Decision No 2/2002

of 8 January 2003

of the Committee established under the Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment on the modification of the Annex 1 of the Agreement

(2003/154/EC)

THE COMMITTEE,

Having regard to the Agreement between the European Community and the Swiss Confederation on mutual recognition (the Agreement) in relation to Conformity Assessment signed on the 21 of June 1999, and in particular Article 10 (5) thereof,

Whereas the Agreement entered into force on 1 June 2002;

Whereas the text of some sectoral chapters of Annex 1 must be modified to take account of legislative changes and changes to designating authorities in Switzerland and the Community,

DECIDES AS FOLLOWS:

Article 1

The respective Sections of the following sectoral chapters of Annex 1 of the Agreement are deleted and replaced with the text at Attachment A:

- Chapter 1 on machinery; Sections I and III,

- Chapter 2 on personal protective equipment; Sections I and III,

- Chapter 4 on medical devices; Sections I, III, IV and V,

- Chapter 5 on gas appliances and boilers; Sections I and III,

- Chapter 6 on pressure vessels; Sections I, III, IV and V,

- Chapter 7 on telecommunications terminal equipment; Title and Sections I, III, IV and V,

- Chapter 8 on equipment and protective systems intended for use in potentially explosive atmospheres; Sections I and III,

- Chapter 9 on electrical equipment and electromagnetic compatibility; Sections I and III,

- Chapter 10 on construction plant and equipment; Sections I, III and IV,

- Chapter 11 on measuring instruments and prepackages; Sections I, III and V,

- Chapter 12 on motor vehicles; Sections I, III and V,

- Chapter 13 on agricultural and forestry tractors; Sections I, III and V,

- Chapter 14 on good laboratory practice (GLP); "Scope and Coverage" and Sections I, III and IV,

- Chapter 15 on medicinal products GMP Inspection and Batch Certification; "Scope and Coverage" and Sections I and II.

Article 2

This Decision, done in duplicate, is signed by the Co-Chairs or other persons authorised to act on behalf of the Parties.

This Decision shall be effective from the date of the later of these signatures.

Signed in Bern, 12 December 2002.

On behalf of the Swiss Confederation

Oscar Zosso

Signed in Brussels, 8 January 2003.

On behalf of the European Commission

Paul de Lusignan

ANNEX

Attachment A

CHAPTER 1

MACHINERY

Section I

Legislation, regulations and administrative provisions

Provisions covered by Article 1(2)

>TABLE>

Section III

Designating authorities

European Community:

>TABLE>

>TABLE>

CHAPTER 2

PERSONAL PROTECTIVE EQUIPMENT

Section I

Legislation, regulations and administrative provisions

Provisions covered by Article 1(2)

>TABLE>

Section III

Designating authorities

European Community:

>TABLE>

>TABLE>

CHAPTER 4

MEDICAL DEVICES

Section I

Legislation, regulations and administrative provisions

Provisions covered by Article 1(2)

>TABLE>

Section III

Designating authorities

European Community:

>TABLE>

>TABLE>

Section IV

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

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

Section V

Additional provisions

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

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

2. Labelling of medical devices

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

3. Information exchange

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

4. European databank

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

CHAPTER 5

GAS APPLIANCES AND BOILERS

Section I

Legislation, regulations and administrative provisions

Provisions covered by Article 1(1)

>TABLE>

Provisions covered by Article 1(2)

>TABLE>

Section III

Designating authorities

European Community:

>TABLE>

>TABLE>

CHAPTER 6

PRESSURE VESSELS

Section I

Legislation, regulations and administrative provisions

Provisions covered by Article 1(1)

>TABLE>

Section III

Designating authorities

European Community:

>TABLE>

>TABLE>

Section IV

Special rules relating to the designation of conformity assessment bodies

For the designation of conformity assessment bodies, the designating authorities shall comply with the general principles contained in Annex 2 and those in Annex III to Directive 87/404/EEC or Annexes IV or V to Directive 97/23/EC.

