2002A5430 — EN — 01.04.2014 — 002.001

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This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents

►B	AGREEMENT between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment (OJ L 114, 30.4.2002, p.369)

Amended by:

		Official Journal
		No	page	date
►M1	DECISION No 2/2002 of 8 January 2003	L 68	1	12.3.2003
M2	DECISION No 1/2004 of 16 January 2004	L 34	72	6.2.2004
►M3	DECISIONNo 1/2005 OF THE COMMITTEE of 7 March 2005	L 93	40	12.4.2005
M4	DECISION No 2/2005 of 30 March 2005	L 110	78	30.4.2005
M5	DECISION No 3/2005 of 25 October 2005	L 322	29	9.12.2005
M6	DECISION No 4/2005 of 25 October 2005	L 322	31	9.12.2005
►M7	DECISION No 1/2006 of 29 September 2006	L 325	22	24.11.2006
►M8	AGREEMENT revising the Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment	L 386	51	29.12.2006
►M9	DECISION NO 2/2006 of 13 December 2006	L 32	135	6.2.2007
M10	DECISION No 1/2008 of 12 March 2008	L 282	22	25.10.2008
►M11	DECISION No 1/2009 of 21 December 2009	L 147	11	12.6.2010
►M12	DECISION No 1/2010 OF THE COMMITTEE ESTABLISHED UNDER THE AGREEMENT BETWEEN THE EUROPEAN COMMUNITY AND THE SWISS CONFEDERATION ON MUTUAL RECOGNITION IN RELATION TO CONFORMITY ASSESSMENT of 18 October 2010	L 46	51	19.2.2011
►M13	DECISION No 1/2011 OF THE COMMITTEE ESTABLISHED UNDER THE AGREEMENT BETWEEN THE EUROPEAN COMMUNITY AND THE SWISS CONFEDERATION ON MUTUAL RECOGNITION IN RELATION TO CONFORMITY ASSESSMENT of 20 December 2011	L 80	31	20.3.2012
►M14	DECISION No 1/2012 OF THE COMMITTEE ESTABLISHED UNDER THE AGREEMENT BETWEEN THE EUROPEAN COMMUNITY AND THE SWISS CONFEDERATION ON MUTUAL RECOGNITION IN RELATION TO CONFORMITY ASSESSMENT of 17 December 2012	L 136	17	23.5.2013
►M15	DECISION No 1/2014 OF THE COMMITTEE ESTABLISHED UNDER THE AGREEMENT BETWEEN THE EUROPEAN COMMUNITY AND THE SWISS CONFEDERATION ON MUTUAL RECOGNITION IN RELATION TO CONFORMITY ASSESSMENT of 1 April 2014	L 182	61	21.6.2014

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▼B

AGREEMENT

between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment

Article 1

Purpose

1.  The Community and Switzerland hereby grant mutual acceptance of reports, certificates, authorisations and conformity marks issued by the ►M8  bodies recognised in accordance with the procedures of this Agreement (hereinafter recognised conformity assessment bodies) ◄ and of the manufacturer's declarations of conformity certifying conformity to the requirements of the other Party in the areas covered by Article 3.

2.  In order to avoid duplication of procedures when Swiss and Community requirements are deemed equivalent, the Community and Switzerland shall mutually accept reports, certificates and authorisations issued by ►M8  recognised conformity assessment bodies ◄ and manufacturer's declarations of conformity certifying conformity to their respective requirements in the areas covered by Article 3. Reports, certificates, authorisations and manufacturer's declarations of conformity shall in particular indicate conformity with the Community legislation. Conformity marks required by the legislation of one of the Parties must be affixed to products placed on the market of that Party.

3.  The Committee provided for in Article 10 shall specify the cases in which paragraph 2 shall apply.

Article 2

Definitions

1.  For the purposes of this Agreement:

2.   ►M8  The definitions laid down by ISO and IEC may be used to establish the meaning of the general terms relating to conformity assessment contained in this Agreement. ◄

Article 3

Scope

1.  This Agreement covers the obligatory conformity assessment procedures ensuing from the legislative, regulatory and administrative provisions listed in Annex 1.

2.  Annex 1 defines the product sectors covered by this Agreement. The Annex is divided up into sectoral chapters and these are subdivided in principle as follows:

3.  Annex 2 sets out general rules applicable to the designation of conformity assessment bodies.

▼M8

Article 4

Origin

The provisions of this Agreement shall apply to products covered by this Agreement irrespective of their origin.

Article 5

Recognised conformity assessment bodies

The Parties hereby agree that conformity assessment bodies recognised in accordance with the procedure provided for in Article 11 fulfil the conditions of eligibility to assess conformity.

Article 6

Designating authorities

1.  The Parties hereby undertake to ensure that their designating authorities have the necessary power and competence to designate conformity assessment bodies or withdraw designation, suspend or remove suspension of designated conformity assessment bodies under their respective jurisdiction.

2.  For the designation of conformity assessment bodies, the designating authorities shall observe the general principles for designation set out in Annex 2, subject to the provisions of the respective section IV in Annex 1. These designating authorities shall observe the same principles when withdrawing designation, suspending or removing suspension.

▼B

Article 7

Verification of designation procedures

1.  The Parties shall exchange information concerning the procedures used to ensure ►M8  recognised conformity assessment bodies under their jurisdiction ◄ comply with the general principles of designation outlined in Annex 2 subject to the provisions of the respective section IV in Annex 1.

2.  The Parties shall compare methods used to verify conformity of the bodies with the general principles of designation outlined in Annex 2, subject to the provisions of the respective section IV in Annex 1. Existing systems for the accreditation of conformity assessment bodies in the Parties may be used for the purpose of such comparisons.

3.  Verification shall be carried out in accordance with the procedure implemented by the Committee under Article 10 below.

Article 8

Verification of compliance of conformity assessment bodies

1.  Each Party shall, in exceptional circumstances, have the right to contest the technical competence of the conformity assessment bodies proposed by the other Party or ►M8  of recognised conformity assessment bodies ◄ under the jurisdiction of the other Party.

For this purpose, it shall submit in writing an objective and reasoned argument to the other Party ►M8  ————— ◄ .

2.  In the event of a disagreement between the Parties, confirmed in the Committee, a verification of the technical competence of the conformity assessment body in question shall be undertaken in accordance with requirements jointly by the Parties, with the participation of the competent authorities concerned.

The result of that verification shall be discussed in the Committee with a view to resolving the issue as soon as possible.

3.  Each Party shall ensure that the conformity assessment bodies under its jurisdiction are available for verification of their technical competence as required.

4.  Unless otherwise decided by the Committee, the disputed body shall be suspended by the competent designating authority from the time disagreement has been established until agreement has been reached in the Committee. ►M8  Such suspension shall be indicated in the common list of recognised conformity assessment bodies referred to in Annex 1. ◄

Article 9

Implementation of the Agreement

1.  The Parties shall cooperate with a view to ensuring the satisfactory application of the legislative, regulatory and administrative provisions listed in Annex 1.

2.  The designating authorities shall ascertain by appropriate means whether the ►M8  recognised conformity assessment bodies under their jurisdiction ◄ are observing the general principles of designation listed in Annex 2, subject to the provisions listed in the respective section IV in Annex 1.

3.   ►M8  The recognised conformity assessment bodies ◄ shall cooperate in an appropriate way in the framework of the coordination and comparison work conducted by each of the Parties in respect of the sectors covered by Annex 1 in order to ensure that the conformity assessment procedures provided for in the laws and regulations of the Parties covered by this Agreement are applied in a consistent manner. ►M8  The designating authorities shall use their best endeavours to ensure that recognised conformity assessment bodies cooperate in an appropriate way. ◄

Article 10

Committee

1.  A Committee on mutual recognition in relation to conformity assessment (hereinafter referred to as the ‘Committee’), is hereby established. It shall be composed of representatives of the Parties, and shall be responsible for the management and monitoring of the smooth functioning of this Agreement. To that end, it shall issue recommendations and take decisions in the circumstances provided for in this Agreement. It shall act by mutual agreement.

2.  The Committee shall establish its own rules of procedure, which shall contain, inter alia, provisions on the convening of meetings, the appointment of the chairman and the chairman's term of office.

3.  The Committee shall meet as and when necessary and at least once a year. Either Party may request the convening of a meeting.

▼M8

4.  The Committee may consider any matter related to this Agreement. In particular, it shall be responsible for:

▼B

5.  The Committee may, on a proposal from one of the Parties, modify the Annexes to this Agreement.

▼M8

Article 11

Recognition, withdrawal of recognition, modification of the scope, and suspension of conformity assessment bodies

1.  The following procedure shall apply for the recognition of conformity assessment bodies in relation to the requirements set out in the relevant Chapters of Annex 1:

2.  A Party can withdraw or suspend the recognition or remove the suspension of recognition of a conformity assessment body under its jurisdiction. The Party concerned shall immediately notify the other Party of its decision in writing, together with the date of such decision. The withdrawal, suspension, or removal of suspension shall take effect at that date. Such withdrawal or suspension shall be indicated in the common list of recognised conformity assessment bodies referred to in Annex 1.

3.  A Party can propose that the scope of activity of a recognised conformity assessment body under its jurisdiction be amended. For scope extensions and scope reductions the procedures provided for in Article 11(1) and (2) respectively shall apply.

4.  A Party can, in exceptional circumstances, contest the technical competence of a recognised conformity assessment body under the jurisdiction of the other Party. In this case Article 8 shall apply.

5.  Reports, certificates, authorisation and conformity marks issued by a conformity assessment body after the date at which its recognition has been withdrawn or suspended need not be recognised by the Parties. Reports, certificates, authorisations and conformity marks issued by a conformity assessment body before the date its recognition has been withdrawn shall continue to be recognised by the Parties unless the responsible designating authority has limited or cancelled their validity. The Party under whose jurisdiction the responsible designating authority is operating shall notify the other Party in writing of any such changes relating to a limitation or cancellation of validity.

