‘ANNEX 1

PRODUCT SECTORS

This Annex is divided up into the following chapters by sector:

Chapter 1 Machinery

Chapter 2 Personal protective equipment

Chapter 3 Toys

Chapter 4 Medical devices

Chapter 5 Gas appliances and boilers

Chapter 6 Pressure vessels

Chapter 7 Radio equipment and telecommunications terminal equipment

Chapter 8 Equipment and protective systems intended for use in potentially explosive atmospheres

Chapter 9 Electrical equipment and electromagnetic compatibility

Chapter 10 Construction plant and equipment

Chapter 11 Measuring instruments and pre-packages

Chapter 12 Motor vehicles

Chapter 13 Agricultural and forestry tractors

Chapter 14 Good laboratory practice (GLP)

Chapter 15 Medicinal products GMP inspection and batch certification

Chapter 16 Construction products

CHAPTER 1

MACHINERY

Section I

Legislative, regulatory and administrative provisions

Provisions covered by Article 1(2)

European Community 1. Directive 98/37/EC of the European Parliament and of the Council of 22 June 1998 on the approximation of the laws of the Member States relating to machinery (OJ L 207, 23.7.1998, p. 1), as last amended by Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 (OJ L 331, 7.12.1998, p. 1). Switzerland 100. Federal Law of 19 March 1976 on the safety of technical installations and equipment (RO 1977 2370), as last amended on 18 June 1993 (RO 1995 2766). 101. Ordinance of 12 June 1995 on the safety of technical installations and equipment (RO 1995 2770), as last amended on 27 March 2002 (RO 2002 853). 102. Ordinance of 12 June 1995 on the procedures of conformity assessment of technical installations and equipment (RO 1995 2783).

Section II

Conformity assessment bodies

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

Section III

Designating authorities

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

Section IV

Special rules relating to the designation of conformity assessment bodies

For the designation of conformity assessment bodies, the designating authorities shall comply with the general principles contained in Annex 2 to this Agreement and the assessment criteria set out in Annex VII to Directive 98/37/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 paragraph 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.

CHAPTER 2

PERSONAL PROTECTIVE EQUIPMENT

Section I

Legislative, regulatory and administrative provisions

Provisions covered by Article 1(2)

European Community 1. Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment, as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003 (OJ L 284, 31.10.2003, p. 1). Switzerland 100. Federal Law of 19 March 1976 on the safety of technical installations and equipment (RO 1977 2370), as last amended on 18 June 1993 (RO 1995 2766). 101. Ordinance of 12 June 1995 on the safety of technical installations and equipment (RO 1995 2770), as last amended on 27 March 2002 (RO 2002 853). 102. Ordinance of 12 June 1995 on the procedures of conformity assessment of technical installations and equipment (RO 1995 2783).

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 V to Directive 89/686/EEC.

CHAPTER 3

TOYS

Section I

Legislative, regulatory and administrative provisions

Provisions covered by Article 1(2)

European Community 1. Council Directive 88/378/EEC of 3 May 1988 on the approximation of the laws of the Member States concerning the safety of toys (OJ L 187, 16.7.1988, p. 1) and corrected by corrigenda (OJ L 281, 14.10.1988, p. 55 and OJ L 37, 9.2.1991, p. 42), as last amended by Council Directive 93/68/EEC of 22 July 1993 (OJ L 220, 30.8.1993, p. 1). Switzerland 100. Federal Law of 9 October 1992 on foodstuffs and commodities (RO 1995 1469) as last amended on 21 March 2003 (RO 2003 4803). 101. Ordinance of 23 November 2005 on foodstuffs and commodities (RO 2005 5451) as last amended on 15 November 2006 (RO 2006 4909). 102. Ordinance of EDI of 27 March 2002 on the safety of toys (RO 2002 1082) as last amended on 15 November 2006 (RO 2006 5157).

Section II

Conformity assessment bodies

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

Section III

Designating authorities

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

Section IV

Special rules relating to the designation of conformity assessment bodies

For the designation of conformity assessment bodies, the designating authorities shall comply with the general principles contained in Annex 2 to this Agreement and the assessment criteria set out in Annex III to Directive 88/378/EEC.

Section V

Supplementary provisions

1. Information concerning the certificate and the technical file

In accordance with Article 10(4) of Directive 88/378/EEC, the designating authorities may obtain on request a copy of the certificate and, on reasoned request, a copy of the technical file and the reports on the examinations and tests carried out.

2. Notification of grounds for refusal by approved bodies

In accordance with Article 10(5) of Directive 88/378/EEC, the Swiss bodies shall inform the Swiss Federal Office of Public Health when refusing to issue an EC type-examination certificate. The Federal Office shall likewise notify the Commission of the European Communities thereof.

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, 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 93/42/EEC, in Annex 8 to Directive 90/385/EEC and in Annex IX to Directive 98/79/EC, in respect of the bodies designated under those Directives.

Section V

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 Community 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 Community or Switzerland, as appropriate.

