21999A0204(01)
Agreement on mutual recognition between the European Community and
the United States of America - Joint Declaration
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 1 Definitions
1. The following terms and definitions shall apply to this Agreement
only:
- 'Designating Authority` means a body with power to designate,
monitor, suspend, remove suspension of, or withdraw conformity
assessment bodies as specified under this Agreement.
- 'Designation` means the identification by a Designating Authority
of a conformity assessment body to perform conformity assessment
procedures under this Agreement.
- 'Regulatory Authority` means a government agency or entity that
exercises a legal right to control the use or sale of products
within a Party's jurisdiction and may take enforcement action to
ensure that products marketed within its jurisdiction comply with
legal requirements.
2. Other terms concerning conformity assessment used in this
Agreement shall have the meaning given elsewhere in this Agreement
or in the definitions contained in Guide 2 (1996 edition) of the
International Organization for Standardisation (ISO) and the
International Electrotechnical Commission (IEC). In the event of an
inconsistency between ISO/IEC Guide 2 and definitions in this
Agreement, the definitions in this Agreement shall prevail.
Article 2 Purpose 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 3 General obligations
1. The United States shall, as specified in the Sectoral Annexes,
accept or recognise results of specified procedures, used in
assessing conformity to specified legislative, regulatory, and
administrative provisions of the United States, produced by the
other Party's conformity assessment bodies and/or authorities.
2. The European Community and its Member States shall, as specified
in the Sectoral Annexes, accept or recognise results of specified
procedures, used in assessing conformity to specified legislative,
regulatory and administrative provisions of the European Community
and its Member States, produced by the other Party's conformity
assessment bodies and/or authorities.
3. Where sectoral transition arrangements have been specified in
Sectoral Annexes, the above obligations will apply following the
successful completion of those sectoral transition arrangements,
with the understanding that the conformity assessment procedures
utilised assure conformity to the satisfaction of the receiving
Party, with applicable legislative, regulatory and administrative
provisions of that Party, equivalent to the assurance offered by the
receiving Party's own procedures.
Article 4 General coverage of the Agreement
1. This Agreement applies to conformity assessment procedures for
products and/or processes and to other related cooperative
activities as described in this Agreement.
2. Sectoral Annexes may include:
(a) a description of the relevant legislative, regulatory and
administrative provisions pertaining to the conformity assessment
procedures and technical regulations;
(b) a statement on the product scope and coverage;
(c) a list of Designating Authorities;
(d) a list of agreed conformity assessment bodies or authorities or
a source from which to obtain a list of such bodies or authorities
and a statement of the scope of the conformity assessment procedures
for which each has been agreed;
(e) the procedures and criteria for designating the conformity
assessment bodies;
(f) a description of the mutual recognition obligations;
(g) a sectoral transition arrangement;
(h) the identity of a sectoral contact point in each Party's
territory; and
(i) a statement regarding the establishment of a Joint Sectoral
Committee.
3. This Agreement shall not be construed to entail mutual acceptance
of standards or technical regulation of the Parties and, unless
otherwise specified in a Sectoral Annex, shall not entail the mutual
recognition of the equivalence of standards or technical
regulations.
Article 5 Transitional arrangements
The Parties agree to implement the transitional commitments on
confidence building as specified in the Sectoral Annexes.
1. The Parties agree that each sectoral transition arrangement shall
specify a time period for completion.
3. Passage from the transitional phase to the operational phase
shall proceed as specified in each Sectoral Annex, unless either
Party documents that the conditions provided in such Sectoral Annex
for a successful transition are not met.
Article 6 Designating 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 7 Designation 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 8 Suspension 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 9 Withdrawal 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 10 Monitoring 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 11 Conformity 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 12 Exchange of information
1. The Parties shall exchange information concerning the
implementation of the legislative, regulatory, and administrative
provisions identified in the Sectoral Annexes.
2. Each Party shall notify the other Party of legislative,
regulatory and administrative changes related to the subject matter
of this Agreement at least 60 days before their entry into force.
Where considerations of safety, health or environmental protection
require more urgent action a Party shall notify the other Party as
soon as practicable.
3. Each Party shall promptly notify the other Party of any changes
to its Designating Authorities and/or conformity assessment bodies.
4. The Parties shall exchange information concerning the procedures
used to ensure that the listed conformity assessment bodies under
their responsibility comply with the legislative, regulatory, and
administrative provisions outlined in the Sectoral Annexes.
5. Regulatory Authorities identified in the Sectoral Annexes shall
consult as necessary with their counterparts, to ensure the
maintenance of confidence in conformity assessment procedures and to
ensure that all technical requirements are identified and are
satisfactorily addressed.
