2.1.

The provisions of this Annex shall apply to the following types of telecommunications terminal equipment, radio transmitters and information technology equipment:

2.2.

A list of the interfaces and services covered by each Party is referenced at Attachment 2.

2.3.

Both Parties agree that the following is an illustrative but not exhaustive list of covered categories of radio transmitters:

3.1.

This Annex shall apply to all mandatory approval requirements, adopted within the territories of the Parties, by government organisations and/or bodies which have the legal powers to enforce a technical requirement, for the equipment referenced in Attachment 2. The relevant technical requirements are specified under the legislation referenced in Attachment 1.

3.2.

Any requirements and conformity assessment procedures applied to domestic products shall be applied with no additional requirements or variations to products or conformity assessment results originating from the other Party.

4.1.

Both Parties affirm that their conformity assessment bodies, recognised under this Annex, are authorised to perform the following activities with regard to each other's technical requirements for telecommunications terminal equipment, radio transmitters and information technology equipment:

4.2.

Certificates of conformity delivered by the designated conformity assessment bodies of each Party under the provisions of this Annex will be recognised by the authorities of the other Party without any further assessment of the products.

5.1.

5.2.

6.1.

There will be a transitional period of 18 months before the provisions of this Annex, notably section 4, become fully operational.

6.2.

This transitional period will be used by the Parties:

6.3.

During the transitional period the Parties will also reciprocally recognise test reports and related documents issued by designated conformity assessment bodies of the other party in accordance with the provisions of this Annex. To this end, the approving authorities listed in Attachment 5 shall accept test reports and related documents, and evaluations from the designated bodies in the territory of the other Party, for the purposes of approval, without imposing additional requirements, and shall ensure that:

6.4.

Each approving authority commits itself to issuing approvals or advising the applicant no later than six (6) weeks from receipt of the test report and evaluation from a designated body in the territory of the other Party.

6.5.

At the end of the transitional period the Parties will proceed to full mutual recognition of certificates of compliance issued by designated bodies in 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 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 will implement such action prior to the expiry of the transitional period.

7.1.

Any subcontracting shall be in accordance with the subcontracting requirements of the other Party.

7.2.

The conformity assessment bodies shall record and retain details of its investigation of the competence and compliance of its subcontractors and maintain a register of all subcontracting. These details will be available to the other Party on request.

7.3.

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.

7.4.

When a report of misuse of a mark of conformity or of a hazard involving an approved product covered under this Annex has occurred, both Parties will jointly determine the scope of the misuse and the nature and degree of corrective action to be taken.

7.5.

The Joint Committee established under the Framework Mutual Recognition Agreement may appoint a Joint Telecommunications Group which shall meet as required to discuss technical, conformity assessment and technology issues relating to this Annex.

7.6.

Each Party shall establish a contact point to provide answers to all reasonable inquiries from the other Party regarding procedures, regulations and complaints.

7.7.

As provided in the transitional arrangements set out in section 6.2 the Parties may jointly sponsor two seminars, one in Canada and one in the European Community, concerning the relevant technical and product approval requirements during the first year after the Annex enters into force.

7.8.

The Parties shall also inform each other of changes to relevant regulations, specifications, test methods, standards and administrative procedures within thirty (30) working days of their domestic notification.

7.9.

In the event that there are changes to the regulations referenced in Attachment 1 or the introduction of new regulations affecting conformity assessment procedures taking place in either Party, the Parties will update this Annex.

7.10.

Where products covered by this Annex are subject also to electrical safety or EMC requirements the relevant provisions of the Sectoral Annexes on electrical safety and EMC will also apply.

1.1.

The provisions of this Annex shall apply to the following:

2.1.

The relevant technical requirements are specified under the legislation and regulations referenced in Attachment 1.

2.2.

Any requirements and conformity assessment procedures applied by one Party to its domestic products shall be applied with no additional requirements or variations to products or conformity assessment results originating from the other Party.

3.1.

Each Party agrees to recognise all of the other Party's reports, certificates, and technical construction files, as required, under their respective legislation without any further assessment of the products.

3.2.

Both Parties agree to recognise each other's suppliers declarations of compliance, as required under their respective legislation.

(a)

The designating authorities for the purpose of this Annex are listed in Attachment 2.

(b)

Each Party shall notify the other within ten (10) working days of changes in the identity of their designating authorities and their authority to carry out the obligations under this Annex.