3. Information exchange

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

4. European databank

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

CHAPTER 5

GAS APPLIANCES AND BOILERS

Section I

Legislative, regulatory and administrative provisions

Provisions covered by Article 1(1)

European Community 1. Council Directive 92/42/EEC of 21 May 1992 on efficiency requirements for new hot-water boilers fired with liquid or gaseous fuels (OJ L 167, 22.6.1992, p. 17), as subsequently amended. Switzerland 100. Ordinance of 16 December 1985 on Air Pollution Control (OAPC) (Annex 3 and 4) (RS 814.318.142.1), as subsequently amended.

Provisions covered by Article 1(2)

European Community 2. Council Directive 90/396/EEC of 29 June 1990 on the approximation of the laws of the Member States relating to appliances burning gaseous fuels, as last amended by Council Directive 93/68/EEC of 22 July 1993 (OJ L 220, 30.8.1993, p. 1). Switzerland 101. Federal Law of 19 March 1976 on the safety of technical installations and equipment (RO 1977 2370), as last amended on 18 June 1993 (RO 1995 2766). 102. Ordinance of 12 June 1995 on the safety of technical installations and equipment (RO 1995 2770), as last amended on 27 March 2002 (RO 2002 853). 103. Ordinance of 12 June 1995 on the procedures of conformity assessment of technical installations and equipment (RO 1995 2783).

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 V to Directive 90/396/EEC.

CHAPTER 6

PRESSURE VESSELS

Section I

Legislative, regulatory and administrative provisions

Provisions covered by Article 1(1)

European Community 1. Council Directive 84/525/EEC of 17 September 1984 on the approximation of the laws of the Member States relating to seamless, steel gas cylinders (OJ L 300, 19.11.1984, p. 1), as subsequently amended. 2. Council Directive 84/526/EEC of 17 September 1984 on the approximation of the laws of the Member States relating to seamless, unalloyed aluminium and aluminium alloy gas cylinders (OJ L 300, 19.11.1984, p. 20), as subsequently amended. 3. Council Directive 84/527/EEC of 17 September 1984 on the approximation of the laws of the Member States relating to welded unalloyed steel gas cylinders (OJ L 300, 19.11.1984, p. 48), as subsequently amended. 4. Council Directive 1999/36/EC of 29 April 1999 on transportable pressure equipment (OJ L 138, 1.6.1999, p. 20), as last amended by Commission Directive 2001/2/EC of 4 January 2001 (OJ L 005, 10.1.2001, p. 4), as subsequently amended. Switzerland 100. No legislation relating to Directives 84/525/EEC, 84/526/EEC and 84/527/EEC. 101. Relating to Directive 1999/36/EC: Ordinance of 29 November 2002 on the transport of dangerous goods by road (RS 741.621) as subsequently amended. Ordinance of 3 December 1996 on the transport of dangerous goods by rail (RS 742.401.6) as subsequently amended.

Provisions covered by Article 1(2)

European Community 5. Council Directive 87/404/EEC of 25 June 1987 on the approximation of the laws of the Member States relating to simple pressure vessels (OJ L 220, 8.8.1987, p. 48), as last amended by Council Directive 93/68/EEC of 22 July 1993 (OJ L 220, 30.8.1993, p. 1). 6. Directive 97/23/EC of the European Parliament and of the Council of 29 May 1997 on the approximation of the laws of the Member States concerning pressure equipment (OJ L 181, 9.7.1997, p. 1), as last amended by Regulation No 1882/2003 of the European Parliament and of the Council of 29 September 2003 (OJ L 284, 31.10.2003, p. 1). Switzerland 102. Federal Law of 19 March 1976 on the safety of technical installations and equipment (RO 1977 2370), as last amended on 18 June 1993 (RO 1995 2766). 103. Ordinance of 20 November 2002 on the safety of simple pressure vessels (RO 2003 107). 104 Ordinance of 20 November 2002 on the safety of pressure equipment (RO 2003 38).

Section II

Conformity assessment bodies

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

Section III

Designating authorities

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

Section IV

Special rules relating to the designation of conformity assessment bodies

For the designation of conformity assessment bodies, the designating authorities shall comply with the general principles contained in Annex 2 to this Agreement and the assessment criteria set out in Annex III to Directive 87/404/EEC, Annexes IV or V to Directive 97/23/EC or Annexes I, II or III to Directive 99/36/EC.

Section V

Supplementary provisions

1. Recognition of certificates and conformity marks

By way of derogation of Article 1(2) of this Agreement, both Parties shall recognise certificates and conformity marks on the compliance of transportable pressure vessels with Directive 99/36/EC which have been issued by conformity assessment bodies recognised in accordance with the procedure provided for in Article 11 of this Agreement.

