give notice of its consent or objection to a proposed conformity assessment body to the Joint Committee normally within 120 business days. The listing of an agreed conformity assessment body in Section V of this Sectoral Annex shall occur upon notice of consent to the Joint Committee and the Joint Committee's decision to list such body. These listing procedures shall supersede the procedures in Article 7(c) of the Agreement in its entirety and the time periods set out in Article 7(d) of the Agreement. |
Upon receipt of a complete proposal, the EC shall give notice of consent or objection to the Joint Committee within 60 days. The Joint Committee shall monitor the recognition of conformity assessment bodies and confirm such a recognition by listing them in Section V of this Sectoral Annex. |
|
EC conformity assessment bodies listed in Section V shall have NRTL status in the US. |
The US conformity assessment bodies listed in Section V shall have Notified Body status within the EC. |
|
With regard to the suspension of a conformity assessment body listed in this Sectoral Annex, the period specified in Article 8(e) of the Agreement shall begin to run after a Party has notified the Joint Sectoral Committee or the Joint Committee, pursuant to Article 8(c) of the Agreement, that it proposes to revoke the conformity assessment body's recognition in accordance with its procedures under its applicable domestic law. Except as provided for in this Section, procedures for designation, listing, suspension and withdrawal of conformity assessment bodies under this Sectoral Annex shall be carried out in accordance with Articles 7, 8 and 9 of the Agreement. |
|
SECTION VII
JOINT SECTORAL COMMITTEE FOR ELECTRICAL SAFETY
The Joint Sectoral Committee for Electrical Safety (JSC/ES) consists of representatives of the US and the EC. OSHA shall represent the US on this Joint Sectoral Committee. The EC and OSHA may invite the participation of others as deemed necessary. Each Party shall have one vote and decisions shall be made by unanimous consent, unless otherwise specified herein. The Joint Sectoral Committee shall determine its own rules of procedure.
The Joint Committee may address any matter related to the effective functioning of this Sectoral Annex, including:
SECTORAL ANNEX FOR RECREATIONAL CRAFT
PREAMBLE
This Annex constitutes a Sectoral Annex to the Agreement on Mutual Recognition between the United States and the European Community.
The purpose of this Sectoral Annex is to establish a framework to accept certificates of conformity issued in the territory of one Party in accordance with the regulatory requirements of the other Party as referenced in this Sectoral Annex.
To facilitate that purpose, a transitional period of 18 months is arranged to build confidence as defined in this Sectoral Annex, Section VI.
SECTION I
LEGISLATIVE, REGULATORY, AND ADMINISTRATIVE REQUIREMENTS
For the European Community:
Directive 94/25/EC of the European Parliament and of the Council of 16 June 1994 on the approximation of the laws, regulations, and administrative provisions of the Member States relating to recreational craft.
For the US:
46 USC Chapter 43, 33 CFR 81, 84, 159, 179, 181, 183 and 46 CFR 58.
SECTION II
SCOPE AND COVERAGE
This Sectoral Annex applies to all recreational craft which in the European Community or the United States are subject to conformity assessment by a conformity assessment body or an approval procedure, as applicable, before being put on the market.
The product coverage for each Party shall be determined by the following relevant requirements:
for the European Community:
Recreational craft as defined in Directive 94/25/EC;
for the United States:
Any product falling under the scope of 46 USC Chapter 43, 33 CFR 81, 84, 159, 179, 181, 183 and 46 CFR 58.
The Parties agree that for mutual recognition to operate under this Sectoral Annex, the following arrangements shall apply:
for approvals to European Community requirements, conformity assessment bodies designated by the US shall establish compliance as required to be demonstrated by Directive 94/25/EC. This demonstration of compliance shall be recognised in the European Community and products so certified shall have unrestricted access to the EC market for sale as recreational craft, pursuant to Section I;
for approvals to United States requirements, conformity assessment bodies designated by the European Community shall establish compliance as required to be demonstrated as set forth in paragraph 2(b) of this Section, and products so certified shall have unrestricted access to the US market for sale as recreational craft, pursuant to Section I.
SECTION III
AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES
|
EC access to the US market |
US access to the EC market |
|
— Belgium — Ministère des Communications et de l'infrastructure — Ministerie van Verkeer en Infrastructuur — Germany — Bundesministerium für Wirtschaft — Spain — Ministerio de Fomento — France — Ministère de l'Equipment, des Transports et du Logement — Italy — Ministero dell'Industria, del Commercio e dell'Artigianato — Netherlands — De Minister van Verkeer en Waterstaat — Finland — Merenkulkuhallitus/sjöfartsstyrelsen — Sweden — Under the authority of the Government of Sweden: — Styrelsen for ackreditering och teknisk kontroll (SWEDAC) — United Kingdom — Department of Trade and Industry |
National Institute for Standards and Technology (NIST) |
SECTION IV
DESIGNATING, LISTING, SUSPENDING AND WITHDRAWING CONFORMITY ASSESSMENT BODIES
For the purpose of this Sectoral Annex, each Party shall designate competent conformity assessment bodies to carry out conformity assessment and approval to the requirements of the other Party. Such designation shall be carried out according to the procedures set out in Article 7 of the Agreement. A list of conformity assessment bodies together with the products and procedures for which they have been listed, is set out in Section V below.
Each Party agrees that the listed conformity assessment bodies comply with the requirements for such bodies established by the other Party. These are:
for the European Community, bodies which are Notified Bodies in accordance with Directive 94/25/EC, are deemed to be in compliance with US requirements;
for the US, in accordance with the requirements set out in the regulations listed in Section I, the conformity assessment bodies listed in Section V are designated by NIST using the evaluation procedures contained in the appropriate EN-45000 series of standards or the corresponding ISO/IEC Guides.
With regard to the designation, listing, suspension and withdrawal of conformity assessment bodies under this Sectoral Annex, the specific procedures in Articles 7, 8 and 9 of the Agreement shall be followed.
SECTION V
CONFORMITY ASSESSMENT BODIES
|
EC access to the US market |
US access to the EC market |
|
The names and scope of responsibilities of Conformity Assessment Bodies located in the EC and listed in accordance with this Sectoral Annex: |
The names and scope of responsibilities of Conformity Assessment Bodies located in the US and listed in accordance with this Sectoral Annex: |
|
(to be provided by EC) |
►M6
|
SECTION VI
TRANSITIONAL ARRANGEMENT
There shall be a transitional period of 18 months prior to the operations of this Sectoral Annex.
The purpose of the transitional arrangement is to provide a mean whereby the Parties to this Agreement can cooperate to establish a system for designating conformity assessment bodies and can mutually build confidence in the abilities of these bodies. Successful completion of this transitional arrangement is intended to result in a determination that conformity assessment bodies comply with the applicable criteria and to have the equipment approved by the conformity assessment bodies of the exporting country accepted by the approval authority of the importing country.
During this transitional period, the parties shall:
exchange information on technical data and conformity assessment criteria and procedures, thus developing greater familiarity with their respective regulatory requirements; and
carry out or recommend any applicable policy, legislative and regulatory changes necessary for the provisions of this Annex.
Product Scope
All products covered by Section II of this Annex.
Cooperation
During this transitional period, both Parties shall endeavour to sponsor jointly seminars for the purpose of improving the understanding of technical specifications applicable in each Party's jurisdiction.
Inspections
Inspections or audits shall be permitted to verify compliance of conformity assessment bodies with their responsibilities under this Agreement. The scope of these inspections or audits shall be agreed upon in advance by both Parties.
SECTION VII
ADDITIONAL PROVISIONS
In accordance with the relevant provisions of the Agreement, the Parties shall ensure the continued availability of the names of their respective notified bodies or conformity assessment bodies, and shall regularly supply details of certifications issued in order to facilitate post market surveillance.
The Parties note that, to the extent that requirements for electrical safety or electromagnetic compatibility may apply to products covered by this Sectoral Annex, the provisions of the Sectoral Annexes on Electrical Safety and Electromagnetic Compatibility apply.
SECTION VIII
DEFINITIONS
‘Notified Body’ means a third party authorised to perform the conformity assessment tasks specified in Directive 94/25/EC, which has been appointed by a Member State from the bodies falling within its jurisdiction. The Notified Body has the necessary qualifications to meet requirements laid down in Directive 94/25/EC and has been notified to the Commission and to the other Member States.
United States — European Union amended sectoral annex for pharmaceutical good manufacturing practices (GMPS)
PREAMBLE
This Annex constitutes a Sectoral Annex to the Agreement on Mutual Recognition between the United States and the European Union, amending the Sectoral Annex for Pharmaceutical Good Manufacturing Practices done in 1998.
CHAPTER 1
DEFINITIONS, PURPOSE, SCOPE AND PRODUCT COVERAGE
Article 1
Definitions
For purposes of this Annex:
‘Assessment pursuant to this Annex’ means:
An assessment pursuant to this Annex includes a reassessment.
‘Recognized authority’ means:
‘Capable authority’ means an authority that the Food and Drug Administration (FDA) FDA has determined is capable according to the criteria and procedures specified in Appendix 4 and referred to in the U.S. laws, regulations and administrative provisions listed in Appendix 1. For greater certainty, a finding that a regulatory authority is ‘capable’ does not require that the authority maintain procedures for conducting inspections and overseeing manufacturing facilities that are identical to FDA's procedures.
‘Equivalent authority’ means an authority in respect of which the EU has made a positive equivalence determination according the criteria and procedures specified in Appendix 4 and as referred to in the EU laws, regulations and administrative provisions listed in Appendix 1.
‘Equivalence’ means that the regulatory system under which an authority operates is sufficiently comparable to assure that the process of inspection and the ensuing official GMP documents will provide adequate information to determine whether respective statutory and regulatory requirements of the authorities have been fulfilled. For greater certainty, ‘equivalence’ does not require that the respective regulatory systems have identical procedures.
‘Enforcement’ means an action taken by an authority to protect the public from products of suspect quality, safety and efficacy or to assure that products are manufactured in compliance with appropriate laws, regulations, standards and commitments made as part of the approval to market a product.
‘Good Manufacturing Practices’ (GMPs) means systems that assure proper design, monitoring, and control of manufacturing processes and facilities, the adherence to which assures the identity, strength, quality, and purity of pharmaceuticals. GMPs include strong quality management systems, obtaining appropriate quality raw materials (including starting materials) and packaging materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories.
‘Inspection’ means an on-site evaluation of a manufacturing facility to determine whether such manufacturing facility is operating in compliance with Good Manufacturing Practices and/or commitments made as part of the approval to market a product.
‘Inspection Report’ means a report written by an investigator or inspector of an authority listed in Appendix 2 concerning an inspection of a manufacturing facility that the investigator or inspector conducted that describes the purpose and scope of an inspection and includes written observations and findings bearing on the manufacturing facilities conformance to applicable GMP requirements set out in the laws, regulations and administrative procedures listed in Appendix 1 and any commitments made as part of the approval to market a product.
‘Official GMPs document’ means a document issued by an authority listed in Appendix 2 following an inspection of a manufacturing facility. Examples of official GMPs documents include inspection reports, certificates issued by an authority attesting the compliance of a manufacturing facility with GMPs, GMPs non-compliance statement issued by authorities of the EU, and notice of observations, untitled letters, warning letters, and import alerts issued by the FDA.
‘Pharmaceuticals’ includes drugs and medicinal products as defined in the laws and regulations listed in Appendix 1.
‘Post-approval inspections’ means GMP surveillance inspections during the marketing of products.
‘Pre-approval inspections’ means pharmaceutical inspections of manufacturing facilities carried out in the territory of a Party as part of the review of an application before marketing approval is granted.
‘Regulatory System’ means the body of legal requirements for Good Manufacturing Practices, inspections, and enforcements that ensure public health protection and legal authority to assure adherence to these requirements.
Article 2
Purpose
This Annex facilitates the exchange of official GMPs documents between the Parties and reliance on the factual findings in such documents. This Annex seeks to facilitate trade and benefit public health by allowing each Party to leverage and to reallocate its inspection resources, including by avoiding duplication of inspections, so as to improve oversight of manufacturing facilities and better address quality risk and prevent adverse health consequences.
Article 3
Scope
1. The provisions of this Annex apply to pharmaceutical inspections of manufacturing facilities carried out in the territory of a Party during the marketing of products (hereafter referred to as ‘post-approval inspections’) and, to the extent provided for in Article 11, before products are marketed (hereafter referred to as ‘pre-approval inspections’), as well as, to the extent provided for in Article 8(3), to pharmaceutical inspections of manufacturing facilities carried out outside the territory of either Party.
2. Appendix 1 names the laws, regulations and administrative provisions governing these inspections and the GMPs requirements.
