Cet accord vise à faciliter le commerce entre la Communauté européenne et le Canada en reconnaissant mutuellement les…

21998A1016(01) 21998A1016(01) Agreement on mutual recognition between the European Community and Canada Official Journal L 280 , 16/10/1998 P. 0003 - 0065 Dates: of document: 14/05/1998 of effect: 01/11/1998; Entry into force See Art 19 And OJ L 280/98 P. 66 of signature: 14/05/1998; London end of validity: 99/99/9999 Authentic language: The official languages ; German ; English ;

Danish ; Spanish ; Finnish ; French ; Greek ; Italian ; Dutch ;

Portuguese ; Swedish Author:

European Community ; Canada Subject matter: Commercial policy ; External relations ; Technical barriers Directory code: 11404000 EUROVOC descriptor: mutual recognition principle ; sectoral agreement ; sectoral planning ; Canada ; EC agreement ; EC joint committee Legal basis:

192E113................... Adoption 192E228-P2F1.............. Adoption 192E228-P3L1.............. Adoption 192E228-P4................ Adoption Instruments cited:

276A0706(01)..............

294A1223(01)..............

294A1223(07)..............

Amended by:

Adopted by.... 398D0566.......... DP20/7/98 Amended by.... 202D0342.......... Amendment ANN from 27/03/2002 Subsequent related instruments:

Amendment proposed by 500PC0563.........

AGREEMENT on mutual recognition between the European Community and Canada The EUROPEAN COMMUNITY and the GOVERNMENT OF CANADA ('the Parties`), CONSIDERING the traditional links of friendship that exist between Canada and the European Community;

CONSIDERING that on the basis of past experience under the 1976 Framework Agreement on commercial and economic cooperation between the European Communities and Canada, and in order to further develop their dialogue in the area of standards as specified in the 1990 Declaration on EC-Canada relations, both Parties have expressed a desire to establish a more formal framework for the conduct of collaboration in the field of mutual recognition in relation to conformity assessment;

CONSIDERING the Parties' interest in strengthening the rules governing free and unhindered international trade;

CONSIDERING the improved conditions for trade between the Parties which the mutual recognition of tests, certificates and marks of conformity will bring about;

RECOGNISING the importance of maintaining their respective high standards of health and safety;

BEARING IN MIND their status as Parties to the Agreement Establishing the World Trade Organisation and conscious in particular of their obligations under the World Trade Organisation Agreement on Technical Barriers To Trade, HAVE AGREED AS FOLLOWS:

Article I Definitions General terms concerning conformity assessment used in this Agreement and its Annexes shall have the meaning given in the definitions contained in Guide 2 (1996 edition) of the International Organisation for Standardisation and the International Electrotechnical Commission, unless specifically defined otherwise in this Agreement and its Sectoral Annexes. In addition, the following terms and definitions shall apply to this Agreement:

In the event of an inconsistency between ISO/IEC Guide 2 and definitions in this Agreement or its Annexes, the definitions in this Agreement shall prevail.

Article II General obligations 1. The Sectoral Annexes to this Framework Agreement constitute integral parts of this Agreement.

Article III General coverage of the Agreement 1. This Agreement applies to conformity assessment procedures for products covered by its Sectoral Annexes.

Article IV Transitional arrangements 1. The Parties agree to implement the transition commitments on confidence building where included in the Sectoral Annexes.

Article V Civil liability 1. Nothing in this Agreement is intended to change or modify the law in the territory of either Party applicable to civil liability of manufacturers, distributors, suppliers, conformity assessment bodies, designating bodies, regulatory authorities or governments, to consumers or among each other, in respect of the design, manufacture, testing, inspection, distribution or sale of products that have undergone conformity assessment pursuant to this Agreement.

The Parties, through the Joint Committee, shall from time to time consider whether their respective conformity assessment bodies continue to meet that requirement and whether the interests of the Parties are adequately protected.

Article VI Designating authorities 1. The Parties shall ensure that the designating authorities responsible for designating the conformity assessment bodies specified in the Sectoral Annexes shall have the necessary authority to designate, monitor, suspend and withdraw the designations of such bodies.

Article VII Conformity assessment bodies 1. The conformity assessment bodies designated in the territory of the exporting Party shall operate to the requirements of the importing Party and fulfil the conditions of eligibility for conformity in relation to those requirements.

Article VIII Verification and suspension of conformity assessment bodies 1. Each Party has the right to challenge the technical competence and compliance of conformity assessment bodies under the jurisdiction of the other Party. This right will be exercised under exceptional circumstances only and justified, in an objective and reasoned manner in writing, to the Joint Committee. The Joint Committee will discuss such requests.

