2001/366/EC: Council Decision of 4 April 2001 on the conclusion of a Protocol to the Europe Agreement establishing an Association between the European Communities and their Member States, of the one part, and the Republic of Hungary, of the other part, on Conformity Assessment and Acceptance of Industrial Products (PECA) - Information relating to the entry into force of the Protocol to the Agreement establishing an Association between the European Communities and their Member States, of the one part, and the Republic of Hungary, of the other part, on Conformity Assessment and Acceptance of Industrial Products (PECA)
Date: 2001-04-04
Institutions: Council of the European Union
Subjects: Hungary, association agreement (EU), committee (EU), industrial product, product safety, protocol to an agreement

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COUNCIL DECISION

of 4 April 2001

on the conclusion of a Protocol to the Europe Agreement establishing an Association between the
European Communities and their Member States, of the one part, and the Republic of Hungary, of
the other part, on Conformity Assessment and Acceptance of Industrial Products (PECA)

(2001/366/EC)

THE COUNCIL OF THE EUROPEAN UNION,

and in particular Article 133 thereof,

Having regard to the Treaty establishing the European
in
Community,
conjunction with the first sentence of the first subparagraph of
Article 300(2), the first sentence of the first subparagraph of
Article 300(3) and Article 300(4) thereof,

Having regard to the proposal from the Commission,

(8)

(9)

appropriate

The
should
established to ensure the proper functioning of
Protocol.

procedures

internal

be
the

It is necessary to empower the Commission to make
certain technical amendments to the Protocol and to
take certain decisions for its implementation,

Whereas:

(1)

(2)

(3)

(4)

(5)

(6)

(7)

establishing an association
The Europe Agreement
between the European Communities and their Member
States, of the one part, and the Republic of Hungary, of
the other part (1), hereinafter referred to as the (cid:145)Europe
Agreement(cid:146), entered into force on 1 February 1994.

Article 73(2) of the Europe Agreement provides that
cooperation in the
standardisation and
fields of
conformity assessment shall seek to achieve, amongst
other things, the conclusion of agreements on mutual
recognition.

Article 108(2) of the Europe Agreement provides that
the Association Council may delegate to the Association
Committee any of its powers.

Article 2 of Decision 93/742/Euratom, ECSC, EC, of the
Council and the Commission of 13 December 1993 on
the conclusion of the Europe Agreement (2), provides
for the Community decision-making procedures and for
the presentation of
the Community position in the
Association Council and in the Association Committee.

the Association
Article 14 of Decision No 1/94 of
Council between the European Communities and their
Member States, of the one part, and the Republic of
Hungary, of the other part of 7 March 1994 on its rules
the Association
of
Committee may set up further subcommittees or groups
to assist in carrying out its duties.

procedure (3)

provides

that

The Protocol to the Europe Agreement, on Conformity
Assessment and Acceptance of Industrial Products, was
signed on behalf of the Community in Brussels on 26
February 2001 and should be approved.

Certain tasks for implementation have been conferred
the
upon the Association Council, and in particular,
power to amend the Annexes to the Protocol.

(1) OJ L 347, 31.12.1993, p. 2.
(2) OJ L 347, 31.12.1993, p. 1.
(3) OJ L 242, 17.9.1994, p. 23.

HAS DECIDED AS FOLLOWS:

Article 1

The Protocol
to the Europe Agreement, on Conformity
Assessment and Acceptance of Industrial Products (hereinafter
referred to as (cid:145)the Protocol(cid:146)), as well as the declaration annexed
to the Final Act thereto, are hereby approved on behalf of the
Community.

The text of the Protocol, and of the declaration annexed to the
Final Act thereto is attached to this Decision.

