Este acuerdo establece las condiciones para que la Comunidad Europea y los Estados Unidos de América reconozcan…

21999A0204(01) 21999A0204(01) Agreement on mutual recognition between the European Community and the United States of America - Joint Declaration Official Journal L 031 , 04/02/1999 P. 0003 - 0080 Dates: of document: 18/05/1998 of effect: 01/12/1998; Entry into force See Art 21 And OJ L 31/99 P. 81 of signature: 18/05/1998; 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 ; United States of America Subject matter: Commercial policy ; External relations ; Technical barriers Directory code: 11404000 EUROVOC descriptor: mutual recognition principle ; EC agreement ;

United States Legal basis:

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

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

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

Amended by:

Adopted by.... 399D0078.......... DP22/6/98 Amended by.... 201D0123(01)...... Amendment ANN from 12/12/2000 Amended by.... 201D0203(02)...... Amendment ANN from 04/12/2000 Amended by.... 201D0813.......... Completion ANN from 16/01/2001 Amended by.... 201D0814.......... Completion ANN from 21/05/2001 Amended by.... 201D0815.......... Completion ANN from 26/06/2001 Amended by.... 201D0816.......... Completion ANN from 17/07/2001 Amended by.... 201D0817.......... Completion ANN from 20/07/2001 Amended by.... 202D0288.......... Completion ANN from 05/10/2001 Amended by.... 202D0289.......... Amendment ANN from 21/11/2001 Amended by.... 202D0290.......... Completion ANN from 20/11/2001 Amended by.... 202D0291.......... Completion ANN from 30/11/2001 Amended by.... 202D0292.......... Completion ANN from 15/01/2002 Amended by.... 202D0293.......... Completion ANN from 12/02/2002 Amended by.... 202D0295.......... Completion ANN from 22/03/2002 Amended by.... 202D0872.......... Amendment ANN from 16/04/2002 Amended by.... 202D0873.......... Completion ANN from 06/05/2002 Amended by.... 202D0874.......... Completion ANN from 25/07/2002 Amended by.... 202D0875.......... Completion ANN from 28/08/2002 Amended by.... 202D0876.......... Completion ANN from 20/09/2002 Amended by.... 203D0108.......... Amendment ANN from 20/11/2002 Amended by.... 203D0109.......... Amendment ANN from 22/01/2003 Amended by.... 203D0110.......... Amendment ANN from 05/02/2003 Amended by.... 203D0648.......... Completion ANN from 03/09/2003 Amended by.... 203D0649.......... Amendment ANN from 03/09/2003 Amended by.... 204D0702.......... Completion ANN from 19/07/2004 Subsequent related instruments:

Relation...... 202D0294..........

AGREEMENT on mutual recognition between the European Community and the United States of America The EUROPEAN COMMUNITY, and THE UNITED STATES OF AMERICA, hereinafter referred to as 'the Parties`, CONSIDERING the traditional links of friendship that exist between the United States of America (US) and the European Community (EC);

DESIRING to facilitate bilateral trade between them;

RECOGNISING that mutual recognition of conformity assessment activities is an important means of enhancing market access between the Parties;

RECOGNISING that an agreement providing for mutual recognition of conformity assessment activities is of particular interest to small and medium-sized businesses in the US and the EC;

RECOGNISING that any such mutual recognition also requires confidence in the continued reliability of the other Party's conformity assessments;

RECOGNISING the importance of maintaining each Party's high levels of health, safety, environmental and consumer protection;

RECOGNISING that mutual recognition agreements can positively contribute in encouraging greater international harmonisation of standards;

NOTING that this Agreement is not intended to displace private sector bilateral and multilateral arrangements among conformity assessment bodies or to affect regulatory regimes allowing for manufacturers' self-assessments and declarations of conformity;

BEARING IN MIND that the Agreement on Technical Barriers to Trade, an agreement annexed to the Agreement establishing the World Trade Organization (WTO), imposes obligations on the Parties as Contracting Parties to the WTO, and encourages such Contracting Parties to enter into negotiations for the conclusion of agreements for the mutual recognition of results of each other's conformity assessment;

RECOGNISING that any such mutual recognition needs to offer an assurance of conformity with applicable technical regulations or standards equivalent to the assurance offered by the Party's own procedures;

RECOGNISING the need to conclude an Agreement on Mutual Recognition (MRA) in the field of conformity assessment with sectoral annexes; and BEARING in mind the respective commitments of the Parties under bilateral, regional and multilateral environment, health, safety and consumer protection agreements.

HAVE AGREED AS FOLLOWS:

Article 1Definitions

Article 2Purpose of the Agreement

This Agreement specifies the conditions by which each Party will accept or recognise results of conformity assessment procedures, produced by the other Party's conformity assessment bodies or authorities, in assessing conformity to the importing Party's requirements, as specified on a sector-specific basis in the Sectoral Annexes, and to provide for other related cooperative activities. The objective of such mutual recognition is to provide effective market access throughout the territories of the Parties with regard to conformity assessment for all products covered under this Agreement. If any obstacles to such access arise, consultations will promptly be held. In the absence of a satisfactory outcome of such consultations, the Party alleging its market access has been denied, may, within 90 days of such consultation, invoke its right to terminate the Agreement in accordance with Article 21.

Article 3General obligations

Article 4General coverage of the Agreement

Article 5Transitional arrangements

The Parties agree to implement the transitional commitments on confidence building as specified in the Sectoral Annexes.

Article 6Designating Authorities

The Parties shall ensure that the Designating Authorities specified in the Sectoral Annexes have the power and competence in their respective territories to carry out decisions under this Agreement to designate, monitor, suspend, remove suspension of, or withdraw conformity assessment bodies.

