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AGREEMENT

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

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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

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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 atmosphere
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 or 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

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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.

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CHAPTER 2

PERSONAL PROTECTIVE EQUIPMENT

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 Chapter V of Regulation (EU) 2016/425.

Section V

Supplementary provisions

1.    Economic operators

1.1.    Specific obligations of economic operators pursuant to the legislation under Section I

Pursuant to the legislation under Section I, economic operators established in the EU or Switzerland are subject to equivalent obligations.

In order to avoid unnecessary duplication of obligations:

1.2.    Authorised representative

For the purpose of the obligation in Article 9(2) of Regulation (EU) 2016/425 and the corresponding Swiss provisions, authorised representative shall mean any natural or legal person established within the European Union or Switzerland who has received a written mandate from a manufacturer to act on his behalf pursuant to Article 9(1) of Regulation (EU) 2016/425 or the corresponding Swiss provisions.

1.3.    Cooperation with market surveillance authorities

The competent national market surveillance authority of a Member State of the European Union or Switzerland may, on reasoned request, ask the relevant economic operators in the European Union and in Switzerland to provide all the information and documentation necessary to demonstrate the conformity of a PPE with the legislation in section I.

That authority may contact the economic operator established within the territory of the other Party either directly or with the assistance of the competent national market surveillance authority of the other Party. It may request manufacturers or, where applicable, authorised representatives and importers to provide the documentation in a language easily understood by that authority. It may request the economic operators to cooperate on any action taken to eliminate the risks posed by the PPE.

2.    Exchange of experience

Swiss designating authorities may take part in the exchange of experience between the Member States' national authorities referred to in Article 35 of Regulation (EU) 2016/425.

3.    Coordination of conformity assessment bodies

Swiss designated conformity assessment bodies may take part in the coordination and cooperation mechanisms provided for in Article 36 of Regulation (EU) 2016/425, directly or by means of designated representatives.

4.    Mutual assistance of market surveillance authorities

Pursuant to Article 9(1) of the Agreement, the Parties shall ensure efficient cooperation and exchange of information between their market surveillance authorities. The market surveillance authorities of Member States and Switzerland shall cooperate and exchange information. They shall give each other assistance on an adequate scale by supplying information or documentation concerning economic operators based in a Member State or in Switzerland.

5.    Procedure for dealing with PPE presenting a risk not restricted to the national territory

Pursuant to Article 12(4) of this Agreement, where the market surveillance authorities of a Member State or Switzerland have taken action or have sufficient reason to believe that a PPE covered by this Chapter presents a risk to the health or safety of persons covered by the legislation in Section I of this Chapter, and if they consider that non-compliance is not restricted to their national territory, they shall inform the European Commission, the other Member States and Switzerland without delay of:

This information shall include all available details, in particular the data necessary for the identification of the non-compliant PPE, their origin, the nature of the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator. In particular, it shall be indicated whether the non-compliance is due to either:

Switzerland or Member States shall without delay inform 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 PPE concerned.

Member States and Switzerland shall ensure that appropriate restrictive measures are taken in respect of the PPE concerned, such as withdrawal of the PPE from their market, without delay.

6.    Safeguard procedure in case of objections against national measures

Should Switzerland or a Member State disagree with the national measure in paragraph 5, it shall inform the European Commission of its objections within three months of the receipt of the information.

Where, on completion of the procedure set out in paragraph 5, 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 contrary to the relevant legislation referred to in Section I, the European Commission shall without delay enter into consultation with the Member States, Switzerland, and via the Swiss authorities the relevant economic operator or operators. It shall evaluate the national measure, in order to determine whether the national measure is justified or not.

If the national measure is considered:

A Party may forward the issue to the Committee established under Article 10 of this Agreement, pursuant to paragraph 8.

7.    Compliant PPE which nevertheless present a risk

Where a Member State or Switzerland finds that, although a PPE that an economic operator has made available on the EU and on the Swiss market is in compliance with the legislation referred to in Section I of this Chapter, it presents a risk for the health or safety of persons, it shall take all appropriate measures and immediately inform the Commission, other Member States and Switzerland. That information shall include all available details, in particular the data necessary for the identification of the PPE concerned, the origin and the supply chain of the PPE, the nature of the risk involved and the nature and duration of the national measures taken.

The Commission shall without delay enter into consultation with the Member States, Switzerland, and via the Swiss authorities the relevant economic operator or operators, and shall evaluate the national measures taken, in order to determine whether the national measure is justified or not, and, where necessary, propose appropriate measures.

A Party may forward the issue to the Committee established under Article 10 of this Agreement, pursuant to paragraph 8.

8.    Safeguard clause in case of remaining disagreement between the Parties

In case of a disagreement between the Parties on measures at stake in paragraphs 6 and 7 above, the issue will be forwarded to the Committee established under Article 10 of this Agreement, 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:

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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:

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CHAPTER 4

MEDICAL DEVICES

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 under this Chapter, the designating authorities shall:

The Parties shall make available assessors for the pool established under Regulation (EC) No 920/2013, Article 40 of Regulation (EU) 2017/745 and Article 36 of Regulation (EU) 2017/746. The designating authorities of the Parties shall cooperate for the assessment of notified bodies in line with Article 39 of Regulation (EU) 2017/745 and Article 35 of Regulation (EU) 2017/746. They shall participate in peer reviews pursuant to Article 48 of Regulation (EU) 2017/745 and Article 44 of Regulation (EU) 2017/746.

Section V

Supplementary provisions

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

Any manufacturer or his authorised representative 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.

For devices imported from third countries, in view of their distribution in the Union and Switzerland, the label, or the outer packaging, or instructions for use, shall contain the name and address of the single authorised representative of the manufacturer established within the Union or Switzerland, as appropriate.

3.    Information exchange and cooperation

In accordance with Article 9 of the Agreement,

4.    European databases

The competent Swiss authorities shall have access to the European databases established under Article 12 of Directive 98/79/EC, Article 14a of Directive 93/42/EEC, Article 3 of Regulation (EU) No 920/2013, Article 33 of Regulation (EU) 2017/745 and Article 30 of Regulation (EU) 2017/746. They shall transmit to the Commission and/or body responsible for managing the databases the data provided for in those Articles collected in Switzerland for entry into the European databases.

5.    Transitional provisions

By way of derogation to the legislation in Section I, devices which comply with Regulation (EU) 2017/745 and Regulation (EU) 2017/746 may be placed on the market of both Parties respectively.

By way of derogation to the legislation in Section I, notified bodies which are designated and notified in accordance with Regulation (EU) 2017/745 and Regulation (EU) 2017/746 may carry out assessment procedures laid down in these regulations and issue certificates in accordance with these Regulations. Such certificates shall be recognized by the Parties.

CHAPTER 5

GAS APPLIANCES AND BOILERS

Section I

Legislative, regulatory and administrative provisions

Provisions covered by Article 1(1)

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 Chapter IV of Regulation (EU) 2016/426.

Section V

Supplementary provisions

1.    Economic operators

1.1.    Specific obligations of economic operators pursuant to the legislation under Section I

Pursuant to the legislation under Section I, economic operators established in the EU or Switzerland are subject to equivalent obligations.

In order to avoid unnecessary duplication of obligations:

1.2.    Authorised representative

For the purpose of the obligation in Article 8(2) of Regulation (EU) 2016/426 and the corresponding Swiss provisions, authorised representative shall mean any natural or legal person established within the European Union or Switzerland who has received a written mandate from a manufacturer to act on his behalf pursuant to Article 8(1) of Regulation (EU) 2016/426 or the corresponding Swiss provisions.

1.3.    Cooperation with market surveillance authorities

The competent national market surveillance authority of a Member State of the European Union or Switzerland may, on reasoned request, ask the relevant economic operators in the European Union and in Switzerland to provide all the information and documentation necessary to demonstrate the conformity of an appliance or fitting with the legislation in section I.

That authority may contact the economic operator established within the territory of the other Party either directly or with the assistance of the competent national market surveillance authority of the other Party. It may request manufacturers or, where applicable, authorised representatives and importers to provide the documentation in a language easily understood by that authority. It may request the economic operators to cooperate on any action taken to eliminate the risks posed by the appliance or the fitting.

2.    Exchange of experience

Swiss designating authorities may take part in the exchange of experience between the Member States' national authorities referred to in Article 34 of Regulation (EU) 2016/426.

3.    Coordination of conformity assessment bodies

Swiss designated conformity assessment bodies may take part in the coordination and cooperation mechanisms provided for in Article 35 of Regulation (EU) 2016/426, directly or by means of designated representatives.