Article 13 Sectoral contact points
Each Party shall appoint and confirm in writing contact points to be
responsible for activities under each Sectoral Annex.
Article 14 Joint Committee of the Parties
1. The Parties hereby establish a Joint Committee consisting of
representatives of each Party. The Joint Committee comprised shall
be responsible for the effective functioning of the Agreement.
2. The Joint Committee may establish Joint Sectoral Committees
comprised of appropriate Regulatory Authorities and others deemed
necessary.
3. Each Party shall have one vote in the Joint Committee. The Joint
Committee shall make its decisions by unanimous consent. The Joint
Committee shall determine its own rules and procedures.
4. The Joint Committee may consider any matter relating to the
effective functioning of this Agreement. In particular it shall be
responsible for:
(a) listing, suspension, withdrawal and verification of conformity
assessment bodies in accordance with this Agreement;
(b) amending transitional arrangements in Sectoral Annexes;
(c) resolving any questions relating to the application of this
Agreement and its Sectoral Annexes not otherwise resolved in the
respective Joint Sectoral Committees;
(d) providing a forum for discussion of issues that may arise
concerning the implementation of this Agreement;
(e) considering ways to enhance the operation of this Agreement;
(f) coordinating the negotiation of additional Sectoral Annexes; and
(g) considering whether to amend this Agreement or its Sectoral
Annexes in accordance with Article 21.
5. When a Party introduces new or additional conformity assessment
procedures affecting a Sectoral Annex, the Parties shall discuss the
matter in the Joint Committee with a view to bringing such new or
additional procedures within the scope of this Agreement and the
relevant Sectoral Annex.
Article 15 Preservation of regulatory authority
1. Nothing in this Agreement shall be construed to limit the
authority of a Party to determine, through its legislative,
regulatory and administrative measures, the level of protection it
considers appropriate for safety; for protection of human, animal,
or plant life or health; for the environment; for consumers; and
otherwise with regard to risks within the scope of the applicable
Sectoral Annex.
2. Nothing in this Agreement shall be construed to limit the
authority of a Regulatory Authority to take all appropriate and
immediate measures whenever it ascertains that a product may: (a)
compromise the health or safety of persons in its territory; (b) not
meet the legislative, regulatory, or administrative provisions
within the scope of the applicable Sectoral Annex; or (c) otherwise
fail to satisfy a requirement within the scope of the applicable
Sectoral Annex. Such measures may include withdrawing the products
from the market, prohibiting their placement on the market,
restricting their free movement, initiating a product recall, and
preventing the recurrence of such problems, including through a
prohibition on imports. If the Regulatory Authority takes such
action, it shall inform its counterpart authority and the other
Party within 15 days of taking such action, providing its reasons.
Article 16 Suspension 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 17 Confidentiality
1. Each Party agrees to maintain, to the extent required under its
laws, the confidentiality of information exchanged under this
Agreement.
2. In particular, neither Party shall disclose to the public, nor
permit a conformity assessment body to disclose to the public,
information exchanged under this Agreement that constitutes trade
secrets, confidential commercial or financial information, or
information that relates to an ongoing investigation.
3. A Party or a conformity assessment body may, upon exchanging
information with the other Party or with a conformity assessment
body of the other Party, designate the portions of the information
that it considers to be exempt from disclosure.
4. Each Party shall take all precautions reasonably necessary to
protect information exchanged under this Agreement from unauthorised
disclosure.
Article 18 Fees
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 19 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 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 20 Territorial 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 21 Entry into force, amendment and termination
1. This Agreement including its Sectoral Annexes on
Telecommunication Equipment, Electromagnetic Compatibility,
Electrical Safety, Recreational Craft, Pharmaceutical Good
Manufacturing Practices (GMPs), and Medical Devices shall enter into
force on the first day of the second month following the date on
which the Parties have exchanged letters confirming the completion
of their respective procedures for the entry into force of this
Agreement.
2. This Agreement including any Sectoral Annex may, through the
Joint Committee, be amended in writing by the Parties. The Parties
may add a Sectoral Annex upon the exchange of letters. Such Annex
shall enter into force 30 days following the date on which the
Parties have exchanged letters confirming the completion of their
respective procedures for the entry into force of the Sectoral
Annex.
3. Either Party may terminate this Agreement in its entirety or any
individual Sectoral Annex thereof by giving the other Party six
months notice in writing. In the case of termination of one or more
Sectoral Annexes, the Parties will seek to achieve by consensus to
amend this Agreement, with a view to preserving the remaining
Sectoral Annexes, in accordance with the procedures in this Article.