Section V

Additional provisions

1. Recognition of certificates by Switzerland

Where the provisions of Swiss legislation listed in Section I lay down a conformity assessment procedure, Switzerland shall recognise certificates issued by a designated Community body listed in Section II which certifies that the product conforms to either Directive 87/404/EEC or Directive 97/23/EC.

2. Technical documentation

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

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

CHAPTER 7

RADIO EQUIPMENT AND TELECOMMUNICATIONS TERMINAL EQUIPMENT

Section I

Legislation, regulations and administrative provisions

Provisions covered by Article 1(2)

>TABLE>

Section III

Designating authorities

European Community:

>TABLE>

>TABLE>

Section IV

Special rules relating to the designation of conformity assessment bodies

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

Section V

Additional provisions

1. TCAM

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

2. Market surveillance

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

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

3. Regulated interfaces

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

4. Interfaces offered by public telecommunications network operators

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

5. Application of essential requirements

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

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

6. Authorisation to disconnect

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

7. Harmonised standards

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

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

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

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

9. Safeguard clause relating to industrial products

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

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

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

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

9.5. Where the Committee considers that the measure is

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

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

CHAPTER 8

EQUIPMENT AND PROTECTIVE SYSTEMS INTENDED FOR USE IN POTENTIALLY EXPLOSIVE ATMOSPHERES

Section I

Legislation, regulations and administrative provisions

Provisions covered by Article 1(2)

>TABLE>

Section III

Designating authorities

European Community:

>TABLE>

>TABLE>

CHAPTER 9

ELECTRICAL EQUIPMENT AND ELECTROMAGNETIC COMPATIBILITY

Section I

Legislation, regulations and administrative provisions

Provisions covered by Article 1(2)

>TABLE>

Section III

Designating authorities

European Community:

>TABLE>

>TABLE>

CHAPTER 10

CONSTRUCTION PLANT AND EQUIPMENT

Section I

Legislation, regulations and administrative provisions

Provisions covered by Article 1(1)

>TABLE>

Section III

Designating authorities

European Community:

>TABLE>

>TABLE>

Section IV

Special rules relating to the designation of conformity assessment bodies

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

CHAPTER 11

MEASURING INSTRUMENTS AND PREPACKAGES

Section I

Legislation, regulations and administrative provisions

Provisions covered by Article 1(1)

>TABLE>

Provisions covered by Article 1(2)

>TABLE>

Section III

Designating authorities

Provisions covered by Article 1(1)

European Community:

>TABLE>

>TABLE>

Provisions covered by Article 1(2)

European Community:

>TABLE>

>TABLE>

Section V

Additional provisions

1. Information exchange

The conformity assessment bodies listed in Section II 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 listed in Section II may request the information provided for in point 1.6 of Annex II to Directive 90/384/EEC.

2. Prepackages

Switzerland shall recognise checks carried out in accordance with the provisions of Community legislation listed in Section I by a Community body listed in Section II in the case of Community prepackages placed on the market in Switzerland.

As regards statistical checking of the quantities declared on prepackages, the European Community shall recognise the Swiss method laid down in Articles 3 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 prepackages 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 I 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 Annex II point 3.2.1 refers, shall be supplemented by the letters necessary for the sign "CH".

3.2. For the purposes of this Agreement, the Ordinance on the qualification of measuring instruments (RS 941.210) shall be read with the following amendments:

In the Annex, the text under point 3, signs identifying the service issuing the stamp; the following shall be added:

"3.5. Offices of the Member States of the Community".

The Member States of the European Community shall be identified using the acronyms defined in Annex II to Directive 71/316/EEC.

3.3. By way of derogation from the last sentence of Article 1(2) of this Agreement, the rules on marking for measuring instruments placed on the Swiss market are as follows:

Where Swiss and Community legislation are deemed equivalent within the meaning of Article 1(2) of this Agreement, the marking that must be affixed is the CE 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.