4.    Mutual assistance of market surveillance authorities

Pursuant to Article 9(1) of the Agreement, the Parties shall ensure efficient cooperation and exchange of information between their market surveillance authorities. The market surveillance authorities of Member States and Switzerland shall cooperate and exchange information. They shall give each other assistance on an adequate scale by supplying information or documentation concerning economic operators based in a Member State or in Switzerland.

5.    Procedure for dealing with appliances or fittings presenting a risk not restricted to the national territory

Pursuant to Article 12(4) of this Agreement, where the market surveillance authorities of a Member State or Switzerland have taken action or have sufficient reason to believe that an appliance or fitting covered by this Chapter presents a risk to the health or safety of persons or to domestic animals or property covered by the legislation in Section I of this Chapter, and if they consider that non-compliance is not restricted to their national territory, they shall inform the European Commission, the other Member States and Switzerland without delay of:

This information shall include all available details, in particular the data necessary for the identification of the non-compliant appliance or fitting, their origin, the nature of the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator. In particular, it shall be indicated whether the non-compliance is due to either:

Switzerland or Member States shall without delay inform 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 appliance or fitting concerned.

Member States and Switzerland shall ensure that appropriate restrictive measures are taken in respect of the appliance or fitting concerned, such as withdrawal of appliance or fitting from their market, without delay.

6.    Safeguard procedure in case of objections against national measures

Should Switzerland or a Member State disagree with the national measure in paragraph 5, it shall inform the European Commission of its objections within three months of the receipt of the information.

Where, on completion of the procedure set out in paragraph 5, 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 contrary to the relevant legislation referred to in Section I, the European Commission shall without delay enter into consultation with the Member States, Switzerland, and via the Swiss authorities the relevant economic operator or operators. It shall evaluate the national measure, in order to determine whether the national measure is justified or not.

If the national measure relating to an appliance or fitting is considered:

A Party may forward the issue to the Committee established under Article 10 of this Agreement, pursuant to paragraph 8.

7.    Compliant appliances or fittings which nevertheless present a risk

Where a Member State or Switzerland finds that, although an appliance or fitting that an economic operator has made available on the EU and on the Swiss market is in compliance with the legislation referred to in Section I of this Chapter, it presents a risk for the health or safety of persons or to domestic animals or property, it shall take all appropriate measures and immediately inform the Commission, other Member States and Switzerland. That information shall include all available details, in particular the data necessary for the identification of the appliance or fitting concerned, the origin and the supply chain of the appliance or fitting, the nature of the risk involved and the nature and duration of the national measures taken.

The Commission shall without delay enter into consultation with the Member States, Switzerland, and via the Swiss authorities the relevant economic operator or operators, and shall evaluate the national measures taken, in order to determine whether the national measure is justified or not, and, where necessary, propose appropriate measures.

A Party may forward the issue to the Committee established under Article 10 of this Agreement, pursuant to paragraph 8.

8.    Safeguard clause in case of remaining disagreement between the Parties

In case of a disagreement between the Parties on measures at stake in paragraphs 6 and 7 above, the issue will be forwarded to the Committee established under Article 10 of this Agreement, 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:

9.    Information exchange

In accordance with Article 12 of this Agreement, the Parties shall exchange information on the types of gas and the corresponding supply pressures of gaseous fuels used on their territory referred to in Annex II of Regulation (EU) 2016/426. Further Switzerland shall inform about the changes thereof within six months after the announcement of the envisaged changes. The European Union shall inform about the changes thereof within six months after it received the notification by a Member State.

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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 Chapter 4 of Directive 2014/29/EU, Chapter 4 of Directive 2014/68/EU or Chapter 4 of Directive 2010/35/EU.

Section V

Supplementary provisions

1.    Economic operators

1.1.    Specific obligations of economic operators pursuant to the legislation under Section I

Pursuant to the legislation under Section I, economic operators established in the EU or Switzerland are subject to equivalent obligations.

In order to avoid unnecessary duplication of obligations:

1.2.    Authorised representative

For the purpose of the obligation in Article 5(2) of Directive 2010/35/EU, respectively Article 7(2) of Directive 2014/29/EU, or Article 7(2) of Directive 2014/68/EU and the corresponding Swiss provisions, authorised representative shall mean any natural or legal person established within the European Union or Switzerland who has received a written mandate from a manufacturer to act on his behalf pursuant to Article 5(1) of Directive 2010/35/EU, respectively Article 7(1) of Directive 2014/29/EU, or Article 7(1) of Directive 2014/68/EU or the corresponding Swiss provisions.

1.3.    Cooperation with market surveillance authorities

The competent national market surveillance authority of a Member State of the European Union or Switzerland may, on reasoned request, ask the relevant economic operators in the European Union and in Switzerland to provide all the information and documentation necessary to demonstrate the conformity of a product with the legislation in Section I.

That authority may contact the economic operator established within the territory of the other Party either directly or with the assistance of the competent national market surveillance authority of the other Party. It may request manufacturers or, where applicable, authorised representatives and importers to provide the documentation in a language easily understood by that authority. It may request the economic operators to cooperate on any action taken to eliminate the risks posed by the product.

2.    Exchange of experience

Swiss designating authorities may take part in the exchange of experience between the Member States' national authorities referred to in Article 28 of Directive 2010/35/EU, Article 32 of Directive 2014/29/EU and Article 37 of Directive 2014/68/EU.

3.    Coordination of conformity assessment bodies

Swiss designated conformity assessment bodies may take part in the coordination and cooperation mechanisms provided for in Article 29 of Directive 2010/35/EU, Article 33 of Directive 2014/29/EU and Article 38 of Directive 2014/68/EU, directly or by means of designated representatives.

4.    Mutual assistance of market surveillance authorities

Pursuant to Article 9(1) of the Agreement, the Parties shall ensure efficient cooperation and exchange of information between their market surveillance authorities. The market surveillance authorities of Member States and Switzerland shall cooperate and exchange information. They shall give each other assistance on an adequate scale by supplying information or documentation concerning economic operators based in a Member State or in Switzerland.

5.    Procedure for dealing with products presenting a risk not restricted to the national territory

Pursuant to Article 12(4) of this Agreement, where the market surveillance authorities of a Member State or Switzerland have taken action or have sufficient reason to believe that a product covered by this chapter presents a risk to the health or safety of persons or to other aspects of public interest protection referred to in the relevant legislation in Section I of this Chapter and if they consider that non-compliance is not restricted to their national territory, they shall inform the European Commission, the other Member States and Switzerland without delay of:

This information shall include all available details, in particular the data necessary for the identification of the non-compliant product, the origin of the product, the nature of the alleged non-compliance and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator. In particular, it shall be indicated whether the non-compliance is due to either:

Switzerland or Member States other than the Member State initiating the procedure shall without delay inform 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 product concerned.

Member States and Switzerland shall ensure that appropriate restrictive measures are taken in respect of the product concerned, such as withdrawal of the product from their market, without delay.

6.    Safeguard procedure in case of objections against national measures

Should it disagree with the notified national measure in paragraph 5, Switzerland or a Member State shall inform the European Commission of its objections within three months of the receipt of the information.

Where, on completion of the procedure set out in paragraph 5, 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 contrary to the relevant legislation referred to in Section I, the European Commission shall without delay enter into consultation with the Member States and Switzerland, and via the Swiss authorities 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:

A Party may forward the issue to the Committee established under Article 10 of this Agreement, pursuant to paragraph 8.

7.    Compliant products which nevertheless present a risk

Where a Member State or Switzerland finds that, although a product that an economic operator has made available on the EU and on the Swiss market is in compliance with the legislation referred to in Section I of this Chapter, it presents a risk for the health or safety of persons or to other aspects of public interest protection referred to in the relevant legislation in Section I of this Chapter, it shall take all appropriate measures and immediately inform the Commission, other Member States and Switzerland. That information shall include all available details, in particular the data necessary for the identification of the product concerned, the origin and the supply chain of the product, the nature of the risk involved and the nature and duration of the national measures taken.

The Commission shall without delay enter into consultation with the Member States, Switzerland, and via the Swiss authorities the relevant economic operator or operators, and shall evaluate the national measures taken, in order to determine whether the national measure is justified or not, and where necessary propose appropriate measures.

A Party may forward the issue to the Committee established under Article 10 of this Agreement, pursuant to paragraph 8.