Failing such consensus, the Agreement shall terminate at the end of
six months from the date of notice.
4. Following termination of the Agreement in its entirety or any
individual Sectoral Annex thereof, a Party shall continue to accept
the results of conformity assessment procedures performed by
conformity assessment bodies under this Agreement prior to
termination, unless a Regulatory Authority in 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 22 Final provisions
1. The Sectoral Annexes referred to in Article 21(1), as well as any
New Sectoral Annexes added pursuant to Article 21(2), shall form an
integral part of this Agreement.
2. For a given product or sector, the provisions contained in the
relevant Sectoral Annexes shall apply in the first place, and the
provisions of this text in addition to those provisions. In the case
of any inconsistency between the provisions of a Sectoral Annex and
this text, the Sectoral Annex shall prevail, to the extent of that
inconsistency.
3. This Agreement shall not affect the rights and obligations of the
Parties under any other international agreement.
4. In the case of the Sectoral Annex on Medical Devices, the Parties
shall review the status of such Annex at the end of three years from
entry into force.
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.
2. The following is a non-exclusive list of the equipment,
interfaces, and services included within the scope of this Sectoral
Annex:
>TABLE POSITION>
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.
2. Conformity Assessment Procedures
Taking into account the legislative, regulatory, and administrative
provisions as identified in Section I, each Party recognises that
the conformity assessment bodies of the other Party, listed in
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.
2. Post-market surveillance, border measures and internal movement
2.1. 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. Numbering and labelling systems shall not introduce
additional requirements within the meaning of this Sectoral Annex.
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. Joint Sectoral Committee
3.1. A combined Joint Sectoral Committee for this Sectoral Annex and
the Electromagnetic Compatibility (EMC) Sectoral Annex is hereby
established (the JSC). The JSC shall operate during the transitional
period and after completion of the transitional arrangement. The JSC
shall meet as appropriate to discuss technical, conformity
assessment and technology issues relating to this Sectoral Annex and
the EMC Sectoral Annexes. The JSC shall determine its own rules of
procedure.
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.
4. Contact point
Each Party shall establish a contact point to provide answers to all
reasonable inquiries from the other Party regarding procedures,
regulations, and complaints under this Sectoral Annex.
5. Regulatory changes and updating the Sectoral Annex
In the event that there are changes to the legislative, regulatory,
and administrative provisions referenced in Section I or the
introduction of new legislative, regulatory, and administrative
provisions affecting either Party's conformity assessment procedures
under the Agreement, such changes shall take effect for the purpose
of this Sectoral Annex at the same time they take effect
domestically within the territory of each Party. The parties shall
update this Sectoral Annex to reflect the changes.
SECTION VIII
TRANSITIONAL ARRANGEMENT
2. The purpose of this transitional arrangement is to provide a
means whereby the Parties to the Agreement can build confidence in
and an understanding of each other's system for designating and
listing conformity assessment bodies and in the ability of these
bodies to test and certify products. Successful completion of the
transitional arrangement should result in the determination that
conformity assessment bodies listed in Section V comply with the
applicable criteria and are competent to conduct conformity
assessment activities on behalf of the other Party. Upon successful
completion of the transition period, the results of conformity
assessment procedures performed by the exporting Party's conformity
assessment bodies listed in Section V of the exporting country shall
be accepted by the importing Party.
3. This transitional period shall be used by the Parties:
(a) to consider new legislative changes needed to support the
objectives of the Agreement;
(b) to initiate regulatory changes needed to support the objectives
of the Agreement;
(c) to exchange information on and develop better understanding of
their respective regulatory requirements;
(d) to develop mutually agreed mechanisms for exchanging information
on changes in technical requirements or methods of designating
conformity assessment bodies; and
(e) to monitor and evaluate the performance of the listed conformity
assessment bodies during the transitional period.
4. Parties may designate, list, suspend and withdraw conformity
assessment bodies during the transitional period according to the
procedures in Section VI of this Sectoral Annex.
5. During the transitional period each Party shall accept and
evaluate test reports and related documents issued by designated
conformity assessment bodies of the other Party. To this end, the
Parties shall ensure that:
(a) on receipt of tests reports, related documents and a first
evaluation of conformity, the dossiers are promptly examined for
completeness;
(b) the applicant is informed in a precise and complete manner of
any deficiency;
(c) any request for additional information is limited to omissions,
inconsistencies or variances from the technical regulations or
standards; and
(d) procedures for assessing the conformity for equipment, modified
subsequent to a determination of compliance, are limited to
procedures necessary to determine continued conformance.