2. Technical documentation

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

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

CHAPTER 7

RADIO EQUIPMENT AND TELECOMMUNICATIONS TERMINAL EQUIPMENT

Section I

Legislative, regulatory and administrative provisions

Provisions covered by Article 1(2)

European Community 1. Directive 1999/5/EC of the European Parliament and of the Council of 9 March 1999 on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity, as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003 (OJ L 284, 31.10.2003, p. 1). 2. Commission Decision 2000/299/EC of 6 April 2000 establishing the initial classification of radio equipment and telecommunications terminal equipment and associated identifiers (OJ L 97, 19.4.2000, p. 13). 3. Commission Decision 2000/637/EC of 22 September 2000 on the application of Article 3(3)(e) of Directive 1999/5/EC to radio equipment covered by the regional arrangement concerning radiotelephone service on inland waterways (OJ L 269, 21.10.2000, p. 50). 4. Commission Decision 2000/638/EC of 22 September 2000 on the application of Article 3(3)(e) of Directive 1999/5/EC to marine radio communication equipment intended to be fitted to seagoing non-SOLAS vessels and which is intended to participate in the global maritime distress and safety system (GMDSS) and not covered by Council Directive 96/98/EC on marine equipment (OJ L 269, 21.10.2000, p. 52). 5. Commission Decision 2001/148/EC of 21 February 2001 on the application of Article 3(3)(e) of Directive 1999/5/EC to avalanche beacons (OJ L 55, 24.2.2001, p. 65). 6. Commission Decision 2004/71/EC of 4 September 2003 on essential requirements relating to marine radio communication equipment which is intended to be used on non-SOLAS vessels and to participate in the Global Maritime Distress and Safety System (GMDSS) (OJ L 16, 23.1.2004, p. 54). 7. Commission Decision 2005/53/EC of 25 January 2005 on the application of Article 3(3)(e) of Directive 1999/5/EC of the European Parliament and of the Council to radio equipment intended to participate in the Automatic Identification System (AIS) (OJ L 22, 26.1.2005, p. 14). 8. Commission Decision 2005/631/EC of 29 August 2005 concerning essential requirements as referred to in Directive 1999/5/EC of the European Parliament and of the Council ensuring access of Cospas-Sarsat locator beacons to emergency services (OJ L 225, 31.8.2005, p. 28). Switzerland 100. Federal Law of 30 April 1997 on Telecommunications (LTC); (RO 1997 2187), as last amended on 24 March 2006 (RO 2007 737 and 921). 101. Ordinance of 14 June 2002 on Telecommunications Equipment; (RO 2002 2086) as last amended on 16 April 2008 (RO 2008 1903). 102. Ordinance of 14 June 2002 of the Federal Office of Communications on Telecommunications Equipment (RO 2002 2111), as last amended on 17 September 2007 (RO 2007 4427). 103. Annex 1 to the Federal Office of Communications Ordinance on Telecommunications Equipment (RO 2002 2111), as last amended on 21 November 2005 (RO 2005 5139). 104. List of technical standards published in the Feuille Fédérale with titles and references, as last amended on 9 October 2007 (FF 2007 6431). 105. Ordinance of 9 March 2007 on Telecommunication Services (RO 2007 945).

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 Annex VI to Directive 1999/5/EC.

Section V

Supplementary provisions

1. TCAM

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

2. Market surveillance

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

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

3. Regulated interfaces

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

4. Interfaces offered by public telecommunications network operators

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

5. Application of essential requirements

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

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

6. Authorisation to disconnect

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

7. Harmonised standards

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

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

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

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

9. Safeguard clause relating to industrial products

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

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

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

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

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

CHAPTER 8

EQUIPMENT AND PROTECTIVE SYSTEMS INTENDED FOR USE IN POTENTIALLY EXPLOSIVE ATMOSPHERES

Section I

Legislative, regulatory and administrative provisions

Provisions covered by Article 1(2)

European Community 1. Directive 94/9/EC of the European Parliament and of the Council of 23 March 1994 on the approximation of the laws of the Member States concerning equipment and protective systems intended for use in potentially explosive atmospheres, as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003 (OJ L 284, 31.10.2003, p. 1) and corrected by corrigenda (OJ L 21, 26.1.2000, p. 42 and OJ L 304, 5.12.2000, p. 19). Switzerland 100. Federal Law of 24 June 1902 concerning the electrical weak and heavy current installations (RO 19 252 and RS 4 798), as last amended on 17 June 2005 (RO 2006 2197). 101. Ordinance on of 2 March 1998 on the safety of equipment and protective systems intended for use in potentially explosive atmospheres (RO 1998 963), as last amended on 2 February 2000 (RO 2002 763). 102. Federal Law of 19 March 1976 on the safety of technical installations and equipment (RO 1977 2370), as last amended on 18 June 1993 (RO 1995 2766). 103. Ordinance of 12 June 1995 on the safety of technical installations and equipment (RO 1995 2770), as last amended on 27 March 2002 (RO 2002 853). 104. Ordinance of 12 June 1995 on the procedures of conformity assessment of technical installations and equipment (RO 1995 2783).

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 Annex XI to Directive 94/9/EC.

Section V

Supplementary provisions

1. Information exchange

The conformity assessment bodies recognised under this Agreement shall provide the other conformity assessment bodies with the information concerning EC type- examination certificates and additions issued and withdrawn as well as quality system approvals issued and withdrawn as provided for, respectively, in Annex III, point 7, Annex IV, point 6 and Annex VII, point 6 of Directive 94/9/EC. In addition they shall keep at the disposal of the other conformity assessment bodies the annexes to the EC type-examination certificates issued as provided for in Annex III, point 8 of Directive 94/9/EC.