3. Appendix 2 lists all the authorities responsible for the oversight of facilities that manufacture products within the product coverage of this Annex.
4. Articles 6, 7, 8, 9, 10 and 11 of the Agreement do not apply to this Annex.
Article 4
Product coverage
1. These provisions apply to marketed finished pharmaceuticals for human or animal use, intermediates (for the EU as defined in EU legislation) and in-process materials (for the United States as defined under U.S. law), certain marketed biological products for human use, and active pharmaceutical ingredients, only to the extent they are regulated by the authorities of both Parties as listed in Appendix 2 and subject to Article 20.
2. Human blood, human plasma, human tissues and organs, and veterinary immunologicals are excluded from the scope of this Annex.
3. Appendix 3 contains the list of products covered by this Annex.
CHAPTER 2
DETERMINATION OF RECOGNITION
Article 5
Assessments
1. Each Party shall conduct assessments of authorities listed in Appendix 2 pursuant to this Annex on the request of the other Party as expeditiously as possible, including for authorities added to Appendix 2 after the effective date of this Annex and as regards products listed in Appendix 3 (including those that are included in the scope of this Annex pursuant to Article 20 after the effective date of this Annex).
2. Each Party shall use the criteria and procedure specified in Appendix 4 to conduct assessments pursuant to this Annex.
Article 6
Participation in and completion of assessments
Each Party with respect to the authorities listed in Appendix 2 shall participate in the procedure as described in Appendix 4. Each Party shall exercise good faith efforts to complete assessments pursuant to this Annex as expeditiously as possible. To this end:
The EU shall complete an assessment of the FDA for human pharmaceuticals under this Annex no later than by 1 July 2017.
The FDA shall complete an assessment under this Annex of each EU Member State authority for human pharmaceuticals listed in Appendix 2 as set out in Appendix 5.
Article 7
Recognition of authorities
1. Each Party shall determine whether to recognize an authority according to the criteria specified in Appendix 4. Each Party shall promptly notify the Joint Sectoral Committee of any determination to recognize an authority of the other Party. The Joint Sectoral Committee shall maintain a list of recognized authorities and shall keep the list up-to-date. The list shall be made publicly available by each Party.
2. The assessing Party shall promptly notify the other Party and the relevant authority of any deficiencies identified in the course of the assessment. In the event of a negative determination, the assessing Party shall notify the other Party and the relevant authority of the reasons for the negative determination and provide sufficient detail to allow the authority to understand corrective measures that must be taken to attain a positive determination. A Party may request the other Party to conduct a reassessment of any authority for which the other Party has made a negative determination once the authority has taken necessary corrective measures in accordance with Article 5.
3. An assessing Party shall, upon request of the other Party, promptly discuss with the other Party in the Joint Sectoral Committee the reasons for a negative determination. In case of a negative determination, efforts shall be made by the Joint Sectoral Committee to discuss within 3 months the appropriate timeframe and exact steps to be taken to reassess the relevant authority.
CHAPTER 3
OPERATIONAL ASPECTS
Article 8
Recognition of inspections
1. A Party shall recognize pharmaceutical inspections and accept official GMPs documents issued by a recognized authority of the other Party for manufacturing facilities located in the territory of the issuing authority, except as provided in paragraph 2.
2. A Party may in specific circumstances opt not to accept an official GMPs document issued by a recognized authority of the other Party for manufacturing facilities located in the territory of the issuing authority. Examples of such circumstances include the indication of material inconsistencies or inadequacies in an inspection report, quality defects identified in the post-market surveillance or other specific evidence of serious concern in relation to product quality or consumer safety. A Party opting not to accept an official GMPs document issued by a recognized authority of the other Party shall notify the other Party and the relevant authority of the reasons for not accepting the document and may request clarification from that authority. The authority shall endeavour to respond to the request for clarification in a timely manner and shall normally provide the clarification based on input from one or more members of the inspection team.
3. A Party may accept official GMPs documents issued by a recognized authority of the other Party for manufacturing facilities located outside the territory of the issuing authority.
4. Each Party may determine the terms and conditions under which it accepts official GMPs documents issued under paragraph 3.
5. For purposes of this Annex, to accept an official GMPs document means to rely on the factual findings in such document.
Article 9
Batch testing
In the EU, as provided in Article 51 paragraph 2 of Directive 2001/83/EC of the European Parliament and of the Council ( 1 ) and in Article 55 paragraph 2 of Directive 2001/82/EC of the European Parliament and of the Council ( 2 ), the qualified person will be relieved of responsibility for carrying out the controls laid down in Article 51 paragraph 1 of Directive 2001/83/EC and in Article 55 paragraph 1 of Directive 2001/82/EC provided that these controls have been carried out in the United States, the product was manufactured in the United States and that each batch/lot is accompanied by a batch certificate (in alignment with the WHO certification scheme on the quality of medicinal products) issued by the manufacturer certifying that the product complies with requirements of the marketing authorization and signed by the person responsible for releasing the batch/lot.
Article 10
Transmission of official GMPs documents
If an importing Party requests a recognized authority of the other Party for a post-approval official GMPs document, the recognized authority shall transmit the document to the Party within 30 calendar days of the date of the request. If, based on that document, the importing Party determines that a new inspection of the manufacturing facility is needed, the importing Party shall notify the relevant recognized authority of the other Party and request, in accordance with Article 11, the recognized authority of the other Party to conduct a new inspection.
Article 11
Requests for pre-approval and post-approval inspections
1. A Party or a recognized authority of a Party may request in writing that a recognized authority of the other Party conduct a pre-approval or post-approval inspection of a manufacturing facility. The request shall include the reason for the request and identify the precise issues to be addressed in the inspection and the requested timeline for completing the inspection and transmitting the official GMPs documents.
2. In the EU, requests shall be sent directly to the relevant recognized authority, with a copy to the European Medicines Agency (EMA).
3. Within 15 calendar days of receipt of the request, the recognized authority shall acknowledge receipt and confirm whether it will conduct the inspection in accordance with the requested timelines. Where the authority receiving the request is of the opinion that official GMPs documents relevant to the request are already available or are pending, it should inform the requesting authority accordingly and share these documents upon request.
4. For greater certainty, if the recognized authority indicates that it will not conduct the inspection, the requesting authority has the right to conduct its own inspection of the manufacturing facility and the requested authority has the right to join the inspection.
Article 12
Maintenance
Each Party shall maintain ongoing activities to monitor that recognized authorities in its territory maintain the criteria for recognition. For the purpose of such monitoring activities, each Party shall rely on established programmes that include regular audits or assessments of authorities based on the criteria specified in Appendix 4. The frequency and nature of such activities shall be consistent with international best practices. A Party may invite the other Party to participate in these monitoring activities at the other Party's expense. Each Party shall notify the other Party of any significant changes to its monitoring programmes.
Article 13
Suspension of a recognized authority
1. Each Party has the right to suspend recognition of a recognized authority of the other Party. This right shall be exercised in an objective and reasoned manner and communicated in writing to the other Party and the recognized authority.
2. A Party suspending recognition of a recognized authority of the other Party shall, upon request of the other Party or the authority whose recognition was suspended, promptly discuss in the Joint Sectoral Committee the suspension, the reason therefore, and corrective actions that would need to be taken for the suspension to be lifted.
3. Upon the suspension of an authority previously listed as a recognized authority, a Party is no longer obligated to accept official GMPs documents of the suspended authority. A Party shall continue to accept official GMPs documents of that authority prior to suspension, unless the Party decides otherwise based on health or safety considerations. The suspension shall remain in effect until the Parties decide to lift the suspension or until a positive determination of recognition has been made in accordance with Article 7 pursuant to a reassessment.
CHAPTER 4
JOINT SECTORAL COMMITTEE
Article 14
Role and composition of the Joint Sectoral Committee
1. A Joint Sectoral Committee is set up to monitor the activities performed under this Annex.
2. The Committee shall be co-chaired by a representative of the FDA for the United States and a representative of the EU who each shall have one vote in the Joint Sectoral Committee. The Joint Sectoral Committee shall make its decision by unanimous consent. The Joint Sectoral Committee shall determine its own rules and procedures.
3. The Joint Sectoral Committee's functions include in particular:
developing and keeping up to date the list of recognized authorities, including any limitation in terms of inspection type or products, and the list of authorities in Appendix 2 and communicating the lists to all authorities listed in Appendix 2 and the Joint Committee,
providing a forum to discuss issues relating to this Annex, including relating to disagreements as regards determinations of recognition or suspension and timelines for completing assessments under this Annex of authorities listed in Appendix 2;
in accordance with Article 20 and Appendix 3, considering the status, and taking decisions on the inclusion, of the products referred to in Article 20; and
adopting, where necessary, appropriate complementary technical and administrative arrangements for the effective implementation of this Annex.
4. The Joint Sectoral Committee shall meet at the request of either Party with respect to issues relating to disagreements as regards to determinations of recognition or suspension and otherwise at such times as the Parties may agree. The Joint Sectoral Committee may meet in person or by other means.
CHAPTER 5
REGULATORY COOPERATION AND INFORMATION EXCHANGE
Article 15
Regulatory cooperation
The Parties shall inform and consult one another, as permitted by law, on proposals to introduce new controls or to change existing technical regulations or significant changes to pharmaceutical inspection procedures and to provide the opportunity to comment on such proposals.
Article 16
Exchange of information
The Parties shall establish appropriate arrangements, including access to relevant databases, for the exchange of official GMPs documents and other appropriate information related to the inspection of a manufacturing facility and the exchange of information concerning any confirmed problem reports, corrective actions, recalls, rejected import consignments and other regulatory and enforcement problems for products subject to this Annex.
Article 17
Alert System
Each Party shall maintain an Alert System that permits authorities of the other Party when relevant to be made aware proactively and with the appropriate speed in case of quality defect, recalls, counterfeit or falsified products, or potential serious shortages and other problems concerning quality or non-compliance with GMP, which could necessitate additional controls or suspension of the distribution of the affected products.
CHAPTER 6
SAFEGUARD CLAUSE
Article 18
Safeguard clause
1. Each Party recognizes that the importing country has a right to fulfil its legal responsibilities by taking actions necessary to ensure the protection of human and animal health at the level of protection it deems appropriate. An authority of a Party has the right to conduct its own inspection of a manufacturing facility in the territory of the other Party.
2. An authority of a Party conducting its own inspection of a manufacturing facility in the territory of the other Party should be an exception from the normal practice of a Party as of the date on which the Articles referred to in Article 19(2) become applicable.
3. An authority of a Party, prior to conducting an inspection under paragraph 1, shall notify the other Party in writing and the authority of the other Party has the right to join the inspection conducted by the Party.
CHAPTER 7
FINAL PROVISIONS
Article 19
Entry Into Force
1. This Annex shall enter into force on the date on which the Parties have completed an Exchange of Letters confirming completion of any respective procedures for the entry into force of this Annex.
2. Notwithstanding paragraph 1, Articles 8, 10, 11 and 12 of this Annex shall not apply until 1 November 2017, except as provided in paragraph 4.
3. Notwithstanding paragraph 1, Article 9 of this Annex shall not apply until the date on which all the EU Member State authorities for human pharmaceuticals listed in Appendix 2 have been recognized by the FDA.
4. If, by 1 November 2017, the FDA has not completed assessments under this Annex of at least eight Member State authorities for human pharmaceuticals listed in Appendix 2, despite having received complete capability assessment packages from those authorities as specified in paragraph II.A.1 of Appendix 4 in accordance with the schedule set out in Appendix 5, application of the Articles referred to in paragraph 2 shall be postponed to the date on which the FDA has completed assessments of at least eight such authorities.
Article 20
Transitory Provisions
1. No later than by 15 July 2019, the Joint Sectoral Committee shall consider whether to include veterinary products within the product coverage of this Annex. The Joint Sectoral Committee shall exchange views on the organisation of the assessment of respective authorities by 15 December 2017.
2. No later than 15 July 2022, the Joint Sectoral Committee shall consider whether to include vaccines for human use and plasma derived pharmaceuticals within the product coverage of this Annex. Without prejudice to this consideration, as of the effective date of this Annex, a Party shall notify the relevant authority of the other Party in advance of conducting a post-approval inspection of a manufacturing facility of such products located in the territory of the Party and give the authority the option of joining the inspection. In order to support the inclusion of vaccines for human use and plasma derived pharmaceuticals within the product coverage of this Annex, the Joint Sectoral Committee shall take into account, in particular, the experience gained through such joint inspections.
3. No later than 15 July 2019, the Joint Sectoral Committee shall review experience gained in order to decide whether the provisions on pre-approval inspections provided in Article 11 shall be reviewed.
4. Products referred to in paragraphs 1 and 2 shall be included within the product coverage of this Annex only once the Joint Sectoral Committee so decides pursuant to paragraphs 1 and 2.