Article 2

The President of
Community,
Article 17 of the Protocol.

transmit

the Council

the
the diplomatic note provided for in

shall, on behalf of

Article 3

After consultation with the special committee appointed

1.
by the Council, the Commission shall:

(a) carry into effect

joint

team or teams of experts,

the notifications, acknowledgements,
suspensions and withdrawals of bodies, and appointments
of
in accordance with
Articles 10, 11 and 14(c), of the Protocol, and Section IV
of the Good Laboratory Practice (GLP) Annex and Section
III of the Good Manufacturing Practice (GMP) Annex to the
Protocol;

(b) bring about the consultations, exchange of

information,
the requests
for verifications and for participation in
verifications, in accordance with Articles 3, 12 and 14(d),
(e), and Section II of the GLP Annex and Sections III and
IV of the Annexes to the Protocol concerning machinery,
electrical safety, electromagnetic compatibility, hot water
boilers, gas appliances, medical devices, GLP and GMP;

(c)

if necessary, reply to requests in accordance with Article
11, Sections III and IV of the Annexes to the Protocol
safety, electromagnetic
concerning machinery, electrical

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compatibility, hot-water boilers, gas appliances, medical
devices, GLP and GMP.

Following consultation of the special committee referred
2.
to in paragraph 1,
the Commission shall determine the
position to be taken by the Community in the Association
Council and, where applicable, in the Association Committee,
with regard to:

(a) amendments to the Annexes in accordance with Article 14

point (a) of the Protocol;

(b) any decisions regarding disagreements on the results of the
verifications and the suspensions, in part or totally, of any
notified body in accordance with the second and third
subparagraphs of Article 11 of the Protocol;

(c) any measures taken in the application of the safeguard
the Protocol
clauses in Section IV of
safety, electromagnetic
concerning machinery, electrical
compatibility, hot-water boilers, gas appliances, medical
devices and GLP;

the Annexes of

(d) the entry into operation of the Sectoral Annex on GLP for

medicinal products, in accordance with section IV thereof;

(e)

the pre-operational phase and the measures to be taken in
accordance with points 3.3, 3.4, 4.12, 4.17 and 5.1 of
Section III of the GMP Annex to the Protocol;

(f) any measures concerning the verification, suspension, or
as having mutual
industrial products

withdrawal of
acceptance under Article 4 of the Protocol.

In all other cases,

the position to be taken by the
3.
Community in the Association Council and, where applicable,
in the Association Committee, with regard to this Protocol
shall be determined by the Council, acting by qualified
majority on a proposal from the Commission.

Done at Luxembourg, 4 April 2001.

For the Council

The President

B. ROSENGREN

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to the Europe Agreement establishing an Association between the European Communities and
their Member States, of the one part, and the Republic of Hungary, of the other part, on
conformity Assessment and Acceptance of Industrial Products (PECA)

PROTOCOL

THE EUROPEAN COMMUNITY AND THE REPUBLIC OF HUNGARY, hereinafter referred to as (cid:145)the Parties(cid:146),

WHEREAS Hungary has applied for membership of the European Union and such membership implies the effective
implementation of the acquis of the European Community,

RECOGNISING that
the progressive adoption and implementation of Community law by Hungary provides the
opportunity to extend certain benefits of the internal market and to ensure its effective operation in certain sectors
before accession,

CONSIDERING that,
Community law,

in the sectors covered by this Protocol, Hungarian national

law substantially takes over

CONSIDERING their shared commitment to the principles of free movement of goods and to promoting product
quality, so as to ensure the health and safety of their citizens and the protection of the environment, including through
technical assistance and other forms of cooperation between them,

DESIRING to conclude a Protocol to the Europe Agreement on Conformity Assessment and Acceptance of Industrial
Products (hereinafter referred to as (cid:145)this Protocol(cid:146)) providing for the application of the mutual acceptance of industrial
products which fulfil the requirements for being lawfully placed on the market in one of the Parties and of the mutual
recognition of the results of conformity assessment of industrial products which are subject to Community or national
law, noting that Article 73 of the Europe Agreement provides, where appropriate, for the conclusion of an agreement
on mutual recognition,

NOTING the close relationship between the European Community and Iceland, Liechtenstein and Norway through the
Agreement on the European Economic Area, which makes it appropriate to consider the conclusion of a parallel
European Conformity Assessment Agreement between Hungary and these countries equivalent to this Protocol,

BEARING IN MIND their status as Contracting Parties to the Agreement establishing the World Trade Organisation, and
conscious in particular of their obligations under the World Trade Organisation Agreement on Technical Barriers to
Trade,

HAVE AGREED AS FOLLOWS:

Article 1

Purpose

(2) the mutual

recognition of

the results of conformity
assessment of industrial products subject to Community
law, both
law and to the equivalent Hungarian national
listed in the Annexes on mutual recognition of results of
conformity assessment.