Article IX Exchange of information 1. The Parties shall exchange information concerning the implementation of the legislative, regulatory and administrative provisions identified in the Sectoral Annexes.

Article X Monitoring of the Agreement 1. The Parties may hold ad hoc consultations within the Joint Committee to ensure the satisfactory functioning of this Agreement.

Article XI Joint Committee 1. There shall be established under this Agreement a Joint Committee of the two Parties, which will be responsible for the effective functioning of the Agreement.

Each Party may invite its representatives from the joint sectoral groups to attend meetings of the Joint Committee when its sectoral interests are the subject of an agenda item.

Article XII Joint sectoral groups 1. The Joint Committee may establish joint sectoral groups for individual Sectoral Annexes comprising the appropriate designating and regulatory authorities and experts of the Parties. These groups will address the specific conformity assessment and regulatory issues related to a given sector.

Article XIII Sectoral contact point, management of information, assistance and emergency action 1. Each Party shall appoint and confirm in writing the names and addresses of contact points to be responsible for activities under each Sectoral Annex.

Article XIV Safeguards 1. The appropriate regulatory authorities of each Party retain all authority under the applicable law of that Party, to interpret and, as set out in paragraph 2 below, enforce their respective legislative and regulatory provisions. A regulatory authority of the importing Party is not the legal representative of the exporting Party.

Article XV Market access 1. Each Party's obligation to accord mutual recognition within the terms of a Sectoral Annex to this Agreement is conditional upon the other Party continuing: (a) to provide access to its market for products that, having been subjected to conformity assessment procedures, can be demonstrated to meet the applicable technical requirements; and (b) to maintain in existence legal and regulatory authorities capable of implementing the provisions of this Agreement.

Article XVI Fees Each Party shall ensure that, for conformity assessment procedures carried out pursuant to this Agreement and its Sectoral Annexes, no fees are charged in its territory for conformity assessment services provided by the other Party.

Article XVII Agreements with other countries Except where there is written agreement between the Parties, obligations contained in mutual recognition agreements concluded by either Party with a country not party to this Agreement shall have no force and effect with regard to the other Party.

Article XVIII Territorial application This Agreement and its Annexes shall apply, on the one hand, to the territories in which the Treaty establishing the European Community is applied, and under the conditions laid down in that Treaty and, on the other hand, to the territory of Canada.

Article XIX Entry into force, modification and duration 1. This Agreement and its Annexes shall enter into force on the first day of the second month following the date on which the Parties have exchanged diplomatic notes confirming the completion of their respective procedures for the entry into force of this Agreement.

Article XX Final provisions This Agreement and the Sectoral Annexes are drawn up in two originals in the Danish, Dutch, English, Finnish, French, German, Greek, Italian, Portuguese, Spanish and Swedish languages, each text being equally authentic.

Hecho en Londres, el catorce de mayo de mil novecientos noventa y ocho.

Udfördiget i London den fjortende maj nitten hundrede og otteoghalvfems.

Geschehen zu London am vierzehnten Mai neunzehnhundertachtundneunzig. øółżõ ėĮ˙ Ė˙żōčż˙, ėĮłĖ ōõśńĮąėėõęłĖ ĢńĄ˙į ščūłń õżżłńśŽėłń õżõżČżĮń ˙śĮž.

Done at London on the fourteenth day of May in the year one thousand nine hundred and ninety-eight.

Fait š Londres, le quatorze mai mil neuf cent quatre-vingt-dix-huit.

Fatto a Londra, addü quattordici maggio millenovecentonovantotto.

Gedaan te London, de veertiende mei negentienhonderd achtennegentig.

Feito em Londres, em catorze de Maio de mil novecentos e noventa e oito.

Tehty Lontoossa neljōntenōtoista pōivōnō toukokuuta vuonna tuhatyhdeksōnsataayhdeksōnkymmentōkahdeksan.

Som skedde i London den fjortonde maj nittonhundranittioõtta.

Por la Comunidad Europea For Det Europöiske Föllesskab FŽr die Europōische Gemeinschaft Ćłń Į÷ż ÅįęųĘńŪśČ Ź˙łżŽĮ÷Įń For the European Community Pour la Communautł europłenne Per la Comunitš europea Voor de Europese Gemeenschap Pela Comunidade Europeia Euroopan yhteisŠn puolesta Põ Europeiska gemenskapens vōgnar >REFERENCE TO A GRAPHIC> Por el Gobierno de Canadń For Canadas regering FŽr die Regierung Kanadas Ćłń Į÷ż śįņąęż÷ė÷ Į˙į ŹńżńōĄ For the Government of Canada Pour le gouvernement du Canada Per il governo del Canada Voor de regering van Canada Pelo Governo do Canadń Kanadan hallituksen puolesta Põ Kanadas regerings vōgnar >REFERENCE TO A GRAPHIC> SECTORAL ANNEX ON TELECOMMUNICATIONS TERMINAL EQUIPMENT, INFORMATION TECHNOLOGY EQUIPMENT AND RADIO TRANSMITTERS 1. PURPOSE The purpose of this Annex is to establish a framework for the acceptance of test reports and, at the end of a transitional period, certificates of conformity issued in the territory of one Party in accordance with the regulatory requirements of the other Party, as referenced in Attachment 1.