5. Where the FDA identifies the need for a post-approval inspection of a manufacturing facility in a territory of a Member State authority of which an assessment under this Annex is pending or that the FDA has otherwise not recognized, the FDA shall notify that authority and the EMA in writing.
No later than 30 calendar days of the date it receives a notification pursuant to paragraph 5, the authority in whose territory the manufacturing facility is located or EMA on behalf of this authority shall inform the FDA whether it has opted to request a recognized authority of the EU to conduct the inspection and, if so, whether such recognized authority of the EU will conduct the inspection by the date specified in the notification. The authority in whose territory the manufacturing facility is located shall be allowed to join the inspection.
In the case that a recognized authority of the EU will conduct the inspection, the recognized authority or EMA on behalf of this authority shall inform the FDA of the date(s) on which it will conduct the inspection and submit the official GMPs documents relevant to the inspection to the FDA and the authority of the territory in which the inspection has been conducted by the date specified in the notification in accordance with the applicable laws, regulations and administrative provisions listed in Appendix 1. The FDA shall have the option to participate in the inspection.
In the case that a recognized authority of the EU will not conduct the inspection and the FDA conducts the inspection, the authority of the territory in which the inspection has been conducted has the right to participate in the inspection and the FDA shall submit the official GMPs documents relevant to the inspection to this authority.
Article 21
Termination
1. The Annex shall terminate on 15 July 2019 in the event that the FDA, by that date, has not completed an assessment under this Annex of each EU Member State authority for human pharmaceuticals listed in Appendix 2, provided that the FDA has received complete capability assessment packages as specified in paragraph II.A.1 of Appendix 4 from each Member State authority in accordance with the schedule set out in Appendix 5.
2. The date specified in paragraph 1 shall be extended by 90 calendar days for each authority that provides a complete capability assessment package as specified in paragraph II.A.1 of Appendix 4 after the applicable deadline set out in Appendix 5 but before 15 July 2019.
3. The FDA shall, on request, discuss any disagreement raised by the EU regarding an assessment in the Joint Sectoral Committee. If the Joint Sectoral Committee cannot agree on resolution of the disagreement, the EU may notify in writing to the FDA its formal disagreement and the Annex shall terminate three months from the date of such notification or on such other date as the Joint Sectoral Committee may agree.
Appendix 1
List of Applicable Laws, Regulations and Administrative Provisions
FOR THE UNITED STATES
Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301 et seq. Of particular relevance: 21 USC 351(a)(2)(B) (drug adulterated if not manufactured in conformance with current good manufacturing practice); 21 U.S.C. 355(d)(3); 21 U.S.C. 355(j)(4)(A) (approval of human drug contingent on adequacy of methods, facilities, and controls for manufacturing, processing, and packing to preserve the identity, strength, quality, and purity of drug); 21 U.S.C. 360b(c)(2)(A)(i); 360b(d)(1)(C) (approval of animal drug contingent on contingent on adequacy of methods, facilities, and controls for manufacturing, processing, and packing to preserve the identity, strength, quality, and purity of drug); 21 U.S.C. 374 (inspection authority); 21 U.S.C. 384(e) (recognition of foreign government inspections)
Public Health Service Act Section 351, 42 U.S.C. 262. Of particular relevance: 42 U.S.C. 262(a)(2)(C)(i)(II) (licensing of biologic contingent on demonstration that the facility in which it is manufactured, processed, packed, or held meets standards designed to assure that the product continues to be safe, pure, and potent); 42 U.S.C. 262(j) (Federal Food, Drug, and Cosmetic Act applies to biologic products)
21 CFR Part 210 (Current Good Manufacturing Practice in Manufacturing, Processing, Packing or Holding Drugs; General)
21 CFR Part 211 (Current Good Manufacturing Practice for Finished Pharmaceuticals)
21 CFR Part 600, Subpart B (Establishment Standards); Subpart C (Establishment Inspection)
FOR THE EUROPEAN UNION
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use;
Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products;
Directive 2001/20/EC of European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use;
Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC;
Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency;
Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use;
Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products;
Commission delegated Regulation (EU) No 1252/2014 of 28 May 2014 of the European Parliament and of the Council with regard to principles and guidelines of good manufacturing practice for active substances for medicinal products for human use;
Current version of the Guide to good manufacturing practices contained in volume IV of Rules governing medicinal products in the European Union and compilation of the community procedures on inspections and exchange of information.
Appendix 2
LIST OF AUTHORITIES
UNITED STATES
The Food and Drug Administration
EUROPEAN UNION
|
Country |
For medicinal products for human use |
For medicinal products for veterinary use |
|
Austria |
Austrian Agency for Health and Food Safety/Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH |
See responsible authority for human medicinal products |
|
Belgium |
Federal agency for medicines and health products/Federaal Agentschap voor geneesmiddelen en gezondheidsproducten/Agence fédérale des médicaments et produits de santé |
See responsible authority for human medicinal products |
|
Bulgaria |
Bulgarian Drug Agency/ИЗПЪЛНИТЕЛНА АГЕНЦИЯ ПО ЛЕКАРСТВАТА |
Bulgarian Food Safety Agency/Българска агенция по безопасност на храните |
|
Cyprus |
Ministry of Health — Pharmaceutical Services/Φαρμακευτικές Υπηρεσίες, Υπουργείο Υγείας |
Ministry of Agriculture, Rural Development and Environment-Veterinary Services/Κτηνιατρικές Υπηρεσίες- Υπουργείο Γεωργίας, Αγροτικής Ανάπτυξης και Περιβάλλοντος |
|
Czech Republic |
State Institute for Drug Control/Státní ústav pro kontrolu léčiv (SÚKL) |
Institute for State Control of Veterinary Biologicals and Medicaments/Ústav pro státní kontrolu veterinárních biopreparátů a léčiv (ÚSKVBL) |
|
Croatia |
Agency for Medicinal Products and Medical Devices/Agencija za lijekove i medicinske proizvode (HALMED) |
Ministry of Agriculture, Veterinary and Food Safety Directorate/Ministarstvo Poljoprivrede, Uprava za veterinarstvo i sigurnost hrane |
|
Denmark |
Danish Medicines Agency/Laegemiddelstyrelsen |
See responsible authority for human medicinal products |
|
Germany |
Federal Institute for Drugs and Medical Devices/Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) Paul-Ehrlich-Institute (PEI), Federal Institute for Vaccines and Biomedicines/Paul-Ehrlich-Institut (PEI) Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel Federal Ministry of Health/Bundesministerium für Gesundheit (BMG)/Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG) (1) |
Federal Office for Consumer Protection and Food Safety/Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL) Federal Ministry of Food and Agriculture, Bundesministerium für Ernährung und Landwirtschaft |
|
Estonia |
State Agency of Medicines/Ravimiamet |
See responsible authority for human medicinal products |
|
Greece |
National Organisation for Medicines/Ethnikos Organismos Farmakon (EOF) — (ΕΘΝΙΚΟΣ ΟΡΓΑΝΙΣΜΟΣ ΦΑΡΜΑΚΩΝ)) |
See responsible authority for human medicinal products |
|
Spain |
Spanish Agency of Medicines and Medical Devices/Agencia Española de Medicamentos y Productos Sanitarios (2) |
See responsible authority for human medicinal products |
|
Finland |
Finnish Medicines Agency/Lääkealan turvallisuus- ja kehittämiskeskus (FIMEA) |
See responsible authority for human medicinal products |
|
France |
French National Agency for Medicines and Health Products Safety Agence nationale de sécurité du médicament et des produits de santé (ANSM) |
French agency for food, environmental and occupational health safety — National Agency for Veterinary Medicinal Products/Agence Nationale de Sécurité Sanitaire de l'alimentation, de l'environnement et du travail-Agence Nationale du Médicament Vétérinaire (Anses-ANMV) |
|
Hungary |
Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet/National Institute of Pharmacy and Nutrition |
National Food Chain Safety Office, Directorate of Veterinary Medicinal Products/Nemzeti Élelmiszerlánc-biztonsági Hivatal, Állatgyógyászati Termékek Igazgatósága (ÁTI) |
|
Ireland |
Health Products Regulatory Authority (HPRA) |
See responsible authority for human medicinal products |
|
Italy |
Italian Medicines Agency/Agenzia Italiana del Farmaco |
Direction General for Animal Health and Veterinary Medicinal Products Ministero della Salute, Direzione Generale della Sanità Animale e dei Farmaci Veterinari |
|
Latvia |
State Agency of Medicines/Zāļu valsts aģentūra |
Assessment and Registration Department of the Food and Veterinary Service/Pārtikas un veterinārā dienesta Novērtēšanas un reģistrācijas departaments |
|
Lithuania |
State Medicines Control Agency/Valstybinė vaistų kontrolės tarnyba |
State Food and Veterinary Service/Valstybinės maisto ir veterinarijos tarnyba |
|
Luxembourg |
Minìstere de la Santé, Division de la Pharmacie et des Médicaments |
See responsible authority for human medicinal products |
|
Malta |
Medicines Regulatory Authority |
Veterinary Medicines and Animal Nutrition section VMANS) (Veterinary Regulation Directorate (VRD) within The Veterinary and Phytosanitary Regulation Department (VPRD) |
|
Netherlands |
Healthcare Inspectorate/Inspectie voor de Gezondheidszorg (IGZ) |
Medicines Evaluation Board/Bureau Diergeneesmiddelen, College ter Beoordeling van Geneesmiddelen (CBG) |
|
Poland |
The Main Pharmaceutical Inspectorate/Główny Inspektorat Farmaceutyczny (GIF) |
See responsible authority for human medicinal products |
|
Portugal |
National Authority of Medicines and Health Products/INFARMED, I.P Autoridade Nacional do Medicamento e Produtos de Saúde, I.P |
General Directorate of Food and Veterinary/DGAV — Direção Geral de Alimentação e Veterinária (PT) |
|
Romania |
National Agency for Medicines and Medical Devices/Agenția Națională a Medicamentului și a Dispozitivelor Medicale |
National Sanitary Veterinary and Food Safety Authority/Autoritatea Națională Sanitară Veterinară și pentru Siguranța Alimentelor |
|
Sweden |
Medical Products Agency/Läkemedelsverket |
See responsible authority for human medicinal products |
|
Slovenia |
Agency for Medicinal Products and Medical Devices of the Republic of Slovenia/Javna agencija Republike Slovenije za zdravila in medicinske pripomočke (JAZMP) |
See responsible authority for human medicinal products |
|
Slovak Republic (Slovakia) |
State Institute for Drug Control/Štátny ústav pre kontrolu liečiv (ŠÚKL) |
Institute for State Control of Veterinary Biologicals and Medicaments/Ústav štátnej kontroly veterinárnych biopreparátov a liečiv (USKVBL) |
|
United Kingdom |
Medicines and Healthcare products Regulatory Agency |
Veterinary Medicines Directorate |
|
(1) For the purpose of this Annex, and without prejudice to the internal division of competence in Germany on matters falling within the scope of this Annex, ZLG shall be understood as covering all the competent Laender authorities issuing GMP documents and conducting pharmaceutical inspections. (2) For the purpose of this Annex, and without prejudice to the internal division of competence in Spain on matters falling within the scope of this Annex, Agencia Española de Medicamentos y Productos Sanitarios shall be understood as covering all the competent regional authorities issuing GMP documents and conducting pharmaceutical inspections. |
||
Appendix 3
LIST OF PRODUCTS COVERED BY THE ANNEX
Recognizing that precise definition of medicinal products and drugs are to be found in the laws, regulations and administrative provisions referred to in Appendix 1, an indicative list of products covered by the Annex is given below. This applies to processing, packaging, testing and sterilizing facilities, including contract facilities performing these functions.
Marketed finished pharmaceuticals for human use in various pharmaceutical dosage forms such as tablets, capsules, ointments, and injectables, including:
Medical gases;
Radiopharmaceuticals or radioactive biological products;
Herbal (botanical) products ( *1 ); and
Homeopathic products;
In process materials (for the United States as defined under U.S. law) and intermediates (for the European Union as defined in EU legislation);
Active pharmaceutical ingredients or bulk drug substance;
Investigational products (clinical trial material) ( *3 ); and
Veterinary products (*2) :
veterinary pharmaceuticals, including prescription and non-prescription drugs, with the exclusion of veterinary immunologicals;
pre-mixes for the preparation of veterinary medicated feeds (EU), Type A medicated articles for the preparation of veterinary medicated feeds (US);
Appendix 4
CRITERIA AND PROCEDURE FOR ASSESSMENTS UNDER THIS ANNEX
I. CRITERIA FOR ASSESSMENTS UNDER THIS ANNEX
Each Party will apply the following criteria to determine whether to recognize an authority listed in Appendix 2:
The authority has the legal and regulatory authority to conduct inspections against a standard for GMP (as defined in Article 1).