8.    Safeguard clause in case of remaining disagreement between the Parties

In case of a disagreement between the Parties on measures at stake in paragraphs 6 and 7 above, the issue will be forwarded to the 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:

CHAPTER 7

RADIO EQUIPMENT AND TELECOMMUNICATIONS TERMINAL EQUIPMENT

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, designating authorities shall comply with the general principles contained in Annex 2 to this Agreement and the assessment criteria set out in Chapter IV of Directive 2014/53/EU.

Section V

Supplementary provisions

1.    Amendments to legislative, regulatory and administrative provisions of Section I

Without prejudice to Article 12(2) of this Agreement, the European Union shall notify Switzerland of implementing and delegated acts of the Commission under Directive 2014/53/EU adopted after 13 June 2016 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.

2.    Economic operators

2.1.    Specific obligations of economic operators pursuant to the legislation under Section I

Pursuant to the legislation under Section I, economic operators established in the EU or Switzerland are subject to equivalent obligations.

In order to avoid unnecessary duplication of obligations:

2.2.    Provision of information on radio equipment and software by manufacturer

2.3.    Authorised representative

For the purpose of the obligation in Article 11(2) of Directive 2014/53/EU and the corresponding Swiss provisions, authorised representative shall mean any natural or legal person established within the European Union or Switzerland who has received a written mandate from a manufacturer to act on his behalf pursuant to Article 11(1) of Directive 2014/34/EU or the corresponding Swiss provisions.

2.4.    Cooperation with market surveillance authorities

The competent national market surveillance authority of a Member State of the European Union or Switzerland may, on reasoned request, ask the relevant economic operators in the European Union and in Switzerland to provide all the information and documentation necessary to demonstrate the conformity of radio equipment with the legislation in Section I.

That authority may contact the economic operator established within the territory of the other Party either directly or with the assistance of the competent national market surveillance authority of the other Party. It may request manufacturers or, where applicable, authorised representatives and importers to provide the documentation in a language easily understood by that authority. It may request the economic operators to cooperate on any action taken to eliminate the risks posed by the radio equipment.

3.    Assignment of radio equipment classes

Member States and Switzerland shall notify each other the interfaces they intend to regulate on their territory in cases foreseen under Article 8(1) of Directive 2014/53/EU. When establishing the equivalence of regulated radio interfaces and assigning a radio equipment class, the European Union shall take account of the radio 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, putting into service and use

6.    Coordination of conformity assessment bodies

Swiss designated conformity assessment bodies may take part in the coordination and cooperation mechanisms provided for in Article 38 of Directive 2014/53/EU, directly or by means of designated representatives.

Conformity assessment bodies shall inform the other bodies recognised under this chapter concerning type examination certificates which they have refused, withdrawn, suspended or restricted, and upon request concerning certificates they have issued.

Conformity assessment bodies shall inform the Member States and Switzerland of type examination certificates issued and/or additions thereto, in those cases where harmonised standards have not been applied or not been fully applied. The Member States, Switzerland, the European Commission and the other bodies may, on request, obtain a copy of the type examination certificates and/or additions thereto, a copy of the technical documentation and the results of the examinations carried out.

7.    Exchange of experience

Swiss designating authorities may take part in the exchange of experience between the Member States' national authorities referred to in Article 37 of Directive 2014/53/EU.

8.    Telecommunication Conformity Assessment and Market Surveillance Committee

Switzerland may participate as observer in the Telecommunication Conformity Assessment and Market Surveillance Committee work and that of its sub-groups.

9.    Cooperation between market surveillance authorities

Pursuant to Article 9 paragraph1 of the Agreement, the Parties shall ensure efficient cooperation and exchange of information between their market surveillance authorities. The market surveillance authorities of Member States and Switzerland shall cooperate and exchange information. They shall give each other assistance on an adequate scale by supplying information or documentation concerning economic operators based in a Member State or in Switzerland.

10.    Objections to 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 Commission to act in accordance with the procedure provided for in Article 11 of Regulation (EU) No 1025/2012 of the European Parliament and of the Council ( 2 ). The Committee shall be informed of the result of the procedure.

11.    Procedure for dealing with equipment presenting a risk caused by non-compliance not restricted to the national territory

Pursuant to Article 12(4) of this Agreement, where the market surveillance authorities of a Member State or Switzerland have found that equipment covered by this chapter does not comply with requirements laid down in the legislation in Section I of this Chapter, and if they consider that non-compliance is not restricted to their national territory, they shall inform the European Commission, the other Member States and Switzerland without delay of:

This information shall include all available details, in particular the data necessary for the identification of the non-compliant equipment, its origin, the nature of the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator. In particular, it shall be indicated whether the non-compliance is due to either:

Switzerland or Member States shall without delay inform 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 equipment concerned.

Member States and Switzerland shall ensure that appropriate restrictive measures are taken in respect of the equipment concerned, such as its withdrawal from their market, without delay.

12.    Safeguard procedure in case of objections against national measures

Should Switzerland or a Member State disagree with the national measure in paragraph 11, it shall inform the European Commission of its objections within three months of the receipt of the information.

Where, on completion of the procedure set out in paragraph 11, 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 contrary to the relevant legislation referred to in Section I, the European Commission shall without delay enter into consultation with the Member States, Switzerland, and via the Swiss authorities the relevant economic operator or operators. It shall evaluate the national measure, in order to determine whether the national measure is justified or not. If the national measure is considered:

A Party may forward the issue to the Committee established under Article 10 of this Agreement, pursuant to paragraph 14.

13.    Compliant radio equipment which nevertheless present a risk

Where a Member State or Switzerland finds that, although radio equipment that an economic operator has made available on the EU and on the Swiss market is in compliance with the legislation referred to in Section I of this Chapter, it presents a risk to health and safety of persons or to other aspects of public interest protection, it shall take all appropriate measures and immediately inform the Commission, other Member States and Switzerland. That information shall include all available details, in particular the data necessary for the identification of the product concerned, the origin and the supply chain of the product, the nature of the risk involved and the nature and duration of the national measures taken.

The Commission shall without delay enter into consultation with the Member States, Switzerland, and via the Swiss authorities the relevant economic operator or operators, and shall evaluate the national measures taken, in order to determine whether the national measure is justified or not, and where necessary, propose appropriate measures.

A Party may forward the issue to the Committee established under Article 10 of this Agreement, pursuant to paragraph 14.

14.    Safeguard clause in case of remaining disagreement between the Parties

In case of a disagreement between the Parties on measures pursuant to paragraphs 10 and 11 above, the issue will be forwarded to the Committee established under Article 10 of this Agreement, 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

CHAPTER 8

EQUIPMENT AND PROTECTIVE SYSTEMS INTENDED FOR USE IN POTENTIALLY EXPLOSIVE ATMOSPHERE

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, designating authorities shall comply with the general principles contained in Annex 2 to this Agreement and assessment criteria set out in Chapter 4 of Directive 2014/34/EU.

Section V

Supplementary provisions

1.    Economic operators

1.1.    Specific obligations of economic operators pursuant to the legislation under Section I

Pursuant to the legislation under Section I, economic operators established in the EU or Switzerland are subject to equivalent obligations.

In order to avoid unnecessary duplication of obligations:

1.2.    Authorised representative

For the purpose of the obligation in Article 7(2) of Directive 2014/34/EU and the corresponding Swiss provisions, authorised representative shall mean any natural or legal person established within the European Union or Switzerland who has received a written mandate from a manufacturer to act on his behalf pursuant to Article 7(1) of Directive 2014/34/EU or the corresponding Swiss provisions.

1.3.    Cooperation with market surveillance authorities

The competent national market surveillance authority of a Member State of the European Union or Switzerland may, on reasoned request, ask the relevant economic operators in the European Union and in Switzerland to provide all the information and documentation necessary to demonstrate the conformity of a product with the legislation in Section I.

That authority may contact the economic operator established within the territory of the other Party either directly or with the assistance of the competent national market surveillance authority of the other Party. It may request manufacturers or, where applicable, authorised representatives and importers to provide the documentation in a language easily understood by that authority. It may request the economic operators to cooperate on any action taken to eliminate the risks posed by the product.

2.    Exchange of experience

Swiss designating authorities may take part in the exchange of experience between the Member States' national authorities referred to in Article 32 of Directive 2014/34/EU.

3.    Coordination of conformity assessment bodies

Swiss designated conformity assessment bodies may take part in the coordination and cooperation mechanisms provided for in Article 33 of Directive 2014/34/EU, directly or by means of designated representatives.

Conformity assessment bodies shall provide the other bodies recognised under this chapter carrying out similar conformity assessment activities covering the same product with relevant information on issues relating to negative and, on request, positive conformity assessment results.