▼B

Article 12

Information exchange

1.  The Parties shall exchange all relevant information regarding implementation and application of the legislative, regulatory and administrative provisions listed in Annex 1.

2.  Each Party shall inform the other Party of the changes it intends to make to the legislative, regulatory and administrative provisions relating to the subject matter of this Agreement and shall notify ►M8  in writing ◄ the other Party of the new provisions at least 60 days before their entry into force.

▼M8

2a.  Each Party shall notify changes to its designating authorities and competent authorities to the other Party in writing.

▼B

3.  Where the legislation of one of the Parties stipulates that a specific item of information must be made available to the competent authority by a person established in its territory, that authority may also approach the competent authority of the other Party or enter into direct contact with the manufacturer or, if appropriate, the latter's agent in the territory of the other Party, in order to obtain that information.

4.  Each Party shall immediately notify the other Party of safeguard measures taken in its territory.

Article 13

Confidentiality

Representatives, experts and other agents of the Parties shall be required, even after their duties have ceased, not to disclose information acquired under this Agreement which is of the kind covered by the obligation of professional secrecy. This information may not be used for purposes other than those envisaged by this Agreement.

Article 14

Dispute settlement

Each Party may refer any dispute relating to the interpretation or application of this Agreement to the Committee. The Committee shall endeavour to settle the dispute, and must be supplied with any information which may facilitate a thorough examination of the situation with a view to finding an acceptable solution. For that purpose, the Committee shall consider every possible means of maintaining the smooth functioning of this Agreement.

Article 15

Agreements with third countries

The Parties hereby agree that mutual recognition agreements concluded by either Party with a country that is not party to this Agreement shall in no circumstances entail an obligation upon the other Party in terms of the acceptance of manufacturer's declarations of conformity as well as of reports, certificates, authorisations and marks issued by conformity assessment bodies in that third country, unless there is an explicit agreement between the Parties.

Article 16

Annexes

The Annexes to this Agreement shall form an integral part thereof.

Article 17

Territorial application

This Agreement shall apply, as regards the Community, to the territories in which the Treaty establishing the European Community is applied under the conditions laid down in that Treaty, on the one hand, and to the territory of Switzerland, on the other.

Article 18

Revision

1.  If a Party wishes to have this Agreement revised, it shall inform the Committee. Modifications to this Agreement shall enter into force after the respective internal procedures have been completed.

2.  The Committee may modify Annexes 1 and 2 to this Agreement on a proposal from one of the Parties.

Article 19

Suspension

Where a Party establishes that the other Party is failing to comply with the conditions of this Agreement, it may, after consulting the Committee, suspend application of Annex 1 in full or in part.

Article 20

Acquired rights

The Parties shall continue to recognise reports, certificates, authorisations and conformity marks and manufacturers' declarations of conformity issued in accordance with, and prior to the expiry of, this Agreement, provided that the request for conformity evaluation to be started was made before the notice of non-renewal or denunciation was given.

Article 21

Entry into force and duration

1.  This Agreement shall be ratified or approved by the Parties in accordance with their own procedures. It shall enter into force on the first day of the second month following the last notification of deposit of the instruments for ratification or approval of all the following seven agreements:

2.  This Agreement shall be concluded for an initial period of seven years. It shall be tacitly extended, unless the Community or Switzerland notifies the other Party to the contrary before the expiry of that period. Where such notification is given, the provisions of paragraph 4 shall apply.

3.  The Community or Switzerland may denounce this Agreement by notifying the other Party. Where such notification is given, the provisions of paragraph 4 shall apply.

4.  The seven agreements referred to in paragraph 1 shall cease to apply six months after receipt of the non-renewal notice described in paragraph 2 or the denunciation notice described in paragraph 3.

Hecho en Luxemburgo, el veintiuno de junio de mil novecientos noventa y nueve. El presente Acuerdo se establecerá por duplicado en lenguas alemana, danesa, española, finesa, francesa, griega, inglesa, italiana, neerlandesa, portuguesa y sueca y cada uno de estos textos será auténtico.

Udfærdiget i Luxembourg, den enogtyvende juni nitten hundrede og nioghalvfems i to eksemplarer på dansk, engelsk, finsk, fransk, græsk, italiensk, nederlandsk, portugisisk, spansk, svensk og tysk, idet hver af disse tekster har samme gyldighed.

Geschehen zu Luxemburg am einundzwanzigsten Juni neunzehnhundertneunundneunzig in zwei Urschriften in dänischer, deutscher, englischer, finnischer, französischer, griechischer, italienischer, niederländischer, portugiesischer, schwedischer und spanischer Sprache, wobei jeder Wortlaut gleichermaßen verbindlich ist.

Έγινε στο Λουξεμβούργο, στις είκοσι μία Ιουνίου χίλια εννιακόσια ενενήντα εννέα. Η παρούδα συμφωνία καταρτίζεται εις διπλούν στα αγγλικά, τα γαλλικά, τα γερμανικά, τα δανικά, τα ελληνικά, τα ισπανικά, τα ιταλικά, τα ολλανδικά, τα πορτογαλικά, τα σουηδικά και τα φινλανδικά, καθένα από τα κείμενα αυτά είναι αυθεντικό.

Done at Luxembourg on the twenty-first day of June in the year one thousand and ninety-nine. This Agreement is drawn up in duplicate in the Danish, Dutch, English, Finnish, French, German, Greek, Italian, Portuguese, Spanish and Swedish languages, each text being equally authentic.

Fait à Luxembourg, le vingt-et-un juin mil neuf cent quatre-vingt dix-neuf, en double exemplaire, en langues allemande, anglaise, danoise, espagnole, finnoise, française, grecque, italienne, néerlandaise, portugaise et suédoise, chacun de ces textes faisant également foi.

Fatto a Lussemburgo, addì ventuno giugno millenovecentonovantanove, in due copie nelle lingue danese, finlandese, francese, greco, inglese, italiano, olandese, portoghese, spagnolo, svedese e tedesco; tutte facenti ugualmente fede.

Gedaan te Luxemburg, de eenentwintigste juni negentienhonderd negenennegentig, in tweevoud in de Deense, de Duitse, de Engelse, de Finse, de Franse, de Griekse, de Italiaanse, de Nederlandse, de Portugese, de Spaanse en de Zweedse taal, zijnde alle teksten gelijkelijk authentiek.

Feito em Luxemburgo, em vinte e um de Junho de mil novecentos e noventa e nove, em dois exemplares em língua alemã, inglesa, dinamarquesa, espanhola, finlandesa, francesa, grega, italiana, neerlandesa, portuguesa e sueca, todas as versões fazendo igualmente fé.

Tehty Luxemburgissa kahdentenakymmenentenäensimmäisenä päivänä kesäkuuta vuonna tuhatyhdeksänsataayhdeksänkymmentäyhdeksän kahtena kappaleena englannin, espanjan, hollannin, italian, kreikan, portugalin, ranskan, ruotsin, saksan, suomen ja tanskan kielellä, ja jokainen teksti on yhtä todistusvoimainen.

Utfärdat i Luxemburg den tjugoförsta juni nittonhundranittionio i två exemplar på det danska, engelska, finska, franska, grekiska, italienska, nederländska, portugisiska, spanska, svenska och tyska språket, vilka samtliga texter är lika giltiga.

Por la Comunidad Europea

For Det Europæiske Fællesskab

Für die Europäische Gemeinschaft

Για την Ευρωπαϊκή Κοινότητα

For the European Community

Pour la Communauté européenne

Per la Comunità europea

Voor de Europese Gemeenschap

Pela Comunidade Europeia

Euroopan yhteisön puolesta

På Europeiska gemenskapens vägnar

Por la Confederación Suiza

For Det Schweiziske Edsforbund

Für die Schweizerische Eidgenossenschaft

Για την Ελβετική Συνομοσπονδία

For the Swiss Confederation

Pour la Confédération suisse

Per la Confederazione svizzera

Voor de Zwitserse Bondsstaat

Pela Confederação Suíça

Sveitsin valaliiton puolesta

På Schweiziska edsförbundets vägnar

ANNEX 1

PRODUCT SECTORS

	This Annex is divided up into the following Chapters by sector:
Chapter 1	Machinery
Chapter 2	Personal protective equipment
Chapter 3	Toys
Chapter 4	Medical devices
Chapter 5	Gas appliances and boilers
Chapter 6	Pressure vessels
Chapter 7	Radio equipment and telecommunications terminal equipment
Chapter 8	Equipment and protective systems intended for use in potentially explosive atmospheres
Chapter 9	Electrical equipment and electromagnetic compatibility
Chapter 10	Construction plant and equipment
Chapter 11	Measuring instruments and prepackages
Chapter 12	Motor vehicles
Chapter 13	Agricultural and forestry tractors
Chapter 14	Good laboratory practice (GLP)
Chapter 15	Medicinal products GMP Inspection and Batch Certification
Chapter 16	Construction products
Chapter 17	Lifts
Chapter 18	Biocidal products
Chapter 19	Cableway installations
Chapter 20	Explosives for civil use

▼M11

CHAPTER 1

MACHINERY

Section I

Legislative, regulatory and administrative provisions

Section II

Conformity assessment bodies

The Committee established under Article 10 of this Agreement shall draw up and keep up to date, according to the procedure described in Article 11 of the Agreement, a list of the conformity assessment bodies.

Section III

Designating authorities

The Committee established under Article 10 of this Agreement shall draw up and keep up to date a list of the designating authorities notified by the Parties.