(a)

Conformity assessment bodies designated under this Annex shall be recognised as competent to perform the conformity assessment activities for EMC. Each Party shall ensure that the designated bodies comply with the criteria and standards set out in the regulatory requirements of the other Party. A list of designated bodies is included in Attachment 3.

(b)

Designation, suspension or withdrawal of conformity assessment bodies under this Annex shall be in conformance with procedures determined by the Joint Committee established under the Framework Mutual Recognition Agreement.

5.1.

The mutual recognition provisions of this Annex, notably section 3, will take effect 18 months following the entry into force of this Annex.

5.2.

During the period between the signing of the Agreement and its coming into effect, the Parties will work together to:

6.1.

Any subcontracting of conformity assessment shall be in accordance with the subcontracting requirements of the other Party.

6.2.

The conformity assessment bodies shall record and retain details of its investigation into the competence and compliance of its subcontractors and maintain a register of all subcontracting. These details will be available promptly to the other Party on request.

6.3.

For the purpose of post-market surveillance, the Parties may establish labelling, numbering or marking requirements. The assignment of numbers or affixing of labels or marks may take place in the territory of the exporting party.

6.4.

Each Party shall establish a contact point to provide answers to all reasonable inquiries from the other Party regarding procedures, regulations and complaints.

6.5.

The Parties shall also inform each other of changes to relevant regulations, specifications, test methods, standards and administrative procedures within thirty (30) working days of their domestic notification.

6.6.

In the event that there are changes to the technical regulations and conformity assessment procedures referenced in Attachment 1 or in the event of the introduction of new regulations in the jurisdiction of either Party, the Parties will update this Annex.

6.7.

Where products covered by this Annex are subject also to electrical safety or radio or telecommunication attachment requirements the relevant provisions of the Sectoral Annexes on electrical safety, telecommunication terminal equipment, information technology equipment and radio transmitters will also apply.

1.1.

The purpose of this Annex is to establish a framework for the acceptance of electrical products through the recognition of conformity assessment carried out by bodies which comply with the requirements of the other Party, while maintaining the integrity of the safety system in each of the Parties.

1.2.

This Annex also sets out procedures for the recognition of:

2.1.

For access to the EC: the safety of electrical equipment falling within the scope of the Low Voltage Directive (Council Directive 73/23/EEC of 19 February 1973 as amended by Directive 93/68/EEC) (1).

2.2.

For access to Canada: low voltage electrical equipment, including medical devices, covered by the Canadian Electrical Code, except for those products specifically excluded under the Low Voltage Directive (other than medical devices).

2.3.

The legislative, regulatory and administrative requirements applicable in each Party and the regulatory authorities responsible for electrical safety are listed in Attachment 1.

3.1.

Authorities set out in Attachment 2 are those organisations/public authorities responsible for assuring the competence and the control of CABs to certify electrical equipment in their territories to the requirements of the other Party.

4.1.

The transitional arrangements shall operate for a term of eighteen (18) months from the time this MRA enters into force.

4.2.

The purpose of the transition phase is to provide the responsible/designating authorities with an opportunity to build confidence and understanding of each other's procedures for recognising CABs and in the ability of those bodies to carry out their mandates. Successful completion of the transition phase should result in the determination by the responsible authorities that nominated CABs comply with the applicable criteria and are competent to conduct conformity assessment activities acceptable to the other Party.

4.3.

During the transition phase, the authorities may jointly sponsor two seminars, one in Canada and one in the EC, concerning the relevant technical and product approval requirements.

5.1.

During the transition phase, Canadian CABs shall accept test reports and related documents issued by nominated CABs in the other territory. For Community CABs, they must satisfy the following requirements:

5.2.

During the transition phase, Community CABs will:

5.3.

Canadian certification organisations shall ensure that:

6.1.

During the transition phase, the Joint Committee shall develop mutually acceptable mechanisms and procedures for marking of products to be exported to Canada in order to indicate their conformity with Canadian requirements. Such markings shall be under the control of CABs recognised by the responsible/designating authorities, provide for traceability, give sufficient information to consumers, and not give rise to confusion with other markings of conformity. For access to the EC market, the CE marking shall apply.

7.1.

During the operational phase, the Parties will proceed to full mutual recognition of results of conformity assessment activities, as required under their respective legislation. CABs recognised by the responsible designating authorities shall operate as follows:

7.2.