The authority manages conflict of interest in an ethical manner.
The authority has the ability to evaluate risks and mitigate them.
The authority maintains appropriate oversight of manufacturing facilities within its jurisdiction.
The authority has and uses sufficient resources.
The authority employs trained and qualified inspectors with the skills and knowledge to identify manufacturing practices that may lead to patient harm.
The authority has the tools necessary to take action to protect the public from harm due to poor quality drugs or medicinal products.
II. PROCEDURES FOR ASSESSMENTS UNDER THIS ANNEX
A. Assessment of EU authorities by FDA
1. To receive a capability assessment for an authority listed in Appendix 2, each Member State authority shall submit capability assessment packages containing the following materials before the FDA will initiate an assessment:
a finalized Joint Audit Programme audit report of an audit, where the FDA has been given three months advance notice to be an observer, that includes the full report of the observed inspection, any associated corrective measures, and all documents cited by the auditors in the report for the indicators as identified by FDA in the Joint Audit Programme audit checklist as essential for the assessment and for any indicators that required the authority to propose a corrective and preventative action;
a completed conflicts of interest questionnaire established by the FDA signed by a principal of the authority;
a total of four inspection reports including the report from the inspections observed during the Joint Audit Program audit;
standard operating procedures or a description on how the authority finalizes inspection reports;
standard operating procedures related to training and inspector qualification, including training files for all inspectors who conducted the inspections in the reports provided to the FDA (pursuant to subparagraph (iii)); and
its most recent inventory of manufacturing facilities within its territory and under the authority's jurisdiction, including type of manufacturing facility of products falling within the product coverage of this Annex, and upon request, completion of a table provided by the FDA detailing types of manufacturing facilities.
2. During a capability assessment, the FDA may require additional information or further clarification from the Member State authority.
3. The FDA may waive the requirement to submit certain information listed under II.A.1 and may request alternative information from the Member State authority. The decision to waive any assessment materials will be made by the FDA on a case by case basis.
4. Upon receipt of all requisite information specified in paragraph II.A from a Member State authority, the FDA intends to submit such information for official translation into English within a reasonable timeframe. The FDA will complete assessments and determine capability of the Member State authority no later than 70 calendar days from the date the FDA receives a translation of all requisite information specified in paragraph II.A for the Member State authority. The FDA will dedicate two capability assessment teams; therefore, the FDA shall conduct assessments of two Member State authorities at any given time.
B. Assessment of FDA by the EU
The EU will carry out its assessment of FDA based on:
The performance of an audit in line with the elements of the Joint Audit Programme taking into account audits performed in the framework of the Pharmaceutical Inspection Convention/Scheme (PIC/S) and audits performed in the context of Article 111(b)(1) of Directive 2001/83/EC.
An assessment of the equivalence of legislative and regulatory GMP requirements.
C. Reassessment of authorities
In the event an assessing Party issues a negative determination or suspension of an authority of the other Party, it may reassess the authority. The scope of the reassessment shall relate to the reasons for the negative determination or suspension.
III. MAINTAINING RECOGNITION
To maintain recognition, it is required that the authority continue to meet the criteria set out in paragraph I.A and remain subject to the monitoring activities described in Article 12 which for Member State authorities the FDA requires monitoring through an audit program that includes an audit (that the FDA has the option to observe) of each recognized Member State authority every five to six years. In case an authority has not been subject to an audit for a period of 6 years, the other Party shall have the right to audit such authority.
Appendix 5
SCHEDULE FOR INITIAL ASSESSMENT OF MEMBER STATE AUTHORITIES
Member State authorities for human pharmaceuticals listed in Appendix 2 shall submit complete capability assessment packages containing the information specified in paragraph II.A.1 of Appendix 4 according to the following schedule:
The FDA shall complete assessments under this Annex of Member State authorities for human pharmaceuticals listed in Appendix 2 as set out in paragraph II.A.4 and according to the following schedule, provided that the FDA receives complete capability assessment packages for such authorities containing the information specified in paragraph II.A.1 of Appendix 4 according to the schedule set out in paragraph 1:
For each Member State authority:
The EU shall submit a final audit report to the FDA no later than 60 days before the due date of the capability assessment package for the authority.
The FDA shall provide a finalized capability assessment package checklist to the authority no later than 20 days after the FDA receives the audit report.
The authority shall submit the capability assessment package to FDA no later than 40 days after the authority receives the capability assessment package checklist.
SECTORAL ANNEX ON MEDICAL DEVICES
PREAMBLE
This Annex constitutes a Sectoral Annex to the Agreement on Mutual Recognition in Regulation to Conformity Assessment between the United States and the European Community.
Carrying out the provisions of this Annex will further public health protection, will be an important means of facilitating commerce in medical devices and will lead to reduced costs for regulators and manufacturers of both Parties.
CHAPTER 1
PURPOSE, SCOPE AND COVERAGE OF THE SECTORAL ANNEX
Article 1
Purpose
1. The purpose of this Annex is to specify the conditions under which a Party will accept the results of quality system-related evaluations and inspections and premarket evaluations of the other Party with regard to medical devices as conducted by listed conformity assessment bodies (CABs) and to provide for other related cooperative activities.
2. This Annex is intended to evolve as programmes and policies of the Parties evolve. The Parties will review this Annex periodically, in order to assess progress and identify potential enhancements to this Annex as
Food and Drug Administration (FDA)
and EC policies evolve over time.
Article 2
Scope
1. The provisions of this Annex shall apply to the exchange and, where appropriate, endorsement of the following types of reports from CABs assessed to be equivalent:
under the US system, surveillance/post-market and initial/pre-approval inspection reports;
under the US system, premarket (510(k)) product evaluation reports;
under the EC system, quality system evaluation reports; and
under the EC system, EC type examination and verification reports.
Appendix 1 names the legislation, regulations, and related procedures under which:
products are regulated as medical devices by each Party;
CABs are designated and confirmed; and
these reports are prepared.
2. For purposes of this Annex, equivalence means that: CABs in the EC are capable of conducting product and quality systems evaluations against US regulatory requirements in a manner equivalent to those conducted by FDA; and CABs in the US are capable of conducting product and quality systems evaluations against EC regulatory requirements in a manner equivalent to those conducted by EC CABs.
Article 3
Product Coverage
There are three components to this agreement each covering a discrete range of products:
Quality System Evaluations — US-type surveillance/post-market and initial/pre-approval inspection reports and EC-type quality system evaluation reports will be exchanged with regard to all products regulated under both US and EC law as medical devices.
Product Evaluation — US-type premarket (510(k)) product evaluation reports and EC-type-testing reports will be exchanged only with regard to those products classified under the US system as Class I/Class II — Tier 2 medical devices which are listed in Appendix 2.
Post-Market Vigilance Reports — Post-market vigilance reports will be exchanged with regard to all products regulated under both US and EC law as medical devices.
Additional products and procedures may be made subject to this Annex by agreement of the Parties.
Article 4
Regulatory Authorities
The regulatory authorities shall have the responsibility of implementing the provisions of this Annex, including the designation and monitoring of CABs. Regulatory authorities are specified in Appendix 3. Each Party will promptly notify the other Party in writing of any change in the regulatory authority for a country.
CHAPTER 2
TRANSITION PERIOD
Article 5
Length and purpose of transition period
►M14 There shall be a five-year transition period immediately following the date of entry into force of the Agreement. Based on progress made during the transition period, and in particular when the Parties consider that a representative number of conformity assessment bodies are listed in Appendix 5, in accordance with Article 9, the Joint Committee may decide to end the transition period and proceed to the operational period. ◄ During the transition period, the Parties will engage in confidence-building activities for the purpose of obtaining sufficient evidence to make determinations concerning the equivalence of CABs of the other Party with respect to the ability to perform quality system and product evaluations or other reviews resulting in reports to be exchanged under this Annex.
Article 6
Listing of CABs
Each Party shall designate CABs to participate in confidence-building activities by transmitting to the other Party a list of CABs which meet the criteria for technical competence and independence, as identified in Appendix 1. The list shall be accompanied by supporting evidence. Designated CABs will be listed in Appendix 4 for participation in the confidence building activities once confirmed by the importing Party. Non-confirmation would have to be justified based on documented evidence.
Article 7
Confidence Building Activities
1. At the beginning of the transitional period, the Joint Sectoral Group will establish a joint confidence building programme calculated to provide sufficient evidence of the capabilities of the designated CABs to perform quality system or product evaluations to the specifications of the Parties.
2. The joint confidence building program should include the following actions and activities:
seminars designed to inform the Parties and CABs about each Party's regulatory system, procedures, and requirements;
workshops designed to provide the Parties with information regarding requirements and procedures for the designation and surveillance of CABs;
exchange of information about reports prepared during the transition period;
joint training exercises; and
observed inspections.
3. During the transition period, any significant problem that is identified with a CAB may be the subject of cooperative activities, as resources allow and as agreed to by the regulatory authorities, aimed at resolving the problem.
4. Both Parties will exercise good faith efforts to complete the confidence building activities as expeditiously as possible to the extent that the resources of the Parties allow.
5. Both the EC and the US will each prepare annual progress reports which will describe the confidence building activities undertaken during each year of the transition period. The form and content of the reports will be determined by the Parties through the Joint Sectoral Committee.
Article 8
Other transition period activities
1. During the transition period, the Parties will jointly determine the necessary information which must be present in quality system and product evaluation reports.
2. The Parties will jointly develop a notification and alert system to be used in case of defects, recalls, and other problems concerning product quality that could necessitate additional actions (e.g., inspections by the Parties of the importing country) or suspension of the distribution of the product.
CHAPTER 3
END OF TRANSITION PERIOD
Article 9
Equivalence Assessment
1. ►M14 Prior to the start of the operational period, the Parties shall proceed to a joint assessment of the equivalence of the CABs that participated in the confidence-building activities. ◄ CABs will be determined to be equivalent provided they have demonstrated proficiency through the submission of a sufficient number of adequate reports. CABs may be determined to be equivalent with regard to the ability to perform any type of quality system or product evaluation covered by this Annex and with regard to any type of product covered by this Annex. The parties shall develop a list contained in Appendix 5 of CABs determined to be equivalent which shall contain a full explanation of the scope of the equivalency determination, including any appropriate limitations, with regard to performing any type of quality system or product evaluation.
2. The Parties shall allow CABs not listed for participation in the MRA, or listed for participation only as to certain types of evaluations, to apply for participation in this MRA once the necessary measures have been taken or sufficient experience has been gained, in accordance with Article 16.
3. Decisions concerning the equivalence of CABs must be agreed to by both Parties.
CHAPTER 4
OPERATIONAL PERIOD
Article 10
Start of the operational period
1. The operational period will start at the end of the transition period after the Parties have developed the list of CABs found to be equivalent. The provisions of this Chapter will apply only with regard to listed CABs and only to the extent of any specifications and limitations contained on the list with regard to a CAB.
2. The operational period will apply to quality system evaluation reports and product evaluation reports generated by CABs listed in accordance with this Annex for the evaluations performed in the respective territories of the Parties, except if the Parties agree otherwise.
Article 11
Exchange and endorsement of quality system evaluation reports
1. Listed EC CABs will provide FDA with reports of quality system evaluations, as follows:
for pre-approval quality system evaluations, EC CABs will provide full reports; and
for surveillance quality system evaluations, EC CABs will provide abbreviated reports.
2. Listed US CABs will provide to the EC Notified Body of the manufacturer's choice:
full reports of initial quality system evaluations;
abbreviated reports of quality systems surveillance audits.
3. If the abbreviated reports do not provide sufficient information, the importing Party may request additional clarification from the CAB.
4. Based on the determination of equivalence in light of the experience gained, the quality system evaluation reports prepared by the CABs listed as equivalent will normally be endorsed by the importing Party, except under specific and delineated circumstances. Examples of such circumstances include indications of material inconsistencies or inadequacies in a report, quality defects identified in post-market surveillance or other specific evidence of serious concern in relation to product quality or consumer safety. In such cases, the importing Party may request clarification from the exporting Party which may lead to a request for re-inspection. The Parties will endeavour to respond to requests for clarification in a timely manner. Where divergence is not clarified in this process, the importing Party may carry out the quality system evaluation.
Article 12
Exchange and endorsement of product evaluation reports
1. EC CABs listed for this purpose will, subject to the specifications and limitations on the list, provide to the FDA 510(k) premarket notification assessment reports prepared to US medical device requirements.
2. US CABs will, subject to the specifications and limitations on the list, provide to the EC notified body of the manufacturer's choice, type examination and verification reports prepared to EC medical device requirements.