Section IV

Special rules relating to the designation of conformity assessment bodies

For the designation of conformity assessment bodies, the designating authorities shall comply with the general principles contained in Annex 2 to this Agreement and the assessment criteria set out in Annex XI to Directive 2006/42/EC.

Section V

Supplementary provisions

1.    Second-hand machinery

The legislative, regulatory and administrative provisions listed in section I shall not apply to second-hand machinery.

The principle contained in Article 1(2) of this Agreement shall apply, however, to machinery legally placed on the market and/or put into service in one of the Parties and exported as second-hand machinery to the market of the other Party.

The other provisions relating to second-hand machinery, e.g. those relating to safety in the place of work in force in the importing state, shall remain applicable.

2.    Information exchange

In accordance with Article 9 of this Agreement, the Parties shall exchange information needed to ensure a proper implementation of this chapter.

The Parties hereby undertake to forward all relevant technical documents at the request of the authorities of the other Party.

3.    Person named in the declaration of conformity of machines, authorised to compile the technical file

The declaration of conformity of the machinery must contain the name and address of the person authorised to compile the technical file, who must be established in the respective Parties’ territory.

The Parties shall mutually recognise this person. The manufacturer, his authorised representatives or, where neither of these is present, the person responsible for placing products on the market of one Party, shall not be obliged to designate a person, who is responsible for compiling the technical file, in the territory of the other Party.

▼B

CHAPTER 2

PERSONAL PROTECTIVE EQUIPMENT

▼M1

Section I

Legislation, regulations and administrative provisions

▼B

Section II

Conformity assessment bodies

The Committee established under Article 10 of this Agreement shall draw up and keep up to date, according to the procedure described in Article 11 of the Agreement, a list of the conformity assessment bodies.

▼M9

▼M1

Section III

Designating authorities

▼B

Section IV

Special rules relating to the designation of conformity assessment bodies

For the designation of conformity assessment bodies, the designating authorities shall comply with the general principles contained in Annex 2 and those in Annex V to Directive 89/686/EEC.

▼M14

CHAPTER 3

TOYS

Section I

Legislative, regulatory and administrative provisions

Section II

Conformity assessment bodies

The Committee established under Article 10 of this Agreement shall draw up and keep up to date, according to the procedure described in Article 11 of the Agreement, a list of the conformity assessment bodies.

Section III

Designating authorities

The Committee established under Article 10 of this Agreement shall draw up and keep up to date a list of the designating authorities notified by the Parties.

Section IV

Special rules relating to the designation of conformity assessment bodies

For the designation of conformity assessment bodies, the designating authorities shall comply with the general principles contained in Annex 2 to this Agreement and with Article 24 of Directive 2009/48/EC.

Section V

Supplementary provisions

1.    Exchange of information concerning the certificate of conformity and the technical documentation

The market surveillance authorities of the Member States or Switzerland may, on reasoned request, ask for the technical documentation, or a translation of parts thereof from a manufacturer based in the territory of either Switzerland or a Member State. The market surveillance authorities of the Member states and Switzerland may request from a Swiss or a European Union-based manufacturer the relevant part of the technical documentation into an official language of the requesting authority or in English.

When a market surveillance authority requests the technical documentation or a translation of parts thereof from a manufacturer, it may set a deadline for receipt of 30 days, unless a shorter deadline is justified in the case of serious and immediate risk.

If the manufacturer based on the territory of either Switzerland or a Member State does not comply with this provision, the market surveillance authority may require it to have a test performed by a designated body at its own expense within a specified period in order to verify compliance with the harmonised standards and essential requirements.

2.    Information requests to designated bodies

The market surveillance authorities of the Member States and of Switzerland may request a designated body in Switzerland or in a Member State to provide information relating to any type examination certificate which that body has issued or withdrawn, or which relates to any refusal to issue such a certificate, including the test reports and technical documentation.

3.    Information obligations of designated bodies

In accordance with Article 36(2) of Directive 2009/48/EC, designated bodies shall provide the other bodies designated under this Agreement which carry out similar conformity assessment activities covering the same toys with relevant information on issues relating to negative and, on request, positive conformity assessment results.

4.    Exchange of experience

Swiss national authorities may take part in the exchange of experience between the Member States’ national authorities responsible for the notification procedure referred to in Article 37 of Directive 2009/48/EC.

5.    Coordination of designated bodies

Designated Swiss conformity assessment bodies may take part in the coordination and cooperation mechanisms and sectoral groups or groups of notified bodies provided for in Article 38 of Directive 2009/48/EC, directly or by means of designated representatives.

6.    Market access

Importers based in the European union or Switzerland shall indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the toy or, when that is not possible, on its packaging or in a document accompanying the toy.

The Parties mutually recognise this indication of the coordinates of the manufacturer and importer, registered trade name or registered trade mark and the address at which they can be contacted, which must be mentioned as above. For the purpose of this specific obligation, “importer” shall mean any natural or legal person established within the territory of either the European Union or Switzerland who places a toy from a third country on the European Union or on the Swiss market.

7.    Harmonised standards

Switzerland recognises harmonised standards conferring a presumption of conformity with the legislation referred to in Section 1 of this Chapter. Where Switzerland considers that compliance with a harmonised standard does not entirely satisfy the requirements which are set out in the legislation listed in Section I, it shall bring the matter before the Committee and give its reasons.

The Committee shall consider the case and may ask the European Union to act in accordance with the procedure provided for in Article 14 of Directive 2009/48/EC. The Committee shall be informed of the result of the procedure.

8.    Procedure for dealing with toys presenting a non-compliance that is not restricted to their national territory ( 1 )

Pursuant to Article 12(4) of this Agreement, in cases where the market surveillance authorities of a Member State or Switzerland have taken action or have sufficient reasons to believe that a toy covered by Section I of the present Chapter presents a risk to the health or safety of persons, and if they consider that the non-compliance is not restricted to their national territory, they shall inform each other and the European Commission immediately of:

The market surveillance authorities of the Member States or Switzerland other than the one initiating this procedure shall inform without delay the European Commission and the other national authorities of any measures adopted and of any additional information at their disposal relating to the non-compliance of the toy concerned.

The Parties shall ensure that appropriate restrictive measures in respect of the toy concerned, such as withdrawal of the toy from their market, are taken without delay.

9.    Safeguard procedure in case of objections against national measures

Should it disagree with the notified national measure, Switzerland or a Member State shall inform the European Commission of its objections.

Where, on completion of the procedure set out in paragraph 8 above, objections are raised by a Member State or Switzerland against a measure taken by Switzerland or a Member State respectively, or where the European Commission considers a national measure to be non-compliant with the legislation referred to in this Chapter, the European Commission shall without delay enter into consultation with the Member States, Switzerland and the relevant economic operator or operators and shall evaluate the national measure in order to determine if it is justified or not.

In case of an agreement between the Parties on the results of their investigations, the Member States and Switzerland shall take the measures necessary to ensure that appropriate restrictive measures are taken in respect of the toy concerned, such as the withdrawal of the toy from their market, without delay.

In case of a disagreement between the Parties on the results of their investigations, the issue will be forwarded to the Committee, which may decide to have an expert study carried out.

Where the Committee considers that the measure is:

▼B

CHAPTER 4

MEDICAL DEVICES

▼M1

Section I

Legislation, regulations and administrative provisions

▼B

Section II

Conformity assessment bodies

The Committee established under Article 10 of this Agreement shall draw up and keep up to date, according to the procedure described in Article 11 of the Agreement, a list of the conformity assessment bodies.

▼M1

Section III

Designating authorities

Section IV

Special rules relating to the designation of conformity assessment bodies listed in Section II

For the designation of conformity assessment bodies, the designating authorities shall comply with the general principles contained in Annex 2 to this Agreement and those in Annex XI to Directive 93/42/EEC, in Annex VIII to Directive 90/385/EEC and in Annex IX to Directive 98/79/EC, in respect of the bodies designated under those Directives.

Section V

Additional provisions

1.   Registration of the person responsible for placing devices on the market

Any manufacturer who places on the market of one of the Parties the medical devices referred to in Article 14 of Directive 93/42/EEC or Article 10 of Directive 98/79/EC shall inform the competent authorities of the Party in which he has his registered place of business of the particulars referred to in those Articles. The Parties shall reciprocally recognise that registration. The manufacturer shall not be obliged to designate a person responsible for placing devices on the market established in the territory of the other Party.

2.   Labelling of medical devices

Manufacturers of both Parties shall indicate their name or trade name and address on the label of medical devices specified in Annex 1, point 13.3(a) to Directive 93/42/EEC and in vitro diagnostic medical devices specified in Annex 1, point 8.4(a), to Directive 98/79/EC. They shall not be obliged to indicate the name and address of the person responsible for placing the device on the market, of the representative or of the importer established within the territory of the other Party on the label, outer packaging or instructions for use.

3.   Information exchange

In accordance with Article 9 of the Agreement, the Parties shall in particular exchange the information referred to in Article 8 of Directive 90/385/EEC, Article 10 of Directive 93/42/EEC and Article 11 of Directive 98/79/EC.

4.   European databank

The competent Swiss authorities shall have access to the European databanks established under Article 12 of Directive 98/79/EC and Article 14a of Directive 93/42/EEC. They shall transmit to the Commission and/or body responsible for managing the databank the data provided for in those Articles collected in Switzerland for entry into the European databank.

▼B

CHAPTER 5

GAS APPLIANCES AND BOILERS

▼M1

Section I

Legislation, regulations and administrative provisions

▼B

Section II

Conformity assessment bodies

The Committee established under Article 10 of this Agreement shall draw up and keep up to date, according to the procedure described in Article 11 of the Agreement, a list of the conformity assessment bodies.