Article 7Designation and listing procedures

The following procedures shall apply with regard to the designation of conformity assessment bodies and the inclusion of such bodies in the list of conformity assessment bodies in a Sectoral Annex: (a) The Designating Authority identified in a Sectoral Annex shall designate conformity assessment bodies in accordance with the procedures and criteria set forth in that Sectoral Annex; (b) A Party proposing to add a conformity assessment body to the list of such bodies in a Sectoral Annex shall forward its proposal of one or more designated conformity assessment bodies in writing to the other Party with a view to a decision by the Joint Committee; (c) Within 60 days following receipt of the proposal, the other Party shall indicate its position regarding either its confirmation or its opposition. Upon confirmation, the inclusion in the Sectoral Annex of the proposed conformity assessment body or bodies shall take effect; and (d) In the event that the other Party contests on the basis of documented evidence the technical competence or compliance of a proposed conformity assessment body, or indicates in writing that it requires an additional 30 days to more fully verify such evidence, such conformity assessment body shall not be included on the list of conformity assessment bodies in the applicable Sectoral Annex. In this instance, the Joint Committee may decide that the body concerned be verified. After the completion of such verification, the proposal to list the conformity assessment body in the Sectoral Annex may be resubmitted to the other Party.

Article 8Suspension of listed conformity assessment bodies

The following procedures shall apply with regard to the suspension of a conformity assessment body listed in a Sectoral Annex: (a) A Party shall notify the other Party of its contestation of the technical competence or compliance of a conformity assessment body listed in a Sectoral Annex and the contesting Party's intent to suspend such conformity assessment body. Such contestation shall be exercised when justified in an objective and reasoned manner in writing to the other Party; (b) The conformity assessment body shall be given prompt notice by the other Party and an opportunity to present information in order to refute the contestation or to correct the deficiencies which form the basis of the contestation; (c) Any such contestation shall be discussed between the Parties in the relevant Joint Sectoral Committee. If there is no Joint Sectoral Committee, the contesting Party shall refer the matter directly to the Joint Committee. If agreement to suspend is reached by the Joint Sectoral Committee or, if there is no Joint Sectoral Committee, by the Joint Committee, the conformity assessment body shall be suspended; (d) Where the Joint Sectoral Committee or Joint Committee decides that verification of technical competence or compliance is required, it shall normally be carried out in a timely manner by the Party in whose territory the body in question is located, but may be carried out jointly by the Parties in justified cases; (e) If the matter has not been resolved by the Joint Sectoral Committee within 10 days of the notice of contestation, the matter shall be referred to the Joint Committee for a decision. If there is no Joint Sectoral Committee, the matter shall be referred directly to the Joint Committee. If no decision is reached by the Joint Committee within 10 days of the referral to it, the conformity assessment body shall be suspended upon the request of the contesting Party; (f) Upon the suspension of a conformity assessment body listed in a Sectoral Annex, a Party is no longer obligated to accept or recognise the results of conformity assessment procedures performed by that conformity assessment body subsequent to suspension. A Party shall continue to accept the results of conformity assessment procedures performed by that conformity assessment body prior to suspension, unless a Regulatory Authority of the Party decides otherwise based on health, safety or environmental considerations or failure to satisfy other requirements within the scope of the applicable Sectoral Annex; and (g) The suspension shall remain in effect until agreement has been

reached by the Parties upon the future status of that body.

Article 9Withdrawal of listed conformity assessment bodies

The following procedures shall apply with regard to the withdrawal from a Sectoral Annex of a conformity assessment body: (a) A Party proposing to withdraw a conformity assessment body listed in a Sectoral Annex shall forward its proposal in writing to the other Party; (b) Such conformity assessment body shall be promptly notified by the other Party and shall be provided a period of at least 30 days from receipt to provide information in order to refute or to correct the deficiencies which form the basis of the proposed withdrawal; (c) Within 60 days following receipt of the proposal, the other Party shall indicate its position regarding either its confirmation or its opposition. Upon confirmation, the withdrawal from the list in the Sectoral Annex of the conformity assessment body shall take effect; (d) In the event the other Party opposes the proposal to withdraw by supporting the technical competence and compliance of the conformity assessment body, the conformity assessment body shall not at that time be withdrawn from the list of conformity assessment bodies in the applicable Sectoral Annex. In this instance, the Joint Sectoral Committee or the Joint Committee may decide to carry out a joint verification of the body concerned. After the completion of such verification, the proposal for withdrawal of the conformity assessment body may be resubmitted to the other Party; and (e) Subsequent to the withdrawal of a conformity assessment body listed in a Sectoral Annex, a Party shall continue to accept the results of conformity assessment procedures performed by that conformity assessment body prior to withdrawal, unless a Regulatory Authority of the Party decides otherwise based on health, safety and environmental considerations or failure to satisfy other requirements within the scope of the applicable Sectoral Annex.

Article 10Monitoring of conformity assessment bodies

The following shall apply with regard to the monitoring of conformity assessment bodies listed in a Sectoral Annex: (a) Designating Authorities shall assure that their conformity assessment bodies listed in a Sectoral Annex are capable and remain capable of properly assessing conformity of products or processes, as applicable, and as covered in the applicable Sectoral Annex. In this regard, Designating Authorities shall maintain, or cause to maintain, ongoing surveillance over their conformity assessment bodies by means of regular audit or assessment; (b) The Parties undertake to compare methods used to verify that the conformity assessment bodies listed in the Sectoral Annexes comply with the relevant requirements of the Sectoral Annexes. Existing systems for the evaluation of conformity assessment bodies may be used as part of such comparison procedures; (c) Designating Authorities shall consult as necessary with their counterparts, to ensure the maintenance of confidence in conformity assessment procedures. With the consent of both Parties, this consultation may include joint participation in audits/inspections related to conformity assessment activities or other assessments of conformity assessment bodies listed in a Sectoral Annex; and; (d) Designating Authorities shall consult, as necessary, with the relevant Regulatory Authorities of the other Party to ensure that all technical requirements are identified and are satisfactorily addressed.