The Commission, the Member States, Switzerland and the other bodies recognised under this chapter may request a copy of the type examination certificates and additions thereto. On request, the Commission, Member States, and Switzerland may obtain a copy of the technical documentation and the results of the examinations carried out by a body recognised under this chapter.

4.    Mutual assistance of market surveillance authorities

Pursuant to Article 9(1) of the Agreement, the Parties shall ensure efficient cooperation and exchange of information between their market surveillance authorities. The market surveillance authorities of Member States and Switzerland shall cooperate and exchange information. They shall give each other assistance on an adequate scale by supplying information or documentation concerning economic operators based in a Member State or in Switzerland.

5.    Procedure for dealing with products presenting a risk not restricted to the national territory

Pursuant to Article 12(4) of this Agreement, where the market surveillance authorities of a Member State or Switzerland have found that a product covered by this Chapter does not comply with requirements laid down in the legislation in Section I of this Chapter, and if they consider that non-compliance is not restricted to their national territory, they shall inform the European Commission, the other Member States and Switzerland without delay of:

This information shall include all available details, in particular the data necessary for the identification of the non-compliant product, its origin, the nature of the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator. In particular, it shall be indicated whether the non-compliance is due to either:

Switzerland, or Member States shall without delay inform 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 product concerned.

Member States and Switzerland shall ensure that appropriate restrictive measures are taken in respect of the product concerned, such as withdrawal of product from their market, without delay.

6.    Safeguard procedure in case of objections against national measures

Should Switzerland or a Member State disagree with the national measure in paragraph 5, it shall inform the European Commission of its objections within three months of the receipt of the information.

Where, on completion of the procedure set out in paragraph 5, 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 contrary to the relevant legislation referred to in Section I, the European Commission shall without delay enter into consultation with the Member States, Switzerland, and via the Swiss authorities the relevant economic operator or operators. It shall evaluate the national measure, in order to determine whether the national measure is justified or not.

If the national measure relating to a product is considered:

A Party may forward the issue to the Committee established under Article 10 of this Agreement, pursuant to paragraph 8.

7.    Compliant products which nevertheless present a risk

Where a Member State or Switzerland finds that, although a product that an economic operator has made available on the EU and on the Swiss market is in compliance with the legislation referred to in Section I of this Chapter, it presents a risk for the health or safety of persons or to domestic animals or property, it shall take all appropriate measures and immediately inform the Commission, other Member States and Switzerland. That information shall include all available details, in particular the data necessary for the identification of the product concerned, the origin and the supply chain of the product, the nature of the risk involved and the nature and duration of the national measures taken.

The Commission shall without delay enter into consultation with the Member States, Switzerland, and via the Swiss authorities the relevant economic operator or operators, and shall evaluate the national measures taken, in order to determine whether the national measure is justified or not, and, where necessary, propose appropriate measures.

A Party may forward the issue to the Committee established under Article 10 of this Agreement, pursuant to paragraph 8.

8.    Safeguard clause in case of remaining disagreement between the Parties

In case of a disagreement between the Parties on measures at stake in paragraphs 6 and 7 above, the issue will be forwarded to the Committee established under Article 10 of this Agreement, 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:

CHAPTER 9

ELECTRICAL EQUIPMENT AND ELECTROMAGNETIC COMPATIBILITY

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, designating authorities shall comply with the general principles contained in Annex 2 to this Agreement and the assessment criteria set out in Chapter 4 of Directive 2014/30/EU.

Section V

Supplementary provisions

1.    Economic operators

1.1.    Specific obligations of economic operators pursuant to the legislation under Section I

Pursuant to the legislation under Section I, economic operators established in the EU or Switzerland are subject to equivalent obligations.

In order to avoid unnecessary duplication of obligations:

1.2.    Authorised representative

For the purpose of the obligation in Article 8(2) of Directive 2014/30/EU, respectively Article 7(2) of Directive 2014/35/EU and the corresponding Swiss provisions, authorised representative shall mean any natural or legal person established within the European Union or Switzerland who has received a written mandate from a manufacturer to act on his behalf pursuant to Article 8(1) of Directive 2014/30/EU, respectively Article 7(1) of Directive 2014/35/EU or the corresponding Swiss provisions.

1.3.    Cooperation with market surveillance authorities

The competent national market surveillance authority of a Member State of the European Union or Switzerland may, on reasoned request, ask the relevant economic operators in the European Union and in Switzerland to provide all the information and documentation necessary to demonstrate the conformity of equipment with the legislation in section I.

That authority may contact the economic operator established within the territory of the other Party either directly or with the assistance of the competent national market surveillance authority of the other Party. It may request manufacturers or, where applicable, authorised representatives and importers to provide the documentation in a language easily understood by that authority. It may request the economic operators to cooperate on any action taken to eliminate the risks posed by the equipment.

2.    Exchange of experience

Swiss designating authorities may take part in the exchange of experience between the Member States' national authorities referred to in Article 35 of Directive 2014/30/EU.

3.    Coordination of conformity assessment bodies

Swiss designated conformity assessment bodies may take part in the coordination and cooperation mechanisms provided for in Article 36 of Directive 2014/30/EU, directly or by means of designated representatives.

4.    Committee on Electromagnetic Compatibility and Committee on Electrical equipment

Switzerland may participate as an observer in the work of the Committee on Electromagnetic Compatibility and the Committee on Electrical equipment and of their subgroups.

5.    Standards

For the purpose of this Chapter and according to Article 14 of Directive 2014/35/EU and the corresponding Swiss provisions, competent authorities of Member States and Switzerland shall also regard as complying with their safety objectives for electrical equipment in the scope of Directive 2014/35/EU, equipment manufactured in accordance with the safety provisions of the standards in force in the Member State of manufacture or in Switzerland, if it ensures a safety level equivalent to that required in their own territory.

6.    Conformity assessment bodies

The Parties shall inform each other of and mutually recognise the bodies responsible for the tasks described in Annex III to Directive 2014/30/EU.

Conformity assessment bodies shall provide the other bodies recognised under this chapter carrying out similar conformity assessment activities covering the same equipment with relevant information on issues relating to negative and, on request, positive conformity assessment results.

The Commission, the Member States, Switzerland and the other bodies recognised under this chapter may request a copy of the type examination certificates and additions thereto. On request, the Commission, Member States, and Switzerland may obtain a copy of the technical documentation and the results of the examinations carried out by a body recognised under this chapter.

7.    Cooperation between market surveillance authorities

Pursuant to Article 9(1) of the Agreement, the Parties shall ensure efficient cooperation and exchange of information between their market surveillance authorities. The market surveillance authorities of Member States and Switzerland shall cooperate and exchange information. They shall give each other assistance on an adequate scale by supplying information or documentation concerning economic operators based in a Member State or in Switzerland.

8.    Procedure for dealing with equipment presenting a risk not restricted to the national territory

Pursuant to Article 12(4) of this Agreement, where the market surveillance authorities of a Member State or Switzerland have taken action or have sufficient reason to believe that equipment covered by this chapter presents a risk to aspects of public interest protection covered by the legislation in Section I of this Chapter and if they consider that non-compliance is not restricted to their national territory, they shall inform the European Commission, the other Member States and Switzerland without delay of:

This information shall include all available details, in particular the data necessary for the identification of non-compliant equipment, its origin, the nature of the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator. In particular, it shall be indicated whether the non-compliance is due to either:

Switzerland or Member States shall without delay inform 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 equipment concerned.

Member States and Switzerland shall ensure that appropriate restrictive measures are taken in respect of equipment concerned, such as its withdrawal from their market, without delay.

9.    Safeguard procedure in case of objections against national measures

Should Switzerland or a Member State disagree with the national measure in paragraph 8, it shall inform the European Commission of its objections within three months of the receipt of the information.

Where, on completion of the procedure set out in paragraph 8, 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 contrary to the relevant legislation referred to in Section I, the European Commission shall without delay enter into consultation with the Member States, Switzerland, and via the Swiss authorities the relevant economic operator or operators. It shall evaluate the national measure, in order to determine whether the national measure is justified or not.

If the national measure is considered:

A Party may forward the issue to the Committee established under Article 10 of this Agreement, pursuant to paragraph 11.

10.    Compliant equipment which nevertheless present a risk

Where a Member State or Switzerland finds that, although an equipment within the scope of Directive 2014/35/EU that an economic operator has made available on the EU and on the Swiss market is in compliance with the legislation referred to in Section I of this Chapter, it presents a risk to the health or safety of persons, or to domestic animals or to property, it shall take all appropriate measures and immediately inform the Commission, other Member States and Switzerland. That information shall include all available details, in particular the data necessary for the identification of equipment concerned, the origin and the supply chain of the product, the nature of the risk involved and the nature and duration of the national measures taken.