The purpose of this Protocol is to facilitate the elimination by
the Parties of technical barriers to trade in respect of industrial
products. The means to this end is the progressive adoption
and implementation by Hungary of national
law, which is
equivalent to Community law.

This Protocol provides for:

Article 2

Definitions

(1) the mutual acceptance of industrial products, listed in the
Annexes on mutual acceptance of
industrial products,
which fulfil the requirements to be lawfully placed on the
market in one of the Parties;

(cid:151) (cid:145)industrial products(cid:146) means products, as specified in Article
8 of the Europe Agreement and in Protocol 3 thereto,

For the purpose of this Protocol,

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(cid:151) (cid:145)Community law(cid:146) means any legal act and implementing
the European Community applicable to a
practice of
particular situation, risk or category of industrial products,
as interpreted by the Court of
Justice of the European
Communities,

users or other persons, or any other
legitimate concern
protected by legislation identified in the Annexes, it may take
appropriate measures to withdraw such a product from the
market, to prohibit its placing on the market, putting into
service or use, or to restrict its free movement. The Annexes
shall provide for the procedure to be applied in such cases.

(cid:151) (cid:145)national

law(cid:146) means any legal act and implementing
practice by which Hungary takes over Community law
applicable to a particular situation, risk or category of
industrial products.

The terms used in this Protocol shall have the meaning given
in Community law and Hungarian national law.

Article 7

Extension of coverage

Article 3

Alignment of legislation

As Hungary adopts and implements further national law taking
over Community law, the Parties may amend the Annexes or
add new Annexes, in accordance with the procedure laid down
in Article 14.

For the purpose of
this Protocol, Hungary agrees to take
appropriate measures, in consultation with the Commission of
to maintain or complete the
the European Communities,
in particular in the fields of
take-over of Community law,
standardisation,
conformity
metrology,
assessment, market surveillance, general safety of products, and
producer’s liability.

accreditation,

Article 4

Mutual acceptance of industrial products

industrial products, which fulfil

The Parties agree that, for the purpose of mutual acceptance,
industrial products listed in the Annexes on mutual acceptance
of
the requirements to be
lawfully placed on the market of a Party, may be placed on the
further restriction. This
market of the other Party, without
shall be without prejudice to Article 35 of
the Europe
Agreement.

Article 8

Origin

in the

this Protocol

shall apply to industrial
The provisions of
to
products which originate
non-preferential
rules of origin. Proof of origin may be
demonstrated by a certificate of origin. Such certificate is not
required in the case of importation of products covered by a
proof of origin according to Protocol 4 to the Europe
Agreement.

according

Parties

Article 9

Article 5

Obligations of Parties as regards their authorities and
bodies

Mutual recognition of the results of conformity
assessment procedures

The Parties agree to recognise the results of conformity
assessment procedures carried out
in accordance with the
Community or national law listed in the Annexes on mutual
recognition of the results of conformity assessment. The Parties
shall not require procedures to be repeated, nor shall they
impose additional requirements, for the purposes of accepting
that conformity.