This Annex constitutes a Sectoral Annex to the Framework Agreement on mutual recognition between Canada and the European Community.

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

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

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

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

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

5.2. Designated conformity assessment bodies (a) For the purpose of this Annex, each Party will designate competent conformity assessment bodies to carry out conformity assessment to the requirements of the other Party. Each Party shall ensure that the designated bodies comply with the criteria and standards set out in the regulatory requirements of the other Party.

In making designations, the Parties shall indicate the products and procedures for which they have been designated. A list of designated bodies, together with an indication of the products and procedures for which they have been designated, is included in Attachment 4. (b) Conformity assessment bodies designated under this Annex shall be recognised as competent to perform the conformity assessment activities for which they have been designated. (c) Designation, suspension or withdrawal of conformity assessment bodies under this Annex shall be in conformance with procedures determined by the Joint Committee established under the Framework Mutual Recognition Agreement. (d) Where a complaint or any other circumstance arises concerning a conformity assessment body's ability to perform under this Annex, the appropriate designating authority must take action to the mutual satisfaction of the Parties. Where necessary, such problems may be considered by the Joint Committee established under the Framework Mutual Recognition Agreement in order to reach a solution.

6.2. This transitional period will be used by the Parties: (a) to exchange information on and develop better understanding of their respective regulatory requirements; (b) to develop mutually agreed mechanisms for exchanging information on changes in technical requirements or methods of designating conformity assessment bodies; (c) to monitor and evaluate the work carried out by designated conformity assessment bodies operating during the transitional period.

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

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

6.5. At the end of the transitional period the Parties will proceed to full mutual recognition of certificates of compliance issued by designated bodies in the other Party. Any proposal made during or at the end of the transitional period to limit the scope of recognition of any designated conformity assessment body or to exclude it from the list of bodies designated under this Annex shall be based on objective criteria and documented. Any such body may apply for reconsideration once the necessary corrective action has been taken.

To the extent possible, the Parties will implement such action prior to the expiry of the transitional period.

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

Post-market surveillance 7.3. For the purpose of post-market surveillance, the Parties may maintain any existing labelling and numbering requirements. The assignment of the numbers may take place in the territory of the exporting Party. The numbers will be allocated by the importing Party.

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

Joint Telecommunications Group 7.5. The Joint Committee established under the Framework Mutual Recognition Agreement may appoint a Joint Telecommunications Group which shall meet as required to discuss technical, conformity assessment and technology issues relating to this Annex.

Exchange of information and mutual assistance 7.6. Each Party shall establish a contact point to provide answers to all reasonable inquiries from the other Party regarding procedures, regulations and complaints.

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

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

Regulatory changes and updating the Annex 7.9. In the event that there are changes to the regulations referenced in Attachment 1 or the introduction of new regulations affecting conformity assessment procedures taking place in either Party, the Parties will update this Annex.

Cross-referencing 7.10. Where products covered by this Annex are subject also to electrical safety or EMC requirements the relevant provisions of the Sectoral Annexes on electrical safety and EMC will also apply.

Attachment 1 Legislative, regulatory and administrative provisions >TABLE POSITION> Attachment 2 Coverage >TABLE POSITION> Attachment 3 Designating authorities >TABLE POSITION> Attachment 4 Designated conformity assessment bodies (This should give name, address, telephone and fax number, contact point, products, standards and conformity assessment procedures for which designation has been made, by reference to the legislative requirements of the other Party.) Attachment 5 Approval authorities >TABLE POSITION> Appendix 1 RADIO TRANSMITTERS STANDARDS LIST UNDER RADIOCOMMUNICATION REGULATIONS >TABLE POSITION> >TABLE POSITION> Additional radio standards specifications may be found in the broadcasting regulatory section of the index. >TABLE POSITION> >TABLE POSITION> SECTORAL ANNEX ON ELECTROMAGNETIC COMPATIBILITY (EMC) 1. SCOPE AND COVERAGE 1.1. The provisions of this Annex shall apply to the following:

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

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

4.2. Designated conformity assessment bodies (a) Conformity assessment bodies designated under this Annex shall be recognised as competent to perform the conformity assessment activities for EMC. Each Party shall ensure that the designated bodies comply with the criteria and standards set out in the regulatory requirements of the other Party. A list of designated bodies is included in Attachment 3. (b) Designation, suspension or withdrawal of conformity assessment bodies under this Annex shall be in conformance with procedures determined by the Joint Committee established under the Framework Mutual Recognition Agreement.