▼M1

Section III

Designating authorities

▼B

Section IV

Special rules relating to the designation of conformity assessment bodies

For the designation of conformity assessment bodies, the designating authorities shall comply with the general principles contained in Annex 2 to this Agreement and those in Annex V to Directive 92/42/EEC, in respect of the bodies designated under that Directive, and in Annex V to Directive 90/396/EEC, in respect of the bodies designated thereunder.

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CHAPTER 6

PRESSURE VESSELS

Section I

Legislative, regulatory and administrative provisions

Provisions covered by Article 1(2)

Section II

Conformity assessment bodies

The Committee established under Article 10 of this Agreement shall draw up and keep up to date, according to the procedure described in Article 11 of the Agreement, a list of the conformity assessment bodies.

Section III

Designating authorities

The Committee established under Article 10 of this Agreement shall draw up and keep up to date a list of the designating authorities notified by the Parties.

Section IV

Special rules relating to the designation of conformity assessment bodies

For the designation of conformity assessment bodies, the designating authorities shall comply with the general principles contained in Annex 2 to this Agreement and the assessment criteria set out in Annex III to Directive 2009/105/EC, Annexes IV or V to Directive 97/23/EC or Chapter 4 of Directive 2010/35/EU.

Section V

Additional provisions

1.    Simple pressure vessels and pressure equipment

It shall be sufficient for manufacturers, their authorised representatives or, where neither of these is present, the person responsible for placing products on the market, to hold the technical documents required by the national authorities for inspection purposes at their disposal in the territory of one of the Parties for a period of at least 10 years after the last date of manufacture of the product. The Parties undertake to forward all relevant documents to the authorities of the other Party upon request.

2.    Transportable pressure equipment

1.   Market access

2.   Information exchange regarding technical documentation and cooperation regarding corrective action

Economic operators of Switzerland or a Member State shall, further to a reasoned request from the competent national authority of Switzerland or a Member State, provide it with all the information and documentation necessary to demonstrate the conformity of the transportable pressure equipment with Directive 2010/35/EU or the relevant Swiss legislation in a language easily understood by that authority or in English. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by transportable pressure equipment which they have placed on the market.

3.    Identification of economic operators

Economic operators shall, on request from the market surveillance authority of either an EU Member State or Switzerland, identify the following to it for a period of at least 10 years:

4.    Mutual assistance of market surveillance authorities

To ensure efficient cooperation for actions concerning economic operators based in a Member State or in Switzerland, the market surveillance authorities of a Member State and Switzerland shall give each other assistance on an adequate scale by supplying information or documentation, by carrying out appropriate investigation or any other appropriate measure, by participating in investigations initiated by the other Party.

5.    Procedure for dealing with transportable pressure equipment presenting a risk at national level

6.    Safeguard procedure

Should it disagree with the notified national measure, Switzerland or a Member State shall inform the European Commission of its objections.

1.   Objections against national measures

Where, on completion of the procedure set out in paragraph 3 of section 5 above, objections are raised by a Member State or Switzerland against a measure taken by Switzerland or a Member State or where the Commission considers a national measure to be non-compliant with the relevant legislation referred to in Section I, the European Commission shall without delay enter into consultation with the Member States, Switzerland and the relevant economic operator or operators and shall evaluate the national measure, in order to determine whether the national measure is justified or not. If the national measure is considered:

2.   Disagreement between the Parties

In case of a disagreement between the Parties the issue will be forwarded to the Joint Committee, which will decide on an appropriate course of action, including the possibility to have an expert study carried out.

Where the Committee considers that the measure is:

7.    Free movement of transportable pressure equipment

Without prejudice to the procedures in paragraph 3 and 4 above, no Member State or Switzerland shall prohibit, restrict or impede on its territory the free movement, the making available on the market and the use of transportable pressure equipment, which complies with the legal provisions in Section I.

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CHAPTER 7

RADIO EQUIPMENT AND TELECOMMUNICATIONS TERMINAL EQUIPMENT

Section I

Legislation, regulations and administrative provisions

▼B

Section II

Conformity assessment bodies

The Committee established under Article 10 of this Agreement shall draw up and keep up to date, according to the procedure described in Article 11 of the Agreement, a list of the conformity assessment bodies.

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Section III

Designating authorities

Section IV

Special rules relating to the designation of conformity assessment bodies

For the designation of conformity assessment bodies, designating authorities shall comply with the general principles contained in Annex 2 to this Agreement and those in Annex VI to Directive 1999/5/EC.

Section V

Additional provisions

1.   TCAM

Switzerland shall participate as observer in TCAM work and that of its subgroups.

2.   Market surveillance

The Parties shall notify each other of the authorities established on their territory responsible for carrying out the surveillance tasks involved in the implementation of their legislation as set out in Section I.

The Parties shall notify each other of their market surveillance activities within the bodies designated for this purpose.

3.   Regulated interfaces

The Parties shall inform each other of the interfaces they have regulated on their territory. When establishing the equivalence of notified interfaces and determining equipment class identifiers, the European Community shall take account of the interfaces regulated in Switzerland.

4.   Interfaces offered by public telecommunications network operators

The Parties shall inform each other of interfaces offered on their territory by public telecommunications network operators.

5.   Application of essential requirements

When the Commission intends to adopt a decision to apply a requirement set in Article 3(3) of Directive 1999/5/EC, it shall consult Switzerland on the issue before submitting it formally to the Committee.

When Switzerland intends to adopt a technical and administrative regulation to apply a requirement set in Article 7.4 of the Ordinance on Telecommunications Equipment, it shall consult the Commission on the issue before submitting it formally to the Committee.

6.   Authorisation to disconnect

Where one of the Parties considers that apparatus declared to comply with its legislation causes serious damage to a network or radioelectric interference, or degradation of a network or its operation, and that Party has authorised the operator to refuse connection of the apparatus, disconnect it or withdraw it from service, it shall inform the other Party of this authorisation.

7.   Harmonised standards

Where Switzerland considers that compliance with a harmonised standard does not guarantee that the essential requirements of its legislation as listed in Section I will be fulfilled, it shall inform the Committee and give its reasons.

The Committee shall consider the case and may ask the European Community to act in accordance with the procedure provided for in Article 5 of Directive 1999/5/EC. The Committee shall be informed of the result of the procedure.

8.   Mutual notification concerning radiocommunication equipment which conforms to requirements but is not intended for use in the spectrum of one of the parties

When either of the Parties adopts any appropriate measure to prohibit or restrict the placing on its market and/or require the withdrawal from its market of radiocommunications equipment, including types of radio equipment which has caused or which it reasonably considers will cause harmful interference, including interference with existing or planned services on nationally allocated frequency bands, it shall notify the other party thereof giving its reasons and naming the countries concerned.

9.   Safeguard clause relating to industrial products

9.1.

Where either of the Parties takes a measure to prohibit the placing of its market of a telecommunications installation declared to be in compliance with Directive 1999/5/EC, it shall immediately inform the other party, giving the reasons for its decision and stating how non compliance was established.

9.2.	The Parties shall consider the measure and the evidence presented to them and shall notify each other of the results of their investigations.

9.3.	If the parties agree regarding the results of their investigations they shall take the appropriate measures to ensure that such products are not placed on the market.

9.4.	If the Parties disagree regarding the results of their investigations, the case shall be forwarded to the Committee, which may decide to have an expert study carried out.

9.5.	Where the Committee considers that the measure is (a) unjustified, the national authority of the Party which took the measure shall withdraw it; (b) justified, they shall take the appropriate measures to ensure that products are not placed on the market

▼B

CHAPTER 8

EQUIPMENT AND PROTECTIVE SYSTEMS INTENDED FOR USE IN POTENTIALLY EXPLOSIVE ATMOSPHERES

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Section I

Legislation, regulations and administrative provisions

▼B

Section II

Conformity assessment bodies

The Committee established under Article 10 of this Agreement shall draw up and keep up to date, according to the procedure described in Article 11 of the Agreement, a list of the conformity assessment bodies.

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QS SCHAFFHAUSEN AG

Wiesengasse, 20

8222 Beringen

Switzerland

Tel. (41) 52 687 20 10

Fax (41) 52 682 18 02

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Section III

Designating authorities

▼B

Section IV

Special rules relating to the designation of conformity assessment bodies

For the designation of conformity assessment bodies, designating authorities shall comply with the general principles contained in Annex 2 and those in Annex XI to Directive 94/9/EC.

Section V

Supplementary provisions

1.   Information exchange

The conformity assessment bodies listed in section II shall provide the Member States, the competent Swiss authorities and/or the other conformity assessment bodies with the information provided for in Article 9(2) of Directive 76/117/EEC.

2.   Technical documentation

It shall be sufficient for manufacturers, their authorised representatives or the person responsible for placing products on the market to hold the technical documents required by the national authorities for inspection purposes at their disposal in the territory of one of the Parties for a period of at least ten years after the last date of manufacture of the product.

The Parties hereby undertake to forward all relevant technical documents at the request of the authorities of the other Party.

CHAPTER 9

ELECTRICAL EQUIPMENT AND ELECTROMAGNETIC COMPATIBILITY

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Section I

Legislation, regulations and administrative provisions

▼B

Section II

Conformity assessment bodies

The Committee established under Article 10 of this Agreement shall draw up and keep up to date, according to the procedure described in Article 11 of the Agreement, a list of the conformity assessment bodies.

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Section III

Designating authorities

▼B

Section IV

Special rules relating to the designation of conformity assessment bodies

For the designation of conformity assessment bodies, designating authorities shall comply with the general principles contained in Annex 2 and those in Annex II to Directive 89/336/EEC.

Section V

Supplementary provisions

1.   Technical documentation

It shall be sufficient for manufacturers, their authorised representatives or the person responsible for placing products on the market to hold the technical documents required by the national authorities for inspection purposes at their disposal in the territory of one of the Parties for a period of at least ten years after the last date of manufacture of the product.

The Parties hereby undertake to forward all relevant documents at the request of the authorities of the other Party.