2. Technical documentation

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

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

CHAPTER 9

ELECTRICAL EQUIPMENT AND ELECTROMAGNETIC COMPATIBILITY

Section I

Legislative, regulatory and administrative provisions

Provisions covered by Article 1(2)

European Community 1. Directive 2006/95/EC of the European Parliament and of the Council of 12 December 2006 on the approximation of the laws of the Member States relating to electrical equipment designed for use within certain voltage limits (codified version) (OJ L 374, 27.12.2006, p. 10). 2. Directive 2004/108/EC of the European Parliament and of the Council of 15 December 2004 on the approximation of the laws of the Member States relating to electromagnetic compatibility and repealing Directive 89/336/EEC (OJ L 390, 31.12.2004, p. 24). Switzerland 100. Federal Law of 24 June 1902 concerning the electrical weak and heavy current installations (RO 19 252 and RS 4 798), as last amended on 17 June 2005 (RO 2006 2197). 101. Ordinance of 30 March 1994 on electrical weak current installations (RO 1994 1185), as last amended on 2 February 2000 (RO 2000 734). 102. Ordinance of 30 March 1994 on electrical heavy current installations (RO 1994 1199), as last amended on 8 December 1997 (RO 1998 54). 103. Ordinance of 9 April 1997 on electrical low voltage equipment (RO 1997 1016), as last amended on 2 February 2000 (RO 2000 734 and 764). 104. Ordinance of 9 April 1997 on electromagnetic compatibility (RO 1997 1008), as last amended on 4 December 2000 (RO 2000 3012). 105. Ordinance of 14 June 2002 on Telecommunications Equipment; (RO 2002 2086) as last amended on 9 March 2007 (RO 2007 995).

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 Annex VI to Directive 2004/108/EC.

Section V

Supplementary provisions

1. Technical documentation

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

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

2. Indication of the name and address of the manufacturer

It shall be sufficient for manufacturers, their authorised representatives or, where neither of these is present the person responsible for placing products on the market established in the territory of one of the Parties to indicate their name or trade name and address as specified in Article 9(2) of Directive 2004/108/EC. They shall not be obliged to be established or appoint a representative in the territory of the Party in which the products are placed on the market in order to fulfil that provision.

3. Standardisation bodies

In accordance with Article 11 of Directive 2006/95/EC, the Parties shall notify each other of the bodies responsible for drawing up the standards referred to in Article 5 of this Directive.

4. Notified bodies

The Parties shall inform each other of and mutually recognise the bodies made responsible for drawing up technical reports and/or certificates pursuant to Articles 8(2) and 9(3) of Directive 2006/95/EC as well as those made responsible for the tasks as described in Annex III to Directive 2004/108/EC.

5. Safeguard clause

Where either of the Parties takes a measure to prohibit the placing on its market of a product declared to be in compliance with Directive 2004/108/CE, it shall immediately inform the other Party, giving the reasons for its decision and stating how non-compliance was established.

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

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

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

Where the Committee considers that the measure is

(a) unjustified, the national authority of the Party which took the measure shall withdraw it;

(b) justified, they shall take the appropriate measures to ensure that products are not placed on the market.

CHAPTER 10

CONSTRUCTION PLANT AND EQUIPMENT

Section I

Legislative, regulatory and administrative provisions

Provisions covered by Article 1(2)

European Community 1. Directive 2000/14/EC of the European Parliament and of the Council of 8 May 2000 on the approximation of the laws of the Member States relating to the noise emission in the environment by equipment for use outdoors (OJ L 162, 3.7.2000, p. 1), as amended by Directive 2005/88/EC of the European Parliament and of the Council of 14 December 2005 (OJ L 344, 27.12.2005, p. 44) and corrected by corrigendum (OJ L 165, 17.6.2006, p. 35). Switzerland 100. Ordinance of 22 May 2007 on the noise emission in the environment by equipment for use outdoors (RO 2007 2827).

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.

CHAPTER 11

MEASURING INSTRUMENTS AND PRE-PACKAGES

Section I

Legislative, regulatory and administrative provisions

Provisions covered by Article 1(1)

Provisions covered by Article 1(2)