Article 11Conformity assessment bodies

Each Party recognises that the conformity assessment bodies listed in the Sectoral Annexes fulfil the conditions of eligibility to assess conformity in relation to its requirements as specified in the Sectoral Annexes. The Parties shall specify the scope of the conformity assessment procedures for which such bodies are listed.

Article 12Exchange of information

Where considerations of safety, health or environmental protection require more urgent action a Party shall notify the other Party as soon as practicable.

Article 13Sectoral contact points

Each Party shall appoint and confirm in writing contact points to be responsible for activities under each Sectoral Annex.

Article 14Joint Committee of the Parties

Article 15Preservation of regulatory authority

Article 16Suspension of recognition obligations

Either Party may suspend its obligations under a Sectoral Annex, in whole or in part, if: (a) a Party suffers a loss of market access for the Party's products within the scope of the Sectoral Annex as a result of the failure of the other Party to fulfil its obligations under the Agreement; (b) the adoption of new or additional conformity assessment requirements as referenced in Article 14(5) results in a loss of market access for the Party's products within the scope of the Sectoral Annex because conformity assessment bodies designated by the Party in order to meet such requirements have not been recognized by the Party implementing the requirements; or; (c) the other Party fails to maintain legal and regulatory authorities capable of implementing the provisions of this Agreement.

Article 17Confidentiality

Article 18Fees

Each Party shall endeavour to ensure that fees imposed for services under this Agreement shall be commensurate with the services provided. Each Party shall ensure that, for the sectors and conformity assessment procedures covered under this Agreement, it shall charge no fees with respect to conformity assessment services provided by the other Party.

Article 19Agreements with other countries

Except where there is written agreement between the Parties, obligations contained in mutual recognition agreements concluded by either Party with a party not a signatory to this Agreement (a third party) shall have no force and effect with regard to the other Party in terms of acceptance of the results of conformity assessment procedures in the third party.

Article 20Territorial application

This Agreement 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 the United States.

Article 21Entry into force, amendment and termination

Failing such consensus, the Agreement shall terminate at the end of six months from the date of notice.

Article 22Final provisions

This Agreement and the Sectoral Annexes are drawn up in two original in the Danish, Dutch, English, Finnish, French, German, Greek, Italian, Portuguese, Spanish and Swedish languages, each text being equally authentic. In the event of inconsistencies of interpretation, the English text shall be determinative.

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

Udfördiget i London den attende maj nitten hundrede og otteoghalvfems.

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

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

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

Fatto a Londra, addü diciotto maggio millenovecentonovantotto.

Gedaan te Londen, de achttiende mei negentienhonderd achtennegentig.

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

Tehty Lontoossa kahdeksantenatoista pōivōnō toukokuuta vuonna tuhatyhdeksōnsataayhdeksōnkymmentōkahdeksan.

Som skedde i London den artonde 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 los Estados Unidos de Amłrica For Amerikas Forenede Stater FŽr die Vereinigten Staaten von Amerika Ćłń ĮłĖ ĒżųüążõĖ Š˙ūłĮõčõĖ Į÷Ė ĮüõęłśČĖ For the United States of America Pour les États-Unis d'Amłrique Per gli Stati Uniti d'America Voor de Verenigde Staten van Amerika Pelos Estados Unidos da Amłrica Amerikan yhdysvaltojen puolesta Põ Amerikas fŠrenta staternas vōgnar >REFERENCE TO A GRAPHIC> SECTORAL ANNEX FOR TELECOMMUNICATION EQUIPMENT PREAMBLE This Annex constitutes a Sectoral Annex to the Agreement on Mutual Recognition of Conformity Assessment between the United States and the European Community.

SECTION I

LEGISLATIVE, REGULATORY AND ADMINISTRATIVE PROVISIONS >TABLE POSITION>

SECTION II

SCOPE AND COVERAGE 1. This Sectoral Annex shall apply to equipment, interfaces, and services subject to Section I. In general terms the provisions of this Sectoral Annex shall apply to the following types of telecommunication terminal equipment, satellite terminal equipment, radio transmitters, and information technology equipment: (a) equipment intended for connection to the public telecommunications network in order to send, process or receive information, whether the equipment is to be connected directly to the 'termination` of the network or to inter-work with such a network, being connected directly or indirectly to the termination point. The system of connection may be wire, radio, optical or other electro-magnetic means; (b) equipment capable of being connected to a public telecommunications network even if it is not its intended purpose, including information technology equipment having a communication port; and (c) all radio transmitters subject to an equipment authorisation procedure by either Party.

SECTION III

CONFORMITY ASSESSMENT PROCEDURES FOR TELECOMMUNICATION EQUIPMENT 1. Description of Mutual Recognition Obligations In accordance with the provisions of the Agreement, the result of the conformity assessment procedures produced by a Party's conformity assessment bodies listed in Section V shall be recognised by the Regulatory Authorities of the other Party without any further conformity assessment of the products, pursuant to Section I.

Section V, are authorised to perform the following procedures with

regard to the importing Party's technical requirements for telecommunication terminal, satellite terminal equipment, radio transmitters or information technology equipment: (a) testing and issuing of test reports; (b) issuing certificates of conformity to the requirements of the laws and regulations applicable in the territories of the Parties for products covered under this Sectoral Annex; and (c) performing quality assurance certification pursuant to Directive 98/13/EC.

SECTION IV

AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V >TABLE POSITION>

SECTION V

CONFORMITY ASSESSMENT BODIES >TABLE POSITION>

SECTION VI

DESIGNATING, LISTING, SUSPENDING, WITHDRAWING AND MONITORING CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V >TABLE POSITION>

SECTION VII

ADDITIONAL PROVISIONS 1. Sub-contracting 1.1. Any sub-contracting by conformity assessment bodies shall be in accordance with the sub-contracting requirements of the other Party.

Notwithstanding the use of sub-contracting, the final results of conformity assessment remain the full responsibility of the listed conformity assessment body. In the EC, these requirements are described in Council Decision 93/465/EEC.

1.2. The conformity assessment bodies shall record and retain details of their investigation of the competence and compliance of their subcontractors and maintain a register of all sub-contracting.