The Parties will encourage the establishment of mutual recognition agreements between the European accreditation organisations and the SCC.

7.3.

Following the entry into force of the operational phase, the inclusion of additional CABs will be done in accordance with the rules set out in the Framework Agreement and in this Annex.

8.1.

Upon request, a CAB may be required to provide additional documentary evidence to facilitate its passage from the transitional to the operational phase.

8.2.

In the event that a proposal is made during, or at the end of the transition phase, requesting a responsible/designating authority to limit the scope of recognition of any designated CAB or to exclude it from the list of bodies accredited/designated, in accordance with the procedures outlined in the Framework Agreement, such a proposal shall be based on objective reasons and shall be properly documented in writing to the Joint Committee.

8.3.

A CAB which has been granted limited recognition or has been denied recognition, may apply for re-evaluation after corrective action has been taken.

9.1.

The authorities in each Party (see Attachments 1 and 2) retain the right to question the performance of CABs operating in the context of this Annex. (Upon reasoned request, the authorities in one Party may request a copy of the certification report prepared to its requirements in the territory of the exporting Party. This report shall be provided promptly and without charge.)

9.2.

CABs shall have in place a plan of action with their certification clients, for enabling the withdrawal of non-conforming or hazardous products from the market place. That plan shall identify a contact point responsible for initiating action with manufacturers of the products in question.

10.1.

The Joint Committee established under the Mutual Recognition Agreement shall appoint a Joint Electrical Safety Group (JESG).

10.2.

The Group (JESG) shall consist of an equal number of representatives from Canada and the EC.

10.3.

The Group may review issues of concern to either Party and no one shall refuse a request by the other to address such issues.

10.4.

The Group may issue recommendations to the Joint Committee regarding concerns raised by the representatives of either Canada or the EC.

10.5.

The Group shall establish its own rules of procedures, and take its decisions and adopt its recommendations by consensus of the Parties.

1.1.

This Annex applies to all recreational craft, including personal watercraft, which in the European Community or in Canada are subject to a conformity assessment or approval procedure by an independent conformity assessment or approval body.

1.2.

The product coverage shall be as determined by the relevant legislation of each party, which is:

1.3.

Parties agree that mutual recognition will operate under this Annex according to the following arrangements:

2.1.

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.

2.2.

For Canada:

Regulatory requirements — The Canada Shipping Act, Chapter 1487, Small Vessel Regulations referenced in Transport Canada's Publication No TP1332

Construction standards for small vessels which includes personal watercraft as defined by and certified to ISO/DIS 13590.

3.1.

For the European Community:

Member States administrations or entities as indicated in Attachment 1.

3.2.

For Canada:

Canadian coastguard.

4.1.

For the purpose of the Annex, each Party will designate competent conformity assessment bodies to carry out conformity assessment and approvals to the requirements of the other Party. Such designation will be carried out according to the procedures set out in the Mutual Recognition Framework Agreement. A list of designated conformity assessment bodies, together with the products and procedures for which they have been designated, is in Attachment 2.

4.2.

Each Party will accept that the designated conformity assessment bodies comply with the requirements for such bodies established by the other Party.

These are:

(a)

exchange information on, and develop greater familiarity with, their respective regulatory requirements;

and

(b)

carry out the policy, legislative and regulatory changes necessary for the provisions of this Annex.

6.1.

In accordance with the relevant provisions of the Mutual Recognition Framework Agreement, the Parties shall ensure the continued availability of the names of their respective notified bodies or conformity assessment bodies, and will regularly supply details of certifications issued in order to facilitate post-market surveillance.

6.2.

The Parties note that, to the extent that requirements for electrical safety or electromagnetic compatibility apply to products covered by this Sectoral Annex, the provisions of the Sectoral Annexes on electrical equipment and electromagnetic compatibility shall apply.

1.1.

This Mutual Recognition Agreement (MRA) Sectoral Annex on good manufacturing practices (GMP) compliance certification pertaining to medicinal products/drugs has been developed by the European Community (EC) and Canada to:

2.1.

The underlying premise behind a MRA for GMP compliance certification is that it can be demonstrated that Canada and the EC Member States have equivalent GMP compliance programmes, and therefore the issuance of a certificate of manufacturing authorisation/licence by an authority of one Party certifying that a facility is in compliance with GMPs, would be all the evidence required by the other Party to accept that facility as being in compliance for the manufacturing/control of medicinal/drug products or to issue a similar certificate of manufacturing authorisation/licence. It should be understood that equivalent does not mean identical but it does mean leading to the same result.