2.   Standardisation bodies

In accordance with Article 11 of Directive 73/23/EEC, the Parties shall notify each other of the bodies responsible for drawing up the standards referred to in Article 5 of this Directive.

3.   Competent bodies

The Parties shall inform each other of and mutually recognise the bodies made responsible for drawing up technical reports and/or certificates pursuant to Article 8(2) of Directive 73/23/EEC and Article 10(2) of Directive 89/336/EEC.

4.   Special measures

In accordance with Article 6(2) of Directive 89/336/EEC, each Party shall inform the other of the special measures taken pursuant to paragraph 1 of that Article.

5.   Competent authorities

In accordance with Article 10(6) of Directive 89/336/EEC, each Party shall notify the other of the competent authorities referred to in that Article.

CHAPTER 10

CONSTRUCTION PLANT AND EQUIPMENT

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Section I

Legislation, regulations and administrative provisions

▼B

Section II

Conformity assessment bodies

The Committee established under Article 10 of this Agreement shall draw up and keep up to date, according to the procedure described in Article 11 of the Agreement, a list of the conformity assessment bodies.

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Section III

Designating authorities

Section IV

Special rules relating to the designation of conformity assessment bodies

For the designation of conformity assessment bodies, designating authorities shall comply with the general principles contained in Annex 2 and those in Annex IX to Directive 2000/14/EC of the European Parliament and the Council.

▼B

CHAPTER 11

MEASURING INSTRUMENTS AND PREPACKAGES

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Section I

Legislative, regulatory and administrative provisions

Section II

Conformity assessment bodies

The Committee established under Article 10 of this Agreement shall draw up and keep up to date, according to the procedure described in Article 11 of the Agreement, a list of the conformity assessment bodies.

Section III

Designating authorities

Section IV

Special rules relating to the designation of conformity assessment bodies

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For the designation of conformity assessment bodies, designating authorities shall comply with the general principles contained in Annex 2 to this Agreement and the assessment criteria set out in Annex V to Directive 2009/23/EC and in Article 12 to Directive 2004/22/EC, as regards the products covered by those Directives.

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Section V

Supplementary provisions

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1.    Information exchange

The conformity assessment bodies recognised under this Agreement shall periodically provide the Member States and the competent Swiss authorities with the information provided for in point 1.5 of Annex II to Directive 2009/23/EC.

The conformity assessment bodies recognised under this Agreement may request the information provided for in point 1.6 of Annex II to Directive 2009/23/EC.

2.    Prepackages

Switzerland shall recognise checks carried out in accordance with the provisions of European Union legislation listed in section I by a European Union body recognised under this Agreement in the case of European Union prepackages placed on the market in Switzerland.

As regards statistical checking of the quantities declared on prepackages, the European Union shall recognise the Swiss method laid down in Annex 3 Point 7 of the Ordinance of 5 September 2012 on the declaration of quantities for unpackaged and prepackaged products (RS 941.204) as equivalent to the European Union method laid down in Annex II of Directives 75/106/EEC and 76/211/EEC, as amended by Directive 78/891/EEC. Swiss producers whose prepackages conform to European Union legislation and have been checked according to the Swiss method shall affix the ‘e’ mark on their products exported to the EU.

3.    Marking

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4.   Measuring instruments covered by Directive 2004/22/EC

4.1.   Information exchange, market surveillance and administrative cooperation

In accordance with Article 18 of Directive 2004/22/EC, the competent authorities of the Member States and Switzerland shall assist each other in the fulfilment of their obligations to carry out market surveillance.

In particular, the competent authorities shall exchange:

The Member States and Switzerland shall ensure that all necessary information relating to the certificates and quality system approvals is made available to bodies they have notified.

Each Party shall inform the other Party which competent authorities it has designated for such an exchange of information.

4.2.   Technical documentation and declaration of conformity

It shall be sufficient for manufacturers, their authorised representatives or the person responsible for placing products on the market to hold the technical documentation and declarations of conformity required by the national authorities for inspection purposes at their disposal in the territory of one of the Parties for a period of at least 10 years after the last date of manufacture of the product.

The Parties hereby undertake to forward all relevant documents at the request of the authorities of the other Party.

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CHAPTER 12

MOTOR VEHICLES

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Section I

Legislative, regulatory and administrative provisions

Provisions covered by Article 1(2)

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Section II

Conformity assessment bodies

The Committee established pursuant to Article 10 of this Agreement shall draw up and keep up-to-date, according to the procedure described in Article 11 of the Agreement, a list of the conformity assessment bodies.

Section III

Designating authorities

The Committee established pursuant to Article 10 of this Agreement shall draw up and keep up-to-date a list of the designating authorities notified by the Parties.

Section IV

Special rules relating to the designation of conformity assessment bodies

For the designation of conformity assessment bodies, the designating authorities shall refer to their respective legislative, regulatory and administrative provisions as listed in Section I.

Section V

Supplementary provisions

The provisions of this Section shall apply exclusively to relations between Switzerland and the European Union.

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1.    Amendments to Annex IV respectively to acts listed in Annex IV of Directive 2007/46/EC

Without prejudice to article 12(2), the European Union shall notify Switzerland of amendments to Annex IV and to acts listed in Annex IV of Directive 2007/46/EC after 1 December 2013 without delay after their publication in the Official Journal of the European Union.

Switzerland shall notify the European Union without delay of the relevant amendments of the Swiss legislation, at the latest by the date of application of these amendments in the European Union.

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2.    Information exchange

The competent type-approval authorities in Switzerland and the Member States shall in particular exchange the information referred to in Article 8(5) to (8) of the Framework Directive 2007/46/EC.

In the event of refusal by Switzerland or a Member State to grant type-approval in accordance with Article 8(3) of the Framework Directive 2007/46/EC, it shall immediately send the other Member States, Switzerland and the Commission a detailed file explaining the reasons for its decision and setting out the evidence for its findings.

3.    Recognition of vehicle type-approval

Switzerland shall also recognise vehicle type-approval granted before the entry into force of this Agreement in accordance with Council Directive 70/156/EEC of 6 February 1970 (OJ L 42, 23.2.1970, p. 1), as last amended by Commission Directive 2007/37/EC of 21 June 2007 (OJ L 161, 22.6.2007, p. 60), by the authorities responsible for type-approval where that approval is still valid in the European Union.

The European Union shall recognise Swiss type-approval where Switzerland’s requirements are deemed to be equivalent to those of the Framework Directive 2007/46/EC.

Recognition of Swiss-issued type-approval shall be suspended should Switzerland fail to adapt its legislation to all the European Union type-approval legislation in force.

4.    Safeguard clauses

1.    Vehicles, systems, components or separate technical units in compliance with the applicable legislation

2.    Vehicles, systems, components or separate technical units not in conformity with the approved type

▼B

CHAPTER 13

AGRICULTURAL OR FORESTRY TRACTORS

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Section I

Legislative, regulatory and administrative provisions

Provisions covered by Article 1(2)

▼B

Section II

Conformity assessment bodies

The Committee established under Article 10 of this Agreement shall draw up and keep up to date, according to the procedure described in Article 11 of the Agreement, a list of the authorities responsible for type-approval, technical services and testing bodies.

European Community

Switzerland

Authority responsible for type-approval

Swiss Federal Roads Office

CH-3003 Berne

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Section III

Designating authorities

▼B

Section IV

Special rules relating to the designation of conformity assessment bodies

For the designation of conformity assessment bodies, the designating authorities shall refer to their respective legislative, regulatory and administrative provisions as listed in section I.

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Section V

Supplementary provisions

The provisions of this section shall apply exclusively to relations between Switzerland and the Community.

1.   Information exchange

The competent Member State's and Swiss authorities shall notify each other of conforming (Article 5 and 6, Directive 74/150/EEC, as last amended) or non-conforming (Article 8, Directive 74/150/EEC, as last amended by Commission Directive 2001/3/EC) vehicles, devices and systems placed on the market.

In the event of refusal by Switzerland or the Member States to grant type-approval in accordance with Article 4 of Directive 74/150/EEC, as last amended by Directive 2001/3/EC, their competent authorities shall notify each other of their decision and give the reasons for it.

2.   Recognition of vehicle type-approval

Switzerland shall also recognise tractor or separate technical unit type-approvals granted before the entry into force of this Agreement in accordance with Directive 74/150/EEC, as last amended by Commission Directive 2001/3/EC, by the authorities responsible for type-approval in the EU Member States where that approval is still valid in the EC.

The European Community shall recognise Swiss type-approval where Switzerland's requirements are deemed to be equivalent to those of Directive 74/150/EEC, as last amended by Commission Directive 2001/3/EC.

Recognition of Swiss-issued type-approval shall be suspended should Switzerland fail to adapt its legislation to all the Community type-approval legislation in force.

3.   Vehicle type-approval safeguard clauses

Registration and entry into service

Measures related to the conformity of production

Nonconformity with the approved type

▼B

CHAPTER 14

GOOD LABORATORY PRACTICE (GLP)

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Scope and coverage

The provisions of this Chapter shall apply to the testing of chemicals according to GLP, being either substances or preparations, covered by the legislative, regulatory and administrative provisions listed in section I. For the purposes of this Chapter the provisions of Article 4 of this Agreement concerning origin do not apply.

Unless specific definitions are given, the definition of terms in the ‘OECD Principles of Good Laboratory Practice’ as revised in 1997 [ENV/MC/CHEM(98)17] based on OECD Council Decision of 12 May 1981 C(81)30(Final)] amended on 26 November 1997 [C(97) 186 FINAL], as well as Council Decision-Recommendation of 2 October 1989 [C(89)87(Final)] and GLP Consensus documents, OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring, and all amendments made thereto, shall apply.