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

6.2. The conformity assessment bodies shall record and retain details of its investigation into the competence and compliance of its subcontractors and maintain a register of all subcontracting.

These details will be available promptly to the other Party on request.

Post-market surveillance 6.3. For the purpose of post-market surveillance, the Parties may establish labelling, numbering or marking requirements. The assignment of numbers or affixing of labels or marks may take place in the territory of the exporting party.

Exchange of information and mutual assistance 6.4. Each Party shall establish a contact point to provide answers to all reasonable inquiries from the other Party regarding procedures, regulations and complaints.

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

Regulatory changes and updating the Annex 6.6. In the event that there are changes to the technical regulations and conformity assessment procedures referenced in Attachment 1 or in the event of the introduction of new regulations in the jurisdiction of either Party, the Parties will update this Annex.

Cross-referencing 6.7. Where products covered by this Annex are subject also to electrical safety or radio or telecommunication attachment requirements the relevant provisions of the Sectoral Annexes on electrical safety, telecommunication terminal equipment, information technology equipment and radio transmitters will also apply.

Attachment 1 Legislative, regulatory and administrative provisions >TABLE POSITION> Attachment 2 Designating authorities The designating authority for Canada is Industry Canada.

The designating authorities for the European Community are as follows:

Telestyrelsen

Danmarks Elektriske Materielkontrol (DEMKO)

Ministerio de Fomento

Ministerio de Industria y Energża

Bundesministerium fŽr Wissenschaft und Verkehr

Bundesministerium fŽr wirtschaftliche Angelegenheiten

LiikenneministeriŠ/Trafikministeriet

Kauppa- ja teollisuusministeriŠ/Handels- och industriministeriet

Styrelsen fŠr ackreditering och teknisk kontroll (SWEDAC)

1.2. This Annex also sets out procedures for the recognition of: (a) conformity assessment bodies (CABs) in Canada by the European Community (EC); and (b) CABs in the EC by Canada.

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

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

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

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

5.2. During the transition phase, Community CABs will: (a) test products to Canadian requirements; (b) issue a comprehensive testing and evaluation file (i.e. assessment data, reports) for submission by the manufacturer of the tested products to a certification organisation in Canada.

5.3. Canadian certification organisations shall ensure that: (a) they inform the applicant and the Community CAB in a precise and complete manner of any deficiency; (b) they limit any request for additional information or samples to omissions, inconsistencies or variances from the technical regulations or standards; and (c) certification is done on the basis of existing procedures, including the application of their mark.

CABs from the EC will be accredited in accordance with Standards Council of Canada (SCC) criteria for accreditation of certification bodies recognised in Canada and will be issued a certificate of accreditation. The following conditions are deemed to be equivalent to those prescribed criteria: (i) evidence of satisfactory performance in the transition phase; and (ii) accreditation by a European accreditation organisation according to applicable and relevant ISO/IEC guides adapted to Canadian and European conditions for accreditation of certification organisations; and (iii) evidence of procedures for follow-up of certification activities including the identification of a contact point responsible for initiating action with manufacturers of the products when necessary.

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

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

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

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

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

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

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

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

Attachment 1 Legislative, regulatory and administrative requirements and regulatory authorities (re Articles 2(3) and 9(1)) >TABLE POSITION> Attachment 2 Designating authorities The authorities responsible for the designation of conformity assessment bodies under this Agreement are: (a) for the European Community:

Styrelsen fŠr ackreditering och teknisk kontroll (SWEDAC)

SECTORAL ANNEX ON RECREATIONAL CRAFT

SECTION I

Scope and coverage 1.1. This Annex applies to all recreational craft, including personal watercraft, which in the European Community or in Canada are subject to a conformity assessment or approval procedure by an independent conformity assessment or approval body.

1.2. The product coverage shall be as determined by the relevant legislation of each party, which is: (a) for the European Community: recreational craft as defined in Article 1 of Directive 94/25/EC; (b) for Canada: pleasure craft as defined by the Canada Shipping Act, Chapter 1487, Small Vessel Regulations as referenced in Transport Canada's Publication No TP1332.