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

2.2. Nothing in this Sectoral Annex shall prevent the Parties from removing products from the market that do not in fact conform to the requirements for approval.

2.3. The Parties agree that border inspections and checks of products which have been certified, labelled or marked as conforming with the importing Party's requirements specified in Section I shall be completed as expeditiously as possible. With regard to any inspections related to internal movement within their respective territories, the Parties agree that these shall be completed in no less a favourable manner than for like domestic goods.

3.2. The JSC consists of representatives of the US and the EC for telecommunications and EMC. JSC representatives may each invite manufacturers and other entities as deemed necessary. The representatives for the US shall have one vote in the JSC. The representatives of the EC shall have one vote in the JSC. Decisions of the JSC shall be made by unanimous consent. In the event of disagreement either the US or EC representative may raise the matter in the Joint Committee.

3.3. The JSC may address any matter related to the effective functioning of this Sectoral Annex, including: (a) providing a forum for discussion of issues and resolving problems that may arise concerning the implementation of this Sectoral Annex; (b) developing a mechanism for ensuring consistency of interpretations of legislation, regulations, standards, and conformity assessment procedures; (c) advising the Parties on matters relating to this Sectoral Annex; and (d) providing guidance and, if necessary, developing guidelines during the transitional period to facilitate the successful completion of the transitional period.

SECTION VIII

TRANSITIONAL ARRANGEMENT 1. There shall be a transitional period of 24 months.

Appendix 1 Lists of acronyms and glossary >TABLE POSITION> SECTORAL ANNEX FOR ELECTROMAGNETIC COMPATIBILITY (EMC) PREAMBLE This Annex constitutes a Sectoral Annex to the Agreement on Mutual Recognition of Conformity Assessment between the United States and the European Community.

SECTION I

LEGISLATIVE, REGULATORY AND ADMINISTRATIVE PROVISIONS >TABLE POSITION>

SECTION II

SCOPE AND COVERAGE >TABLE POSITION>

SECTION III

CONFORMITY ASSESSMENT PROCEDURES FOR EQUIPMENT IDENTIFIED IN SECTION II 1. Description of Mutual Recognition Obligations In accordance with the provisions of the Agreement, the results of the conformity assessment procedures produced by a Party's conformity assessment bodies listed in Section V, shall be recognised by the Regulatory Authorities of the other Party without any further conformity assessment of the products, pursuant to

Section I.

Section V, are authorised to perform the following procedures with

regard to the importing Party's technical requirements for equipment identified in Section II: (a) testing and issuing of the test reports, (b) issuing certificates of conformity to the requirements of the laws and regulations applicable in the territories of the Parties for products covered under this Sectoral Annex.

SECTION IV

AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V >TABLE POSITION>

SECTION V

CONFORMITY ASSESSMENT BODIES >TABLE POSITION>

SECTION VI

DESIGNATING, LISTING, SUSPENDING, WITHDRAWING AND MONITORING CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V >TABLE POSITION>

SECTION VII

ADDITIONAL PROVISIONS 1. Sub-contracting 1.1. Any sub-contracting by conformity assessment bodies shall be in accordance with the sub-contracting requirements of the other Party.

Notwithstanding the use of sub-contracting, the final results of conformity assessment remain the full responsibility of the listed conformity assessment body. In the EC, these requirements are described in Council Directive 93/465/EEC.

1.2. The conformity assessment bodies shall record and retain details of its investigation of the competence and compliance of its sub-contractors and maintain a register of all sub-contracting.

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

2.2. Nothing in this Sectoral Annex shall prevent the Parties from removing products from the market that do not in fact conform to the requirements for approval.

2.3. The Parties agree that border inspections and checks of products which have been certified, labeled or marked as conformity with the importing Party's requirements specified in Section I shall be completed as expeditiously as possible. With regard to any inspections related to internal movement within their respective territories, the Parties agree that these shall be completed in no less a favorable manner than for like domestic goods.

3.2. The JSC consists of representatives of the US and the EC for telecommunications and EMC. JSC representatives may each invite manufacturers and other entities as deemed necessary. The representatives for the US shall one vote in the JSC. The representatives of the EC shall have one vote in the JSC. Decisions of the JSC shall be made by unanimous consent. In the event of disagreement either the US or EC representatives may raise the matter in the Joint Committee.

3.3. The JSC may address any matter related to the effective functioning of this Sectoral Annex, including: (a) providing a forum for discussion of issues and resolving problems that may arise concerning the implementation of this Sectoral Annex; (b) developing a mechanism for ensuring consistency of interpretations of legislation, regulations, standards, and conformity assessment procedures; (c) advising the Parties on matters relating to this Sectoral Annex; (d) providing guidance and, if necessary, developing guidelines during the transitional period to facilitate the successful completion of the transitional period.

SECTION VIII

TRANSITIONAL ARRANGEMENT 1. There shall a transitional period of 24 months.

SECTORAL ANNEX FOR ELECTRICAL SAFETY PREAMBLE This Annex constitutes a Sectoral Annex to the Agreement on Mutual Recognition between the United States and the European Community.

SECTION I

LEGISLATIVE, REGULATORY AND ADMINISTRATIVE PROVISIONS >TABLE POSITION>

SECTION II

SCOPE AND COVERAGE >TABLE POSITION>

SECTION III

DESCRIPTION OF MUTUAL RECOGNITION OBLIGATIONS In accordance with the provisions of the Agreement, EC conformity assessment bodies listed in Section V of this Annex shall be recognised to test, certify and mark products within the scope of their Nationally Recognised Testing Laboratory (NRTL) recognition for assessing conformity to US requirements.