The Commission shall without delay enter into consultation with the Member States, Switzerland, and via the Swiss authorities the relevant economic operator or operators, and shall evaluate the national measures taken, in order to determine whether the national measure is justified or not, and, where necessary, propose appropriate measures.

A Party may forward the issue to the Committee established under Article 10 of this Agreement, pursuant to paragraph 11.

11.    Safeguard clause in case of remaining disagreement between the Parties

In case of a disagreement between the Parties on measures pursuant to paragraphs 9 and 10 above, the issue will be forwarded to the Committee established under Article 10 of this Agreement, 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

▼M11

CHAPTER 10

CONSTRUCTION PLANT AND EQUIPMENT

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, designating authorities shall comply with the general principles contained in Annex 2 to this Agreement and those assessment criteria set out in Annex IX to Directive 2000/14/EC of the European Parliament and of the Council.

Section V

Supplementary provisions

1.    Location of the manufacturer

By way of derogation from Article 4 of Directive 2000/14/EC, it shall be sufficient that the manufacturer or his authorised representative or, where neither of these is present, the person responsible for placing the equipment on the market or putting it into service is established in the territory of one of the Parties.

2.    Information exchange

In accordance with Article 9 of the Agreement, the Parties shall in particular exchange the information referred to in Articles 9 and 14(3) of Directive 2000/14/EC.

In addition, the conformity assessment bodies recognised under this Agreement shall provide the other conformity assessment bodies with the information concerning quality system approvals issued and withdrawn as provided for in Annex VIII, point 6 of Directive 2000/14/EC.

3.    Collection of noise data

The competent Swiss authorities shall have access to the database established under Article 16 of Directive 2000/14/EC. They shall transmit to the Commission and/or body responsible for managing the database the data provided for in this Article as collected in Switzerland for entry into the database.

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CHAPTER 11

MEASURING INSTRUMENTS AND PREPACKAGES

Section I

Legislative, regulatory and administrative provisions

Provisions covered by Article 1(1)

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, designating authorities shall comply with the general principles contained in Annex 2 to this Agreement and the assessment criteria set out in Chapter 4 of Directive 2014/31/EU and Chapter 4 of Directive 2014/32/EU, as regards the products covered by those Directives.

Section V

Supplementary provisions

1.    Prepackages

Switzerland shall recognise checks carried out in accordance with the provisions of Union legislation listed in Section I by a Union body recognised under this Agreement in the case of 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 Union legislation and have been checked according to the Swiss method shall affix the ‘e’ mark on their products exported to the EU.

2.    Marking

2.1.

For the purposes of this Agreement, the provisions of Council Directive 2009/34/EC of 23 April 2009 shall be read with the following adaptations: (a)  To the first indent of point 3.1.of Annex 1 and to the first indent of point 3.1.1.1 (a) of Annex II, the following shall be added to the text in brackets: ‘CH for Switzerland’. (b)  The drawings to which point 3.2.1 of Annex II refers, are supplemented by the following drawing:

2.2.

By the way of derogation from Article 1 of this Agreement, the rules on marking for measuring instruments placed on the Swiss market are as follows: The marking that must be affixed is the EC marking and supplementary metrology marking or the national sign of the EC Member State concerned as provided in the first indent of point 3.1 of Annex I and the first indent of point 3.1.1.1 of Annex II to Directive 2009/34/EC of 23 April 2009.

3.    Non-automatic weighing instruments covered by Directive 2014/31/EU and measuring instruments covered by Directive 2014/32/EU

3.1.    Economic operators

3.1.1.    Specific obligations of economic operators pursuant to the legislation under Section I

Pursuant to the legislation under Section I, economic operators established in the EU or Switzerland are subject to equivalent obligations.

In order to avoid unnecessary duplication of obligations:

3.1.2.    Authorised representative

For the purpose of the obligation in Article 7(2) of Directive 2014/31/EU, respectively Article 9(2) of Directive 2014/32/EU and the corresponding Swiss provisions, authorised representative shall mean any natural or legal person established within the European Union or Switzerland who has received a written mandate from a manufacturer to act on his behalf pursuant to Article 7(1) of Directive 2014/31/EU, respectively Article 9(1) of Directive 2014/32/EU or the corresponding Swiss provisions.

3.1.3.    Cooperation with market surveillance authorities

The competent national market surveillance authority of a Member State of the European Union or Switzerland may, on reasoned request, ask the relevant economic operators in the European Union and in Switzerland to provide all the information and documentation necessary to demonstrate the conformity of instrument with the legislation in Section I.

That authority may contact the economic operator established within the territory of the other Party either directly or with the assistance of the competent national market surveillance authority of the other Party. It may request manufacturers or, where applicable, authorised representatives and importers to provide the documentation in a language easily understood by that authority. It may request the economic operators to cooperate on any action taken to eliminate the risks posed by the instrument.

3.2.    Exchange of experience

Swiss designating authorities may take part in the exchange of experience between the Member States' national authorities referred to in Article 34 of Directive 2014/31/EU and Article 39 of Directive 2014/32/EU.

3.3.    Coordination of conformity assessment bodies

Swiss designated conformity assessment bodies may take part in the coordination and cooperation mechanisms provided for in Article 35 of Directive 2014/31/EU, respectively Article 40 of Directive 2014/32/EU, directly or by means of designated representatives.

3.4.    Mutual assistance of market surveillance authorities

Pursuant to Article 9(1) of the Agreement, the Parties shall ensure efficient cooperation and exchange of information between their market surveillance authorities. The market surveillance authorities of Member States and Switzerland shall cooperate and exchange information. They shall give each other assistance on an adequate scale by supplying information or documentation concerning economic operators based in a Member State or in Switzerland.

3.5.    Procedure for dealing with instruments presenting a risk caused by non-compliance not restricted to the national territory

Pursuant to Article 12(4) of this Agreement, where the market surveillance authorities of a Member State or Switzerland have taken action or have sufficient reason to believe that an instrument covered by this chapter presents a risk to aspects of public interest protection covered by Directive 2014/31/EU or Directive 2014/32/EU, or the corresponding Swiss provisions, and if they consider that non-compliance is not restricted to their national territory, they shall inform the European Commission, the other Member States and Switzerland without delay of:

This information shall include all available details, in particular the data necessary for the identification of the non-compliant instrument, the origin of the instrument, the nature of the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator. In particular, it shall be indicated whether the non-compliance is due to either:

Switzerland, or Member States shall without delay inform 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 instrument concerned.

Member States and Switzerland shall ensure that appropriate restrictive measures are taken in respect of the instrument concerned, such as withdrawal of an instrument from their market, without delay.

3.6.    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 within three months of the receipt of the information.

Where, on completion of the procedure set out in paragraph 3.4, 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 contrary to Directive 2014/31/EU or Directive 2014/32/EU, or the corresponding Swiss provisions, the European Commission shall without delay enter into consultation with the Member States, Switzerland, and via the Swiss authorities the relevant economic operator or operators. It shall evaluate the national measure, in order to determine whether the national measure is justified or not.

If the national measure relating to an instrument is considered:

A Party may forward the issue to the Committee established under Article 10 of this Agreement, pursuant to paragraph 3.8.

3.7.    Compliant instruments which nevertheless present a risk to health and safety

Where a Member State or Switzerland finds that, although an instrument that an economic operator has been made available on the EU and on the Swiss market is in compliance with Directive 2014/31/EU or Directive 2014/32/EU, respectively the relevant Swiss legislation, presents a risk to aspects of public interest protection, it shall take all appropriate measures and immediately inform the Commission, other Member States and Switzerland. That information shall include all available details, in particular the data necessary for the identification of the instrument concerned, the origin and the supply chain of the instrument, the nature of the risk involved and the nature and duration of the national measures taken.

The Commission shall without delay enter into consultation with the Member States, Switzerland, and via the Swiss authorities the relevant economic operator or operators, and shall evaluate the national measures taken, in order to determine whether the national measure is justified or not, and where necessary, propose appropriate measures.

A Party may forward the issue to the Committee established under Article 10 of this Agreement, pursuant to paragraph 3.8.

3.8.    Safeguard clause in case of remaining disagreement between the Parties

In case of a disagreement between the Parties on measures at stake in subparagraphs 3.6 and 3.7 above, the issue will be forwarded to the 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:

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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 29 April 2015 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

In such cases, the Member State concerned or Switzerland shall immediately notify the manufacturer, the other Member States, Switzerland and the Commission accordingly, stating the reasons on which its decision is based.