1.3. Parties agree that mutual recognition will operate under this Annex according to the following arrangements: (a) for evaluation against European Community requirements, conformity assessment bodies designated by Canada will establish certificates of compliance according to the provisions of Directive 94/25/EC. These certificates will be recognised in the European Community without any further assessment of the products to which they relate; (b) for approval according to Canadian requirements, conformity assessment bodies designated by the European Community will certify the product according to the requirements set out in Chapter 1487 of the Canada Shipping Act Small Vessel Regulations, and issue the appropriate compliance plates and other required documentation.

Products so certified may be placed on the Canadian market without undergoing any further approval procedures.

SECTION II

Legislative, regulatory and administrative requirements 2.1. For the European Community:

Directive 94/25/EC of the European Parliament and of the Council of 16 June 1994 on the approximation of the laws, regulations and administrative provisions of the Member States relating to recreational craft.

2.2. For Canada:

Regulatory requirements - The Canada Shipping Act, Chapter 1487, Small Vessel Regulations referenced in Transport Canada's Publication No TP1332 Construction standards for small vessels which includes personal watercraft as defined by and certified to ISO/DIS 13590.

SECTION III

Authorities responsible for designating the conformity assessment bodies as specified by conformity assessment modules 3.1. For the European Community:

Member States administrations or entities as indicated in Attachment 1.

3.2. For Canada:

Canadian coastguard.

SECTION IV

Procedures for designating conformity bodies 4.1. For the purpose of the Annex, each Party will designate competent conformity assessment bodies to carry out conformity assessment and approvals to the requirements of the other Party.

Such designation will be carried out according to the procedures set out in the Mutual Recognition Framework Agreement. A list of designated conformity assessment bodies, together with the products and procedures for which they have been designated, is in Attachment 2.

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

These are: (a) for the European Community, bodies which are notified bodies in accordance with Directive 94/25/EC are deemed to be in compliance with Canadian requirements.

A 'notified body` for the EC is a third party authorised to perform the conformity assessment tasks specified in Directive 94/25/EC, which has been appointed by a Member State from the bodies falling within its jurisdiction. The notified body has the necessary qualifications to meet the requirements laid down in Directive 94/25/EC and has been notified to the Commission and to the other Member States; (b) for Canada, the procedures and criteria for designation of conformity assessment bodies shall comply with the relevant provisions of Directive 94/25/EC.

SECTION V

Transitional arrangement There will be a transitional arrangement of 18 months prior to the operation of this Annex. During this transitional period, the Parties will: (a) exchange information on, and develop greater familiarity with, their respective regulatory requirements; and (b) carry out the policy, legislative and regulatory changes necessary for the provisions of this Annex.

SECTION VI

Additional provisions 6.1. In accordance with the relevant provisions of the Mutual Recognition Framework Agreement, the Parties shall ensure the continued availability of the names of their respective notified bodies or conformity assessment bodies, and will regularly supply details of certifications issued in order to facilitate post-market surveillance.

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

Attachment 1 Designating authorities >TABLE POSITION> Attachment 2 Designated conformity assessment bodies

SECTORAL ANNEX ON GOOD MANUFACTURING PRACTICES (GMP) 1. PURPOSE 1.1. This Mutual Recognition Agreement (MRA) Sectoral Annex on good manufacturing practices (GMP) compliance certification pertaining to medicinal products/drugs has been developed by the European Community (EC) and Canada to: (a) enhance bilateral regulatory cooperation; (b) establish mutual recognition for GMP compliance certification and acceptance of manufacturing authorisations/licences directly issued by the authorities designated equivalent after the successful completion of a confidence building exercise; (c) develop an infrastructure for on-going communications/consultations between Canada, the European Commission, and the regulatory authorities of the EC Member States to enable regulators to determine and maintain the equivalency of their GMP compliance programmes.

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

2.3. The MRA on medicinal products/drug GMP is built on three pillars: (a) the concept of a GMP compliance programme (Appendix 4); (b) a 'two-way` alert system (Appendix 5); (c) a transition period including a confidence building exercise (Appendix 6).

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

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

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

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

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

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

7.2. Confidence building programme At the beginning of the transitional period, the joint sectoral group will elaborate a joint confidence building programme. The implementation of this programme will permit the determination of the capability of each Party's authority to perform GMP compliance certification (guidance provided in Appendix 6).

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

7.4. Administrative provision Medicinal products/drugs from manufacturing sites with a good track record of compliance in the importing Party, and that have been placed on a list of qualified sites, will be exempted from retesting requirements. The list will be developed by the joint sectoral group.

7.5. End of transitional period 7.5.1. At the end of the transitional period, the joint sectoral group will proceed to a joint evaluation of the equivalency and capabilities of the compliance programmes of the participating authorities (Appendix 2).

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

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

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

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

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

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

Contact points will be agreed between both Parties to permit authorities and manufacturers to inform the authorities of the other Party with the appropriate speed in case of quality defect, batch recalls, counterfeiting and other problems concerning quality, which could necessitate additional controls or suspension of the distribution of the product.