With regard to US conformity assessment bodies listed in Section V of this Annex, in the event of a challenge within the European Community under Article 8(2) of Council Directive 73/23/EEC of 19 February 1973, test reports issued by such conformity assessment bodies shall be accepted by the European Community Authorities in the same way that reports from European Community notified bodies are accepted. That is, (listed conformity assessment bodies) in the US shall be recognised under Article 11 of Council Directive 73/23/EEC as 'bodies which may make a report in accordance with

Article 8`

SECTION IV

AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V >TABLE POSITION>

SECTION V

CONFORMITY ASSESSMENT BODIES >TABLE POSITION>

SECTION VI

DESIGNATING, LISTING, SUSPENDING AND WITHDRAWING CONFORMITY ASSESSMENT BODIES >TABLE POSITION>

SECTION VII

JOINT SECTORAL COMMITTEE FOR ELECTRICAL SAFETY 1. The Joint Sectoral Committee for Electrical Safety (JSC/ES) consists of representatives of the US and the EC. OSHA shall represent the US on this Joint Sectoral Committee. The EC and OSHA may invite the participation of others as deemed necessary. Each Party shall have one vote and decisions shall be made by unanimous consent, unless otherwise specified herein. The Joint Sectoral Committee shall determine its own rules of procedure.

SECTORAL ANNEX FOR RECREATIONAL CRAFT PREAMBLE This Annex constitutes a Sectoral Annex to the Agreement on Mutual Recognition between the United States and the European Community.

The purpose of this Sectoral Annex is to establish a framework to accept certificates of conformity issued in the territory of one Party in accordance with the regulatory requirements of the other Party as referenced in this Sectoral Annex.

To facilitate that purpose, a transitional period of 18 months is arranged to build confidence as defined in this Sectoral Annex,

Section VI.

SECTION I

LEGISLATIVE, REGULATORY, AND ADMINISTRATIVE REQUIREMENTS 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.

46 USC Chapter 43, 33 CFR 81, 84, 159, 179, 181, 183 and 46 CFR 58.

SECTION II

SCOPE AND COVERAGE 1. This Sectoral Annex applies to all recreational craft which in the European Community or the United States are subject to conformity assessment by a conformity assessment body or an approval procedure, as applicable, before being put on the market.

Recreational craft as defined in Directive 94/25/EC; (b) for the United States:

Any product falling under the scope of 46 USC Chapter 43, 33 CFR 81, 84, 159, 179, 181, 183 and 46 CFR 58.

SECTION III

AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES >TABLE POSITION>

SECTION IV

DESIGNATING, LISTING, SUSPENDING AND WITHDRAWING CONFORMITY ASSESSMENT BODIES 1. For the purpose of this Sectoral Annex, each Party shall designate competent conformity assessment bodies to carry out conformity assessment and approval to the requirements of the other Party. Such designation shall be carried out according to the procedures set out in Article 7 of the Agreement. A list of conformity assessment bodies together with the products and procedures for which they have been listed, is set out in Section V below.

SECTION V

CONFORMITY ASSESSMENT BODIES >TABLE POSITION>

SECTION VI

TRANSITIONAL ARRANGEMENT 1. There shall be a transitional period of 18 months prior to the operations of this Sectoral Annex.

SECTION VII

ADDITIONAL PROVISIONS 1. In accordance with the relevant provisions of the Agreement, the Parties shall ensure the continued availability of the names of their respective notified bodies or conformity assessment bodies, and shall regularly supply details of certifications issued in order to facilitate post market surveillance.

SECTION VIII

DEFINITIONS 'Notified Body` means 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 requirements laid down in Directive 94/25/EC and has been notified to the Commission and to the other Member States.

SECTORAL ANNEX FOR PHARMACEUTICAL GOOD MANUFACTURING PRACTICES (GMPs) PREAMBLE This Annex constitutes a Sectoral Annex to the Agreement on Mutual Recognition between the United States and the European Community.

CHAPTER 1 DEFINITIONS, PURPOSE, SCOPE AND COVERAGE

Article 1Definitions

GMPs are that part of quality assurance which ensures that products are consistently produced and controlled to quality standards. For the purpose of this Annex, GMPs include therefore the system whereby the manufacturer receives the specifications of the product and/or process from the Marketing Authorisation/Product Authorisation or License holder or applicant and ensures the product is made in compliance with its specifications (Qualified Person certification in the EC).

Article 2Purpose

The provisions of this Annex govern the exchange between the Parties and normal endorsement by the receiving authority of official Good Manufacturing Practices (GMPs) inspection reports after a transitional period aimed at determination of the equivalence of the regulatory systems of the Parties, which is the cornerstone of this Annex.

Article 3Scope

The provisions of this Annex shall apply to pharmaceutical inspections carried out in the United States and Member States of the European Community before products are marketed (hereafter referred to as 'pre-approval inspections` as well as during their marketing (hereafter referred to as 'post-approval inspections`).

Appendix 1 names the laws, regulations and administrative provisions governing these inspections and the GMPs requirements.

Appendix 2 lists the authorities participating in activities under this Annex.

Articles 6, 7, 8, 9, 10 and 11 of the Agreement do not apply to this Annex.

Article 4Product coverage

These provisions will apply to medicinal products for human or animal use, intermediates and starting materials (as referred to in the EC) and to drugs for human or animal use, biological products for human use, and active pharmaceutical ingredients (as referred to in the United States), only to the extent they are regulated by the authorities of both Parties as listed in Appendix 2.

Human blood, human plasma, human tissues and organs, and veterinary immunologicals are excluded from the scope of this Annex. Human plasma derivatives (such as immunoglobulins and albumin), investigational medicinal products/new drugs, human radiopharmaceuticals and medicinal gases are also excluded during the transition phase, their situation will be reconsidered at the end of the transition period. Products regulated by the Center for Biologics Evaluation and Research as devices are not covered under this Annex.

Appendix 3 contains an indicative list of products covered by this Annex.

CHAPTER 2 TRANSITION PERIOD

Article 5Length of transition period

A three-year transition period will start immediately after the effective date of the Agreement.