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

A vehicle shall not be deemed to deviate from the approved type where tolerances are permitted by the relevant regulatory acts and those tolerances are respected.

On receipt of such a request, the Member State concerned or Switzerland shall take the requisite action, if necessary in conjunction with the Member State making the request or Switzerland, as soon as possible and in any case within 6 months of the date of the request. Where a failure to conform is established, the approval authority of the Member State or Switzerland which granted the system, component or separate technical unit type-approval or the approval of the incomplete vehicle shall take the measures set out in paragraph 1.

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CHAPTER 13

AGRICULTURAL OR FORESTRY TRACTORS

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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 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 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 Community.

1.    Information exchange

The competent Member State’s and Swiss authorities shall notify each other of conforming Articles 4, 6, 8 and 9 of Directive 2003/37/EC of the European Parliament and of the Council of 26 May 2003 on type-approval of agricultural or forestry tractors, their trailers and interchangeable towed machinery, together with their systems, components and separate technical units and repealing Directive 74/150/EEC, as last amended) or non-conforming Articles 14 and 16 of Directive 2003/37/EC, as last amended) vehicles, systems, components and separate technical units 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 2003/37/EC, as last amended, 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 or 2003/37/EC, both as last amended, 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 2003/37/EC, as last amended.

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

CHAPTER 14

GOOD LABORATORY PRACTICE (GLP)

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)] amended on 9 March 1995 [C(95)8(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 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 GLP monitoring authorities.

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Section I

Legislative, regulatory 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.

Provisions covered by Article 1(2)

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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.

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

For the purpose of this Sectoral Annex, the term ‘Designating Authorities’ means the GLP Monitoring Authorities of the Parties. The Contact Details of the GLP Monitoring Authorities of the Member States of the European Union and of Switzerland can be found in the websites indicated below.

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For the European Union:

http://ec.europa.eu/growth/sectors/chemicals/good-laboratory-practice_en

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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):

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Section V

Supplementary 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 GLP monitoring authorities 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.

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CHAPTER 15

MEDICINAL PRODUCTS, GMP INSPECTION AND BATCH CERTIFICATION

Scope and coverage

The provisions of this Sectoral Chapter cover all medicinal products which are industrially manufactured 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. This includes that each Party recognises conclusions of inspections of manufacturers in third countries carried out by the relevant inspection services of the other Party, inter alia, within the framework of the European Directorate for the Quality of Medicines & HealthCare (EDQM).

The Parties shall cooperate in order to achieve the best use of inspection resources by an appropriate burden sharing.

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. To the products imported from a third country and further exported to the other Party this provision applies only (1) if each batch of the medicinal products has been subject to the re-control in the territory of one of the Parties; and (2) if the manufacturer in the third country has been subject to the inspection by the competent authority of either Party of which the outcome has been that for the products or products category the manufacturer complies with Good Manufacturing Practice. If the above conditions are not met, each Party can require a re-control in its territory.

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 Union 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 i.a. 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:

For inspections in third countries, at the request of an exporter, importer or the competent authority of the other Party, the authorities responsible for the inspection shall certify that the manufacturer complies or does not comply with the GMP requirements recognised as equivalent by the two Parties, and which are listed in Section I of this Chapter.

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

Certificates shall be issued expeditiously, and the time taken should not exceed 30 calendar days. In exceptional cases, i.e. when a new inspection has to be carried out, this period may be extended to 90 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 GM P. The batch certificate shall be signed by the person responsible for releasing the batch for sale or supply, i.e. in the European Union 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 European Union, 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 18-21 of the Ordinance of the Swiss Agency for Therapeutic Products on the requirements for the marketing authorisation of medicinal products.

Section I

Legislative, regulatory and administrative provisions

Provisions covered by Article 1(2)

Section II

Conformity assessment bodies

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

The list of the official GMP Inspection Services of the Member States of the European Union and of Switzerland can be found below.

For conformity assessment bodies of the European Union:

Competent Authorities of the European Union are the following authorities of the Member States of the European Union or authorities succeeding them:

For Swiss conformity assessment bodies:

For all products for human and veterinary use:

http://www.swissmedic.ch/?lang=2

For the official batch release of immunobiological products for veterinary use:

http://www.blv.admin.ch/ivi/index.html?lang=en

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 this 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 on manufacturing/import authorisations and GMP compliance

The Parties shall exchange information on the authorisation status of manufacturers and importers and on the outcome of the inspections, in particular by entering authorisations, GMP certificates and information on GMP non-compliance into the database on GMP managed by the European Medicines Agency (EMA). GMP certificates and information on GMP-compliance shall follow the format in accordance with the procedures published by the EU.

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

The relevant authorities in Switzerland and in the European Union 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 this 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 this 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:

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 this Agreement.

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CHAPTER 16

CONSTRUCTION PRODUCTS

Section I

Legislative, regulatory and administrative provisions

Provisions covered by Article 1(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 this Agreement.

Section V

Supplementary provisions

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1.    Amendments to legislative, regulatory and administrative provisions of Section I

Without prejudice to Article 12(2) of this Agreement, the European Union shall notify Switzerland of implementing and delegated acts of the Commission under Regulation (EU) No 305/2011 adopted after 1 December 2016 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.

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2.   Implementation

The Parties' competent authorities and the organisations in charge of determining, in accordance with Regulation (EU) No 305/2011, the:

shall mutually respect the regulatory needs of the Member States and Switzerland.

3.   European harmonised standards for construction products

4.   European Technical Assessments (ETAs)

5.   Information exchanges

6.   Market access and technical documentation

7.   Exchange of experience

Swiss national authorities may take part in the exchange of experience between the Member States' national authorities referred to in Article 54 of Regulation (EU) No 305/2011.

8.   Coordination of designated notified bodies

Swiss notified bodies may take part in the coordination and cooperation mechanisms provided for in Article 55 of Regulation (EU) No 305/2011, directly or by means of designated representatives.

9.   Procedure for dealing with construction products presenting a risk caused by non-compliance that is not restricted to their national territory

Pursuant to Article 12(4) of this Agreement, where the market surveillance authorities of a Member State or Switzerland have taken action or have sufficient reasons to believe that, owing to a non-compliance with the provisions of the legislation referred to in Section I of this Chapter, a construction product presents a risk caused by non-compliance that they consider not restricted to their national territory, they shall inform each other and the European Commission without delay:

Member States or Switzerland 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 construction product concerned.

Member States and Switzerland shall ensure that appropriate restrictive measures are taken without delay in respect of the construction product concerned, such as withdrawal of the construction product from their market.

10.   Safeguard procedure in case of objections against national measures

Should Switzerland or a Member State disagree with the national measure in Paragraph 9 above, it shall inform the European Commission of its objections within 15 working days of receipt of the information.

Where, on completion of the procedure set out in Paragraph 9 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 Commission shall, without delay, enter into consultation with the Member States, Switzerland and the relevant economic operator or operators. It shall evaluate the national measure, in order to determine whether the national measure is justified or not. If the national measure is considered:

In both cases, a Party may forward the issue to the Committee, pursuant to Paragraph 12.

11.   Compliant construction products which nevertheless present a risk to health and safety

Where a Member State or Switzerland finds that, although a construction product has been made available on the EU and on the Swiss market in compliance with the legislation referred to in Section I of this Chapter, the construction product presents a risk for the fulfilment of the basic requirements for construction works, to the health or safety of persons or to other aspects of public interest protection, it shall take all appropriate measures and immediately inform the Commission, other Member States and Switzerland. That information shall include all available details, in particular the data necessary for the identification of the construction product concerned, the origin and the supply chain of the product, the nature of the risk involved and the nature and duration of the national measures taken.

The Commission shall without delay enter into consultation with the Member States, Switzerland, and the relevant economic operator(s) and shall evaluate the national measures taken, in order to determine whether the national measure is justified or not.

A Party may forward the issue to the Committee, pursuant to Paragraph 12.

12.   Safeguard clause in case of remaining disagreement between the Parties

In case of a disagreement between the Parties on measures at stake in Paragraph 10 and 11 above, the issue will be forwarded to the 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:

DECLARATION FROM THE EUROPEAN COMMISSION

In order to ensure the effective application and implementation of the Chapter on construction products in Annex 1 to the Agreement and in so far as Switzerland has adopted the relevant EU acquis or equivalent measures under the Chapter on construction products, the Commission will, in accordance with the Council Declaration on Swiss attendance of committees ( 3 ) and Article 100 of the Agreement on the European Economic Area, consult Swiss experts in the preparatory stages of draft measures to be submitted subsequently to the Committee established by Article 64 of Regulation (EU) No 305/2011 to assist the Commission in the exercise of its executive powers.