The Parties shall ensure that authorities under their jurisdiction
which are responsible for the effective implementation of
Community and national
law shall continuously apply it.
Further, they shall ensure that these authorities are able, where
appropriate,
suspension and
suspend,
withdraw notification of bodies, to ensure the conformity of
industrial products with Community or national
law or to
require their withdrawal from the market.

to notify,

remove

Article 6

Safeguard clause

Where a Party finds that an industrial product placed on its
territory by virtue of this Protocol, and used in accordance
with its intended use, may compromise the safety or health of

The Parties shall ensure that bodies, notified under
their
respective jurisdiction to assess conformity in relation to
law specified in the
requirements of Community or national
Annexes, continuously comply with the requirements of
they shall
Community or national
take all
necessary steps to ensure that
these bodies maintain the
necessary competence to carry out the tasks for which they are
notified.

law. Further,

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Article 10

Notified bodies

requirements of Community or national
law specified in the
Annexes shall be suspended in part or totally from the date on
which the disagreement of the Parties has been notified to the
Chairman of the Association Council.

Initially, the bodies notified for the purpose of this Protocol
shall be those included in the lists which Hungary and the
Community have exchanged before the completion of
the
procedures for entry into force.

Article 12

Exchange of information and cooperation

the following procedure shall apply for

Afterwards,
the
notification of bodies to assess conformity in relation to the
law specified in the
requirements of Community or national
Annexes:

(a) a Party shall forward its notification to the other Party in

writing;

(b) on the acknowledgement of

the other Party, given in
writing, the body shall be considered as notified and as
competent
in relation to the
conformity
requirements specified in the Annexes from that date.

to assess

it shall

If a Party decides to withdraw a notified body under its
jurisdiction,
inform the other Party in writing. The
body shall cease to assess conformity in relation to the
requirements specified in the Annexes from the date of its
withdrawal at the latest. Nevertheless, conformity assessment
carried out before that date shall remain valid, unless otherwise
decided by the Association Council.

Article 11

Verification of notified bodies

Each Party may request the other Party to verify the technical
competence and compliance of a notified body under its
jurisdiction. Such request shall be justified in order to allow
the Party responsible for the notification to carry out
the
requested verification and report speedily to the other Party.
The Parties may also jointly examine the body, with the
participation of the relevant authorities. To this end, the Parties
their
shall ensure the full cooperation of bodies under
jurisdiction. The Parties shall take all appropriate steps, and use
whatever available means may be necessary, with a view to
resolving any problems which are detected.

If the problems cannot be resolved to the satisfaction of both
Parties,
the Association
Council of their dissent, giving their reasons. The Association
Council may decide on appropriate action.

they may notify the Chairman of

Unless and until decided otherwise by the Association Council,
its
the notification of
the
competence

the body and the recognition of

conformity

relation

assess

to

to

in

In order to ensure a correct and uniform application and
interpretation of this Protocol, the Parties, their authorities and
their notified bodies shall:

(a) exchange

relevant

concerning
all
implementation
in
particular, on procedure to ensure compliance of notified
bodies;

information
practice

including,

law and

of

(b) take part, as appropriate,

in the relevant mechanisms of
information, coordination and other related activities of the
Parties;

(c) encourage their bodies
establishing mutual
voluntary sphere.

to cooperate with a view to
in the

recognition arrangements

Article 13

Confidentiality

Representatives, experts and other agents of the Parties shall be
required, even after their duties have ceased, not to disclose
information acquired under this Protocol which is of the kind
covered by the obligation of professional
secrecy. This
information may not be used for purposes other than those
envisaged by this Protocol.

Article 14

Management of the Protocol

Responsibility for the effective functioning of
this Protocol
shall be held by the Association Council in conformity with
Article 106 of the Europe Agreement. In particular,
it shall
have the power to take decisions regarding:

(a) amending the Annexes;

(b) adding new Annexes;

(c) appointing a joint team or teams of experts to verify the
its

competence of

a notified

body

and

technical
compliance with the requirements;

(d) exchanging

information

actual
on
modifications of the Community and national law referred
to in the Annexes;

proposed

and

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(e) considering new or additional

conformity assessment

procedures affecting a sector covered by an Annex;

(f)

resolving any questions relating to the application of this
Protocol.

The Association Council may delegate the responsibilities set
out under this Protocol, in conformity with Article 108(2) of
the Europe Agreement.

Article 15

Technical cooperation and assistance

results of conformity assessment procedures carried out in that
third country, unless there is an explicit agreement between
the Parties in the Association Council.