Where the measuring instruments are subject to the legislation referred to in Article 1(1) of this Agreement, the marking to be affixed shall be the Swiss sign provided for under points 1 (approval mark) or 21 (verification mark) of the Annex to the Ordinance on the qualification of measuring instruments (RS 941.210) combined with the CE marking and the national sign(s) of the EC Member State concerned as provided in Annex I, point 3.1, first indent and Annex II, point 3.1.1.1, first indent, to Directive 71/316/EEC.

4. Weighing instruments

By way of derogation from Article 1(2) of this Agreement, Switzerland shall recognise certificates confirming the compliance of weighing instruments with Directive 90/384/EEC.

CHAPTER 12

MOTOR VEHICLES

Section I

Legislation, regulations and administrative provisions

Provisions covered by Article 1(2)

>TABLE>

Section III

Designating authorities

European Community:

>TABLE>

>TABLE>

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 Commission Directive 2001/116/EC of 20 December 2001.

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 Directive 2001/116/EC, 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 Directive 2001/116/EC, by the authorities responsible for type-approval listed in section II of this Chapter 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 Directive 2001/116/EC.

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

3. Vehicle type-approval safeguard clauses

Registration and entry into service

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 Directive 2001/116/EC, 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 Directive 2001/116/EC, 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 Directive 2001/116/EC, 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 multi-stage 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 Directive 2001/116/EC.

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

Legislation, regulations and administrative provisions

Provisions covered by Article 1(2)

>TABLE>

Section III

Designating authorities

European Community:

>TABLE>

>TABLE>

Section V

Supplementary provisions

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

1. Information exchange

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

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

2. Recognition of vehicle type-approval

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

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

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

3. Vehicle type-approval safeguard clauses

Registration and entry into service

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 deliver an opinion without delay and take appropriate steps.

Measures related to the conformity of production

1. When a Member State or Switzerland grants type-approval, it shall take the necessary measures to verify, if need be in cooperation with the approval authorities of the other Member States or Switzerland, that production models conform to the approved prototype. Such verification shall be limited to spot checks.

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 information document are found to exist and where these deviations have not been authorised under Article 6(2) or (3) of the Directive 74/150/EEC, as last amended by Directive 2001/3/EC, by the Member State or Switzerland which granted the type-approval. A tractor 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 tractors accompanied by a certificate of conformity 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)] and GLP Consensus documents, OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring, and all amendments made thereto, shall apply.

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

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

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

Section I

Legislation, regulations and administrative provisions

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

Provisions covered by Article 1(1)

>TABLE>

Provisions covered by Article 1(2)

>TABLE>

Section III

Designating authorities

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

European Community:

>TABLE>

>TABLE>

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):

>TABLE>

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, pre-mixes for the preparation of veterinary medicated feedingstuffs and, where appropriate, vitamins, minerals, herbal remedies and homeopathic medicinal products.

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

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

Certification of manufacturers

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

- 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 thirty calendar days. In exceptional cases, inter alia, when a new inspection has to be carried out, this period may be extended to sixty days.

Batch certification

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

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

Official batch release

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

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

Section I

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)

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Section II

Conformity assessment bodies

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

European Community(1)

- Germany:

Bundesministerium für Gesundheit Am Propsthof 78a D - 53108 Bonn; Tel. (49-228) 941 23 40 Fax. (49-228) 941 49 23

for immunologicals:

Paul-Ehrlich-Institut, Federal Agency for Sera & Vaccines Paul-Ehrlichstr. 51-59 D - 63225 Langen; Tel. (49-6103) 77 10 10 Fax. (49-6103) 77 12 34

- Austria:

Bundesministerium für soziale Sicherheit und Generationen Radetzkystraße 2 A - 1030 Wien Tel. (43-1) 711 72 46 42 Fax. (43-1) 714 92 22

- Belgium:

Inspection générale de la Pharmacie/Algemene Farmaceutische Inspectie Vesaliusgebouw V309 Pachecolaan 19 bus 5 B - 1010 Bruxelles Tel. (32-2) 210 49 24 Fax. (32-2) 210 48 80

- Denmark:

Lægemiddelstyrelsen: Frederikssundsvej 378 DK - 2700 Bronshoj Tel. (45-44) 88 91 11 Fax. (45-44) 88 91 95

- Spain:

Agencia Española del Medicamento c/Paseo del Prado, 18-20 E - 28014 Madrid Tel. (34-91) 596 14 64 65 66 Fax. (34-91) 596 14 55

- Finland:

Lääkelaitos Feld 55 FIN - 00301 Helsinki Tel. (358-9) 47 33 41 Fax. (358-9) 71 44 69

- France:

for medicinal products for human use:

Agence Française de Sécurité Sanitaire des Produits de Santé 143-147 Boulevard Anatole France F - 93285 Saint-Denis Cedex Tel. (33-1) 55 87 30 00 Fax. (33-1) 55 87 37 20

for veterinary medicinal products:

Agence Française de Sécurité Sanitaire des Aliments/Agence Nationale du Médicament Vétérinaire (AFSSA - ANMV) BP 90203 F - 35302 Fougeres Tel. (33-2) 99 94 78 78 Fax. (33-2) 99 94 78 99

- Greece:

National Organisation for Medicines (EOF) 284 Mesogion Avenue Holargos GR - 15562 Athinai Tel. (30-210) 650 72 00 Fax. (30-210) 654 95 91

- Ireland:

Irish Medicines Board (Bord Leigheasra na hÉireann) Earlsfort Centre

Earlsfort Terrace

Dublin 2 Ireland Tel. (353-1) 676 49 71 Fax. (353-1) 676 78 36

- Italy:

For medicinal products for human use:

Ministero della Salute Viale della Civiltà Romana 7 I - 00144 Roma Tel. (39-06) 59 94 36 76 Fax. (39-06) 59 94 33 65

For medicinal products for veterinary use:

Ministero della Salute Direzione Generale Sanità Pubblica Veterinaria, Alimenti e Nutrizione Ufficio XI Piazzale G Marconi 25 I - 00144 Roma Tel. (39-06) 59 94 39 46 Fax. (39-06) 59 94 33 17

- Luxembourg:

Direction de la Santé Villa Louvigny

Allée Marconi

L - 2120 Luxembourg Tel. (352) 478-55 90-93 Fax.: (352) 22 44 58

- Netherlands:

Staatstoezicht op de volksgezondheid - Inspectie voor de Gezondheidszorg Postbus 16119 2500 BC Den Haag Netherlands Tel. (31 70) 340 79 11 Fax. (31 70) 340 51 77

- Portugal:

Instituto Nacional da Farmácia e do Medicamento - Infarmed Parque de Saúde de Lisboa Av. do Brasil, 53 P - 1749-004 Lisboa Tel. (351-21) 217 98 52 74 Fax. (351-21) 217 98 72 57

- United Kingdom:

for human and veterinary (non immunologicals):

Medicines Control Agency Market Towers

1 Nine Elms Lane

London SW8 5NQ United Kingdom Tel. (44-20) 72 73 05 00 Fax. (44-20) 72 73 06 76/06 38

for veterinary immunologicals:

Veterinary Medicines Directorate Woodham Lane New Haw

Addlestone

Surrey KT15 3LS United Kingdom Tel. (44-193)-233 69 11 Fax. (44-193)-233 66 18

- Sweden:

Läkemedelsverket (Medical Products Agency) Husargatan 8 PO Box 26 S - 751 03 Uppsala Tel. (46-18) 17 46 00 Fax. (46-18) 54 85 66

Switzerland

Swiss Agency for Therapeutic Products, Swissmedic Erlachstraße 8 CH - 3000 Bern (for all products for human and veterinary use - except immunological products for veterinary use)

Tel. (41-31) 3 22 02 11 Fax. (41-31) 3 22 02 12

Institute for Virology and Immunoprophylaxis Research Station of the Swiss Federal Veterinary Office Sensemattstr. 293 CH - 3147 Mittelhäusern (for immunobiological products for veterinary use)

Tel. (41-31) 848 92 11 Fax. (41-31) 848 92 22

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