2.2.

The acceptance by an authority of a certificate of manufacturing authorisation/licence issued by the other authority will depend on the successful completion of a confidence building exercise and on an evaluation of its results. Only certification by authorities with GMP compliance programmes (including the supporting infrastructure of regulatory requirements, standards, processes, and quality systems, etc.) mutually recognised as equivalent will be accepted.

2.3.

The MRA on medicinal products/drug GMP is built on three pillars:

3.1.

The provisions of this Annex will cover all medicinal products/drugs which have undergone one or a series of manufacturing process(es) (e.g. fabrication, repackaging, labelling, testing, wholesaling activities) in Canada and in the European Community, and to which good manufacturing practice (GMP) requirements apply in both jurisdictions. Recognition will be limited to the manufacturing process(es) carried out and subject to inspections in the respective territories of the Parties.

3.2.

This Annex may also apply, on a voluntary basis, to products covered by the legislation of one Party but not the other if agreed to by the authorities concerned.

3.3.

The product coverage shall be as determined by the relevant legislation of each Party. Appendix 1 names the legislations and contains an indicative list of products concerned.

3.4.

For the purpose of this Annex, GMP includes the system whereby the manufacturer receives the specifications of the product and/or process from the marketing authorisation (MA)/drug identification number (DIN) or licence holder or applicant and ensures the product is made in compliance with the specifications (equivalent to qualified person certification in the EC).

Good manufacturing practice (GMP) is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards:

3.5.

Product or process oriented inspections will be carried out by one Party at the request of the other Party. For pre-approval inspections, the Parties agree to exchange pre-approval inspection reports to the extent required under the importing Party's laws and regulations, for the purpose of their respective product approval procedures. Lot-to-lot release for biologicals is excluded from this Agreement.

4.1.

Each Party will protect from public disclosure any non-public confidential technical, commercial and scientific information, including trade secrets and proprietary information that is provided by the other Party.

4.2.

Each Party reserves the right to make public the results of any conformity assessment, including the conclusions of inspection reports, provided by the other Party, in situations in which public health safety may be affected.

5.1.

A joint sectoral group will be established for the purposes of the management of this Sectoral Agreement. The joint sectoral group will establish its composition and determine its own rules and procedures. Its role is described in Appendix 3. The group will include representatives of the therapeutic products programme in Health Canada, of the European Commission, and of the relevant EC authorities. It will be co-chaired by a member of each of the two Parties.

6.1.

Divergent views which have not been resolved between the authorities will be referred to the joint sectoral group for resolution. In the case of inability of the joint sectoral group to resolve these divergent views, either Party may bring the matter to the attention of the Joint Committee.

7.5.1.

At the end of the transitional period, the joint sectoral group will proceed to a joint evaluation of the equivalency and capabilities of the compliance programmes of the participating authorities (Appendix 2).

7.5.2.

Those determined as not being equivalent to the other Party's GMP compliance programme will not be listed in Appendix 2 at the end of the transitional period. Proposals to limit the recognition of the equivalence of an authority or exclude it from the Appendix should be based on objective criteria and documented evidence.

7.5.3.

Authorities may be placed in Appendix 2 for specific categories of manufacturing processes (e.g. biologicals, radiopharmaceuticals). Excluded authorities (or not included for a given manufacturing process) may apply for re-consideration of their status once the necessary corrective measures have been taken.

8.1.1.

The European Community and Canada agree that, for medicinal products/drugs covered by this Annex, each Party will recognise the conclusions of the GMP compliance programme carried out by the other Party in its territory, and the relevant certificates of manufacturing authorisations/licences granted by the deemed equivalent authorities of the other Party listed in Appendix 2. In addition, the certification by the manufacturer on the conformity of each batch will be recognised by the other Party without re-control at import.

8.1.2.

Manufacturers located in Canada or a Member State of the European Community whose relevant authority is not listed in Appendix 2 or is not included for the relevant category manufacturing processes may ask that an inspection be carried out by any of the authorities listed in Appendix 2. The batch and the compliance certificates issued according to this procedure will be recognised by the other Party provided that equivalent enforcement procedures against that facility can be subsequently ensured in case of non-compliance.