8.1.5. Certification of manufacturers At the request of an exporter, an importer or of an authority of the other Party, the authorities responsible for granting certificates of manufacturing authorisations/licences and for the supervision of the manufacture of medicinal products/drugs will certify that the sites used for manufacture and/or control: (a) are appropriately authorised to manufacture and/or control the relevant medicinal product/drug or to carry out the relevant specified operations, (b) are regularly inspected by the authorities, and (c) comply with the GMP requirements recognised as equivalent by the two Parties.

The certificates of manufacturing authorisation/licence will also identify the site(s) of manufacture. A Canadian and a European Community example of such certificates are attached at Appendix 7 for illustrative purposes.

Certificates of manufacturing authorisations/licences will be issued expeditiously, and the time taken should not exceed 30 days. In cases when a new inspection has to be carried out, this period may be extended to 60 days.

8.1.6. Batch certification Each batch exported will be accompanied by a batch certificate issued by the manufacturer ('self certification`) after a full qualitative and quantitative analysis of all active constituents to ensure that the quality of the products complies with the requirements of the marketing authorisation/product approval.

When issuing this certificate, the manufacturer will take into account the provisions of the current WHO certification scheme on the quality of medicinal products/drugs moving in international commerce. This certificate will attest that the batch meets the specifications and has been manufactured in accordance with the relevant marketing authorisation/product approval, detailing the specifications of the product, the analytical methods referenced, the analytical results obtained, and containing a statement that the batch processing and packaging records were reviewed and found in conformity with GMPs.

The batch certificate will be signed by the person responsible for releasing the batch for sale or supply. In the European Community the 'qualified person` is referred to in Article 21 of Directive 75/319/EEC, and in Canada, the nominated person responsible for manufacturing quality control is as specified in the Food and Drug Regulations, Division 2, Section C.02.014 (1).

8.1.7. Fees The regime of inspection/establishment licence fees is determined by the location of the manufacturer. The cost recovery programmes and the fees pertaining to the issuance of manufacturing authorisations/licences in each jurisdiction will remain the responsibility of that jurisdiction.

The Parties shall endeavour to ensure that any fees imposed for services will be cost-oriented and take into account relevant cost factors. If no services are rendered by one Party, fees should not be charged.

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

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

8.2. Information sharing 8.2.1. In accordance with the general provisions of the Annex, the Parties will exchange all information necessary to determine and maintain the equivalence of GMP compliance programmes. In addition, the relevant authorities in Canada and in the EC will keep each other informed of all new technical guidance, inspection procedures, or changes in regulation (these include: guidance documents, publications of references to standards, forms, documents relating to the application of legal requirements). Each Party will consult the other before adopting these changes to ensure the continued equivalency of the GMP compliance programmes. Concerns will be raised to the joint sectoral group.

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

8.3. Two-way alert system 8.3.1. The joint sectoral group will ensure that an efficient and effective 'two-way` alert system is in place at all times. Elements of such a system are described in Appendix 5.

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

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

Contact points are identified in Appendix 5.

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

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

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

Appendix 1 1. List of applicable legislation 1.1. For the European Community:

Directive 65/65/EEC as modified;

Directive 75/319/EEC as modified;

Directive 81/851/EEC as modified;

Directive 91/356/EEC as modified;

Directive 91/412/EEC as modified;

Regulation (EC) No 2309/93;

Directive 92/25/EEC;

Guide to good distribution practice (94/C 63/03);

Current version of the 'Guide to good manufacturing practice`, Volume IV of Rules governing medicinal products in the European Community.

1.2. For Canada:

Food and Drugs Act and Regulations, Health of Animals Act and Regulations for the issuance of permits for materials of animal origin.

APIs are not GMP regulated).

Appendix 2 Authorities For the European Community: >TABLE POSITION> For Canada:

Therapeutic products programme, Health Canada, Ottawa Bureau of Veterinary Drugs, Food Directorate, Health Canada, Ottawa Appendix 3 Joint sectoral group A joint sectoral group (JSG) will be established to manage the confidence building process and to monitor the operations of the MRA thereafter.

The JSG will be co-chaired by a member from each Party and will determine its own composition, ensuring, to as great a degree as possible, consistent membership. The role of the JSG will be to ensure communications with the Joint Committee and to manage the transition period and to monitor the continued implementation of this Annex including, but not limited to:

The JSG will meet as needed to adopt the confidence building working plan, resolve issues, and monitor the progress of the confidence building exercise. The Joint Committee will be kept informed of the agendas and conclusions of meetings as well as on the progress made during the transition period.