6. Each Party ensures that issuance of approvals, certificates, or
advice to the applicant shall be given no later than six weeks from
receipt of the test report and evaluation from a designated
conformity assessment body in the territory of the other Party.
7. 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 Sectoral 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 shall implement such action prior to the expiry of the
transitional period.
8. The Parties may jointly sponsor two seminars, one in the US and
one in the European Community, concerning the relevant technical and
product approval requirements during the first year after this
Sectoral Annex enters into force.
9. Passage from the transitional phase into the operational phase in
this Sectoral Annex shall take place provided that a representative
number of conformity assessment bodies have been accepted for
recognition under the Electrical Safety Annex.
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.
2. Conformity Assessment Procedures
Taking into account the legislative, regulatory, and administrative
provisions as identified in Section I, each Party recognises that
the conformity assessment bodies of the other Party, listed in
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.
2. Post-market surveillance, border measures and internal movement
2.1. For the purpose of post-market surveillance, the Parties may
maintain any existing labeling 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. Numbering and labeling systems shall not introduce additional
requirements within the meaning of this Sectoral Annex.
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. Joint Sectoral Committee
3.1. A combined Joint Sectoral Committee for this Sectoral Annex and
the Telecommunications Equipment Sectoral Annex is hereby
established (the JSC). The JSC shall operate during the transitional
period and after completion of the transitional arrangement. The JSC
shall meet as appropriate to discuss technical, conformity
assessment and technology issues relating to this Sectoral Annex and
the Telecommunications Equipment Sectoral Annex. The JSC shall
determine its own rules of procedure.
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.
4. Contact point
Each Party shall establish a contact point to provide answers to all
reasonable inquiries from the other Party regarding procedures,
regulations and complaints under this Sectoral Annex.
5. Regulatory changes and updating the Sectoral Annex
In the event that there are changes to the legislative, regulatory
and administrative provisions referenced in Section I or the
introduction of new legislative, regulatory and administrative
provisions affecting either Party's conformity assessment procedures
under the Agreement, such changes shall take effect for the purpose
of this Sectoral Annex at the same time they take effect
domestically within the territory of each Party. The Parties shall
update this Sectoral Annex to reflect the changes.
SECTION VIII
TRANSITIONAL ARRANGEMENT
2. The purpose of this transitional arrangement is to provide a
means whereby the Parties to the Agreement can build confidence in
and understanding of each others system for designating and listing
conformity assessment bodies and in the ability of these bodies to
test and certify products. Successful completion of the transition
arrangement should result in the determination that conformity
assessment bodies listed in Section V comply with the applicable
criteria and are competent to conduct conformity assessment
activities on behalf of the other Party. Upon completion of the
transition period, the results of conformity assessment procedures
performed by the exporting Party's conformity assessment bodies
listed in Section V shall be accepted by the importing Party.
3. This transitional period shall be used by the Parties:
(a) to consider new legislative changes needed to support the
objectives of the Agreement;
(b) to initiate regulatory changes needed to support the objectives
of the Agreement;
(c) to exchange information on and develop better understanding of
their respective regulatory requirements;
(d) to develop mutually agreed mechanisms for exchanging information
on changes in technical requirements or methods of designating
conformity assessment bodies; and
(e) to monitor and evaluate the performance of the listed conformity
assessment bodies during the transitional period.
4. Parties may designate, list, suspend and withdraw conformity
assessment bodies during the transitional period according to the
procedures in Section VI of this Sectoral Annex.
5. During the transitional period each Party shall accept and
evaluate test reports and related documents issued by designated
conformity assessment bodies of the other Party. To this end, the
Parties shall ensure that:
(a) on receipt of test reports, related documents and a first
evaluation of conformity, the dossiers are promptly examined for
completeness;
(b) the applicant is informed in a precise and complete manner of
any deficiency;
(c) any request for additional information is limited to omissions,
inconsistencies or variances from the technical regulations or
standards;
(d) procedures for assessing the conformity for equipment modified
subsequent to a determination of compliance, are limited to
procedures necessary to determine continued conformance.
6. Each Party ensures that issuance of approvals, certificates or
advice to the applicant shall be given no later than six weeks from
receipt of the test report and evaluation from a designated
conformity assessment body in the territory of the other Party.
7. 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 Sectoral 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 shall implement such action prior to the expiry of the
transitional period.
8. The Parties may jointly sponsor two seminars, one in the US and
one in the European Community, concerning the relevant technical and
product approval requirements during the first year after this
Sectoral Annex enters into force.