The Commission also notes that the Chairman of the Committee established pursuant to Article 64 of Regulation (EU) No 305/2011 may decide to invite Swiss experts to talk on particular matters, at the request of a member or on his or her own initiative, in particular in those matters of direct relevance to Switzerland.

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CHAPTER 17

LIFTS

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 this Agreement and the assessment criteria set out in Chapter 4 of Directive 2014/33/EU.

Section V

Supplementary provisions

1.    Economic operators

1.1.    Specific obligations of economic operators pursuant to the legislation under Section I

Pursuant to the legislation under Section I, economic operators established in the EU or Switzerland are subject to equivalent obligations.

In order to avoid unnecessary duplication of obligations:

1.2.    Authorised representative

For the purpose of the obligation in Article 9(2) of Directive 2014/33/EU and the corresponding Swiss provisions, authorised representative shall mean any natural or legal person established within the European Union or Switzerland who has received a written mandate from a manufacturer to act on his behalf pursuant to Article 9(1) of Directive 2014/33/EU or the corresponding Swiss provisions.

1.3.    Cooperation with market surveillance authorities

The competent national market surveillance authority of a Member State of the European Union or Switzerland may, on reasoned request, ask the relevant economic operators in the European Union and in Switzerland to provide all the information and documentation necessary to demonstrate the conformity of a product with the legislation in Section I.

That authority may contact the economic operator established within the territory of the other Party either directly or with the assistance of the competent national market surveillance authority of the other Party. It may request manufacturers or, where applicable, authorised representatives and importers to provide the documentation in a language easily understood by that authority. It may request the economic operators to cooperate on any action taken to eliminate the risks posed by the product.

2.    Exchange of experience

Swiss designating authorities may take part in the exchange of experience between the Member States' national authorities referred to in Article 35 of Directive 2014/33/EU.

3.    Coordination of conformity assessment bodies

Swiss designated conformity assessment bodies may take part in the coordination and cooperation mechanisms provided for in Article 36 of Directive 2014/33/EU, directly or by means of designated representatives.

4.    Mutual assistance of market surveillance authorities

Pursuant to Article 9(1) of the Agreement, the Parties shall ensure efficient cooperation and exchange of information between their market surveillance authorities. The market surveillance authorities of Member States and Switzerland shall cooperate and exchange information. They shall give each other assistance on an adequate scale by supplying information or documentation concerning economic operators based in a Member State or in Switzerland.

5.    Procedure for dealing with lifts or safety components for lifts presenting a risk not restricted to the national territory

Pursuant to Article 12(4) of this Agreement, where the market surveillance authorities of a Member State or Switzerland have taken action or have sufficient reason to believe that a lift or a safety component for lifts covered by this chapter presents a risk to the health or safety of persons or, where appropriate, to the safety of property, covered by the legislation in Section I of this Chapter, and if they consider that non-compliance is not restricted to their national territory, they shall inform the European Commission, the other Member States and Switzerland without delay of:

This information shall include all available details, in particular the data necessary for the identification of the non-compliant lift or safety component for lifts, their origin, the nature of the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator. In particular, it shall be indicated whether the non-compliance is due to either:

Switzerland, or Member States shall without delay inform 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 lift or the safety component for lifts concerned.

Member States and Switzerland shall ensure that appropriate restrictive measures are taken in respect of the lift or the safety component for lifts concerned, such as withdrawal of the lift or safety component for lifts from their market, without delay.

6.    Safeguard procedure in case of objections against national measures

Should Switzerland or a Member State disagree with the notified national measure in paragraph 5, it shall inform the European Commission of its objections within three months of the receipt of the information.

Where, on completion of the procedure set out in paragraph 5, 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 contrary to the relevant legislation referred to in Section I, the European Commission shall without delay enter into consultation with the Member States, Switzerland, and via the Swiss authorities the relevant economic operator or operators. It shall evaluate the national measure, in order to determine whether the national measure is justified or not.

If the national measure relating to a lift is considered justified, all Member States and Switzerland shall take the measures necessary to ensure that the placing on the market or use of the non-compliant lift concerned is restricted or prohibited, or that the lift is recalled, and shall inform the Commission accordingly.

If the national measure relating to a safety component for lift is considered justified, all Member States and Switzerland shall take the measures necessary to ensure that the non-compliant safety component for lifts is withdrawn from their markets, and shall inform the Commission accordingly.

If the national measure is considered unjustified, the Member State concerned or Switzerland shall withdraw that measure.

A Party may forward the issue to the Committee established under Article 10 of this Agreement, pursuant to paragraph 8.

7.    Compliant products which nevertheless present a risk

Where a Member State or Switzerland finds that, although a lift or a safety component for lifts that an economic operator has made available on the EU and on the Swiss market is in compliance with the legislation referred to in Section I of this Chapter, it presents a risk to the health or safety of persons and, where appropriate, the safety of property, it shall take all appropriate measures and immediately inform the Commission, other Member States and Switzerland. That information shall include all available details, in particular the data necessary for the identification of the lift or safety component for lifts concerned, the origin and the supply chain of the product, the nature of the risk involved and the nature and duration of the national measures taken.

The Commission shall without delay enter into consultation with the Member States, Switzerland, and via the Swiss authorities the relevant economic operator or operators, and shall evaluate the national measures taken, in order to determine whether the national measure is justified or not, and where necessary, propose appropriate measures.

A Party may forward the issue to the Committee established under Article 10 of this Agreement, pursuant to paragraph 8.

8.    Safeguard clause in case of remaining disagreement between the Parties

In case of a disagreement between the Parties on measures pursuant to paragraphs 6 and 7 above, the issue will be forwarded to the 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:

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CHAPTER 18

BIOCIDAL PRODUCTS

SCOPE AND COVERAGE

Section I

Legislative, regulatory and administrative provisions

Provisions covered by Article 1(2)

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Section II

Conformity assessment bodies

For the purposes of this Chapter, ‘Conformity Assessment Bodies’ means the authorities of the European Union and competent authorities of EU Member States and of Switzerland responsible for the application of the legislation in Section I.

The contact details of the competent authorities of the Parties can be found on the websites indicated below.

European Union

Biocides:

Switzerland

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

Section III

Supplementary provisions

1.   Amendments to legislative, regulatory and administrative provisions of Section I

Without prejudice to Article 12(2) of this Agreement, the European Union shall notify Switzerland of implementing and delegated acts of the Commission under Regulation (EU) No 528/2012 adopted after 10 October 2014 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.

2.   Procedures of the BPR and its implementing acts that apply between the Parties

3.   Information exchange

In accordance with Article 9 of this Agreement, the Parties shall in particular exchange the information needed to coordinate the procedures under this Chapter as foreseen in Article 71 of the BPR.

Pursuant to Article 29(4) of the BPR, except in cases where Commission Implementing Regulation (EU) No 414/2013 applies, Switzerland shall decline the evaluation of the application if another competent authority is examining an application relating to the same biocidal product or has already authorised it.

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.

Information shall be protected and treated by the competent authorities of the Parties in accordance with Articles 59, 64, 66, 67 of the BPR.

4.   Financial contribution for services provided by the European Chemical Agency (ECHA)

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CHAPTER 19

CABLEWAY INSTALLATIONS

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 Chapter IV of Regulation (EU) 2016/424.

Section V

Supplementary provisions

1.    Economic operators

1.1.    Specific obligations of economic operators pursuant to the legislation under Section I

Pursuant to the legislation under Section I, economic operators established in the EU or Switzerland are subject to equivalent obligations.

In order to avoid unnecessary duplication of obligations:

1.2.    Authorised representative

For the purpose of the obligation in Article 12(2) of Regulation (EU) 2016/424 and the corresponding Swiss provisions, authorised representative shall mean any natural or legal person established within the European Union or Switzerland who has received a written mandate from a manufacturer to act on his behalf pursuant to Article 12(1) of Regulation (EU) 2016/424 or the corresponding Swiss provisions.

1.3.    Cooperation with market surveillance authorities

The competent national market surveillance authority of a Member State of the European Union or Switzerland may, on reasoned request, ask the relevant economic operators in the European Union and in Switzerland to provide all the information and documentation necessary to demonstrate the conformity of a subsystem or safety component with the legislation in section I.