10. Council Directive 71/316/EEC of 26 July 1971 on the approximation of the laws of the Member States relating to common provisions for both measuring instruments and methods of metrological control, as last amended by Commission Directive 2007/13/EC of 7 March 2007 (OJ L 73, 13.3.2007, p. 10). 11. Council Directive 71/317/EEC of 26 July 1971 on the approximation of the laws of the Member States relating to 5 to 50 kilogramme medium accuracy rectangular bar weights and 1 to 10 kilogramme medium accuracy cylindrical weights (OJ L 202, 6.9.1971, p. 14). 12. Council Directive 74/148/EEC of 4 March 1974 on the approximation of the laws of the Member States relating to weights of from 1 mg to 50 kg of above-medium accuracy (OJ L 84, 28.3.1974, p. 3). 13. Council Directive 80/181/EEC of 20 December 1979 on the approximation of the laws of the Member States relating to units of measurement and on the repeal of Directive 71/354/EEC (OJ L 39, 15.2.1980, p. 40) as last amended by Directive 1999/103/EC of the European Parliament and of the Council of 24 January 2000 (OJ L 34, 9.2.2000, p. 17). 14. Council Directive 76/766/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to alcohol tables (OJ L 262, 27.9.1976, p. 149). 15. Council Directive 90/384/EEC of 20 June 1990 on the harmonisation of the laws of the Member States relating to non-automatic weighing instruments (OJ L 189, 20.7.1990, p. 1), as amended by Council Directive 93/68/EEC of 22 July 1993 (OJ L 220, 30.8.1993, p. 1). 16. European Parliament and Council Directive 2004/2022 of 31 March 2004 on measuring instruments (2004/22/EC) (OJ L 135, 30.4.2004, p. 1). Switzerland 102. Federal Law of 9 June 1977 on metrology (RO 1977 2394), as last amended on 17 June 2005 (RO 2006 2197). 103. Ordinance of 23 November 1994 on units of measurement (RO 1994 3109). 104. Ordinance of 15 February 2006 concerning measuring instruments (RO 2006 1453). 105. Ordinance of the Federal Ministry of Justice and Police of 16 April 2004 on non-automatic weighing instruments (RO 2004 2093). 106. Ordinance of the Federal Ministry of Justice and Police of 19 March 2006 on measuring instruments of length (RO 2006 1433). 107. Ordinance of the Federal Ministry of Justice and Police of 19 March 2006 on measure of volume (RO 2006 1525). 108. Ordinance of the Federal Ministry of Justice and Police of 19 March 2006 on measuring systems for liquids other than water (RO 2006 1533). 109. Ordinance of the Federal Ministry of Justice and Police of 19 March 2006 on automatic weighing instruments (RO 2006 1545). 110. Ordinance of the Federal Ministry of Justice and Police of 19 March 2006 on instruments for thermal energy (RO 2006 1569). 111. Ordinance of the Federal Ministry of Justice and Police of 19 March 2006 on measuring instruments for gas quantities (RO 2006 1591). 112. Ordinance of the Federal Ministry of Justice and Police of 19 March 2006 on measuring instruments for exhaust gases of combustion engines (RO 2006 1599). 113. Ordinance of the Federal Ministry of Justice and Police of 19 March 2006 on measuring instruments for the electrical energy and power (RO 2006 1613). 114. Ordinance of 15 August 1986 on weights (RO 1986 2022), as last amended on 21 November 1995 (RO 1995 5646).

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 Annex V to Directive 90/384/EEC and in Article 12 to Directive 2004/22/EC, as regards the products covered by those Directives.

Section V

Supplementary provisions

1. Information exchange

The conformity assessment bodies recognised under this Agreement shall periodically provide the Member States and the competent Swiss authorities with the information provided for in point 1.5 of Annex II to Directive 90/384/EEC.

The conformity assessment bodies recognised under this Agreement may request the information provided for in point 1.6 of Annex II to Directive 90/384/EEC.

2. Pre-packages

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

As regards statistical checking of the quantities declared on pre-packages, the European Community shall recognise the Swiss method laid down in Articles 14 to 17 of the Ordinance on technical provisions concerning the declaration of quantities on industrial pre-packages (RS 941.281.1) as equivalent to the Community 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 pre-packages conform to Community legislation and have been checked according to the Swiss method shall affix the “e” mark on their products exported to the EC.

3. Marking

3.1. For the purposes of this Agreement, the provisions of Council Directive 71/316/EEC of 26 July 1971 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:

3.2. 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 Council Directive 71/316/EEC of 26 July 1971.

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

4.1. Information exchange, market surveillance and administrative cooperation

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

In particular, the competent authorities shall exchange:

— Information concerning the extent to which instruments they examine comply with the provisions of Directive 2004/22/EC, and the results of such examinations,

— EC-type examination and design examination certificates and their annexes issued by notified bodies as well as additions, amendments and withdrawals relating to certificates already issued,

— quality system approvals issued by notified bodies, as well as information on quality systems refused or withdrawn,

— evaluation reports established by notified bodies, when demanded by other authorities,

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

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

4.2. Technical documentation and declaration of conformity

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

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

CHAPTER 12

MOTOR VEHICLES

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 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 type-approval authorities in Switzerland and the Member States shall in particular exchange the information referred to in Article 4(5) and (6) of Directive 70/156/EEC, as last amended by Council Directive 2006/96/EC of 20 November 2006 (OJ L 363, 20.12.2006, p. 81).

In the event of refusal by Switzerland or the Member States to grant type-approval in accordance with Article 4(2) of Directive 70/156/EEC, as last amended by Council Directive 2006/96/EC of 20 November 2006 (OJ L 363, 20.12.2006, p. 81), their competent authorities shall notify each other of their decision and give the reasons for it. The competent Swiss authority shall likewise inform the Commission thereof.

2. Recognition of vehicle type-approval

Switzerland shall also recognise vehicle type-approval granted before the entry into force of this Agreement in accordance with Directive 70/156/EEC, as last amended by Council Directive 2006/96/EC of 20 November 2006 (OJ L 363, 20.12.2006, p. 81), by the authorities responsible for type-approval 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 70/156/EEC, as last amended by Council Directive 2006/96/EC of 20 November 2006 (OJ L 363, 20.12.2006, p. 81).