9. Passage from the transitional phase into the operational phase in
this Sectoral Annex shall take place provided that a representative
number of conformity assessment bodies have been accepted for
recognition under the Electrical Safety Annex.
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.
2. The Joint Committee may address any matter related to the
effective functioning of this Sectoral Annex, including:
- developing improved procedures and criteria for designation in
order to facilitate the assessment and preparation of proposals by
Designating Authorities, with a view towards expediting the period
between designation and listing;
- providing a forum for discussion of issues that may arise
concerning the implementation of this Sectoral Annex;
- advising the Parties on matters relating to this Sectoral Annex;
and
- enhancing the operation of this Sectoral Annex.
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.
2. For the US:
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.
2. The product coverage for each Party shall be determined by the
following relevant requirements:
(a) for the European Community:
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.
3. The Parties agree that for mutual recognition to operate under
this Sectoral Annex, the following arrangements shall apply:
(a) for approvals to European Community requirements, conformity
assessment bodies designated by the US shall establish compliance as
required to be demonstrated by Directive 94/25/EC. This
demonstration of compliance shall be recognised in the European
Community and products so certified shall have unrestricted access
to the EC market for sale as recreational craft, pursuant to Section
I;
(b) for approvals to United States requirements, conformity
assessment bodies designated by the European Community shall
establish compliance as required to be demonstrated as set forth in
paragraph 2(b) of this Section, and products so certified shall have
unrestricted access to the US market for sale as recreational craft,
pursuant to Section I.
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.
2. Each Party agrees that the listed 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 US requirements;
(b) for the US, in accordance with the requirements set out in the
regulations listed in Section I, the conformity assessment bodies
listed in Section V are designated by NIST using the evaluation
procedures contained in the appropriate EN-45000 series of standards
or the corresponding ISO/IEC Guides.
3. With regard to the designation, listing, suspension and
withdrawal of conformity assessment bodies under this Sectoral
Annex, the specific procedures in Articles 7, 8 and 9 of the
Agreement shall be followed.
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.
2. The purpose of the transitional arrangement is to provide a mean
whereby the Parties to this Agreement can cooperate to establish a
system for designating conformity assessment bodies and can mutually
build confidence in the abilities of these bodies. Successful
completion of this transitional arrangement is intended to result in
a determination that conformity assessment bodies comply with the
applicable criteria and to have the equipment approved by the
conformity assessment bodies of the exporting country accepted by
the approval authority of the importing country.
3. During this transitional period, the parties shall:
(a) exchange information on technical data and conformity assessment
criteria and procedures, thus developing greater familiarity with
their respective regulatory requirements; and
(b) carry out or recommend any applicable policy, legislative and
regulatory changes necessary for the provisions of this Annex.
5. Cooperation
During this transitional period, both Parties shall endeavour to
sponsor jointly seminars for the purpose of improving the
understanding of technical specifications applicable in each Party's
jurisdiction.
6. Inspections
Inspections or audits shall be permitted to verify compliance of
conformity assessment bodies with their responsibilities under this
Agreement. The scope of these inspections or audits shall be agreed
upon in advance by both Parties.
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.
2. The Parties note that, to the extent that requirements for
electrical safety or electromagnetic compatibility may apply to
products covered by this Sectoral Annex, the provisions of the
Sectoral Annexes on Electrical Safety and Electromagnetic
Compatibility apply.
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 1 Definitions
1. 'Equivalence` of the regulatory systems means that the systems
are sufficiently comparable to assure that the process of inspection
and the ensuing inspection reports will provide adequate information
to determine whether respective statutory and regulatory
requirements of the authorities have been fulfilled. 'Equivalence`
does not require that the respective regulatory systems have
identical procedures.
2. 'Enforcement` means action taken by an authority to protect the
public from products of suspect quality, safety and efficacy or to
assure that products are manufactured in compliance with appropriate
law, regulations, standards and commitments made as part of the
approval to market a product.
3. 'Good Manufacturing Practices` (GMPs): (The US and EC have agreed
to revisit these concepts)
GMPs mean the requirements found in the respective legislations,
regulations, and administrative provisions for methods to be used
in, and the facilities or controls to be used for the manufacturing,
processing, packing, and/or holding of a drug to assure that such
drug meets the requirements as to safety, and has the identity and
strength, and meets the quality and purity characteristics that it
purports or is represented to possess.
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).
4. 'Inspection` means an on-site evaluation of a manufacturing
facility to determine whether such manufacturing facility is
operating in compliance with Good Manufacturing Practices and/or
commitments made as part of the approval to market a product.