8.1.3.

With respect to medicinal products/drugs covered by the pharmaceutical legislation of the importing Party but not the exporting one, the locally competent inspection service willing to carry out an inspection of the relevant manufacturing operations shall inspect against its own GMPs if relevant, or, in the absence of specific GMP requirements, against the applicable GMPs of the importing Party. This will also be the case when the locally applicable GMPs are not considered equivalent, in terms of quality assurance of the finished products, to the GMPs of the importing Party.

This provision may also apply to the manufacturer of active pharmaceutical ingredients, intermediate products, and products intended for use in clinical trials.

8.1.4.

It will be the responsibility of the authorities covered by the Annex to ensure that any suspension or withdrawal (total or partial) of a manufacturing authorisation, which could affect the protection of public health, is communicated to the other Party with the appropriate degree of urgency as defined in the ‘two-way’ alert programme.

Contact points will be agreed between both Parties to permit authorities and manufacturers to inform the authorities of the other Party 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.

(a)

are appropriately authorised to manufacture and/or control the relevant medicinal product/drug or to carry out the relevant specified operations,

(b)

are regularly inspected by the authorities, and

(c)

comply with the GMP requirements recognised as equivalent by the two Parties.

8.1.8.

Each Party reserves the right to conduct its own inspection for reasons identified to the other Party. Such inspections are to be notified in advance to the other Party, which has the option of joining the inspection. Recourse to this safeguard clause should be an exception.

8.1.9.

The decision to suspend or revoke a licence will rest with the issuing Party.

8.2.1.

In accordance with the general provisions of the Annex, the Parties will exchange all information necessary to determine and maintain the equivalence of GMP compliance programmes. In addition, the relevant authorities in Canada and in the EC will keep each other informed of all new technical guidance, inspection procedures, or changes in regulation (these include: guidance documents, publications of references to standards, forms, documents relating to the application of legal requirements). Each Party will consult the other before adopting these changes to ensure the continued equivalency of the GMP compliance programmes. Concerns will be raised to the joint sectoral group.

8.2.2.

Upon reasoned request, the relevant inspection service shall forward a copy of the last inspection report of the manufacturing or control site, in case analytical operations are contracted out. The request may concern a ‘full inspection report’ or a ‘detailed report’. A ‘full inspection report’ comprises a site master file (compiled by the manufacturer or by the inspectorate) and a narrative report by the inspectorate. A ‘detailed report’ responds to specific queries about a firm by the other Party. Parties will ensure that such inspection reports are forwarded in no more than 30 days, this period being extended to 60 days should a new inspection be carried out.

8.3.1.

The joint sectoral group will ensure that an efficient and effective ‘two-way’ alert system is in place at all times. Elements of such a system are described in Appendix 5.

8.3.2.

It shall be the responsibility of the authorities covered by the Annex to ensure that any suspension or cancellation (total or partial) of certification of compliance is communicated to the other relevant authorities with the appropriate degree of urgency.

8.3.3.

Each Party shall notify the other Party of any confirmed problem reports, corrective actions, or recalls related to products covered under the scope of this Annex. Each Party will respond to special requests for information and will ensure that authorities make available relevant information, as requested.

Contact points are identified in Appendix 5.

9.1.

The continuous monitoring of the GMP compliance programmes determined to be equivalent at the conclusion of the confidence building period and any subsequent decisions concerning that equivalence must be made according to a mutually developed and managed equivalence maintenance programme. This programme will be managed by the joint sectoral group.

9.2.

The Parties undertake to hold regular consultations, under the auspices of the joint sectoral group set up under this Annex, to ensure the continued relevancy and accuracy of this Annex. Canada and Member State authorities may organise meetings to discuss specific questions and issues.

9.3.

Authorities must participate in maintenance activities, as established under the joint sectoral group, in order to maintain their status as listed in Appendix 2.

10.1.

Appendices 1 and 2 constitute integral parts of this Annex.

10.2.

Appendices 3, 4, 5, 6 and 7 are general guidelines.

1.1.

This Mutual Recognition Agreement (MRA) Annex on conformity assessment and compliance certification pertaining to medical devices has been developed by the European Community and Canada to enhance bilateral medical device regulatory cooperation while facilitating global trade and maintaining the same high standards of health and safety in both jurisdictions.

1.2.