Article 6Equivalence assessment

Article 7Participation in the equivalence assessment and

determination The authorities listed in Appendix 2 will actively participate in these programs to build a sufficient body of evidence for their equivalence determination. Both parties will exercise good faith efforts to complete equivalence assessment as expeditiously as possible to the extent the resources of the authorities allow.

Article 8Other transition activities

As soon as possible, the authorities will jointly determine the essential information which must be present in inspection reports and will cooperate to develop mutually agreed inspection report format(s).

CHAPTER 3 END OF TRANSITION PERIOD

Article 9Equivalence determination

Equivalence is established by having in place regulatory systems covering the criteria referred to in Appendix 4, and a demonstrated pattern of consistent performance in accordance with these criteria.

A list of authorities determined as equivalent shall be agreed to by the Joint Sectoral Committee at the end of the transition period, with reference to any limitation in terms of inspection type (e. g. post-approval or pre-approval) or product classes or processes.

The Parties will document insufficient evidence of equivalence lack of opportunity to assess equivalence or a determination of non-equivalence, in sufficient detail to allow the authority being assessed to know how to attain equivalence.

Article 10Authorities not currently listed as equivalent

Authorities not currently listed as equivalent, or not equivalent for certain types of inspections, product classes or processes may apply for reconsideration of their status once the necessary corrective measures have been taken or additional experience is gained.

CHAPTER 4 OPERATIONAL PERIOD

Article 11Start of the operational period

The operational period shall start at the end of the transition period and its provisions apply to inspection reports generated by authorities listed as equivalent for the inspections performed in their territory.

In addition, when an authority is not listed as equivalent based on adequate experience gained during the transition period, the Food and Drug Administration (FDA) will accept for normal endorsement (as provided in Article 12) inspection reports generated as a result of inspections conducted jointly by that authority on its territory and another authority listed as equivalent, provided that the authority of the Member State in which the inspection is performed can guarantee enforcement of the findings of the inspection report and require that corrective measures be taken when necessary. FDA has the option to participate in these inspections, and based on experience gained during the transition period, the Parties will agree on procedures for exercising this option.

In the EC, the qualified person will be relieved of responsibility for carrying out the controls laid down in Article 22 paragraph 1(b) of Council Directive 75/319/EEC provided that these controls have been carried out in the United States and that each batch/lot is accompanied by a batch certificate (in accordance with the WHO certification scheme on the quality of medicinal products) issued by the manufacturer certifying that the product complies with requirements of the marketing authorisation and signed by the person responsible for releasing the batch/lot.

Article 12Nature of recognition of inspection reports

Inspection reports (containing information as established under

Article 8), including a GMP compliance assessment, prepared by

authorities listed as equivalent, will be provided to the authority of the importing Party. Based on the determination of equivalence in light of the experience gained, these inspection reports will normally be endorsed by the authority of the importing Party, except under specific and delineated circumstances. Examples of such circumstances include indications of material inconsistencies or inadequacies in an inspection report, quality defects identified in the post-market surveillance or other specific evidence of serious concern in relation to product quality or consumer safety. In such cases, the authority of the importing Party may request clarification from the authority of the exporting Party which may lead to a request for re-inspection. The authorities will endeavour to respond to requests for clarification in a timely manner.

Where divergence is not clarified in this process, an authority of the importing country may carry out an inspection of the production facility.

Article 13Transmission of post-approval inspection reports

Post-approval GMP inspection reports concerning products covered by this Annex will be transmitted to the authority of the importing country within 60 calendar days of the request. Should a new inspection be needed, the inspection report will be transmitted within 90 calendar days of the request.

Article 14Transmission of pre-approval inspection reports

A preliminary notification that an inspection may have to take place will be made as soon as possible.

Within 15 calendar days, the relevant authority will acknowledge receipt of the request and confirm its ability to carry out the inspection. In the EC, requests will be sent directly to the relevant authority, with a copy to the European Agency for the Evaluation of Medicinal Products (EMEA). If the authority receiving the request cannot carry out the inspection as requested, the requesting authority shall have the right to conduct the inspection.

Reports of pre-approval inspections will be sent within 45 calendar days of the request that transmitted the appropriate information and detailed the precise issued to be addressed during the inspection. A shorter time may be necessary in exceptional cases and these will be described in the request.

Article 15Monitoring continued equivalence

Monitoring activities for the purpose of maintaining equivalence shall include review of the exchange of inspection reports and their quality and timeliness; performance of a limited number of joint inspections and the conduct of common training sessions.

Article 16Suspension

Each Party has the right to contest the equivalence of an authority.

This right will be exercised in an objective and reasoned manner in writing to the other Party. The issue shall be discussed in the Joint Sectoral Committee promptly upon such notification. Where the JSC determines that verification of equivalence is required, it may be carried out jointly by the Parties in a timely manner, pursuant to Article 6.

Efforts will be made by the Joint Sectoral Committee to reach unanimous consent on the appropriate action. If agreement to suspend is reached in the Joint Sectoral Committee, an authority may be suspended immediately thereafter. If no agreement is reached in the Joint Sectoral Committee, the matter is referred to the Joint Committee. If no unanimous consent is reached within 30 days after such notification, the contested authority will be suspended.

Upon the suspension of an authority previously listed as equivalent, a Party is no longer obligated to endorse normally the inspection reports of the suspended authority. A Party shall continue to endorse normally the inspection reports of that authority prior to suspension, unless the authority of the receiving party decides otherwise based on health or safety considerations. The suspension will remain in effect until unanimous consent has been reached by the Parties on the future status of that authority.

CHAPTER 5 JOINT SECTORAL COMMITTEE

Article 17Role and composition of the Joint Sectoral Committee

A Joint Sectoral Committee is set up to monitor the activities under both the transitional and operational phases of this Annex.

The Committee will be co-chaired by a representative of FDA for the U.S. and a representative of the EC who each will have one vote.

Decisions will be taken by unanimous consent.