5. 'Inspection Report` means the written observations and Good
Manufacturing Practices compliance assessment completed by an
authority listed in Appendix 2.
6. 'Regulatory System` means the body of legal requirements for Good
Manufacturing Practices, inspections, and enforcements that ensure
public health protection and legal authority to assure adherence to
these requirements.
Article 2 Purpose
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 3 Scope
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 4 Product 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 5 Length of transition period
A three-year transition period will start immediately after the
effective date of the Agreement.
Article 6 Equivalence assessment
1. The criteria to be used by the Parties to assess equivalence are
listed in Appendix 4. Information pertaining to the criteria under
Community competence will be provided by the Community.
2. The authorities of the parties will establish and communicate to
each other their draft programmes for assessing the equivalence of
the respective regulatory systems in terms of quality assurance of
the products and consumer protection. These programmes will be
carried out, as deemed necessary by the authorities, for post- and
pre-approval inspections and for various product classes or
processes.
3. The equivalence assessment shall include information exchanges
(including inspection reports), joint training, and joint
inspections for the purpose of assessing regulatory systems and the
authorities' capabilities. In conducting the equivalence assessment,
the Parties will ensure that efforts are made to save resources.
4. Equivalence assessment for authorities added to Appendix 2 after
the effective date of this agreement will be conducted as described
in this Annex, as soon as practicable.
Article 7 Participation 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 8 Other 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 9 Equivalence 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 10 Authorities 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 11 Start 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 12 Nature 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 13 Transmission 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 14 Transmission 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 15 Monitoring 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 16 Suspension
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 17 Role 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:
1. making a joint assessment, which must be agreed by both Parties,
of the equivalence of the respective authorities;
2. developing and maintaining the list of equivalent authorities,
including any limitation in terms of inspecting type or products,
and communicating the list to all authorities and the Joint
Committee;
3. providing a forum to discuss issues relating to this Annex,
including concerns that an authority may be no longer equivalent and
opportunity to review product coverage;
4. consideration of the issue of suspension.
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 18 Regulatory 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 19 Information 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 20 Alert 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 21
Each 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:
- human medicinal products including prescription and
non-prescription drugs,
- human biologicals including vaccines, and immunologicals,
- veterinary pharmaceuticals, including prescription and
non-prescription drugs, with the exclusion of veterinary
immunologicals,
- pre-mixes for the preparation of veterinary medicated feeds (EC),
Type A medicated articles for the preparation of veterinary
medicated feeds (US),
- intermediate products and active pharmaceutical ingredients or
bulk pharmaceuticals (US)/starting materials (EC).
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
- Defintion of a crisis/emergency and under what circumstances an
alert is required,
- Standard Operating Procedures (SOPs),
- Mechanism of health hazards evaluation and classification,
- Language of communication and transmission of information.
2. Crisis Management System
- Crisis analysis and communication mechanisms,
- Establishment of contact points,
- Reporting mechanisms.
4. Quality Assurance System
- Pharmacovigilance programme,
- Surveillance/monitoring of implementation of corrective action.
5. Contact points
For the purpose of this agreement, the contact points for the alert
system will be:
for the European Community:
the Executive Director of the European Agency for the Evaluation of
Medicinal Products,
7, Westferry Circus,
Canary Wharf
UK - London E14 4HB,
England.
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 1 Purpose
1. The purpose of this Annex is to specify the conditions under
which a Party will accept the results of quality system-related
evaluations and inspections and premarket evaluations of the other
Party with regard to medical devices as conducted by listed
conformity assessment bodies (CABs) and to provide for other related
cooperative activities.
2. This Annex is intended to evolve as programmes and policies of
the Parties evolve. The Parties will review this Annex periodically,
in order to assess progress and identify potential enhancements to
this Annex as Food and Drug Administration (FDA) and EC policies
evolve over time.
Article 2 Scope
1. The provisions of this Annex shall apply to the exchange and,
where appropriate, endorsement of the following types of reports
from CABs assessed to be equivalent:
(a) under the US system, surveillance/post-market and
initial/pre-approval inspection reports;
(b) under the US system, premarket (510(k)) product evaluation
reports;
(c) under the EC system, quality system evaluation reports; and
(d) under the EC system, EC type examination and verification
reports.
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.
2. For purposes of this Annex, equivalence means that: CABs in the
EC are capable of conducting product and quality systems evaluations
against US regulatory requirements in a manner equivalent to those
conducted by FDA; and CABs in the US are capable of conducting
product and quality systems evaluations against EC regulatory
requirements in a manner equivalent to those conducted by EC CABs.