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

1. Each Member State and Switzerland shall register, permit the sale or entry into service of new vehicles on grounds relating to their construction and functioning if, and only if, they are accompanied by a valid certificate of conformity. In the case of incomplete vehicles, each Member State and Switzerland may not prohibit the sale of such vehicles but may refuse their permanent registration and entry into service so long as they are not completed.

2. Each Member State and Switzerland shall permit the sale or entry into service of components or separate technical units if, and only if, they comply with the requirements of the relevant separate Directive or the requirements of the Swiss legislation equivalent to the relevant separate Directive.

3. If a Member State or Switzerland finds that vehicles, components or separate technical units of a particular type are a serious risk to road safety although they are accompanied by a valid certificate of conformity or are properly marked, it may, for a maximum period of six months, refuse to register such vehicles or may prohibit the sale or entry into service in its territory of such vehicles, components or separate technical units. It shall forthwith notify the other Member States, Switzerland and the Commission thereof, stating the reasons on which its decision is based. If the Member State or Switzerland which granted type-approval disputes the risk to road safety notified to it, the Member States or Switzerland concerned shall endeavour to settle the dispute. The Commission and the Committee shall be kept informed and shall, where necessary, hold appropriate consultations for the purpose of reaching a settlement.

Measures related to the conformity of production

1. When a Member State or Switzerland grants type-approval, it shall take the necessary measures in accordance with Annex X to Framework Directive 70/156/EEC, as last amended by Council Directive 2006/96/EC of 20 November 2006 (OJ L 363, 20.12.2006, p. 81), in relation to that approval to verify, if need be in cooperation with the approval authorities of the other Member States or Switzerland, that adequate arrangements have been made to ensure that vehicles, systems, components or separate technical units produced, conform to the approved type.

2. When a Member State or Switzerland has granted a type approval, it shall take the necessary measures in accordance with Annex X to Framework Directive 70/156/EEC, as last amended by Council Directive 2006/96/EC of 20 November 2006 (OJ L 363, 20.12.2006, p. 81), in relation to that approval to verify, if need be in cooperation with the approval authorities of the other Member States or Switzerland, that the arrangements referred to in paragraph 1 continue to be adequate and that vehicles, systems, components or separate technical units produced, continue to conform to the approved type. Verification to ensure that products conform to the approved type shall be limited to the procedures set out in section 2 of Annex X to Framework Directive 70/156/EEC, as last amended by Council Directive 2006/96/EC of 20 November 2006 (OJ L 363, 20.12.2006, p. 81), and in those separate Directives that contain specific requirements.

Nonconformity with the approved type

1. There shall be failure to conform to the approved type where deviations from the particulars in the type-approval certificate and/or the information package are found to exist and where these deviations have not been authorised under Article 5(3) or (4), by the Member States or Switzerland which granted the type-approval. A vehicle shall not be considered to deviate from the approved type where tolerances are permitted by separate Directives and these tolerances are respected.

2. Where a Member State or Switzerland has granted type-approval and finds that vehicles, components or separate technical units accompanied by a certificate of conformity or bearing an approval mark do not conform to the type it has approved, it shall take the necessary measures to ensure that vehicles, components or separate technical units produced again conform to the approved type. The approval authorities of that Member State or Switzerland shall notify those of the other Member States and/or Switzerland of the measures taken which may extend to withdrawal of type-approval.

3. If a Member State or Switzerland demonstrates that vehicles, components or separate technical units accompanied by a certificate of conformity or bearing an approval mark do not conform to the approved type, it may request the Member State or Switzerland which granted the type-approval to verify that vehicles, components or separate technical units produced conform to the approved type. Such action shall be taken as soon as possible and in any case within six months of the date of the request.

4. In the case of: a vehicle type-approval where the nonconformity of a vehicle arises exclusively from the nonconformity of a system, component or separate technical unit, or a multistage type-approval where the nonconformity of a completed vehicle arises exclusively from the nonconformity of a system, component or separate technical unit being part of the incomplete vehicle, or of the incomplete vehicle itself the vehicle approval authority shall request the Member State(s) or Switzerland which granted any relevant system, component, separate technical unit or incomplete vehicle type-approval(s) to take the necessary action to ensure that vehicles produced again conform to the approved type. Such action shall be taken as soon as possible and in any case within six months of the date of the request, if necessary in conjunction with the Member State or Switzerland making the request. Where a failure to conform is established, the approval authorities 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 Article 11(2) of Directive 70/156/EEC, as last amended by Council Directive 2006/96/EC of 20 November 2006 (OJ L 363, 20.12.2006, p. 81).

5. The approval authorities of the Member States or Switzerland shall inform each other within one month of any withdrawal of type-approval and of the reasons for such a measure.

6. If the Member State or Switzerland which granted type-approval disputes the failure to conform notified to it, the Member States concerned and Switzerland shall endeavour to settle the dispute. The Commission and the Committee shall be kept informed and shall, where necessary, hold appropriate consultations for the purpose of reaching a settlement.