Article 17

Entry into force

This Protocol shall enter into force on the first day of the
second month following the date on which the Parties have
exchanged diplomatic notes confirming the completion of their
respective procedures for entry into force of the Protocol.

The Community may provide technical cooperation and
assistance to Hungary where necessary in order to support the
effective implementation and application of this Protocol.

Article 18

Status of the Protocol

Article 16

Agreements with other countries

Agreements on conformity assessment concluded by either
Party with a country which is not a Party to this Protocol shall
not entail an obligation upon the other Party to accept the

This Protocol shall constitute an integral part of the Europe
Agreement.

This Protocol is drawn up in two originals in Danish, Dutch,
English, Finnish, French, German, Greek,
Italian, Portuguese,
Spanish, Swedish and Hungarian languages, each text being
equally authentic.

Hecho en Bruselas, el veintiseis de febrero del dos mil uno.

Udf(cid:230)rdiget i Bruxelles den seksogtyvende februar to tusind og en.

Geschehen zu Br(cid:252)ssel am sechsundzwanzigsten Februar zweitausendundeins.

‚cime rsiy Bqtn(cid:221)kkey, rsiy e(cid:223)jori (cid:221)ni Uebqotaq(cid:223)ot d(cid:253)o viki(cid:220)dey (cid:221)ma.

Done at Brussels on the twenty-sixth day of February in the year two thousand and one.

Fait (cid:224) Bruxelles, le vingt-six fØvrier deux mille un.

Fatto a Bruxelles, add(cid:236) ventisei febbraio duemilauno.

Gedaan te Brussel, de zesentwintigste februari tweeduizendeneen.

Feito em Bruxelas, em vinte e seis de Fevereiro de dois mil e um.

Tehty Brysseliss(cid:228) kahdentenakymmenenten(cid:228)kuudentena p(cid:228)iv(cid:228)n(cid:228) helmikuuta vuonna kaksituhattayksi.

Som skedde i Bryssel den tjugosj(cid:228)tte februari tjugohundraett.

KØsz(cid:252)lt Br(cid:252)sszelben, 2001. februÆr 26-Æn.

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Por la Comunidad Europea

For Det Europ(cid:230)iske F(cid:230)llesskab

F(cid:252)r die Europ(cid:228)ische Gemeinschaft

Cia sgm Etqxpaœj(cid:222) Joim(cid:252)sgsa

For the European Community

Pour la CommunautØ europØenne

Per la Comunit(cid:224) europea

Voor de Europese Gemeenschap

Pela Comunidade Europeia

Euroopan yhteis(cid:246)n puolesta

P(cid:229) Europeiska gemenskapens v(cid:228)gnar

Az Eur(cid:243)pai K(cid:246)z(cid:246)ssØg nevØben

Por la Repœblica de Hungr(cid:237)a

For Republikken Ungarn

F(cid:252)r die Republik Ungarn

Cia sgm Dglojqas(cid:223)a sgy Otccaq(cid:223)ay

For the Republic of Hungary

Pour la RØpublique de Hongrie

Per la Repubblica d’Ungheria

Voor de Republiek Hongarije

Pela Repœblica da Hungria

Unkarin tasavallan puolesta

P(cid:229) Republiken Ungerns v(cid:228)gnar

A Magyar K(cid:246)ztÆrsasÆg nevØben

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ANNEXES

ANNEXES ON MUTUAL ACCEPTANCE OF INDUSTRIAL PRODUCTS

(for the record)

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ANNEXES ON MUTUAL RECOGNITION OF RESULTS OF CONFORMITY ASSESSMENT

Table of contents

1. Machinery

2.

Electrical safety

3.