3. Based on the determination of equivalence in light of the experience gained, the product evaluation reports prepared by the CABs listed as equivalent will normally be endorsed by the importing Party, except under specific and delineated circumstances. Examples of such circumstances include indications of material inconsistencies, inadequacies, or incompleteness in a product evaluation report, or other specific evidence of serious concern in relation to product safety, performance, or quality. In such cases, the importing Party my request clarification from the exporting Party which may lead to a request for a re-evaluation. The parties will endeavour to respond to requests for clarification in timely manner. Endorsement remains the responsibility of the importing Party.
Article 13
Transmission of quality system evaluation reports
Quality system evaluation reports covered by Article 11 concerning products covered by this Annex shall be transmitted to the importing Party within 60 calendar days of a request by the importing Party. Should a new inspection be requested the time period shall be extended by an additional 30 calendar days. A Party may request a new inspection, for cause, identified to the other Party. If the exporting Party cannot perform an inspection within a specified period time, the importing Party may perform an inspection on its own.
Article 14
Transmission of product evaluation reports
Transmission of product evaluation reports will take place according to the importing Party's specified procedures.
Article 15
Monitoring continued equivalence
Monitoring activities will be carried out in accordance with Article 10 of the Agreement.
Article 16
Listing of Additional CABs
1. During the operational period, additional CABs will be considered for equivalence using the procedures and criteria described in Articles 6, 7, and 9 of this Annex, taking into account the level of confidence gained in the overall regulatory system of the other Party.
2. Once a designating authority considers that such CABs, having undergone the procedures of Articles 6, 7, and 9 of this Annex, may be determined to be equivalent, it will then designate those bodies on an annual basis. Such procedures satisfy the procedures of Articles 7(a) and (b) of the Agreement.
3. Following such annual designations, the procedures for confirmation of CABs under Articles 7(c) and (d) of the Agreement shall apply.
CHAPTER 5
JOINT SPECIAL COMMITTEE
Article 17
Role and composition of the Joint Sectoral Committee
1. A Joint Sectoral Management Committee is set up to monitor the activities under both the transitional and operational phases of this Annex.
2. The Committee will be co-chaired by a representative of the FDA for the US and a representative of the EC who will each have one vote. Decisions will be taken by unanimous consent.
3. The JSC's functions will include:
making a joint assessment of the equivalent of CABs;
developing and maintaining the list of equivalent CABs, including any limitation in terms of their scope of activities and communicating the list of all authorities and the Joint Committee;
providing a forum to discuss issues relating to this Annex, including concerns that a CAB may no longer be equivalent and opportunity to review product coverage; and
consideration of the issue of suspension.
CHAPTER 6
HARMONISATION AND INFORMATION EXCHANGE
Article 18
Harmonisation
During both the transitional and operational phases of this Agreement, both Parties intend to continue to participate in the activities of the Global Harmonisation Task Force and utilise the results of those activities to the extent possible. Such participation involves developing and reviewing documents developed by the Global Harmonisation Task Force and jointly determining whether they are applicable to the implementation of this Agreement.
Article 19
Regulatory cooperation
The Parties and authorities shall inform one another, as permitted by law, of, and consult one another on, proposals to introduce new controls or to change existing technical regulations or inspection procedures and to provide the opportunity to comment on such proposals.
The Parties shall notify each other in writing of any changes to Appendix 1.
Article 20
Alert system and exchange of post-market vigilance reports
1. An alert system will be set up during the transition period and maintained thereafter by which the Parties will notify each other when there is an immediate danger to public health. Elements of such a system will be described in an Appendix to be attached to this Sectoral Annex. As part of that system, each Party shall notify the other Party of any confirmed problem reports, corrective actions, or recalls. These reports are regarded as part of ongoing investigations.
2. Contact points will be agreed between both Parties to permit authorities to be made aware with the appropriate speed in case of quality defect, batch recalls, counterfeiting and other problems concerning quality, which could necessitate additional controls or suspension of the distribution of the product.
Appendix 1
Relevant legislation, regulations and procedures
For the European Community the following legislation applies to Article 2(1):
Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices. Conformity assessment procedures.
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Conformity assessment procedures.
For the United States, the following legislation applies to Article 2(1):
The Federal Food, Drug and Cosmetic Act, 21. U.S.C. §§ 321 et seq.;
The Public Health Service Act, 42 U.S.C. §§ 201 et seq.;
Regulations of the United States Food and Drug Administration found at 21 C.F.R., in particular, Parts 800 to 1299;
Medical Devices; Third-Party Review of Selected Premarket Notifications; Pilot Program, 61 Fed. Reg. 14,789-14,796 (April 3, 1996).
Appendix 2
Scope of product coverage
Initial Coverage of the Transition Period:
Upon entry into force of this Annex ( 3 ), products qualifying for the transitional arrangements under this Agreement include:
all Class I products requiring premarket evaluations in the United States — see Table 1;
those Class II products listed in Table 2.
During the transition period:
The Parties will jointly identify additional product groups, including their related accessories, in line with their respective priorities as follows:
those for which review may be based primarily on written guidance which the Parties will use their best efforts to prepare expeditiously; and
those for which review may be based primarily on international standards, in order for the Parties to gain the requisite experience.
The corresponding additional product lists will be phased in on an annual basis. The Parties may consult with industry and other interested Parties in determining which products will be added.
Commencement of the Operational Period:
at the commencement of the operational period, product coverage shall extend to all Class I/II products covered during the transition period;
the FDA will expand the program to categories of Class II devices as is consistent with the results of the pilot, and with the FDA's ability to write guidance documents if the device pilot for the third party review of medical devices is successful. The MRA will cover to the maximum extent feasible all Class II devices listed in Table 3 for which FDA-accredited third-party review is available in the US.
Unless explicitly included by joint decision of the Parties, this agreement does not cover any US Class II-tier 3 or any Class III product under either system.
TABLE 1
Class I products requiring premarket evaluations in the United States, included in scope of product coverage at beginning of transition period
|
Section No |
Regulation Name Product Code — Device Name |
|
ANESTHESIOLOGY PANEL (868) |
|
|
868.1910 |
Esophageal stethoscope BZW — Stethoscope, esophageal |
|
868.5620 |
Breathing mouthpiece BYP — Mouthpiece, breathing |
|
868.5640 |
Medicinal nonventilatory nebulizer (atomizer) CCQ — Nebulizer, medicinal, non-ventilatory (atomizer) |
|
868.5675 |
Rebreathing device BYW — Device, rebreathing |
|
868.5700 |
Nonpowered oxygen tent FOG — Hood, oxygen, infant BYL — Tent, oxygen |
|
868.6810 |
Tracheobronchial suction catheter BSY — Catheters, suction, tracheobronchial |
|
CARDIOVASCULAR PANEL |
|
|
(None) |
|
|
DENTAL PANEL (872) |
|
|
872.3400 |
Karaya and sodium borate with or without acacia denture adhesive KOM — Adhesive, denture, acacia and karaya with sodium borate |
|
872.3700 |
Dental mercury (USP) ELY — Mercury |
|
872.4200 |
Dental handpieces and accessories EBW — Controller, foot, handpiece and cord EFB — Handpiece, air-powered, dental EFA — Handpiece, belt and/or gear driven, dental EGS — Handpiece, contra- and right-angle attachment, dental EKX — Handpiece, direct drive, ac-powered EKY — Handpiece, water-powered |
|
872.6640 |
Dental operative unit EIA — Unit, operative dental |
|
EAR, NOSE, AND THROAT PANEL (874) |
|
|
874.1070 |
Short increment sensitivity index (SISI) adapter ETR — Adapter, short increment sensitivity index (SISI) |
|
874.1500 |
Gustometer ETM — Gustometer |
|
874.1800 |
Air or water caloric stimulator KHH — Stimulator, caloric-air ETP — Stimulator, caloric-water |
|
874.1925 |
Toynbee diagnostic tube ETK — Tube, toynbee diagnostic |
|
874.3300 |
Hearing aid LRB — Face plate hearing-aid ESD — Hearing-aid, air-conduction |
|
874.4100 |
Epistaxis balloon EMX — Balloon, epistaxis |
|
874.5300 |
ENT — Examination and treatment unit ETF — Unit, examining/treatment, ent |
|
874.5550 |
Powered nasal irrigator KMA — Irrigator, powered nasal |
|
874.5840 |
Anti-stammering device KTH — Device, anti-stammering |
|
GASTROENTEROLOGY — UROLOGY PANEL (876) |
|
|
876.5160 |
Urological clamps for males FHA — Clamp, penile |
|
876.5210 |
Enema kit FCE — Kit, enema, (for cleaning purpose) |
|
876.5250 |
Urine collector and accessories FAQ — Bag, urine collection, leg, for external use |
|
GENERAL HOSPITAL PANEL (880) |
|
|
880.5270 |
Neonatal eye pad FOK — Pad, neonatal eye |
|
880.5420 |
Pressure infuser for I.V. bag KZD — Infusor, pressure, for I.V. bags |
|
880.5680 |
Pediatric position holder FRP — Holder, infant position |
|
880.6250 |
Patient examination glove LZB — Finger cot FMC — Glove, patient examination LYY — Glove, patient examination, latex LZA — Glove, patient examination, poly LZC — Glove, patient examination, speciality LYZ — Glove, patient examination, vinyl |
|
880.6375 |
Patient lubricant KMJ — Lubricant, patient |
|
880.6760 |
Protective restraint BRT — Restraint, patient, conductive FMQ — Restraint, protective |
|
NEUROLOGY PANEL (882) |
|
|
882.1030 |
Ataxiagraph GWW — Ataxiagraph |
|
882.1420 |
Electroencephalogram (EEG) signal spectrum analyser GWS — Analyser, spectrum, electroencephalogram signal |
|
882.4060 |
Ventricular cannula HCD — Cannula, ventricular |
|
882.4545 |