CHAPTER 13

AGRICULTURAL OR FORESTRY TRACTORS

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 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

1. Each Member State and Switzerland shall permit the registration, the sale or entry into service of new tractors on grounds relating to their construction and operation if, and only if, they are accompanied by a valid certificate of conformity.

2. Each Member State and Switzerland shall permit the sale or entry into service of separate technical units if, and only if, they comply with the requirements of the relevant separate Directive or the requirements of the Swiss legislation equivalent to the relevant separate Directive.

3. If a Member State or Switzerland finds that tractors of a particular type maybe a hazard to safety on the road or at work, although they are accompanied by a valid certificate of conformity, it may, for a maximum period of six months, refuse to register new tractors of that type or may prohibit their sale, entry into service or use in its territory. It shall forthwith notify the other Member States, Switzerland and the Commission thereof, stating the reasons on which its decision is based. The Commission shall within six weeks consult the States concerned by the dispute (Member States or Switzerland). The Commission shall conclude whether the measure is justified or not, and the procedure established in Article 16 of Directive 2003/37/EC shall apply.

Measures related to the conformity of production

1. When a Member State or Switzerland grants type-approval, it shall take the measures referred to in Annex IV of Directive 2003/37/EC to verify, if need be in cooperation with the approval authorities of the other Member States or Switzerland, that adequate arrangements have been made to ensure that the vehicles, systems, components or separate technical units produced conform to the approved type. This verification shall be limited to the procedures set out in Section 2 of Annex IV of Directive 2003/37/EC.

2. When a Member State or Switzerland has granted a type approval, it shall take the necessary measures to ensure that it is informed of any cessation of production and of any change in particulars appearing in the information document. If the state in question finds that an amendment to an information document warrants fresh checks or fresh tests and that it is accordingly necessary to amend the existing type-approval certificate or complete a new type-approval certificate, the competent authorities of that state shall inform the manufacturer thereof and shall, within one month of such new documents being completed, send them to the competent authorities of the other Member States or Switzerland.

Nonconformity with the approved type

1. There shall be failure to conform to the approved type where deviations from the particulars in the EC type-approval certificate and/or the information package are found to exist and where these deviations have not been authorised under Article 5(3) of Directive 2003/37/EC as last amended, by the Member State or Switzerland which granted the type-approval. A vehicle shall not be considered to deviate from the approved type where tolerances are permitted by separate Directives and these tolerances are respected.

2. Where a Member State or Switzerland has granted type-approval and finds that a number of vehicles, systems, components or separate technical units accompanied by a certificate of conformity or bearing an EC type-approval mark do not conform to the type it has approved, it shall take the necessary measures to ensure that production models conform to the approved type. The approval authorities of that Member State or Switzerland shall notify those of the other Member States and/or Switzerland of the measures taken which may extend to withdrawal of the type-approval. The said authorities shall take like measures if they are informed by the type-approval authorities of another Member State or Switzerland of such failure to conform.

3. The approval authorities of the Member States or Switzerland shall inform each other within one month of any withdrawal of EC type-approval and of the reasons for such a measure.

4. If the Member State or Switzerland which granted type-approval disputes the failure to conform notified to it, the States (Member States or Switzerland) concerned shall endeavour to settle the dispute. The Commission and the Committee shall be kept informed and shall, where necessary, hold appropriate consultations for the purpose of reaching a settlement.

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.

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(1)

Provisions covered by Article 1(2)

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.

For the European Community:

http://ec.europa.eu/enterprise/chemicals/legislation/glp/national_en.htm

For Switzerland:

http://www.bag.admin.ch/themen/chemikalien/00253/00539/02401/index.html?lang=en

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):

European Community 1. Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (OJ L 50, 20.2.2004, p. 44). 2. Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) (OJ L 50, 20.2.2004, p. 28). Switzerland 100. Federal law of 7 October 1983 on the protection of the environment (RO 1984 1122) as last amended on 16 December 2005 (RO 2006 2677). 101. Federal law of 15 December 2000 on protection against dangerous substances and preparations (RO 2004 4763) as last amended on 17 June 2005 (RO 2006 2197). 102. Federal law of 15 December 2000 on medicinal products and medical devices (RO 2001 2790) as last amended on 20 December 2006 (RO 2006 5599). 103. Ordinance of 18 May 2005 on Good Laboratory Practice (RO 2005 2795).

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.

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 in Switzerland or the European Community, and to which Good Manufacturing Practice (GMP) requirements apply.

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

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

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

“Medicinal products” means all products regulated by pharmaceutical legislation in the European Community and Switzerland as listed in Section I of this Chapter. The definition of medicinal products includes all human and veterinary products, such as chemical and biological pharmaceuticals, immunologicals, radio-pharmaceuticals, stable medicinal products derived from human blood or human plasma, premixes 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:

— is appropriately authorised to manufacture the relevant medicinal product, or to carry out the relevant specified manufacturing operation,

— is regularly inspected by the authorities,

— complies with the national GMP requirements recognised as equivalent by the two parties, and which are listed in Section I of this Chapter. Should different GMP requirements be used as reference, this is to be mentioned in the certificate.