Appendix 4 Components of a GMP compliance programme 1. Legislative and regulatory requirements and scope

Appendix 5 Components of a 'two-way` alert programme 1. Documentation

Contact points For the purpose of this agreement, the contact points for any technical question, such as exchange of inspection reports, inspectors training sessions, technical requirements, will be:

Appendix 6 Phases of a confidence building period The determination of the equivalency of the GMP compliance programmes by the joint sectoral group will be designed around the following three phases:

Appendix 7 Certificate of pharmaceutical manufacturer in the framework of the Agreement on mutual recognition between Canada and the European Community, Sectoral Annex on medicinal products GMP inspection and batch certification >START OF GRAPHIC> As requested by the . (*) on . . ./. . ./. . . (date) (reference: . ), the competent authority of . (**) confirms the following:

The company . whose legally registered address is: . has been authorised, under Directive 75/319/EEC (Article 16) and Directive 81/851/EEC (Article 24) transposed in the national legislation of . (**), under the authorisation reference number covering the following site(s) of manufacture (and contract testing laboratories, if any):

From the knowledge gained during inspections of this manufacturer, the latest of which was conducted on . . ./. . ./. . . (date), it is considered that the company complies with the good manufacturing practice requirements referred to in the Agreement on Mutual Recognition between Canada and the European Community. . . ./. . ./. . . (date) For the competent authority . (Name and signature of the officer responsible) (*) Insert exporting or importing firm or Health Canada. (**) Insert European Community Member State or European Community as required. (***) Delete that which does not apply. >END OF GRAPHIC> >REFERENCE TO A GRAPHIC> >REFERENCE TO A GRAPHIC> >START OF GRAPHIC> Health Santł Canada Canada Establishment Licence Licence Number 100001-A Numłro de la licence P R O G R A M M E D E S PRODUITS THÉRAPEUTIQUES THERAPEUTIC PRODUCTS P R O G R A M M E Licence d'łtablissement This licence is issued in accordance with the Food and Drugs Act & Regulations (Division 1A & 2) for the following activities and categories of drugs:

Cette licence est dłlivrłe conformłment š la Loi et aux Rųglements sur les aliments et drogues (titres 1A et 2) pour les activitłs et les catłgories de drogues suivantes:

STERILE / NO / NON STÉRILE Pharmaceutical Prod. pharmaceutique Vaccines Vaccins Blood (3) Sang Schedule D (4) L'annexe D Schedule C (5) L'annexe C

Cette licence est dłlivrłe conformłment š la Loi et aux Rųglements sur les aliments et drogues (titres 1A et 2) pour les activitłs et les catłgories de drogues suivantes:

STERILE / NO / NON STÉRILE Pharmaceutical Prod. pharmaceutique Vaccines Vaccins Blood (3) Sang Schedule D (4) L'annexe D Schedule C (5) L'annexe C

Cette licence est assujettie aux conditions supplłmentaires indiqułes dans le feuillet ci-joint:

Foreign Site Annex / Annexe concernant les sites łtrangers Issued On / Émise le:1998-01-01 MINISTER OF HEALTH MINISTRE DE LA SANTÉ Countersigned: Director General, Therapeutic Products Directorate Contresignł par: Directeur głnłral, Direction des produits thłrapeutiques This licence is the property of the Therapeutic Products Directorate and must be returned upon demand. Cette licence appartient š la direction des produits thłrapeutiques et doit śtre retournłe sur demande. >END OF GRAPHIC> >REFERENCE TO A GRAPHIC> >REFERENCE TO A GRAPHIC> >START OF GRAPHIC> Health Santł Canada Canada Establishment Licence Licence Number 100125-A Numłro de la licence P R O G R A M M E D E S PRODUITS THÉRAPEUTIQUES THERAPEUTIC PRODUCTS P R O G R A M M E Licence d'łtablissement Foreign Site Annex / Annexe concernant les sites łtrangers The following sites are considered to be in GMP Compliance: Les sites suivants sont considłrłs comme łtant conformes aux BPF:

Company Name / Nom de l'entreprise Street/Rue:

City/Ville:

Country/Pays:

Activity/Activite:

FABRICATE / FABRICATION PACKAGE / CONDITIONNEMENT Category/Catłgorie:

PHARMACEUTICAL / MÉDICAMENT Sterile/Stłrile NO / NON >END OF GRAPHIC> SECTORAL ANNEX ON MEDICAL DEVICES 1. PURPOSE 1.1. This Mutual Recognition Agreement (MRA) Annex on conformity assessment and compliance certification pertaining to medical devices has been developed by the European Community and Canada to enhance bilateral medical device regulatory cooperation while facilitating global trade and maintaining the same high standards of health and safety in both jurisdictions.