Shunt system implantation instrument GYK — Instrument, shunt system implantation |
|
882.4650 |
Neurosurgical suture needle HAS — Needle, neurosurgical suture |
|
882.4750 |
Skull punch GXJ — Punch, skull |
|
OBSTETRICS AND GYNECOLOGY PANEL |
|
|
(None) |
|
|
OPHTHALMOLOGY PANEL (886) |
|
|
886.1780 |
Retinoscope HKM — Retinoscope, battery-powered |
|
886.1940 |
Tonometer sterilizer HKZ — sterilizer, tonometer |
|
886.4070 |
Powered corneal burr HQS — Burr, corneal, ac-powered HOG — Burr, corneal, battery-powered HRG — Engine, trephine, accessories, ac-powered HFR — Engine, trephine, accessories, battery-powered HLD — Engine, trephine, accessories, gas-powered |
|
886.4300 |
Keratone HNO — Keratone, ac-powered HMY — Keratone, battery-powered |
|
886.5850 |
Sunglasses (non-prescription) HQY — Sunglasses (non-prescription including photosensitive) |
|
ORTHOPEDIC PANEL (888) |
|
|
888.1500 |
Ac-powered goniometer KQX — Goniometer, ac-powered |
|
888.4150 |
Callipers for clinical use KTZ — Calliper |
|
PHYSICAL MEDICINE PANEL (890) |
|
|
890.3850 |
Mechanical wheelchair LBE — Stroller, adaptive IOR — Wheelchair, mechanical |
|
890.5180 |
Manual patient rotation bed INY — Bed, patient rotation, manual |
|
890.5710 |
Hot or cold disposable pack IMD — Pack, hot or cold, disposable |
|
RADIOLOGY PANEL (892) |
|
|
892.1100 |
Scintillation gamma camera IYX — Camera, scintillation (gamma) |
|
892.1110 |
Positron camera IZC — Camera, positron |
|
892.1300 |
Nuclear rectilinear scanner IYW — Scanner, rectilinear, nuclear |
|
892.1320 |
Nuclear uptake probe IZD — Probe, uptake, nuclear |
|
892.1330 |
Nuclear whole body scanner JAM — Scanner, whole body, nuclear |
|
892.1410 |
Nuclear electrocardiograph synchroniser IVY — Synchroniser, electrocardiograph, nuclear |
|
892.1890 |
Radiographic-film illuminator IXC — Illuminatore radiographic-film JAG — Illuminatore radiographic-film, explosion-proof |
|
892.1910 |
Radiographic grid IXJ — Grid, radiographic |
|
892.1960 |
Radiographic intensifying screen WAM — Screen, intensifying, radiographic |
|
892.1970 |
Radiographic ECG/respirator synchroniser IXO — Synchroniser, ECG/respirator, radiographic |
|
892.5650 |
Manual radionuclide applicator system IWG — System, applicator, radionuclide, manual |
|
GENERAL AND PLASTIC SURGERY PANEL (878) |
|
|
878.4200 |
Introduction/drainage catheter and accessories KGZ — Accessories, catheter GCE — Adaptor, catheter FGY — Cannula, injection GBA — Catheter, balloon type GBZ — Catheter, cholangiography GBQ — Catheter, continuous irrigation GBY — Catheter, eustachian, general & plastic surgery JCY — Catheter, infusion GBX — Catheter, irrigation GBP — Catheter, multiple lumen GBO — Catheter, nephrostomy, general & plastic surgery GBN — Catheter, pediatric, general & plastic surgery GBW — Catheter, peritoneal GBS — Catheter, ventricular, general & plastic surgery GCD — Connector, catheter GCC — Dilator, catheter GCB — Needle, catheter |
|
878.4320 |
Removable skin clip FZQ — Clip, removable (skin) |
|
878.4460 |
Surgeon's gloves KGO — Surgeon's gloves |
|
878.4680 |
Nonpowered, single patient, portable suction apparatus GCY — Apparatus, suction, single patient use, portable, nonpowered |
|
878.4760 |
Removable skin staple GDT — Staple, removable (skin) |
|
878.4820 |
Ac-powered, battery-powered, and pneumatically powered surgical instrument motor GFG — Bit, surgical GFA — Blade, saw, general and plastic surgery DWH — Blade, saw, surgical, cardiovascular BRZ — Board, arm (with cover) GFE — Brush, dermabrasion GFF — Bur, surgical, general and plastic surgery KDG — Chisel (osteotome) GFD — Dermatome GFC — Driver, surgical, pin GFB — Head, surgical, hammer GEY — Motor, surgical instrument, ac-powered GET — Motor, surgical instrument, pneumatic powered DWI — Saw, electrically powered KFK — Saw, pneumatically powered HAB — Saw, powered, and accessories |
|
878.4960 |
Air or ac-powered operating table and air or ac-powered operating chair and accessories GBB — Chair, surgical, ac-powered FQO — Tabel, operating-room, ac-powered GDC — Tabel, operating-room, electrical FWW — Tabel, operating-room, pneumatic JEA — Tabel, surgical with orthopedic accessories, ac-powered |
|
880.5090 |
Liquid bandage KMF — Bandage, liquid |
TABLE 2
Class II medical devices included in scope of product coverage at beginning of transition period
(US to develop guidance documents identifying US requirements and EC to identify standards needed to meet EC requirements)
|
RA |
892.1000 |
Magnetic resonance diagnostic device MOS — Coil, magnetic resonance, specialty LNH — System, nuclear magnetic resonance imaging LNI — System, nuclear magnetic resonance spectroscopic |
|
DIAGNOSTIC ULTRASOUND |
||
|
RA |
892.1540 |
Nonfetal ultrasonic monitor JAF — Monitor, ultrasonic, nonfetal |
|
RA |
892.1550 |
Ultrasonic pulsed doppler imaging system IYN — System, imaging, pulsed doppler, ultrasonic |
|
RA |
892.1560 |
Ultrasonic pulsed echo imaging system IYO — System, imaging, pulsed echo, ultrasonic |
|
RA |
892.1570 |
Diagnostic ultrasonic transducer ITX — Transducer, ultrasonic, diagnostic |
|
DIAGNOSTIC X — RAY IMAGING DEVICES (except mammographic x-ray systems) |
||
|
RA |
892.1600 |
Angiographic x-ray system IZI — System, x-ray, angiographic |
|
RA |
892.1650 |
Image-intensified fluoroscopic x-ray system MQB — Solid state x-ray imager (flat panel/digital imager) JAA — System, x-ray, fluoroscopic, image-intensified |
|
RA |
892.1680 |
Stationary x-ray system KPR — System, x-ray, stationary |
|
RA |
892.1720 |
Mobile x-ray system IZL — System, x-ray, mobile |
|
RA |
892.1740 |
Tomographic x-ray system IZF — System, x-ray, tomographic |
|
RA |
892.1750 |
Computed tomography x-ray system JAK — System, x-ray, tomography, computed |
|
ECG-RELATED DEVICES |
||
|
CV |
870.2340 |
Electrocardiograph DPS — Electrocardiograph MLC — Monitor, st segment |
|
CV |
870.2350 |
Electrocardiograph lead switching adaptor DRW — Adaptor, lead switching, electrocardiograph |
|
CV |
870.2360 |
Electrocardiograph electrode DRX — Electrode, electrocardiograph |
|
CV |
870.2370 |
Electrocardiograph surface electrode tester KRC — Tester, electrode, surface, electrocardiographic |
|
NE |
882.1400 |
Electroencephalograph GWQ — Electroencephalograph |
|
HO |
880.5725 |
Infusion pump (external only) MRZ — Accessories, pump, infusion FRN — Pump, infusion LZF — Pump, infusion, analytical sampling MEB — Pump, infusion, elastomeric LZH — Pump, infusion, enteral MHD — Pump, infusion, gallstone dissolution LZG — Pump, infusion, insulin MEA — Pump, infusion, pca |
|
OPHTHALMIC INSTRUMENTS |
||
|
OP |
886.1570 |
Ophthalmoscope HLI — Ophthalmoscope, ac-powered HLJ — Ophthalmoscope, battery-powered |
|
OP |
886.1780 |
Retinoscope HKL — Retinoscope, ac-powered |
|
OP |
886.1850 |
Ac-powered slit-lamp biomicroscope HJO — Biomicroscope, slit-lamp, ac-powered |
|
OP |
886.4150 |
Vitreous aspiration and cutting instrument MMC — Dilator, expansive iris (accessory) HQE — Instrument, vitreous aspiration and cutting, ac-powered HKP — Instrument, vitreous aspiration and cutting, battery-powered MLZ — Vitrectomy, instrument cutter |
|
OP |
886.4670 |
Phacofragmentation system HQC — Unit, phacofragmentation |
|
SU |
878.4580 |
Surgical lamp HBI — Illuminator, fiberoptic, surgical field FTF — Illuminator, non-remote FTG — Illuminator, remote HJE — Lamp, fluorescent, ac-powered FQP — Lamp, operating-room FTD — Lamp, surgical GBC — Lamp, surgical, incandescent FTA — Light, surgical, accessories FSZ — Light, surgical, carrier FSY — Light, surgical, ceiling mounted FSX — Light, surgical, connector FSW — Light, surgical, endoscopic FST — Light, surgical, fiberoptic FSS — Light, surgical, floor standing FSQ — Light, surgical, instrument |
|
NE |
882.5890 |
Transcutaneous electrical nerve stimulator for pain relief GZJ — Stimulator, nerve, transcutaneous, for pain relief |
|
NON-INVASIVE BLOOD PRESSURE MEASUREMENT DEVICES |
||
|
CV |
870.1120 |
Blood pressure cuff DXQ — Cuff, blood-pressure |
|
CV |
870.1130 |
Non-invasive blood pressure measurement system (except non-oscillometric) DXN — System, measurement, blood-pressure, non-invasive |
|
HO |
880.6880 |
Steam steriliser (greater than 2 cubic feet) FLE — Steriliser, steam |
|
CLINICAL THERMOMETERS |
||
|
HO |
880.2910 |
Clinical electronic thermometer (except tympanic or pacifier) FLL — Thermometer, electronic, clinical |
|
AN |
868.5630 |
Nebuliser CAF — Nebuliser (direct patient interface) |
|
AN |
868.5925 |
Powered Emergency ventilator |
|
HYPODERMIC NEEDLES AND SYRINGES (except anti-stick and self-destruct) |
||
|
HO |
880.5570 |
Hypodermic single lumen needle MMK — Container, sharpes FMI — Needle, hypodermic, single lumen MHC — Port, intraosseous, implanted |
|
HO |
880.5860 |
Piston syringe FMF — Syringe, piston |
|
OR |
888.3020 |
Intramedullary fixation rod HSB — Rod, fixation, intramedullary and accessories |
|
EXTERNAL FIXATORS (except devices with no external components) |
||
|
OR |
888.3030 |
Single/multiple component metallic bone fixation appliances and accessories KTT — Appliance, fixation, nail/blade/plate combination, multiple component |
|
OR |
888.3040 |
Smooth or threaded metallic bone fixation fastener HTY — Pin, fixation, smooth JDW — Pin, fixation, threaded |
|
SELECTED DENTAL MATERIALS |
||
|
DE |
872.3060 |
Gold based alloys and precious metal alloys for clinical use EJT — Alloy, gold based, for clinical use EJS — Alloy, precious metal, for clinical use |
|
DE |
872.3200 |
Resin tooth bonding agent KLE — Agent, tooth bonding, resin |
|
DE |
872.3275 |
Dental cement EMA — Cement, dental EMB — Zinc oxide eugenol |
|
DE |
872.3660 |
Impression material ELW — Material, impression |
|
DE |
872.3690 |
Tooth shade resin material EBF — Material, tooth shade, resin |
|
DE |
872.3710 |
Base metal alloy EJH — Metal, base |
|
LATEX CONDOMS |
||
|
OB |
884.5300 |
Condom HIS — Condom |
TABLE 3
Medical devices for possible inclusion in scope of product coverage during operational period
|
Product Family |
Section No |
Device Name |
Tier |
|
ANAESTHESIOLOGY PANEL |
|||
|
Anesthesia Devices |
868.5160 |
Gas machine for anesthesia or analgesia |
2 |
|
868.5270 |
Breathing system heater |
2 |
|
|
868.5440 |
Portable oxygen generator |
2 |
|
|
868.5450 |
Respiratory gas humidifier |
2 |
|
|
868.5630 |
Nebuliser |
2 |
|
|
868.5710 |
Electrically powered oxygen tent |
2 |
|
|
868.5880 |
Anesthetic vaporiser |
2 |
|
|
Gas Analyzer |
868.1040 |
Powered Algesimeter |
2 |
|
868.1075 |
Argon gas analyser |
2 |
|
|
868.1400 |
Carbon dioxide gas analyser |
2 |
|
|
868.1430 |
Carbon monoxide gas analyser |
2 |
|
|
868.1500 |
Enflurane gas analyser |
2 |
|
|
868.1620 |
Halothane gas analyser |
2 |
|
|
868.1640 |
Helium gas analyser |
2 |
|
|
868.1670 |
Neon gas analyser |
2 |
|
|
868.1690 |
Nitrogen gas analyser |
2 |
|
|
868.1700 |
Nitrous oxide gas analyser |
2 |
|
|
868.1720 |
Oxygen gas analyser |
2 |
|
|
868.1730 |
Oxygen uptake computer |
2 |
|
|