The Parties recognise the equivalence of each other's compliance monitoring programmes on Good Laboratory Practice that are in accordance with the OECD decisions and recommendations mentioned above and the legislative, regulatory and administrative procedures and principles listed in Section IV.

The Parties mutually accept studies and data generated therefrom, produced by the test facilities of the other Party listed in Section II provided they participate in the Good Laboratory Practice compliance monitoring programme of that Party in accordance with the principles and provisions stated above.

The Parties mutually accept the conclusions of study audits and test facility inspections performed by the monitoring authorities referred to in Section III.

Section I

Legislation, regulations and administrative provisions

With regard to the testing of chemicals according to GLP, the relevant parts of the legislative, regulatory and administrative provisions listed below shall apply.

▼B

Section II

Conformity assessment bodies

For the purpose of this Sectoral Chapter, ‘Conformity Assessment Bodies’ means the test facilities recognised under each Party's GLP monitoring programme.

On the basis of information provided by the Parties according to Section V of this Chapter, the Committee referred to in Article 10 of this Agreement shall establish and keep up to date, according to the procedure described in Article 11 of this Agreement, a list of the test facilities that have been found to be in conformity with the GLP principles.

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Section III

Designating authorities

For the purpose of this sectoral Annex, the term ‘Designating authorities’ means the GLP monitoring authorities of the parties.

Section IV

Special principles for designating conformity assessment bodies

For the purpose of this sectoral chapter, ‘designation of conformity assessment bodies’ means the procedure by which the GLP Monitoring Authorities recognise that test facilities comply with the GLP principles. To this end they shall apply the principles and procedures of their provisions listed below, that are recognised to be equivalent and in conformity with the aforementioned OECD Council Acts C(81)30 Final and C(89)87 (Final):

▼B

Section V

Additional provisions

1.   Information exchange

In accordance with Article 12 of this Agreement, the Parties in particular provide each other at least annually with a list of the test facilities which, in the light of the results of the inspections and study audits, conform to Good Laboratory Practice, as well as of the dates of inspection or audit and their compliance status.

In accordance with Article 6 of the Agreement, the Parties shall inform each other in a timely manner when a test facility coming under the terms of section II of this sectoral Chapter which states that it applies Good Laboratory Practice fails to conform to such practice to an extent which may jeopardise the integrity or authenticity of any such studies it conducts.

The Parties shall supply each other with any additional information on a test facility inspection or study audit in response to a reasonable request from the other Party.

2.   Test Facility Inspections

Each Party may request further test facility inspection or study audits if there is a documented doubt as to whether a test was conducted in accordance with Good Laboratory Practice.

If, in exceptional cases, doubts persist and the requesting Party can justify special concern, it may, in accordance with Article 8 of the Agreement, designate one or more experts of its authorities listed in section III to participate in a laboratory inspection or the audit of a study conducted by the authorities of the other Party.

3.   Confidentiality

In conformity with Article 13 of the Agreement, the Parties shall keep confidential any information brought to their knowledge pursuant to this Sectoral Chapter or that came to their knowledge in the framework of participation in an inspection or study audit and which falls within the definition of a trade secret or confidential commercial or financial information. They shall treat such information with at least the same confidentiality as that accorded to it by the providing Party and ensure that any authority to whom the information is transmitted treats it in the same way.

4.   Cooperation

Based on Article 9 of the Agreement, each Party may, on request, participate as an observer in an inspection of a test facility conducted by the authorities of the other Party with the consent of the test facility concerned in order to maintain a continuing understanding of the other Party's inspection procedures.

CHAPTER 15

MEDICINAL PRODUCTS GMP INSPECTION AND BATCH CERTIFICATION

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Scope and coverage

The provisions of this Sectoral Chapter cover all medicinal products which are industrially manufactured in Switzerland or the European Community, and to which Good Manufacturing Practice (GMP) requirements apply.

For medicinal products covered by this Chapter, each party shall recognise the conclusions of inspections of manufacturers carried out by the relevant inspection services of the other Party and the relevant manufacturing authorisations granted by the competent authorities of the other Party.

The manufacturer's certification of the conformity of each batch to its specifications shall be recognised by the other Party without re-control at import.

In addition, official batch releases carried out by an authority of the exporting Party will be recognised by the other Party.

‘Medicinal products’ means all products regulated by pharmaceutical legislation in the European Community and Switzerland as listed in Section I of this Chapter. The definition of medicinal products includes all human and veterinary products, such as chemical and biological pharmaceuticals, immunologicals, radio-pharmaceuticals, stable medicinal products derived from human blood or human plasma, pre-mixes for the preparation of veterinary medicated feedingstuffs and, where appropriate, vitamins, minerals, herbal remedies and homeopathic medicinal products.

‘GMP’ is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorisation and products specifications. For the purpose of this Chapter it includes the system whereby the manufacturer receives the specification of the product and the process from the marketing authorisation holder or applicant and ensures that the medicinal product is made in compliance with this specification.

With respect to medicinal products covered by the legislation of one Party but not the other, the manufacturing company can request, for the purpose of this Agreement, an inspection be made by the locally competent inspection service. This provision shall apply, inter alia, to the manufacture of active pharmaceutical ingredients, intermediate products and investigational medicinal products, as well as to pre-marketing inspections. Operational arrangements are detailed under section III, paragraph 3.

Certification of manufacturers

At the request of an exporter, importer or the competent authority of the other Party, the authorities responsible for granting manufacturing authorisations and for supervision of the manufacture of medicinal products shall certify that the manufacturer:

The certificates shall also identify the site(s) of manufacture (and contract quality control laboratories, if any).

Certificates shall be issued expeditiously, and the time taken should not exceed thirty calendar days. In exceptional cases, inter alia, when a new inspection has to be carried out, this period may be extended to sixty days.

Batch certification

Each batch exported shall be accompanied by a batch certificate established by the manufacturer (self-certification) after a full qualitative analysis, a quantitative analysis of all the active ingredients and all the other tests or checks necessary to ensure the quality of the product in accordance with the requirements of the marketing authorisation. This certificate shall attest that the batch meets its specifications and shall be kept by the importer of the batch. It will be made available upon request of the competent authority.

When issuing a certificate, the manufacturer shall take account of the provisions of the current WHO certification scheme on the quality of pharmaceutical products moving in international commerce. The certificate shall detail the agreed specifications of the product, the reference of the analytical methods and the analytical results. It shall contain a statement that the batch processing and packaging records were reviewed and found in conformity with GMP. The batch certificate shall be signed by the person responsible for releasing the batch for sale or supply, i.e. in the European Community the ‘qualified person’ referred to in Article 48 of Directive 2001/83/EC and Article 52 of Directive 2001/82/EC, and in Switzerland the ‘responsible person’ referred to in Articles 5 and 10 of the Ordinance on establishment licences.

Official batch release

When an official batch release procedure applies, official batch releases carried out by an authority of the exporting Party (listed in section II) will be recognised by the other Party. The manufacturer shall provide the certificate of the official batch release.

For the Community, the official batch release procedure is specified in document ‘Control Authority Batch Release of Vaccination and Blood Products, 2001’ or subsequent versions and in different specific batch release procedures. For Switzerland, the official batch release procedure is specified in Article 17 of the Federal Law on medicinal products and medical devices and in Articles 18 to 21 of the Ordinance of the Swiss Agency for Therapeutic Products on the requirements for the marketing authorisation of medicinal products.

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Section I

Legislative, regulatory and administrative provisions

Provisions covered by Article 1(2)

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Section II

Conformity assessment bodies

For the purpose of this Chapter ‘Conformity Assessment Bodies’ means the official GMP inspection services of each Party.

European Community ( 2 )

Switzerland

▼B

Section III

Additional provisions

1.   Transmission of inspection reports

Upon reasoned request, the relevant inspection services shall forward a copy of the last inspection report of the manufacturing site or, in case analytical operations are contracted out, of the control site. The request may concern a ‘full inspection report’ or a ‘detailed report’ (see item 2 below). Each party shall deal with these inspection reports with the degree of confidentiality requested by the providing Party.

Parties will ensure that inspection reports are forwarded in no more than 30 calendar days, this period being extended to 60 days should a new inspection be carried out.

2.   Inspection reports

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.

3.   GMP Reference

4.   Nature of inspections

5.   Fees

The regime of inspection/establishment fees is determined by the manufacturer's location. Inspection/establishment fees shall not be charged to manufacturers located on the territory of the other Party.

6.   Safeguard clause for inspections

Each Party reserves the right to have its own inspection conducted for reasons identified to the other Party. Such inspections are to be notified in advance to the other Party and shall, in accordance with Article 8 of the Agreement, be carried out jointly by the competent authorities of the two Parties. Recourse to this safeguard clause should be an exception.

7.   Exchange of information between authorities and approximation of quality requirements

In accordance with the general provisions of the Agreement, the parties shall exchange any information necessary for the mutual recognition of inspections.

The relevant authorities in Switzerland and in the Community shall also keep each other informed of any new technical guidance or inspection procedure. Each party shall consult the other before their adoption and shall endeavour to proceed towards their approximation.

8.   Inspectors training

In accordance with Article 9 of the Agreement, training sessions for inspectors, organised by the authorities, shall be accessible to inspectors of the other Party. The Parties to the Agreement shall keep each other informed on these sessions.

9.   Joint Inspections

In accordance with Article 12 of the Agreement, and by mutual agreement between the Parties, joint inspections may be organised. These inspections are intended to develop common understanding and interpretation of practice and requirements. The setting up of these inspections and their form shall be agreed through procedures approved by the Committee established under Article 10 of the Agreement.

10.   Alert system

Contact points shall 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 batch. A detailed alert procedure shall be agreed.

The Parties shall ensure that any suspension or withdrawal (total or partial) of a manufacturing authorisation, based on non-compliance with GMP and which could have public health implications, are communicated to each other with the appropriate degree of urgency.