Article 3 Product Coverage
There are three components to this agreement each covering a
discrete range of products:
1. Quality System Evaluations - US-type surveillance/post-market and
initial/pre-approval inspection reports and EC-type quality system
evaluation reports will be exchanged with regard to all products
regulated under both US and EC law as medical devices.
2. Product Evaluation - US-type premarket (510(k)) product
evaluation reports and EC-type-testing reports will be exchanged
only with regard to those products classified under the US system as
Class I/Class II - Tier 2 medical devices which are listed in
Appendix 2.
3. Post-Market Vigilance Reports - Post-market vigilance reports
will be exchanged with regard to all products regulated under both
US and EC law as medical devices.
Additional products and procedures may be made subject to this Annex
by agreement of the Parties.
Article 4 Regulatory 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 5 Length 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 6 Listing 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 7 Confidence Building Activities
1. At the beginning of the transitional period, the Joint Sectoral
Group will establish a joint confidence building programme
calculated to provide sufficient evidence of the capabilities of the
designated CABs to perform quality system or product evaluations to
the specifications of the Parties.
2. The joint confidence building program should include the
following actions and activities:
(a) seminars designed to inform the Parties and CABs about each
Party's regulatory system, procedures, and requirements;
(b) workshops designed to provide the Parties with information
regarding requirements and procedures for the designation and
surveillance of CABs;
(c) exchange of information about reports prepared during the
transition period;
(d) joint training exercises; and
(e) observed inspections.
3. During the transition period, any significant problem that is
identified with a CAB may be the subject of cooperative activities,
as resources allow and as agreed to by the regulatory authorities,
aimed at resolving the problem.
4. Both Parties will exercise good faith efforts to complete the
confidence building activities as expeditiously as possible to the
extent that the resources of the Parties allow.
5. Both the EC and the US will each prepare annual progress reports
which will describe the confidence building activities undertaken
during each year of the transition period. The form and content of
the reports will be determined by the Parties through the Joint
Sectoral Committee.
Article 8 Other transition period activities
1. During the transition period, the Parties will jointly determine
the necessary information which must be present in quality system
and product evaluation reports.
2. The Parties will jointly develop a notification and alert system
to be used in case of defects, recalls, and other problems
concerning product quality that could necessitate additional actions
(e.g., inspections by the Parties of the importing country) or
suspension of the distribution of the product.
CHAPTER 3 END OF TRANSITION PERIOD
Article 9 Equivalence Assessment
1. In the final six months of the transition period, the Parties
shall proceed to a joint assessment of the equivalence of the CABs
that participated in the confidence building activities. CABs will
be determined to be equivalent provided they have demonstrated
proficiency through the submission of a sufficient number of
adequate reports. CABs may be determined to be equivalent with
regard to the ability to perform any type of quality system or
product evaluation covered by this Annex and with regard to any type
of product covered by this Annex. The parties shall develop a list
contained in Appendix 5 of CABs determined to be equivalent which
shall contain a full explanation of the scope of the equivalency
determination, including any appropriate limitations, with regard to
performing any type of quality system or product evaluation.
2. The Parties shall allow CABs not listed for participation in the
MRA, or listed for participation only as to certain types of
evaluations, to apply for participation in this MRA once the
necessary measures have been taken or sufficient experience has been
gained, in accordance with Article 16.
3. Decisions concerning the equivalence of CABs must be agreed to by
both Parties.
CHAPTER 4 OPERATIONAL PERIOD
Article 10 Start of the operational period
1. The operational period will start at the end of the transition
period after the Parties have developed the list of CABs found to be
equivalent. The provisions of this Chapter will apply only with
regard to listed CABs and only to the extent of any specifications
and limitations contained on the list with regard to a CAB.
2. The operational period will apply to quality system evaluation
reports and product evaluation reports generated by CABs listed in
accordance with this Annex for the evaluations performed in the
respective territories of the Parties, except if the Parties agree
otherwise.
Article 11 Exchange 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.
2. Listed US CABs will provide to the EC Notified Body of the
manufacturer's choice:
(a) full reports of initial quality system evaluations;
(b) abbreviated reports of quality systems surveillance audits.
3. If the abbreviated reports do not provide sufficient information,
the importing Party may request additional clarification from the
CAB.
4. Based on the determination of equivalence in light of the
experience gained, the quality system evaluation reports prepared by
the CABs listed as equivalent will normally be endorsed by the
importing Party, except under specific and delineated circumstances.