Electromagnetic compatibility

4. Hot-water boilers

5. Gas appliances

6. Medical devices

7. Good Laboratory Practice (GLP) for medicinal products for human use

8. Good Manufacturing Practice (GMP) for medicinal products for human use: inspection and batch certification

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ANNEX ON MUTUAL RECOGNITION OF RESULTS OF CONFORMITY ASSESSMENT

MACHINERY

S e c t i o n I

Community and national law

Community law:

National law:

European Parliament and Council Directive 98/37/EC of 22 June 1998 on the
approximation of the laws of the Member States relating to machinery (OJ L 207,
23.7.1998, p. 1), as amended by European Parliament and Council Directive 98/79/EC of
27 October 1998 (OJ L 331, 7.12.1998, p. 1).

Decree 21/1998 (IV.17) IKIM of the Minister of Industry, Trade and Tourism on the
safety requirements of machinery and assessment of their conformity (Magyar K(cid:246)zl(cid:246)ny
32, 17.4.1998, p. 2606) as last amended by Decree 60/1999 (XII.1) GM (Magyar K(cid:246)zl(cid:246)ny
107, 1.12.1999, p. 6897).

Decree 4/1999 (II.24) GM of MEA on the detailed rules on the designation of testing,
inspection and certification bodies for conformity assessment of
technical products
(Magyar K(cid:246)zl(cid:246)ny 14, 24.2.1999, p. 1036).

S e c t i o n I I

Notifying authorities

European Community

(cid:151) Belgium:

MinistŁre des Affaires Economiques/Ministerie van Economische Zaken.

(cid:151) Denmark:

Direktoratet for Arbejdstilsynet.

(cid:151) Germany:

Bundesministerium f(cid:252)r Arbeit und Sozialordnung.

(cid:151) Greece:

Tpotqce(cid:223)o Am(cid:220)pstngy. Cemij(cid:222) Cqallase(cid:223)a Biolgvam(cid:223)ay

(Ministry of Development. General Secretariat of Industry).

(cid:151) Spain:

(cid:151) France:

(cid:151) Ireland:

(cid:151) Italy:

Ministerio de Ciencia y Tecnolog(cid:237)a.

MinistŁre de l’emploi et de la solidaritØ, Direction des relations du travail, Bureau CT 5.

Department of Enterprise and Employment.

Ministero dell’Industria, del Commercio e dell’Artigianato.

(cid:151) Luxembourg:

MinistŁre du Travail (Inspection du travail et des Mines).

(cid:151) Netherlands:

Ministerie van Sociale Zaken en Werkgelegenheid

(cid:151) Austria:

Bundesministerium f(cid:252)r Wirtschaft und Arbeit

(cid:151) Portugal:

Under the authority of the Government of Portugal: Instituto PortuguŒs da Qualidade.

(cid:151) Finland:

(cid:151) Sweden:

Sosiaali-ja terveysministeri(cid:246) / Social-och h(cid:228)lsov(cid:229)rdsministeriet.

Under the authority of
teknisk kontroll (SWEDAC).

the Government of Sweden: Styrelsen f(cid:246)r ackreditering och

(cid:151) United Kingdom:

Department of Trade and Industry.

Hungary

GazdasÆgi MinisztØrium (Ministry of Economic Affairs (cid:151) MEA).

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S e c t i o n I I I

Notified bodies

European Community

Bodies which have been notified by the Member States of the Community in accordance with the Community law of
Section I and notified to Hungary in accordance with Article 10 of this Protocol.

Hungary

Bodies which have been designated by Hungary in accordance with the Hungarian national
notified to the Community in accordance with Article 10 of this Protocol.

law of Section I and

S e c t i o n I V

Specific arrangements

Safeguard clauses

A. Safeguard clause relating to industrial products:

1. Where a Party has taken a measure to deny free access to its market for industrial products bearing the CE
marking, subject to this Annex, it shall immediately inform the other Party, indicating the reasons for its
decision and how non compliance has been assessed.

2. The Parties shall consider the matter and the evidence brought to their knowledge, and shall report to each

other the results of its investigations.

3.

4.

In case of agreement, the Parties shall take appropriate measures to ensure that such products are not placed
on the market.

In case of disagreement on the outcome of such investigations the matter shall be forwarded to the
Association Council who may decide to have an expertise carried out.