Peripheral Nerve Stimulators |
868.2775 |
Electrical peripheral nerve stimulator |
2 |
|
Respiratory Monitoring |
868.1750 |
Pressure plethysmograph |
2 |
|
868.1760 |
Volume plethysmograph |
2 |
|
|
868.1780 |
Inspiratory airway pressure meter |
2 |
|
|
868.1800 |
Rhinoanemometer |
2 |
|
|
868.1840 |
Diagnostic spirometer |
2 |
|
|
868.1850 |
Monitoring spirometer |
2 |
|
|
868.1860 |
Peak-flow meter for spirometry |
2 |
|
|
868.1880 |
Pulmonary-function data calculator |
2 |
|
|
868.1890 |
Predictive pulmonary-function value calculator |
2 |
|
|
868.1900 |
Diagnostic pulmonary-function interpretation calculator |
2 |
|
|
868.2025 |
Ultrasonic air embolism monitor |
2 |
|
|
868.2375 |
Breathing frequency monitor (except apnea detectors) |
2 |
|
|
868.2480 |
Cutaneous carbon dioxide (PcCO2) monitor |
2 |
|
|
868.2500 |
Cutaneous oxygen monitor (for an infant not under gas anesthesia) |
2 |
|
|
868.2550 |
Pneumotachomometer |
2 |
|
|
868.2600 |
Airway pressure monitor |
2 |
|
|
868.5665 |
Powered percussor |
2 |
|
|
868.5690 |
Incentive spirometer |
2 |
|
|
Ventilator |
868.5905 |
Nonconinuous ventilator (IPPB) |
2 |
|
868.5925 |
Powered emergency ventilator |
2 |
|
|
868.5935 |
External negative pressure ventilator |
2 |
|
|
868.5895 |
Continuous ventilator |
2 |
|
|
868.5955 |
Intermittent mandatory ventilation attachment |
2 |
|
|
868.6250 |
Portable air compressor |
2 |
|
|
CARDIOVASCULAR PANEL |
|||
|
Cardiovascular Diagnostic |
870.1425 |
Programmable diagnostic computer |
2 |
|
870.1450 |
Densitometer |
2 |
|
|
870.2310 |
Apex cardiograph (vibrocardiograph) |
2 |
|
|
870.2320 |
Ballistocardiograph |
2 |
|
|
870.2340 |
Electrocardiograph |
2 |
|
|
870.2350 |
Electrocardiograph lead switching adaptor |
1 |
|
|
870.2360 |
Electrocardiograph electrode |
2 |
|
|
870.2370 |
Electrocardiograph surface electrode tester |
2 |
|
|
870.2400 |
Vectorcardiograph |
1 |
|
|
870.2450 |
Medical cathode-ray tube display |
1 |
|
|
870.2675 |
Oscillometer |
2 |
|
|
870.2840 |
Apex cardiographic transducer |
2 |
|
|
870.2860 |
Heart sound transducer |
2 |
|
|
Cardiovascular Monitoring |
|
Valve, pressure relief, cardiopulmonary bypass |
|
|
870.1100 |
Blood pressure alarm |
2 |
|
|
870.1110 |
Blood pressure computer |
2 |
|
|
870.1120 |
Blood pressure cuff |
2 |
|
|
870.1130 |
Non-invasive blood pressure measurement system |
2 |
|
|
870.1140 |
Venous blood pressure manometer |
2 |
|
|
870.1220 |
Electrode recording catheter or electrode recording probe |
2 |
|
|
870.1270 |
Intracavitary phonocatheter system |
2 |
|
|
870.1875 |
Stethoscope (electronic) |
2 |
|
|
870.2050 |
Biopotential amplifier and signal conditioner |
2 |
|
|
870.2060 |
Transducer signal amplifier and conditioner |
2 |
|
|
870.2100 |
Cardiovascular blood flow-meter |
2 |
|
|
870.2120 |
Extravascular blood flow probe |
2 |
|
|
870.2300 |
Cardiac monitor (including) cardiotachometer and rate alarm) |
2 |
|
|
870.2700 |
Oximeter |
2 |
|
|
870.2710 |
Ear oximeter |
2 |
|
|
870.2750 |
Impedance phlebograph |
2 |
|
|
870.2770 |
Impedance plethysmograph |
2 |
|
|
870.2780 |
Hydraulic, pneumatic, or photoelectric plethysmographs |
2 |
|
|
870.2850 |
Extravascular blood pressure transducer |
2 |
|
|
870.2870 |
Catheter tip pressure transducer |
2 |
|
|
870.2880 |
Ultrasonic transducer |
2 |
|
|
870.2890 |
Vessel occlusion transducer |
2 |
|
|
870.2900 |
Patient transducer and electrode cable (including connector) |
2 |
|
|
870.2910 |
Radiofrequency physiological signal transmitter and receiver |
2 |
|
|
870.2920 |
Telephone electrocardiograph transmitter and receiver |
2 |
|
|
870.4205 |
Cardiopulmonary bypass bubble detector |
2 |
|
|
870.4220 |
Cardiopulmonary bypass heart-lung machine console |
2 |
|
|
870.4240 |
Cardiovascular bypass heat exchanger |
2 |
|
|
870.4250 |
Cardiopulmonary bypass temperature controller |
2 |
|
|
870.4300 |
Cardiopulmonary bypass gas control unit |
2 |
|
|
870.4310 |
Cardiopulmonary bypass coronary pressure gauge |
2 |
|
|
870.4330 |
Cardiopulmonary bypass on-line blood gas monitor |
2 |
|
|
870.4340 |
Cardiopulmonary bypass level sensing monitor and/or control |
2 |
|
|
870.4370 |
Roller-type cardiopulmonary bypass blood pump |
2 |
|
|
870.4380 |
Cardiopulmonary bypass pump speed control |
2 |
|
|
870.4410 |
Cardiopulmonary bypass in-line blood gas sensor |
2 |
|
|
Cardiovascular Therapeutic |
870.5050 |
Patient care suction apparatus |
2 |
|
870.5900 |
Thermal regulation system |
2 |
|
|
Defibrillator |
870.5300 |
DC-defibrillator (including paddles) |
2 |
|
870.5325 |
Defibrillator tester |
2 |
|
|
Echocardiograph |
870.2330 |
Echocardiograph |
2 |
|
Pacemaker and Accessories |
870.1750 |
External programmable pacemaker pulse generator |
2 |
|
870.3630 |
Pacemaker generator function analyser |
2 |
|
|
870.3640 |
Indirect pacemaker generator function anlayser |
2 |
|
|
870.3720 |
Pacemaker electrode function tester |
2 |
|
|
Miscellaneous |
870.1800 |
Withdrawal-infusion pump |
2 |
|
870.2800 |
Medical magnetic tape recorder |
2 |
|
|
None |
Batteries, rechargeable, Class II devices |
2 |
|
|
DENTAL PANEL |
|||
|
Dental Equipment |
872.1720 |
Pulp tester |
2 |
|
872.1740 |
Caries detection device |
2 |
|
|
872.4120 |
Bone cutting instrument and accessories |
2 |
|
|
872.4465 |
Gas-powered jet injector |
2 |
|
|
872.4475 |
Spring-powered jet injector |
2 |
|
|
872.4600 |
Intraoral ligature and wire lock |
2 |
|
|
872.4840 |
Rotary scaler |
2 |
|
|
872.4850 |
Ultrasonic scaler |
2 |
|
|
872.4920 |
Dental electrosurgical unit and accessories |
2 |
|
|
872.6070 |
Ultraviolet activator for polymerisation |
2 |
|
|
872.6350 |
Ultraviolet detector |
2 |
|
|
Dental Material |
872.3050 |
Amalgam alloy |
2 |
|
872.3060 |
Gold-based alloys and precious metal alloys for clinical use |
2 |
|
|
872.3200 |
Resin tooth bonding agent |
2 |
|
|
872.3250 |
Calcium hydroxide cavity liner |
2 |
|
|
872.3260 |
Cavity varnish |
2 |
|
|
872.3275 |
Dental cement (other than zinc oxide-eugenol) |
2 |
|
|
872.3300 |
Hydrophilic resin coating for dentures |
2 |
|
|
872.3310 |
Coating material for resin fillings |
2 |
|
|
872.3590 |
Preformed plastic denture tooth |
2 |
|
|
872.3660 |
Impression material |
2 |
|
|
872.3690 |
Tooth shade resin material |
2 |
|
|
872.3710 |
Base metal alloy |
2 |
|
|
872.3750 |
Bracket adhesive resin and tooth conditioner |
2 |
|
|
872.3760 |
Denture relining, repairing, or rebasing resin |
2 |
|
|
872.3765 |
Pit and fissure sealant and conditioner |
2 |
|
|
872.3770 |
Temporary crown and bridge resin |
2 |
|
|
872.3820 |
Root canal filling resin (other than chloroform use) |
2 |
|
|
872.3920 |
Porcelain tooth |
2 |
|
|
Dental x-ray |
872.1800 |
Extraoral source x-ray system |
2 |
|
872.1810 |
Intraoral source x-ray system |
2 |
|
|
Dental Implants |
872.4880 |
Intraosseous fixation screw or wires |
2 |
|
872.3890 |
Endodontic stabilising splint |
2 |
|
|
Orthodontic |
872.5470 |
Orthodontic plastic bracket |
2 |
|
EAR/NOSE/THROAT PANEL |
|||
|
Diagnostic Equipment |
874.1050 |
Audiometer |
2 |
|
874.1090 |
Auditory impedance tester |
2 |
|
|
874.1120 |
Electronic noise generator for audiometric testing |
2 |
|
|
874.1325 |
Electroglottograph |
2 |
|
|
874.1820 |
Surgical nerve stimulator/locator |
2 |
|
|
Hearing Aids |
874.3300 |
Hearing aid (for bone-conduction) |
2 |
|
874.3310 |
Hearing aid calibrator and analysis system |
2 |
|
|
874.3320 |
Group hearing aid or group auditory trainer |
2 |
|
|
874.3330 |
Master hearing aid |
2 |
|
|
Surgical Equipment |
874.4250 |
Ear, nose, and throat electric or pneumatic surgical drill |
1 |
|
874.4490 |
Argon laser for otology, rhinology, and laryngology |
2 |
|
|
874.4500 |
ENT microsurgical carbon dioxide laser |
2 |
|
|
GASTROENTEROLOGY/UROLOGY PANEL |
|||
|
Endoscope (including angioscopes, laparscopes, ophtalmic endoscopes) |
876.1500 |
Endoscope and accessories |
2 |
|
876.4300 |
Endoscopic electrosurgical unit and accessories |
2 |
|
|
Gastroenterology |
876.1725 |
Gastrointestinal motility monitoring system |
1 |
|
Hemodialysis |
876.5600 |
Sorbent regenerated dialysate delivery system for hemodialysis |
2 |
|
876.5630 |
Peritoneal dialysis system and accessories |
2 |
|
|
876.5665 |
Water purification system for hemodialysis |
2 |
|
|
876.5820 |
Hemodialysis system for accessories |
2 |
|
|
876.5830 |
Hemodialyser with disposable insert (kiil-type) |
2 |
|
|
Lithotriptor |
876.4500 |
Mechanical lithotriptor |
2 |
|
Urology Equipment |
876.1620 |
Urodynamics measurement system |
2 |
|
876.5320 |
Nonimplanted electrical continence device |
2 |
|
|
876.5880 |
Isolated kidney perfusion and transport system and accessories |
2 |
|
|
GENERAL HOSPITAL PANEL |
|||
|
Infusion Pumps and Systems |
880.2420 |
Electronic monitor for gravity flow infusion systems |
2 |
|
880.2460 |
Electrically powered spinal fluid pressure monitor |
2 |
|
|
880.5430 |
Nonelectrically powered fluid injector |
2 |
|
|
880.5725 |
Infusion pump |
2 |
|
|
Neonatal Incubators |
880.5400 |
Neonatal incubator |
2 |
|
880.5410 |
Neonatal transport incubator |
2 |
|
|
880.5700 |
Neonatal phototherapy unit |
2 |
|
|
Piston Syringes |
880.5570 |
Hypodermic single lumen needle |
1 |
|
880.5860 |
Piston syringe (except anti-stick) |
1 |
|
|
880.6920 |
Syringe needle introducer |
2 |
|
|
Miscellaneous |
880.2910 |
Clinical electronic thermometer |
2 |
|
880.2920 |
Clinical mercury thermometer |
2 |
|
|
880.5100 |
AC-powered adjustable hospital bed |
1 |
|
|
880.5500 |
AC-powered patient lift |
2 |
|
|
880.6880 |
Steam Steriliser (greater than 2 cubic feet) |
2 |
|
|
NEUROLOGY PANEL |
|||
|
|
882.1020 |
Rigidity analyser |
2 |
|
|
882.1610 |
Alpha monitor |
2 |
|
Neuro-Diagnostic |
882.1320 |
Cutaneous electrode |
2 |
|
882.1340 |
Nasopharyngeal electrode |
2 |
|
|
882.1350 |
Needle electrode |
2 |
|
|
882.1400 |
Electroencephalograph |
2 |
|
|
882.1460 |
Nystagmograph |
2 |
|
|
882.1480 |
Neurological endoscope |
2 |
|
|
882.1540 |
Galvanic skin response measurement device |
2 |
|
|
882.1550 |
Nerve conduction velocity measurement device |
2 |
|
|
882.1560 |
Skin potential measurement device |
2 |
|
|
882.1570 |
Powered direct-contact temperature measurement device |
2 |
|
|
882.1620 |
Intracranial pressure monitoring device |
2 |
|
|
882.1835 |
Physiological signal amplifier |
2 |
|
|
882.1845 |
Physiological signal conditioner |
2 |
|
|
882.1855 |
Electroencephalogram (EEG) telemetry system |
2 |
|
|
882.5050 |
Biofeedback device |
2 |
|
|
Echoencephalography |
882.1240 |
Echoencephalograph |
2 |
|
RPG |
882.4400 |
Radiofrequency lesion generator |
2 |
|
Neuro Surgery |
none |
Electrode, spinal epidural |
2 |
|
882.4305 |
Powered compound cranial drills, burrs, trephines and their accessories |
2 |
|
|
882.4310 |
Powered simple cranial drills, burrs, trephines and accessories |
2 |
|
|
882.4360 |
Electric cranial drill motor |
2 |
|
|
882.4370 |
Pneumatic cranial drill motor |
2 |
|
|
882.4560 |
Sterotaxic instrument |
2 |
|
|
882.4725 |
Radiofrequency lesion probe |