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 12 Exchange and endorsement of product evaluation reports
1. EC CABs listed for this purpose will, subject to the
specifications and limitations on the list, provide to the FDA
510(k) premarket notification assessment reports prepared to US
medical device requirements.
2. US CABs will, subject to the specifications and limitations on
the list, provide to the EC notified body of the manufacturer's
choice, type examination and verification reports prepared to EC
medical device requirements.
3. Based on the determination of equivalence in light of the
experience gained, the product evaluation reports prepared by the
CABs listed as equivalent will normally be endorsed by the importing
Party, except under specific and delineated circumstances. Examples
of such circumstances include indications of material
inconsistencies, inadequacies, or incompleteness in a product
evaluation report, or other specific evidence of serious concern in
relation to product safety, performance, or quality. In such cases,
the importing Party my request clarification from the exporting
Party which may lead to a request for a re-evaluation. The parties
will endeavour to respond to requests for clarification in timely
manner. Endorsement remains the responsibility of the importing
Party.
Article 13 Transmission 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 14 Transmission of product evaluation reports
Transmission of product evaluation reports will take place according
to the importing Party's specified procedures.
Article 15 Monitoring continued equivalence
Monitoring activities will be carried out in accordance with Article
10 of the Agreement.
Article 16 Listing of Additional CABs
1. During the operational period, additional CABs will be considered
for equivalence using the procedures and criteria described in
Articles 6, 7, and 9 of this Annex, taking into account the level of
confidence gained in the overall regulatory system of the other
Party.
2. Once a designating authority considers that such CABs, having
undergone the procedures of Articles 6, 7, and 9 of this Annex, may
be determined to be equivalent, it will then designate those bodies
on an annual basis. Such procedures satisfy the procedures of
Articles 7(a) and (b) of the Agreement.
3. Following such annual designations, the procedures for
confirmation of CABs under Articles 7(c) and (d) of the Agreement
shall apply.
CHAPTER 5 JOINT SPECIAL COMMITTEE
Article 17 Role and composition of the Joint Sectoral Committee
1. A Joint Sectoral Management Committee is set up to monitor the
activities under both the transitional and operational phases of
this Annex.
2. The Committee will be co-chaired by a representative of the FDA
for the US and a representative of the EC who will each have one
vote. Decisions will be taken by unanimous consent.
3. The JSC's functions will include:
(a) making a joint assessment of the equivalent of CABs;
(b) developing and maintaining the list of equivalent CABs,
including any limitation in terms of their scope of activities and
communicating the list of all authorities and the Joint Committee;
(c) providing a forum to discuss issues relating to this Annex,
including concerns that a CAB may no longer be equivalent and
opportunity to review product coverage; and
(d) consideration of the issue of suspension.
CHAPTER 6 HARMONISATION AND INFORMATION EXCHANGE
Article 18 Harmonisation
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 19 Regulatory 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 20 Alert 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.
2. Contact points will be agreed between both Parties to permit
authorities to be made aware 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.
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.
- Annex II (with the exception of section 4),
- Annex IV,
- Annex V;
(b) Council Directive 93/42/EEC of 14 June 1993 concerning medical
devices. Conformity assessment procedures.
- Annex II (with the exception of section 4),
- Annex III,
- Annex IV,
- Annex V,
- Annex VI.
2. For the United States, the following legislation applies to
Article 2(1):
(a) The Federal Food, Drug and Cosmetic Act, 21. U.S.C. ēē 321 et
seq.;
(b) The Public Health Service Act, 42 U.S.C. ēē 201 et seq.;
(c) Regulations of the United States Food and Drug Administration
found at 21 C.F.R., in particular, Parts 800 to 1299;
(d) Medical Devices; Third-Party Review of Selected Premarket
Notifications; Pilot Program, 61 Fed. Reg. 14,789-14,796 (April 3,
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.
2. During the transition period:
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.
3. Commencement of the Operational Period:
(a) at the commencement of the operational period, product coverage
shall extend to all Class I/II products covered during the
transition period;
(b) the FDA will expand the program to categories of Class II
devices as is consistent with the results of the pilot, and with the
FDA's ability to write guidance documents if the device pilot for
the third party review of medical devices is successful. The MRA
will cover to the maximum extent feasible all Class II devices
listed in Table 3 for which FDA-accredited third-party review is
available in the US.
>TABLE POSITION>
Appendix 4
Conformity assessment bodies
>TABLE POSITION>
(1) It is understood that the date of entry into force will not
occur prior to 1 June 1998, unless the Parties decide otherwise.
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>