The Joint Sectoral Committee's functions will include:

The Joint Sectoral Committee shall meet at the request of either Party and, unless the co-chairs otherwise agree, at least once each year. The Joint Committee will be kept informed of the agenda and conclusions of meetings of the Joint Sectoral Committee.

CHAPTER 6 INFORMATION EXCHANGE

Article 18Regulatory collaboration

The Parties and authorities shall inform and consult one another, as permitted by law, on proposals to introduce new controls or to change existing technical regulations or inspection procedures and to provide the opportunity to comment on such proposals.

The Parties shall notify each other in writing of any changes to Appendix 2.

Article 19Information relating to quality aspects

The authorities will establish an appropriate means of exchanging information on any confirmed problem reports, corrective actions, recalls, rejected import consignments and other regulatory and enforcement problems for products subject to this Annex.

Article 20Alert System

The details of an alert system will be developed during the transitional period. The system will be maintained in place at all times. Elements to be considered in developing such a system are described in Appendix 5.

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

CHAPTER 7 SAFEGUARD CLAUSE

Article 21Each Party recognises that the importing country has a right to

fulfil its legal responsibilities by taking actions necessary to ensure the protection of human and animal health at the level of protection it deems appropriate. This includes the suspension of the distribution, product detention at the border of the importing country, withdrawal of the batches and any request for additional information or inspection as provided in Article 12.

Appendix 1 List of applicable laws, regulations and administrative provisions For the European Community:

Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products, as extended, widened and amended.

Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products, as extended, widened and amended.

Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products, as widened and amended.

Council Directive 91/356/EEC of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use.

Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products.

Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products.

Council Directive 92/25/EEC of 31 March 1992 on the wholesale distribution of medicinal products for human use.

Guide to Good Distribution Practice (94/C 63/03).

Current version of the Guide to Good Manufacturing Practice, Rules Governing Medicinal Products in the European Community, Volume IV.

For the United States:

Relevant sections of the United States Federal Food, Drug, and Cosmetic Act and the United States Public Health Service Act.

Relevant sections of Title 21, United States Code of Federal Regulations (CFR) Parts 1-99, Parts 200-299, Parts 500-599, and Parts 600-799.

Relevant sections of the FDA Investigations Operations Manual, the FDA Regulatory Procedures Manual, the FDA Compliance Policy Guidance Manual, the FDA Compliance Program Guidance Manual, and other FDA guidances.

Appendix 2 List of Authorities UNITED STATES:

In the United States, the regulatory authority is the Food and Drug Administration.

EUROPEAN COMMUNITY:

In the European Community, the regulatory authorities are the following: >TABLE POSITION> Appendix 3 Indicative list of Products covered by the Sectoral Annex Recognising that precise definitions of medicinal products and drugs are to be found in the legislation referred to above, an indicative list of products covered by the agreement is given below:

Appendix 4 Criteria for Assessing Equivalence for Post- and Pre-Approval I. Legal/Regulatory authority and structures and procedures providing for post- and pre-approval:

A. Appropriate statutory mandate and jurisdiction.

B. Ability to issue and update binding requirements and GMPs and guidance documents.

C. Authority to make inspections, review and copy documents, and to take samples and collect other evidence.

D. Ability to enforce requirements and to remove products found in violation of such requirements from the market.

E. Substantive current good manufacturing requirements.

F. Accountability of the regulatory authority.

G. Inventory of current products and manufacturers.

H. System for maintaining or accessing inspection reports, samples and other analytical data, and other firm/product information relating to matters covered by this Sectoral Annex.

II. Mechanisms in place to assure appropriate professional standards and avoidance of conflicts of interest.

III. Administration of the regulatory authority:

A. Standards of education/qualification and training.

B. Effective quality assurance systems measures to ensure adequate job performance.

C. Appropriate staffing and resources to enforce laws and regulations.

IV. Conduct of Inspections:

A. Adequate pre-inspection preparation, including appropriate expertise of investigator/team, review of firm/product and databases, and availability of appropriate inspection equipment.

B. Adequate conduct of inspection, including statutory access to facilities, effective response to refusals, depth and competence of evaluation of operations, systems and documentation; collection of evidence; appropriate duration of inspection and completeness of written report of observations to firm management.

C. Adequate post-inspection activities, including completeness of inspectors' report, inspection report review where appropriate, and conduct of follow-up inspections and other activities where appropriate, assurance of preservation and retrieval of records.

V. Execution of regulatory enforcement actions to achieve corrections, designed to prevent future violations, and to remove products found in violation of requirements from the market.

VI. Effective Use of Surveillance Systems:

A. Sampling and analysis.

B. Recall monitoring.

C. Product defect reporting system.

D. Routine surveillance inspections.

E. Verification of approved manufacturing process changes to marketing authorisations/approved applications.

VII. Additional specific criteria for pre-approval inspections A. Satisfactory demonstration through a jointly developed and administered training program and joint inspections to assess the authorities' capabilities.

B. Pre-inspection preparation includes the review of appropriate records, including site plans and drug master file or similar documentation to enable adequate inspections.

C. Ability to verify chemistry, manufacturing and control data supporting an application is authentic and complete.

D. Ability to access and evaluate research and development data as scientifically sound, especially transfer technology of pilot, scale up and full scale production batches.

E. Ability to verify conformity of the on site processes and procedures with those described in the application.

F. Review and evaluate equipment installation, operational and performance qualification data, and evaluate test method validation.

Appendix 5 Elements to be Considered in Developing a Two-way Alert System 1. Documentation

Telephone +44- 171- 418 8400, Fax 418 8416. for the United States: (to be provided by the U.S.) SECTORAL ANNEX ON MEDICAL DEVICES PREAMBLE This Annex constitutes a Sectoral Annex to the Agreement on Mutual Recognition in Regulation to Conformity Assessment between the United States and the European Community.

Carrying out the provisions of this Annex will further public health protection, will be an important means of facilitating commerce in medical devices and will lead to reduced costs for regulators and manufacturers of both Parties.