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

2.2. The product coverage shall be as determined by the relevant legislation of each Party, which is: (a) for the European Community:

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

However, medical devices incorporating tissues of animal origin and where the device is intended to come into contact with intact skin only, will be included within the scope of this Sectoral Annex.

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

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

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

The confidence building programme should include the following actions and activities: (a) the organisation of seminars aiming to inform regulatory/designating authorities and conformity assessment bodies on each Party's regulatory system, procedures and requirements; (b) the conduct of workshops aiming to provide, for regulatory/designating authorities, a common understanding and exchange of information regarding requirements and procedures for the designation and surveillance of conformity assessment bodies (CABs); (c) for scientific technical evaluations, an inter-comparison exercise which would consist of parallel evaluations (double blind evaluations), made by the conformity assessment body in each territory, of a manufacturer's technical submission against the requirements of the intended market for that device, will be undertaken. Full reports and recommendations shall be exchanged for comparison. A certificate of compliance can be issued by the body responsible for the relevant market during this inter-comparison study. The inter-comparison study should take place on a sampling basis comprising a sufficient number of cases spread over the range of different medium to high-risk technologies with the involvement of each Party's regulatory/designating authorities and CABs.

Additional evidence with respect to the competency of regulatory/designating authorities and CABs can be requested by either Party; (d) for quality systems assessments, an inter-comparison exercise which would consist of the participation of regulatory/designating authorities in audits carried out by CABs of the other Party on the basis of requirements of the other Party. Audit management, methods and reports will be compared. The inter-comparison study should take place on a sampling basis comprising a sufficient number of cases spread over the range of different technologies with the involvement of each Party's regulatory/designating authorities and CABs.

Additional evidence with respect to the competency of regulatory/designating authorities or CABs can be requested by either Party; (e) the design, development and testing of a two-way alert system (see guidance in Attachment IV); (f) the establishment of contact points between regulatory/designating authorities and CABs of both Parties; (g) the participation in information exchange meetings with particular focus on conformity assessment and vigilance, including participation in staff training sessions. The exchange of staff will also be encouraged; and (h) during the confidence building programme, where one Party has developed sufficient confidence in the evaluation methods and results of the other, it may at its own discretion, establish the relevant document of compliance permitting market access for its own jurisdiction based on the evaluation reports of the other Party without the full submission.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

For the purpose of this Agreement, the contact points will be: >START OF GRAPHIC> for Canada:. , and for the European Community (the 15 Member States and the Commission). >END OF GRAPHIC> 8. ATTACHMENTS Attachments I and II constitute integral parts of this Annex.

Attachments III, IV and V are general guidelines.

Attachment I Regulatory/designating authorities eligible to participate in this Agreement >TABLE POSITION> Attachment II >TABLE POSITION> Attachment III Phases and elements of a confidence building programme A. REVIEW AND EVALUATION OF ELEMENTS OF CONFORMITY ASSESSMENT (EXCHANGE OF DOCUMENTATION) 1. Legislative and regulatory requirements and scope

B. INTER-COMPARISON EXERCISE

C. DECISION MAKING ON THE SUCCESS OF THE INTER-COMPARISON STUDY

Attachment IV Components of a 'two-way` alert programme 1. Documentation

Attachment V Guidelines: procedures for the designation and monitoring of conformity assessment bodies A. GENERAL REQUIREMENTS AND CONDITIONS 1. Designating authorities shall only designate legally identifiable entities as conformity assessment bodies.

B. SYSTEM TO DETERMINE CONFORMITY ASSESSMENT BODIES' CAPABILITIES 6. The designating authorities may apply the following processes to determine the technical capabilities of conformity assessment bodies. If necessary, a Party will indicate to the designating authority the possible ways to demonstrate capabilities. (a) Accreditation Accreditation shall constitute a presumption of technical capability in relation to the requirements of the other Party when: (i) the accreditation process is conducted in conformance with the relevant international documentation (EN 45000 series or ISO/IEC guides); and either, (ii) the accreditation body participates in mutual recognition arrangements where it is subject to peer evaluation, which involves evaluation by individuals with recognised expertise in the field of the work being evaluated of the capabilities of accreditation bodies and conformity assessment bodies accredited by them, or (iii) the accreditation body, operating under the authority of a designating authority, takes part, in accordance with procedures to be agreed, in comparison programmes and exchanges of technical experience in order to ensure the continued confidence in the technical competence of the accreditation bodies and conformity assessment bodies. Such programmes may include joint assessments, special cooperation programmes or peer evaluation.

When a conformity assessment body is only accredited to evaluate a product, process or service for compliance with particular technical specifications, designation shall be limited to those technical specifications.