Furthermore this Annex calls for the development of an infrastructure for on-going communications/consultations between regulatory and/or designating authorities and conformity assessment bodies of each Party to enable regulators to determine and maintain the equivalence of their medical device conformity assessment capabilities and to develop a cooperative approach to post-market vigilance.

2.1.

This Annex applies to all medical devices which in Canada or the European Community are subject to conformity assessment procedures, including scientific technical evaluations of high risk medical devices and quality systems assessments, by a conformity assessment body.

2.2.

The product coverage shall be as determined by the relevant legislation of each Party, which is:

It shall not, however, apply to the following products:

Both Parties may, however, decide by common agreement, to extend the application of this Annex to the aforementioned or any other medical devices.

3.1.

Each Party will protect from public disclosure any non-public confidential technical, commercial and scientific information, including trade secrets and proprietary information provided by the other Party.

3.2.

Each Party reserves the right to make public the results of any conformity assessment reports in situations where public health may be affected.

4.1.

Divergent views which have not been resolved between the regulatory authorities will be referred to the joint sectoral group for resolution. In the event that the joint sectoral group is unable to resolve these divergent views, either Party may bring the matter to the attention of the Joint Committee.

5.1.

A joint sectoral group will be established for the purposes of management of this Sectoral Annex. Its role will be to make decisions concerning the definition, establishment, and evaluation of conformity assessment procedures and programmes, the establishment of the ‘two-way’ alert programme, the management of the confidence building period and the definition of a maintenance programme supporting the continued operation of the MRA. The group will include representatives of Health Canada and of the European Community's competent authorities and co-chaired by a member of each of the two Parties.

6.1.

The confidence building period will commence upon the signing of the MRA and is expected to be completed within 18 months.

6.2.

At the beginning of the transitional period, the joint sectoral group will elaborate a joint confidence building programme (guidance provided in Attachment III). The implementation of this programme shall establish each Party's capability to perform conformity assessments in compliance with the requirements and procedures of the other Party. The evidence shall provide practical relevance to the decisions regarding the operational phase.

The confidence building programme should include the following actions and activities:

Participation in activities referenced under (c) and (d) should be understood as means to provide, on an exemplary basis, supplementary evidence in relation to the process of designation and surveillance of CABs.

6.3.

Each of the Parties to the MRA will be responsible for the costs of its participation in the confidence building activities.

6.4.

No later than 18 months after the entry into force of this Agreement, the joint sectoral group shall proceed to a joint evaluation of the experience gained. This evaluation will cover the adequacy of the confidence building programme, the capabilities of regulatory/designating authorities and the capabilities of the designated conformity assessment bodies.

Recommendations to list CABs in Attachment II of this Annex shall be made by participating regulatory/designating authorities, listed in Attachment I, to the joint sectoral group on the basis of the results of the confidence building programme. Conformity assessment bodies that have been accepted by the joint sectoral group will be listed in Attachment II with an indication of their specific conformity assessment expertise and the fields of medical device technologies for which they are recognised. The corresponding regulatory/designating authority responsible for a CAB will also be listed in Attachment II. Proposals to limit the recognition of capabilities of CABs should be based on objective evidence and documented. The joint sectoral group may recommend that a CAB not be listed in Attachment II, provided there is documented evidence demonstrating its lack of capabilities. Excluded CABs may apply for reconsideration of their status once the necessary corrective measures have been taken and confirmed.

Where no agreement on any of the above matters has been reached in the joint sectoral group, the matter will be referred to the Joint Committee under the Framework Agreement.

The Parties shall enter into the operational phase provided that there is representation of each Party's CABs in Attachment II.

The Agreement will also be re-examined at the end of the transitional period to take account of the regulatory evolution of each Party. Consideration shall be given to a single submission/evaluation/quality systems assessment which simultaneously satisfies the requirements of each jurisdiction.

7.1.

The provisions of this section will apply only to conformity assessment carried out in the Parties' respective territories by conformity assessment bodies recognised under this Sectoral Annex.

The European Community and Canada agree that, for medical devices covered by this Annex, each Party will recognise the conclusions of the conformity assessment carried out by the other Party and the certificate of compliance granted by the conformity assessment body of the other Party, without further reassessment.