CHAPTER 1 PURPOSE, SCOPE AND COVERAGE OF THE SECTORAL ANNEX

Article 1Purpose

Article 2Scope

Appendix 1 names the legislation, regulations, and related procedures under which: (a) products are regulated as medical devices by each Party; (b) CABs are designated and confirmed; and (c) these reports are prepared.

Article 3Product Coverage

There are three components to this agreement each covering a discrete range of products:

Additional products and procedures may be made subject to this Annex by agreement of the Parties.

Article 4Regulatory Authorities

The regulatory authorities shall have the responsibility of implementing the provisions of this Annex, including the designation and monitoring of CABs. Regulatory authorities are specified in Appendix 3. Each Party will promptly notify the other Party in writing of any change in the regulatory authority for a country.

CHAPTER 2 TRANSITION PERIOD

Article 5Length and purpose of transition period

There will be a three-year transition period immediately following the date of entry into force of the Agreement. During the transition period, the Parties will engage in confidence-building activities for the purpose of obtaining sufficient evidence to make determinations concerning the equivalence of CABs of the other Party with respect to the ability to perform quality system and product evaluations or other reviews resulting in reports to be exchanged under this Annex.

Article 6Listing of CABs

Each Party shall designate CABs to participate in confidence-building activities by transmitting to the other Party a list of CABs which meet the criteria for technical competence and independence, as identified in Appendix 1. The list shall be accompanied by supporting evidence. Designated CABs will be listed in Appendix 4 for participation in the confidence building activities once confirmed by the importing Party. Non-confirmation would have to be justified based on documented evidence.

Article 7Confidence Building Activities

Article 8Other transition period activities

CHAPTER 3 END OF TRANSITION PERIOD

Article 9Equivalence Assessment

CHAPTER 4 OPERATIONAL PERIOD

Article 10Start of the operational period

Article 11Exchange and endorsement of quality system evaluation

reports 1. Listed EC CABs will provide FDA with reports of quality system evaluations, as follows: (a) for pre-approval quality system evaluations, EC CABs will provide full reports; and (b) for surveillance quality system evaluations, EC CABs will provide abbreviated reports.

Examples of such circumstances include indications of material inconsistencies or inadequacies in a report, quality defects identified in post-market surveillance or other specific evidence of serious concern in relation to product quality or consumer safety.

In such cases, the importing Party may request clarification from the exporting Party which may lead to a request for re-inspection.

The Parties will endeavour to respond to requests for clarification in a timely manner. Where divergence is not clarified in this process, the importing Party may carry out the quality system evaluation.

Article 12Exchange and endorsement of product evaluation reports

Article 13Transmission of quality system evaluation reports

Quality system evaluation reports covered by Article 11 concerning products covered by this Annex shall be transmitted to the importing Party within 60 calendar days of a request by the importing Party.

Should a new inspection be requested the time period shall be extended by an additional 30 calendar days. A Party may request a new inspection, for cause, identified to the other Party. If the exporting Party cannot perform an inspection within a specified period time, the importing Party may perform an inspection on its own.

Article 14Transmission of product evaluation reports

Transmission of product evaluation reports will take place according to the importing Party's specified procedures.

Article 15Monitoring continued equivalence

Monitoring activities will be carried out in accordance with Article 10 of the Agreement.

Article 16Listing of Additional CABs

CHAPTER 5 JOINT SPECIAL COMMITTEE

Article 17Role and composition of the Joint Sectoral Committee

CHAPTER 6 HARMONISATION AND INFORMATION EXCHANGE

Article 18Harmonisation

During both the transitional and operational phases of this Agreement, both Parties intend to continue to participate in the activities of the Global Harmonisation Task Force and utilise the results of those activities to the extent possible. Such participation involves developing and reviewing documents developed by the Global Harmonisation Task Force and jointly determining whether they are applicable to the implementation of this Agreement.

Article 19Regulatory cooperation

The Parties and authorities shall inform one another, as permitted by law, of, and consult one another on, proposals to introduce new controls or to change existing technical regulations or inspection procedures and to provide the opportunity to comment on such proposals.

The Parties shall notify each other in writing of any changes to Appendix 1.

Article 20Alert system and exchange of post-market vigilance

reports 1. An alert system will be set up during the transition period and maintained thereafter by which the Parties will notify each other when there is an immediate danger to public health. Elements of such a system will be described in an Appendix to be attached to this Sectoral Annex. As part of that system, each Party shall notify the other Party of any confirmed problem reports, corrective actions, or recalls. These reports are regarded as part of ongoing investigations.

Appendix 1 Relevant legislation, regulations and procedures 1. For the European Community the following legislation applies to Article 2(1): (a) Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices. Conformity assessment procedures.

Appendix 2 Scope of product coverage 1. Initial Coverage of the Transition Period:

Upon entry into force of this Annex (1), products qualifying for the transitional arrangements under this Agreement include: (a) all Class I products requiring premarket evaluations in the United States - see Table 1; (b) those Class II products listed in Table 2.

The Parties will jointly identify additional product groups, including their related accessories, in line with their respective priorities as follows: (a) those for which review may be based primarily on written guidance which the Parties will use their best efforts to prepare expeditiously; and (b) those for which review may be based primarily on international standards, in order for the Parties to gain the requisite experience.

The corresponding additional product lists will be phased in on an annual basis. The Parties may consult with industry and other interested Parties in determining which products will be added.

JOINT DECLARATION to the Agreement on Mutual Recognition between the European Community and the United States of America The Parties agree that, although in this exceptional case the Agreement on Mutual Recognition between the United States of America and the European Community is being signed while the consistency of the various linguistic versions of the Agreement is being verified, notification of the completion of their respective procedures for the entry into force of the Agreement, as referred to in Article 21(1) of the Agreement, will be made only after the Parties have completed the verification of the texts signed today and, through agreement between the Parties, any discrepancies have been brought into conformity with the English text.

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

For the European Community >REFERENCE TO A GRAPHIC> For the United States of America >REFERENCE TO A GRAPHIC>