2 |
|
|
882.4845 |
Powered rongeur |
2 |
|
|
882.5500 |
Lesion temperature monitor |
2 |
|
|
Stimulators |
882.1870 |
Evoked response electrical stimulator |
2 |
|
882.1880 |
Evoked response mechanical stimulator |
2 |
|
|
882.1890 |
Evoked response photic stimulator |
2 |
|
|
882.1900 |
Evoked response auditory stimulator |
2 |
|
|
882.1950 |
Tremor transducer |
2 |
|
|
882.5890 |
Transcutaneous electrical nerve stimulator for pain relief |
2 |
|
|
OBSTETRICS/GYNAECOLOGY PANEL |
|||
|
Fetal Monitoring |
884.1660 |
Transcervical endoscope (amnioscope) and accessories |
2 |
|
884.1690 |
Hysteroscope and accessories (for performance standards) |
2 |
|
|
884.2225 |
Obstetric-gynecologic ultrasonic imager |
2 |
|
|
884.2600 |
Fetal cardiac monitor |
2 |
|
|
884.2640 |
Fetal phonocardiographic monitor and accessories |
2 |
|
|
884.2660 |
Fetal ultrasonic monitor and accessories |
2 |
|
|
884.2675 |
Fetal scalp circular (spiral) electrode and applicator |
1 |
|
|
884.2700 |
Intrauterine pressure monitor and accessories |
2 |
|
|
884.2720 |
External uterine contraction monitor and accessories |
2 |
|
|
884.2740 |
Perinatal monitoring system and accessories |
2 |
|
|
884.2960 |
Obstetric ultrasonic transducer and accessories |
2 |
|
|
Gynecological Surgery Equipment |
884.1720 |
Gynecologic laparoscope and accessories |
2 |
|
884.4160 |
Unipolar endoscopic coagulator-cutter and accessories |
2 |
|
|
884.4550 |
Gynecologic surgical laser |
2 |
|
|
884.4120 |
Gynecologic electrocautery and accessories |
2 |
|
|
884.5300 |
Condom |
2 |
|
|
Ophthalm. Implants |
886.3320 |
Eye sphere implant |
2 |
|
Contact Lens |
886.1385 |
Polymethylmethacrylate (PMMA) diagnostic contact lens |
2 |
|
886.5916 |
Rigid gas permeable contact lens (daily wear only) |
2 |
|
|
Diagnostic Equipment |
886.1120 |
Ophthalmic camera |
1 |
|
886.1220 |
Corneal electrode |
1 |
|
|
886.1250 |
Euthyscope (AC-powered) |
1 |
|
|
886.1360 |
Visual field laser instrument |
1 |
|
|
886.1510 |
Eye movement monitor |
1 |
|
|
886.1570 |
Ophthalmoscope |
1 |
|
|
886.1630 |
AC-powered photostimulator |
1 |
|
|
886.1640 |
Ophthalmic preamplifier |
1 |
|
|
886.1670 |
Ophthalmic isotope uptake probe |
2 |
|
|
886.1780 |
Retinoscope (AC-powered device) |
1 |
|
|
886.1850 |
AC-powered slitlamp biomicroscope |
1 |
|
|
886.1930 |
Tonometer and accessories |
2 |
|
|
886.1945 |
Transilluminator (AC-powered device) |
1 |
|
|
886.3130 |
Ophthalmic conformer |
2 |
|
|
(Diagnostic/Surgery Equipment) |
886.4670 |
Phacofragmentation System |
2 |
|
Ophthalm. Implants |
886.3340 |
Extraocular orbital implant |
2 |
|
886.3800 |
Scleral shell |
2 |
|
|
Surgical Equipment |
886.5725 |
Infusion pump (performance standards) |
2 |
|
886.3100 |
Ophthalmic tantalum clip |
2 |
|
|
886.3300 |
Absorbable implant (scleral buckling method) |
2 |
|
|
886.4100 |
Radiofrequency electrosurgical cautery apparatus |
2 |
|
|
886.4115 |
Thermal cautery unit |
2 |
|
|
886.4150 |
Vitreous aspiration and cutting instrument |
2 |
|
|
886.4170 |
Cryophthalmic unit |
2 |
|
|
886.4250 |
Ophthalmic electrolysis unit (AC-powered device) |
1 |
|
|
886.4335 |
Operating headlamp (AC-powered device) |
1 |
|
|
886.4390 |
Ophthalmic laser |
2 |
|
|
886.4392 |
Nd:YAG laser for posterior capsulotomy |
2 |
|
|
886.4400 |
Electronic metal locator |
1 |
|
|
886.4440 |
AC-powered magnet |
1 |
|
|
886.4610 |
Ocular pressure applicator |
2 |
|
|
886.4690 |
Ophthalmic photocoagulator |
2 |
|
|
886.4790 |
Ophthalmic sponge |
2 |
|
|
886.5100 |
Ophthalmic beta radiation source |
2 |
|
|
none |
Ophthalmoscopes, replacement batteries, hand-held |
1 |
|
|
ORTHOPEDIC PANEL |
|||
|
Implants |
888.3010 |
Bone fixation cerclage |
2 |
|
888.3020 |
Intramedullary fixation rod |
2 |
|
|
888.3030 |
Single/multiple component metallic bone fixation appliance and accessories |
2 |
|
|
888.3040 |
Smooth or threaded metallic bone fixation |
2 |
|
|
888.3050 |
Spinal interlaminal fixation orthosis |
2 |
|
|
888.3060 |
Spinal intervertebral body fixation orthosis |
2 |
|
|
Surgical Equipment |
888.1240 |
AC-powered dynamometer |
2 |
|
888.4580 |
Sonic surgical instrument and accessories/attachments |
2 |
|
|
none |
Accessories, fixation, spinal interlaminal |
2 |
|
|
none |
Accessories, fixation, spinal intervertebral body |
2 |
|
|
none |
Monitor, pressure, intracompartmental |
1 |
|
|
none |
Orthosis, fixation, spinal intervertebral fusion |
2 |
|
|
none |
Orthosis, spinal pedicle fixation |
|
|
|
none |
System, cement removal extraction |
1 |
|
|
PHYSICAL MEDICINE PANEL |
|||
|
Diagnostic Equipement or (Therapy) |
890.1225 |
Chronaximeter |
2 |
|
890.1375 |
Diagnostic electromyograph |
2 |
|
|
890.1385 |
Diagnostic electromyograph needle electrode |
2 |
|
|
890.1450 |
Powered reflex hammer |
2 |
|
|
890.1850 |
Diagnostic muscle stimulator |
2 |
|
|
890.5850 |
Powered muscle stimulator |
2 |
|
|
Therapeutic Equipment |
890.5100 |
Immersion hydrobath |
2 |
|
890.5110 |
Paraffin bath |
2 |
|
|
890.5500 |
Infrared lamp |
2 |
|
|
890.5720 |
Water circulating hot or cold pack |
2 |
|
|
890.5740 |
Powered heating pad |
2 |
|
|
RADIOLOGY PANEL |
|||
|
MRI |
892.1000 |
Magnetic resonance diagnostic device |
2 |
|
Ultrasound Diagnostic |
884.2660 |
Fetal ultrasonic monitor and accessories |
2 |
|
892.1540 |
Nonfetal ultrasonic monitor |
|
|
|
892.1560 |
Ultrasonic pulsed echo imaging system |
2 |
|
|
892.1570 |
Diagnostic ultrasonic transducer |
2 |
|
|
892.1550 |
Ultrasonic pulsed doppler imaging system |
|
|
|
Angiographic |
892.1600 |
Angiographic x-ray system |
2 |
|
Diagnostic X-Ray |
892.1610 |
Diagnostic x-ray beam-limiting device |
2 |
|
892.1620 |
Cine or spot fluorographic x-ray Camera |
2 |
|
|
892.1630 |
Electrostatic x-ray imaging system |
2 |
|
|
892.1650 |
Image-intensified fluoroscopic x-ray system |
2 |
|
|
892.1670 |
Spot film device |
2 |
|
|
892.1680 |
Stationary x-ray system |
2 |
|
|
892.1710 |
Mammographic x-ray system |
2 |
|
|
892.1720 |
Mobile x-ray system |
2 |
|
|
892.1740 |
Tomographic x-ray system |
1 |
|
|
892.1820 |
Pneumoencephalographic chair |
2 |
|
|
892.1850 |
Radiographic film cassette |
1 |
|
|
892.1860 |
Radiographic film/cassette changer |
1 |
|
|
892.1870 |
Radiographic film/cassette changer programmer |
2 |
|
|
892.1900 |
Automatic radiographic film processor |
2 |
|
|
892.1980 |
Radiologic table |
1 |
|
|
CT Scanner |
892.1750 |
Computed tomography x-ray system |
2 |
|
Radiation Therapy |
892.5050 |
Medical charged-particle radiation therapy system |
2 |
|
892.5300 |
Medical neutron radiation therapy system |
2 |
|
|
892.5700 |
Remote controlled radionuclide-applicator system |
2 |
|
|
892.5710 |
Radiation therapy beam-shaping block |
2 |
|
|
892.5730 |
Radionuclide brachytherapy source |
2 |
|
|
892.5750 |
Radionuclide radiation therapy system |
2 |
|
|
892.5770 |
Powered radiation therapy patient support assembly |
2 |
|
|
892.5840 |
Radiation therapy stimulation system |
2 |
|
|
892.5930 |
Therapeutic x-ray tube housing assembly |
1 |
|
|
Nuclear Medicine |
892.1170 |
Bone densitometer |
2 |
|
892.1200 |
Emission computed tomography system |
2 |
|
|
892.1310 |
Nuclear tomography system |
1 |
|
|
892.1390 |
Radionuclide rebreathing system |
2 |
|
|
GENERAL/PLASTIC SURGERY PANEL |
|||
|
Surgical Lamps |
878.4630 |
Ultraviolet lamp for dermatologic disorders |
2 |
|
890.5500 |
Infrared lamp |
2 |
|
|
878.4580 |
Surgical lamp |
2 |
|
|
Electrosurgical Cutting Equipment |
878.4810 |
Laser surgical instrument for use in general and plastic surgery and in dermatology |
2 |
|
878.4400 |
Electrosurgical cutting and coagulation device and accessories |
2 |
|
|
Miscellaneous |
878.4780 |
Powered suction pump |
2 |
Appendix 3
Authorities responsible for designating conformity assessment bodies
|
EC access to the US market |
US access to the EC market |
|
— Belgium — Ministère de la Santé publique, de l'Environnement et de l'Intégration sociale — Ministerie van Volksgezondheid, Leefmilieu en Sociale Inetgratie — Denmark — Sundhedsministeriet — Germany — Bundesministerium für Gesundheit — Greece — Yπουργείο Yγείας — Ministry of Health — Spain — Ministerio de Sanidad y Consumo — France — Ministère de l'emploi et de la solidarité — Ministère de l'économie, des finances et de l'industrie — Ireland — Department of Health — Italy — Ministero della Sanitá — Luxembourg — Ministère de la Santé — Netherlands — Staat der Nederlanden — Austria — Bundesministerium für Arbeit, Gesundheit und Soziales — Portugal — Ministerio da Saude — Finland — Sosiaali-ja terveysministeriö/Social-och hälsovårdsministeriet — Sweden — Under the authority of the Government of Sweden: — Styrelsen för ackreditering och teknisk kontroll (SWEDAC) — United Kingdom — Department of Health |
Food and Drug Administration (FDA) |
Appendix 4
Conformity assessment bodies
|
EC access to the US market |
US access to the EC market |
|
Conformity assessment bodies located in the EC shall be designated by the Authorities identified in Appendix 3. |
Conformity assessment bodies located in the US shall be designated by the Authorities identified in Appendix 3. |
|
(to be provided by the EC) |
(to be provided by the US) |
JOINT DECLARATION
to the Agreement on Mutual Recognition between the European Community and the United States of America
The Parties agree that, although in this exceptional case the Agreement on Mutual Recognition between the United States of America and the European Community is being signed while the consistency of the various linguistic versions of the Agreement is being verified, notification of the completion of their respective procedures for the entry into force of the Agreement, as referred to in Article 21(1) of the Agreement, will be made only after the Parties have completed the verification of the texts signed today and, through agreement between the Parties, any discrepancies have been brought into conformity with the English text.
Done at London on the eighteenth day of May in the year one thousand nine hundred and ninety-eight.
For the European Community
For the United States of America
( 1 ) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
( 2 ) Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1).
( *1 ) These are included to the extent that they are regulated as drugs by the FDA and medicinal products by the EU.
( *2 ) These products are only included within the product coverage of this Annex to the extent the Joint Sectoral Committee decides to include them pursuant to Article 20.
( *3 ) The FDA does not routinely conduct GMP inspections for investigational medicinal products. Inspection information on these products will be provided to the extent that they are available and resources allow. These products are only included within the product coverage of this Annex to the extent the Joint Sectoral Committee decides to include them.
( 3 ) It is understood that the date of entry into force will not occur prior to 1 June 1998, unless the Parties decide otherwise.