That authority may contact the economic operator established within the territory of the other Party either directly or with the assistance of the competent national market surveillance authority of the other Party. It may request manufacturers or, where applicable, authorised representatives and importers to provide the documentation in a language easily understood by that authority. It may request the economic operators to cooperate on any action taken to eliminate the risks posed by the subsystem or safety component.

2.    Exchange of experience

Swiss designating authorities may take part in the exchange of experience between the Member States' national authorities referred to in Article 37 of Regulation (EU) 2016/424.

3.    Coordination of conformity assessment bodies

Swiss designated conformity assessment bodies may take part in the coordination and cooperation mechanisms provided for in Article 38 of Regulation (EU) 2016/424, directly or by means of designated representatives.

4.    Mutual assistance of market surveillance authorities

Pursuant to Article 9(1) of the Agreement, the Parties shall ensure efficient cooperation and exchange of information between their market surveillance authorities. The market surveillance authorities of Member States and Switzerland shall cooperate and exchange information. They shall give each other assistance on an adequate scale by supplying information or documentation concerning economic operators based in a Member State or in Switzerland.

5.    Procedure for dealing with subsystems or safety components presenting a risk not restricted to the national territory

Pursuant to Article 12(4) of this Agreement, where the market surveillance authorities of a Member State or Switzerland have taken action or have sufficient reason to believe that a subsystem or safety component covered by this Chapter presents a risk to the health or safety of persons or to property covered by the legislation in Section I of this Chapter, and if they consider that non-compliance is not restricted to their national territory, they shall inform the European Commission, the other Member States and Switzerland without delay of:

This information shall include all available details, in particular the data necessary for the identification of the non-compliant subsystem or safety component, its origin, the nature of the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator. In particular, it shall be indicated whether the non-compliance is due to either:

Switzerland or Member States shall without delay inform 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 subsystem or safety component concerned.

Member States and Switzerland shall ensure that appropriate restrictive measures are taken in respect of the subsystem or safety component concerned, such as withdrawal of subsystems or safety components from their market, without delay.

6.    Safeguard procedure in case of objections against national measures

Should Switzerland or a Member State disagree with the national measure in paragraph 5, it shall inform the European Commission of its objections within three months of the receipt of the information.

Where, on completion of the procedure set out in paragraph 5, 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 contrary to the relevant legislation referred to in Section I, the European Commission shall without delay enter into consultation with the Member States, Switzerland, and via the Swiss authorities the relevant economic operator or operators. It shall evaluate the national measure, in order to determine whether the national measure is justified or not.

If the national measure relating to a subsystem or safety component is considered:

A Party may forward the issue to the Committee established under Article 10 of this Agreement, pursuant to paragraph 8.

7.    Compliant subsystems or safety components which nevertheless present a risk

Where a Member State or Switzerland finds that, although a subsystem or safety component that an economic operator has made available on the EU and on the Swiss market is in compliance with the legislation referred to in Section I of this Chapter, it presents a risk to the health or safety of persons or to property, it shall take all appropriate measures and immediately inform the Commission, other Member States and Switzerland. That information shall include all available details, in particular the data necessary for the identification of the subsystem or safety component concerned, the origin and the supply chain of the subsystem or safety component, the nature of the risk involved and the nature and duration of the national measures taken.

The Commission shall without delay enter into consultation with the Member States, Switzerland, and via the Swiss authorities the relevant economic operator or operators, and shall evaluate the national measures taken, in order to determine whether the national measure is justified or not, and, where necessary, propose appropriate measures.

A Party may forward the issue to the Committee established under Article 10 of this Agreement, pursuant to paragraph 8.

8.    Safeguard clause in case of remaining disagreement between the Parties

In case of a disagreement between the Parties on measures at stake in paragraphs 6 and 7 above, the issue will be forwarded to the Committee established under Article 10 of this Agreement, 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:

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CHAPTER 20

EXPLOSIVES FOR CIVIL USE

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 designation of 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 Chapter 5 of Directive 2014/28/EU.

Section V

Supplementary provisions

1.    Economic operators

1.1.    Specific obligations of economic operators pursuant to the legislation under Section I

Pursuant to the legislation under Section I, economic operators established in the EU or Switzerland are subject to equivalent obligations.

In order to avoid unnecessary duplication of obligations:

1.2.    Authorised representative

For the purpose of the obligation in Article 6(2) of Directive 2014/28/EU and the corresponding Swiss provisions, authorised representative shall mean any natural or legal person established within the European Union or Switzerland who has received a written mandate from a manufacturer to act on his behalf pursuant to Article 6(1) of Directive 2014/28/EU or the corresponding Swiss provisions.

1.3.    Cooperation with market surveillance authorities

The competent national market surveillance authority of a Member State of the European Union or Switzerland may, on reasoned request, ask the relevant economic operators in the European Union and in Switzerland to provide all the information and documentation necessary to demonstrate the conformity of a product with the legislation in Section I.

That authority may contact the economic operator established within the territory of the other Party either directly or with the assistance of the competent national market surveillance authority of the other Party. It may request manufacturers or, where applicable, authorised representatives and importers to provide the documentation in a language easily understood by that authority. It may request the economic operators to cooperate on any action taken to eliminate the risks posed by the product.

2.    Exchange of experience

Swiss designating authorities may take part in the exchange of experience between the Member States' national authorities referred to in Article 39 of Directive 2014/28/EU.

3.    Coordination of conformity assessment bodies

Swiss designated conformity assessment bodies may take part in the coordination and cooperation mechanisms provided for in Article 40 of Directive 2014/28/EU, directly or by means of designated representatives.

4.    Mutual assistance of market surveillance authorities

Pursuant to Article 9(1) of the Agreement, the Parties shall ensure efficient cooperation and exchange of information between their market surveillance authorities. The market surveillance authorities of Member States and Switzerland shall cooperate and exchange information. They shall give each other assistance on an adequate scale by supplying information or documentation concerning economic operators based in a Member State or in Switzerland.

5.    Procedure for dealing with explosives presenting a risk not restricted to the national territory

Pursuant to Article 12(4) of this Agreement, where the market surveillance authorities of a Member State or Switzerland have taken action or have sufficient reason to believe that an explosive covered by this chapter presents a risk to the health or safety of persons or to the property or the environment covered by Directive 2014/28/EU respectively the relevant Swiss legislation, and if they consider that non-compliance is not restricted to their national territory, they shall inform the European Commission, the other Member States and Switzerland without delay of:

This information shall include all available details, in particular the data necessary for the identification of the non-compliant explosive, the origin of the explosive, the nature of the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator. In particular, it shall be indicated whether the non-compliance is due to either:

Switzerland, or Member States shall without delay inform 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 explosive concerned.

Member States and Switzerland shall ensure that appropriate restrictive measures are taken in respect of the explosive concerned, such as withdrawal of an explosive from their market, without delay.

6.    Safeguard procedure in case of objections against national measures

Should it disagree with the notified national measure in paragraph 5, Switzerland or a Member State shall inform the European Commission of its objections within three months of the receipt of the information.

Where, on completion of the procedure set out in paragraph 5, 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 contrary to the relevant legislation referred to in Section I, the European Commission shall without delay enter into consultation with the Member States, Switzerland, and via the Swiss authorities the relevant economic operator or operators. It shall evaluate the national measure, in order to determine whether the national measure is justified or not.

If the national measure is considered:

A Party may forward the issue to the Committee established under Article 10 of this Agreement, pursuant to paragraph 8.

7.    Compliant products which nevertheless present a risk

Where a Member State or Switzerland finds that, although an explosive that an economic operator has been made available on the EU and on the Swiss market is in compliance with the legislation referred to in Section I of this Chapter, it presents a risk for the health or safety of persons or to the property or the environment, it shall take all appropriate measures and immediately inform the Commission, other Member States and Switzerland. That information shall include all available details, in particular the data necessary for the identification of the explosive concerned, the origin and the supply chain of the product, the nature of the risk involved and the nature and duration of the national measures taken.

The Commission shall without delay enter into consultation with the Member States, Switzerland and via the Swiss authorities the relevant economic operator or operators, and shall evaluate the national measures taken, in order to determine whether the national measure is justified or not, and where necessary, propose appropriate measures.

A Party may forward the issue to the Committee established under Article 10 of this Agreement, pursuant to paragraph 8.

8.    Safeguard clause in case of remaining disagreement between the Parties

In case of a disagreement between the Parties on measures at stake in paragraphs 6 and 7 above, the issue will be forwarded to the 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:

9.    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.

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

11.    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.

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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.