11.   Contact points

For the purpose of this Agreement, the contact points for any technical question, such as exchanges of inspection reports, inspectors training sessions, technical requirements, are:

for the EC

the Director of the European Agency for the Evaluation of Medicinal Products and

for Switzerland

the official GMP inspection services listed in Section II above.

12.   Divergence of views

Both Parties shall use their best endeavours to resolve any divergence of views concerning inter alia compliance of manufacturers and conclusions of inspection reports. Unresolved divergences of view will be referred to the Committee as established under Article 10 of the Agreement.

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CHAPTER 16

CONSTRUCTION PRODUCTS

Section I

Legislative, regulatory and administrative provisions

Provisions covered by Article 1 paragraphs 1 and 2:

Section II

Conformity assessment bodies

Section III

Designating authorities

The Committee established under Article 10 of this Agreement shall draw up and keep up to date a list of the designating authorities and the competent authorities notified by the Parties.

Section IV

Special rules relating to the designation of conformity assessment bodies

For the designation of conformity assessment bodies, the designating authorities shall comply with the general principles contained in Annex 2 to this Agreement and with the assessment criteria set out in Article 43 of Regulation (EU) No 305/2011.

Section V

Supplementary provisions

1.    European harmonised standards for construction products

For the purpose of this Agreement, Switzerland will publish the reference of the European harmonised standards for construction products after their publishing in the Official Journal of the European Union according to Article 17(5) of the Regulation (EU) No 305/2011.

To state the equivalence of the Swiss systems of assessment and verification of constancy of performance, Switzerland will add to every harmonised standard a conversion table. This conversion table shall ensure the comparability of the Swiss and the European systems of assessment and verification of constancy of performance describing the relevant procedures for them.

2.    European Technical Assessments

3.    Information exchanges

In accordance with Article 9 of this Agreement, the Parties shall exchange information needed to ensure a proper implementation of this chapter.

4.    Technical documentation

It shall be sufficient for manufacturers, their authorised representatives or the person responsible for placing products on the market to hold the technical documents required by the national authorities for inspection purposes at their disposal in the territory of one of the Parties for a period of at least 10 years after the date of placing the product on either Party's market.

The Parties hereby undertake to forward all relevant technical documents at the request of the authorities of the other Party.

5.    Person responsible for placing the products on the market and labelling

The manufacturer shall not be obliged to designate an authorised representative or a person responsible for placing products on the market established in the territory of the other Party, nor to indicate the name and address of an authorised representative, responsible person or importer on the label, outer packaging or instructions for use.

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CHAPTER 17

LIFTS

Section I

Legislative, regulatory and administrative provisions

Section II

Conformity assessment bodies

The Committee established under Article 10 of this Agreement shall draw up and keep up to date, according to the procedure described in Article 11 of the Agreement, a list of the conformity assessment bodies.

Section III

Designating authorities

The Committee established under Article 10 of this Agreement shall draw up and keep up to date a list of the designating authorities notified by the Parties.

Section IV

Special rules relating to the designation of conformity assessment bodies

For the designation of conformity assessment bodies, the designating authorities shall comply with the general principles contained in Annex 2 to this Agreement and the assessment criteria set out in Annex VII to Directive 95/16/EC.

Section V

Supplementary provisions

1.    Information exchange

In accordance with Article 8(3) of Directive 95/16/EC, the European Commission, the authorities listed in section III and the conformity assessment bodies recognised under this Agreement may, on request, obtain from the installer a copy of the declaration of conformity and reports of the tests carried out in the final inspection.

In accordance with Annex V, points A 5 and B 5 of Directive 95/16/EC, they may obtain from the conformity assessment body which has issued the type-examination certificate, a copy of the certificate and, on a reasoned request, a copy of the technical dossier and reports of examinations, calculations and tests carried out.

In accordance with Annex V, points A 7 and B 7 of Directive 95/16/EC, the conformity assessment bodies which have issued type-examination certificates must communicate to the Member States, Switzerland and the other conformity assessment bodies the relevant information concerning the type-examination certificates they have issued or withdrawn.

In accordance with point 6 of Annexes VIII, IX, XII, XIII and XIV of Directive 95/16/EC, the conformity assessment bodies recognised under this Agreement must forward to the other conformity assessment bodies the relevant information concerning the quality assurance system approvals issued or withdrawn.

In the cases referred to in Article 8(2) (i), (ii) and (iii) of Directive 95/16/EC, the person responsible for the design of the lift must supply to the person responsible for the construction, installation and testing of the lift all necessary documents and information for the latter to be able to operate in absolute security.

2.    Technical documentation

It shall be sufficient for manufacturer of a safety component, his authorised representative established in the Union or in Switzerland or, where neither of these is present, the person responsible for placing its safety components on the market to keep with the technical documentation a copy of the declaration of conformity and their additions (as the case may be) required by the national authorities for inspection purposes at their disposal in the territory of one of the Parties) for at least ten years from the date on which the safety component was last manufactured.

It shall be sufficient for the installer of the lift to keep with the technical documentation a copy of the declaration of conformity and their additions and the final inspection certificate (if needed) for 10 years from the date on which the lift was placed on the market.

Where the installer is not established in the Union or in Switzerland, this obligation falls to the relevant notified body.

The Parties hereby undertake to forward all relevant technical documents at the request of the authorities of the other Party.

3.    Market surveillance

The Parties shall notify each other of the authorities established on their territory responsible for carrying out the surveillance tasks involved in the implementation of their legislation as set out in Section I.

The Parties shall notify each other of their market surveillance activities within the bodies designated for this purpose.

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CHAPTER 18

BIOCIDAL PRODUCTS

SCOPE AND COVERAGE

The provisions of this Sectoral Chapter apply to biocidal products as defined in Directive 98/8/EC, with the exemption of:

Commission Directives to include active substances to the Annex I, IA or IB are part of this Chapter.

Switzerland will be free to limit access to its market according to the requirements of its legislation existing at the date of entry into force of this Chapter concerning:

The Parties shall jointly review the situation in 2013.

Section I

Legislative, regulatory and administrative provisions

Section II

Conformity assessment bodies

For the purposes of this Chapter, ‘Conformity Assessment Bodies’ means the competent authorities of the Member States of the European Union and Switzerland for placing biocidal products on the market.

The contact details of the competent authorities of the Member States and of Switzerland can be found on the websites indicated below.

Member States

Biocides: ‘Competent Authorities and other Contact Points’ http://ec.europa.eu/environment/biocides/pdf/ca_contact.pdf

Switzerland

Federal Office of Public Health, Notification Authority for Chemicals www.bag.admin.ch/biocide

Section III

Supplementary provisions

For the purpose of paragraphs 2-5 of this Section, any reference to Directive 98/8/EC shall, as far as Switzerland is concerned, be understood to equally refer to the equivalent Swiss provisions.

1.    Inclusion of active substances in Annex I, IA or IB

Article 11 of Directive 98/8/EC shall apply between the Parties with the following adaptations:

inclusion or subsequent changes to the inclusion, of an active substance in Annex I, IA or IB shall also be considered where an applicant has forwarded the required dossier to the competent authority of Switzerland, and where the receiving competent authority has sent the required evaluation to the Commission.

2.    Mutual recognition of authorisations between Member States and Switzerland

3.    Market access

The applicant shall indicate his name or trade name and address on the label of biocidal products. It will be sufficient, for the purposes of Article 8 of Directive 98/8/EC, if the applicant for an authorisation has a permanent office either within the European Union or Switzerland. The Parties agree that authorisations and other decisions relating to the application of this Chapter may be notified by the competent authorities directly to the applicant in the territory of the other Party.

4.    Information exchange

In accordance with Article 9 of this Agreement, the Parties shall in particular exchange information referred to in Article 18 of Directive 98/8/EC. Confidential information shall be defined and treated in accordance with Article 19 of Directive 98/8/EC.

5.    Safeguard clause

Where a Member State or Switzerland has valid reasons to consider that a biocidal product which it has authorised, registered or is bound to authorise or register pursuant to Article 3 or 4 of Directive 98/8/EC constitutes an unacceptable risk to human or animal health or the environment, it may provisionally restrict or prohibit the use or sale of that product on its territory. It shall immediately inform the Commission, the other Member States and Switzerland of such action and give reasons for its decisions. A decision shall be taken on the matter within 90 days in accordance with the procedure laid down in Article 28(3). If Switzerland disagrees with the Commission Decision, the case will be forwarded to the Joint Committee, which will decide on an appropriate course of action, including the possibility to call an expert meeting. If a settlement is not reached within 90 days, either party may suspend the Biocidal products Chapter in part or in full.

Recourse to this safeguard clause should be an exception.

6.    Transitional period

Article 16(1) of Directive 98/8/EC shall apply between the Parties, with the transitional period up to 14 May 2014 for Switzerland.

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CHAPTER 19

CABLEWAY INSTALLATIONS

Section I

Legislative, regulatory and administrative provisions

Section II

Conformity assessment bodies

The Committee established under Article 10 of this Agreement shall draw up and keep up to date, according to the procedure described in Article 11 of the Agreement, a list of the conformity assessment bodies.

Section III

Designating authorities

The Committee established under Article 10 of this Agreement shall draw up and keep up to date a list of the designating authorities notified by the Parties.

Section IV

Special rules relating to the designation of conformity assessment bodies

For the designation of conformity assessment bodies, the designating authorities shall comply with the general principles contained in Annex 2 to this Agreement and the assessment criteria set out in Annex VIII to Directive 2000/9/EC.

Section V

Supplementary provisions

1.    Information exchange

In accordance with Articles 9 and 12 of this Agreement, the Parties shall exchange information needed to ensure a proper implementation of this Chapter.