For evaluation against European requirements, Health Canada or other conformity assessment bodies designated by Canada shall establish the conclusions of completed conformity assessment as referred to in the active implantable medical device and the medical device Directives, and issue the appropriate certificate of compliance. The responsible authorities in the European Community will, without any further reassessment, accept the certification as evidence of compliance with the premarket requirements of the relevant European Directives.

For evaluating against Canadian requirements, the European CABs shall establish the conclusions of the examination and submit to Health Canada an abbreviated supporting report and certificate of compliance which includes such conclusions. Based on these documents, and without any further reassessment, Health Canada will accept the certification as evidence of compliance with the premarket requirements of the Canadian medical devices Regulations.

Each Party shall make available to the other Party, upon reasoned request, any information which has been reviewed as part of the assessment of a medical device for the purpose of issuing certificates of compliance.

Each Party reserves the right, at any time, to question information with respect to the designation process or the performance of conformity assessments against the requirements of its regulatory regime. Furthermore, each Party reserves the right to conduct its own conformity assessments for reasons identified to the other Party. Justification for such action shall be based on documented evidence and notification is to be provided in advance to the other Party. Recourse to this action should be an exception.

7.2.

The procedures to be followed by the designating authorities of each Party in designating CABs shall respect the criteria laid down in the other Party's regulations or guidelines (non-binding guidance is provided in Attachment V).

7.3.

In accordance with the general provisions of the Annex, the Parties will exchange all information necessary to determine and maintain equivalence of conformity assessment procedures. In addition, each Party shall share with the other Party information generated within the framework of its regulatory system which is relevant for the operation of conformity assessment procedures (i.e. guidance documents, publications of references to standards, forms, documents relating to the application of legal requirements). Each Party shall associate regulatory/designating authorities and conformity assessment bodies of the other Party in activities of exchange of information and experience.

In special cases, particularly emergency situations, all those involved in the implementation of this Annex will endeavour to provide all documentation requested by one of the Parties in an expeditious manner.

7.4.

The joint sectoral group will ensure that an efficient and effective ‘two-way’ alert system is in place at all times. Elements of such a system are described in Attachment IV.

Each Party shall notify the other Party of any confirmed problem reports, corrective actions, or recalls related to products that it has evaluated under the terms of this Agreement. Each Party will respond to special requests for information on particular devices and will ensure that its designated authorities and conformity assessment bodies make available relevant information on these devices, as requested.

It shall be the responsibility of the regulatory authorities covered by this Annex to ensure that any suspension or cancellation (total or partial) of a certificate of compliance is communicated to each other with the appropriate degree of urgency.

7.5.

The regime of registration or conformity assessment fees is determined by the location of the manufacturer. The cost recovery programmes and the fees pertaining to the issuance of a certificate of compliance in each jurisdiction will remain the responsibility of that jurisdiction. Conformity assessment fees will not be charged by one Party to manufacturers located on the territory of the other Party, where the conformity assessment was conducted by a conformity assessment body located in the other Party's territory.

7.6.

The continuous monitoring of the equivalency of designation processes and conformity assessments for each Party's requirements that have been determined to be equivalent at the conclusion of the confidence building programme, and any subsequent decisions concerning that equivalence, must be made according to mutually developed and managed equivalence maintenance and implementation activities. This will be managed by the joint sectoral group.

The Parties will undertake to hold regular consultations, within the joint sectoral group set up under this Annex to ensure the continued relevancy and accuracy of this Annex. The regulatory/designating authorities and conformity assessment bodies will organise meetings to discuss specific questions and issues.

Conformity assessment bodies and regulatory/designating authorities must continue participation in maintenance activities, as established by the joint sectoral group, within the framework of this Annex in order to maintain their status under this Annex as indicated in Attachment II.

Parties may request the addition of regulatory/designating authorities or conformity assessment bodies to Attachment II. The procedure for the acceptance of new regulatory/designating authorities will be as described in the confidence building programme. Conformity assessment bodies will be added to Attachment II upon recommendation from a regulatory/designating authority and joint decision by the joint sectoral group.

7.7.

Contact points are identified in order to permit regulatory authorities and manufacturers to inform the regulatory authorities of the other Party with the appropriate speed in case of quality defects, recalls, and adverse incidents, which could necessitate additional controls or, suspension of the distribution of the product or, suspension or cancellation of a certificate of compliance.

For the purpose of this Agreement, the contact points will be:

for Canada: ..., and

for the European Community (the 15 Member States and the Commission).