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

Certificates shall be issued expeditiously, and the time taken should not exceed 30 calendar days. In exceptional cases, i.a. when a new inspection has to be carried out, this period may be extended to 60 days.

Batch certification

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

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

Official batch release

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

For the Community, the official batch release procedure is specified in document “Control Authority Batch Release of Vaccination and Blood Products, 2001” or subsequent versions and in different specific batch release procedures. For Switzerland, the official batch release procedure is specified in Article 17 of the Federal Law on medicinal products and medical devices and in Articles 18–21 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

With regard to GMP, the relevant parts of the legislative, regulatory and administrative provisions listed below apply. However, the reference quality requirements of products to be exported, including their manufacturing method and product specifications, shall be those of the relevant marketing authorisation granted by the competent authority of the importing Party.

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 Contact Details of the official GMP Inspection Services of the Member States of the European Union and of Switzerland can be found in the websites indicated below.

http://www.hma.eu/index.php?id=148

For Swiss conformity assessment bodies

For all products for human and veterinary use (except immunological products for veterinary use):

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

For immunobiological products for veterinary use

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

For conformity assessment bodies of the European Community

http://ec.europa.eu/enterprise/pharmaceuticals/mra/index_a.htm

Section III

Supplementary 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 thirty calendar days, this period being extended to sixty 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

(a) Manufacturers shall be inspected against the applicable GMP of the exporting party (see section I).

(b) With respect to medicinal products covered by the pharmaceutical legislation of the importing Party but not the exporting one, the locally competent inspection service willing to carry out an inspection of the relevant manufacturing operations shall inspect against its own GMP or, in the absence of specific GMP requirements, against the applicable GMP of the importing Party. For specific products or classes of products (e.g. investigational medicinal products, starting materials not limited to active pharmaceutical ingredients), equivalence of GMP requirements shall be determined according to a procedure established by the Committee.

4. Nature of inspections

(a) Inspections shall routinely assess the compliance of the manufacturer with GMP. These are called general GMP inspections (also regular, periodic, or routine inspections).

(b) “Product- or process-oriented” inspections (which may be “pre-marketing” inspections as relevant) focus on the manufacture of one or a series of product(s) or process(es) and include an assessment of the validation of and compliance with specific process or control aspects as described in the marketing authorisation. Where necessary, relevant product information (the quality dossier of an application/authorisation dossier) shall be provided in confidence to the inspectorate.

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 between authorities and approximation of quality requirements

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

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

8. Inspectors training

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

9. Joint Inspections

In accordance with Article 12 of 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:

For the EC

The Director of the European Medicines Agency.

For Switzerland

The official GMP inspection services listed in Section II above.

12. Divergence of views

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

CHAPTER 16

CONSTRUCTION PRODUCTS

Section I

Legislative, regulatory and administrative provisions

Provisions covered by Article 1(2)

Section II

Conformity assessment bodies

1. 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 this Agreement, a list of the conformity assessment bodies.

2. Conformity assessment bodies can be differentiated in three different bodies involved in the attestation of conformity: Certification body, inspection body and testing laboratory. For the purpose of this Agreement the definitions of Annex III Section 3 to Directive 89/106/EEC shall apply.

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 IV to Directive 89/106/EEC.

Section V

Supplementary provisions

1. European harmonised standards for construction products

(a) For the purpose of this Agreement, Switzerland will publish the reference of the European harmonised standards for construction products after their publishing in the Official Journal of the European Union according to Article 7 of the Directive 89/106/EEC.

(b) To state the equivalence of the Swiss systems of conformity attestation, Switzerland will add to every harmonised standard a conversion table. This conversion table shall ensure the comparability of the Swiss and the European systems of conformity attestation describing the relevant procedures to assess conformity.

2. Interpretative documents and guidance papers

The six Interpretative Documents referred to in Article 3 of the Directive 89/106/EEC and in the Communication 94/C 62/01 of the Commission (OJ C 62, 28.2.1994, p. 1) established according to Article 20 of the Directive 89/106/EEC shall also apply for the purpose of this Agreement.

3. European Technical Approvals

(a) Switzerland shall be entitled to designate Swiss bodies to issue European technical approvals. It shall make sure that designated bodies become members of the European Organisation for Technical Approvals (EOTA) and participate in its work, in particular for establishing guidelines for European technical approvals according to Article 11 of the Directive 89/106/EEC and issuing European technical approvals (ETAs). Switzerland shall notify the Committee established under Article 10 of this Agreement of the names and addresses of such bodies. Decisions of EOTA shall also apply for the purpose of this Agreement. European Technical Approvals are issued by the EOTA Approval Bodies and are recognised by both Parties for the purpose of this Agreement.

(b) “Approval Body” shall mean a public or private law body which is authorised to issue European technical approvals. Approval bodies are designated by the Parties according to their relevant procedures. The Committee established under Article 10 of this Agreement shall draw up and keep up to date a list of the approval bodies. To this end, the notification procedure described in Section II para. 1 in accordance with Article 11 of this Agreement shall also apply to approval bodies analogously. The Parties hereby recognise that the bodies thus listed for the purpose of this Agreement fulfil the conditions to issue European technical approvals.

4. Information exchanges

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

5. Technical documentation

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

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

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

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