The competent authorities in Switzerland and in the Member States as well as the European Commission shall in particular exchange the information referred to in Article 11 and Article 14 of Directive 2000/9/EC.

The conformity assessment bodies designated according to Section IV of this Annex shall exchange the information referred to in Annex V to Directive 2000/9/EC, as regards Module B points 7 and 8, Module D point 6, and Module H points 6 and 7.5.

2.    Technical documentation

It shall be sufficient for manufacturers, their authorised representatives or the person responsible for placing products on the market to hold the technical documentation as required by Directive 2000/9/EC in the territory of one of the Parties.

The Parties hereby undertake to forward all relevant technical documents at the request of the authorities of the other Party.

3.    Market surveillance

The Parties shall notify each other of the authorities established on their territory responsible for carrying out the surveillance tasks involved in the implementation of their legislation as set out in Section I.

The Parties shall notify each other of their market surveillance activities within the bodies designated for this purpose.

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CHAPTER 20

EXPLOSIVES FOR CIVIL USE

Section I

Legislative, regulatory and administrative provisions

Section II

Conformity assessment bodies

The Committee established under Article 10 of this Agreement shall draw up and keep up to date, according to the procedure described in Article 11 of the Agreement, a list of the conformity assessment bodies.

Section III

Designating authorities

The Committee established under Article 10 of this Agreement shall draw up and keep up to date a list of the designating authorities notified by the Parties.

Section IV

Special rules relating to the designation of conformity assessment bodies

For the designation of conformity assessment bodies, the designating authorities shall comply with the general principles contained in Annex 2 to this Agreement and the assessment criteria set out in Article 6(2) of Directive 93/15/EEC and its Annex III.

Section V

Supplementary provisions

1.    Identification of products

Both Parties shall ensure that undertakings in the explosives sector which manufacture or import explosives or assemble detonators shall mark explosives and each smallest packaging unit with a unique identification. Where an explosive is subject to further manufacturing processes, manufacturers shall not be required to mark the explosive with a new unique identification unless the original unique identification is no longer marked in compliance with Directive 2008/43/EC and/or the Explosives Ordinance.

The unique identification shall comprise the components prescribed in the Annex to Directive 2008/43/EC and Annex 14 to the Explosives Ordinance and shall be mutually recognised by both parties.

Each undertaking in the explosives sector and/or manufacturer shall be attributed a three-digit code by the Member State’s or Swiss national authority where it is established. This three-digit code shall be mutually recognised by both Parties if the manufacturing site or the manufacturer is located in the territory of one of the Parties.

2.    Provisions governing the supervision of transfers between the European Union and Switzerland

3.    Information exchange

In accordance with the general provisions of this Agreement, the Member States and Switzerland shall keep at each other’s disposal any relevant information needed to ensure a proper implementation of Directive 2008/43/EC.

4.    Location of the manufacturer

For the purpose of this Chapter, it shall be sufficient that the undertaking in the explosives sector, the manufacturer, an authorised representative or, where neither of these is present, the person responsible for placing the product on the market, is established in the territory of one of the Parties.

▼B

ANNEX 2

GENERAL RULES REGARDING THE DESIGNATION OF CONFORMITY ASSESSMENT BODIES

A.   General terms and conditions

B.   System for verification of conformity assessment bodies' competence

6.

In order to verify the technical competence of conformity assessment bodies, the authorities concerned may use various procedures ensuring an appropriate level of trust between the Parties. If necessary, a Party shall indicate to the designating authority possible ways of demonstrating competence. (a)   Accreditation Accreditation shall constitute a presumption of the technical competence of conformity assessment bodies in relation to the application of the requirements of the other Party provided that the competent accreditation body: — complies with the relevant international provisions in force (EN 45000 standards or ISO/IEC guides); and — is signatory to multilateral arrangements under which it is subject to peer evaluation, or — takes part, under the authority of a Designating Authority, and in accordance with whatever conditions are decided on, in programmes to conduct comparisons and exchange technical experience, in the interests of ensuring continued trust in the technical competence of the accreditation and conformity-assessment bodies. Such programmes could include joint evaluations, special cooperation exercises or conformity assessment. Where the criteria applicable to conformity assessment bodies require the latter to assess the conformity of products, processes or services directly to standards or technical specifications, the designating authorities may use accreditation as a presumption of the conformity assessment body's technical competence provided that it enables assessment of those bodies' ability to apply such standards or technical specifications. Designation shall be limited to those activities of the conformity assessment body. Where the criteria applicable to conformity assessment bodies require the latter to assess the conformity of products, processes or services not directly to standards or technical specifications, but to general (essential) requirements, the designating authorities may use accreditation as a presumption of the conformity assessment body's technical competence provided that it incorporates elements which will enable assessment of the capacity of the conformity assessment body (technical knowledge of the product, of its use, etc.) to assess the conformity of the product to those essential requirements. Designation shall be limited to those activities of the conformity assessment body. (b)   Other means If there is no accreditation scheme, or on other grounds, the authorities concerned shall require the conformity assessment bodies to demonstrate their competence by other means, e.g.: — participation in regional or international mutual recognition arrangements or certification systems; — regular peer evaluation, based on clear criteria and conducted with the appropriate expertise; — aptitude tests; or — comparison of conformity assessment bodies.

C.   Evaluation of the verification system

D.   Formal designation

FINAL ACT

They also took note of the following Declaration annexed to this Final Act:

Hecho en Luxemburgo, el día ventiuno de junio del año mil novecientos noventa y nueve.

Udfærdiget i Luxembourg, den enogtyvende juni nitten hundrede og nioghalvfems.

Geschehen zu Luxemburg am einundzwanzigsten Juni neunzehnhundertneunundneunzig.

Έγινε στο Λουξεμβούργο, στις είκοσι μία Ιουνίου χίλια εννιακόσια ενενήντα εννέα.

Done at Luxembourg on the twenty-first day of June in the year one thousand nine hundred and ninety-nine.

Fait à Luxembourg, le vingt-et-un juin mil neuf cent quatre-vingt dix-neuf.

Fatto a Lussemburgo, addì ventuno giugno millenovecentonovantanove.

Gedaan te Luxemburg, de eenentwintigste juni negentienhonderd negenennegentig.

Feito no Luxemburgo, em vinte e um de Junho de mil novecentos e noventa e nove

Tehty Luxemburgissa kahdentenakymmenentenäensimmäisenä päivänä kesäkuuta vuonna tuhatyhdeksänsataayhdeksänkymmentäyhdeksän.

Som gjordes i Luxemburg den tjugoförsta juni nittonhundranittionio.

Por la Comunidad Europea

For Det Europæiske Fællesskab

Für die Europäische Gemeinschaft

Για την Ευρωπαϊκή Κοινότητα

For the European Community

Pour la Communauté européenne

Per la Comunità europea

Voor de Europese Gemeenschap

Pela Comunidade Europeia

Euroopan yhteisön puolesta

På Europeiska gemenskapens vägnar

Por la Confederación Suiza

For Det Schweiziske Edsforbund

Für die Schweizerische Eidgenossenschaft

Για την Ελβετική Συνομοσπονδία

For the Swiss Confederation

Pour la Confédération suisse

Per la Confederazione svizzera

Voor de Zwitserse Bondsstaat

Pela Confederação Suíça

Sveitsin valaliiton puolesta

På Schweiziska edsförbundets vägnar

JOINT DECLARATION BY THE CONTRACTING PARTIES

on the Revision of Article 4

The Contracting Parties undertake to revise Article 4 of the Agreement on mutual recognition in relation to conformity assessment to include in particular products originating in other countries with which the Parties conclude agreements on mutual recognition in relation to conformity assessment, once such agreements have been concluded.

At that point the provisions of Chapter 12 in Section V of this Agreement will be revised.

JOINT DECLARATION

on the Mutual Recognition of Good Clinical Practice and Inspections Relating thereto

For medicinal products, the results of clinical trials carried out on the territory of the Parties to this Agreement are currently accepted for inclusion in applications for marketing authorisations and their variations or extensions. In principle, the Parties agree to continue to accept these clinical trials for the purpose of marketing authorisations applications. They agree to work towards an approximation of Good Clinical Practice, namely by implementing the current Declarations of Helsinki and Tokyo and all guidance relevant to clinical trials adopted in the framework of the International Conference on Harmonisation. However, due to legislative developments concerning inspections and authorisations of clinical trials in the European Community, detailed arrangements for the mutual recognition of the official supervision of these trials will have to be considered in the near future and laid down in a specific Chapter.

JOINT DECLARATION

by the Contracting Parties on Updating the Annexes

The Contracting Parties undertake to update the Annexes to the Agreement on mutual recognition in relation to conformity assessment not later than one month after its entry into force.

JOINT DECLARATION

on Further Negotiations

The European Community and the Swiss Confederation declare their intention of undertaking negotiations to conclude agreements in areas of common interest such as the updating of Protocol 2 to the 1972 Free Trade Agreement and Swiss participation in certain Community training, youth, media, statistical and environmental programmes. Preparatory work for these negotiations should proceed rapidly once the current bilateral negotiations have been concluded.

DECLARATION

on Swiss attendance of committees

The Council agrees that Switzerland's representatives may, in so far as the items concern them, attend meetings of the following committees and expert working parties as observers:

Switzerland's representatives shall not be present when these committees vote.

In the case of other committees dealing with areas covered by these agreements in which Switzerland has adopted either the acquis communautaire or equivalent measures, the Commission will consult Swiss experts by the method specified in Article 100 of the EEA Agreement.

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( 1 ) This procedure does not imply an obligation of the European Union to grant Switzerland access to the Community Rapid Information System (‘RAPEX’) under Article 12(4) of Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (OJ L 11, 15.1.2002, p. 4).

( 2 ) Up-to-date contact points should be confirmed with the EMEA