5. Where the Association Council finds that the measure is:

(a) unjustified, the national authority of the Party who has taken the measure shall withdraw it;

(b)

justified, the Parties shall take appropriate measures to ensure that such products are not placed on the
market.

B.

Safeguard clause relating to harmonised standards:

1. Where Hungary considers that a harmonised standard referred to in the legislation defined in this Annex does
not meet the essential requirements of such legislation, it shall inform the Association Council giving the
reasons thereof.

2. The Association Council shall consider the matter and may request the Community to proceed in accordance

with the procedure provided for in the Community legislation identified in this Annex.

3. The Community shall keep the Association Council and the other Party informed of the proceedings.

4. The outcome of the procedure shall be notified to the other Party.

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ANNEX ON MUTUAL RECOGNITION OF RESULTS OF CONFORMITY ASSESSMENT

ELECTRICAL SAFETY

S e c t i o n I

Community and national law

Community law:

Council Directive 73/23/EEC of 19 February 1973 on the approximation of the laws of
the Member States relating to electrical equipment designed for use within certain voltage
limits (OJ L 77, 26.3.1973, p. 29), as last amended by Directive 93/68/EEC of 22 July
1993 (OJ L 220, 30.8.1993, p. 1).

National law:

Decree 79/1997. (XII.31.) IKIM of the Minister of Industry, Trade and Tourism on safety
requirements of certain electrical equipment and assessment of conformity with those
requirements (Magyar K(cid:246)zl(cid:246)ny 122, 31.12.1997, p. 10100).

Decree 4/1999. (II.24.) GM of MEA on the detailed rules on the designation of testing,
inspection and certification bodies for conformity assessment of
technical products
(Magyar K(cid:246)zl(cid:246)ny 14, 24.2.1999, p. 1036).

S e c t i o n I I

Notifying authorities

European Community

(cid:151) Belgium:

MinistŁre des Affaires Economiques/Ministerie van Economische Zaken.

(cid:151) Denmark:

Boligministeriet.

(cid:151) Germany:

Bundesministerium f(cid:252)r Arbeit und Sozialordung.

(cid:151) Greece:

Tpotqce(cid:223)o Am(cid:220)pstngy. Cemij(cid:222) Cqallase(cid:223)a Biolgvam(cid:223)ay

(cid:151) Spain:

(cid:151) France:

(Ministry of Development. General Secretariat of Industry).

Ministerio de Ciencia y Tecnolog(cid:237)a.

MinistŁre de l’Øconomie, des finances et de l’industrie, Direction GØnØrale de l’Industrie,
des Technologies de l’Information et des Postes (DiGITIP) ﬂ SQUALPI.

(cid:151) Ireland:

Department of Enterprise and Employment.

(cid:151) Italy:

Ministero dell’ Industria, del Commercio e dell’ Artigianato.

(cid:151) Luxembourg:

MinistŁre de l’Economie (cid:151) Service de l’Energie de l’Etat.

MinistŁre du Travail (Inspection du Travail et des Mines).

(cid:151) Netherlands:

Ministerie van Volksgezondheid, Welzijn en Sport
Sociale Zaken en Werkgelegenheid (others).

(consumer goods). Ministerie van

Ministerie van Sociale Zaken en Werkgelegenheid (others).

(cid:151) Austria:

Bundesministerium f(cid:252)r Wirtschaft und Arbeit.

(cid:151) Portugal:

Under the authority of the Government of Portugal: Instituto PortuguŒs da Qualidade.

(cid:151) Finland:

(cid:151) Sweden:

Kauppa- ja teollisuusministeri(cid:246) / Handels- och industriministeriet.

Under the authority of
teknisk kontroll (SWEDAC).

the Government of Sweden: Styrelsen f(cid:246)r ackreditering och

(cid:151) United Kingdom:

Department of Trade and Industry.

17.5.2001

EN

Official Journal of the European Communities

L 135/47

Hungary:

GazdasÆgi MinisztØrium (Ministry of Economic Affairs (cid:151) MEA).

S e c t i o n I I I

Notified bodies

European Community

Bodies which have been notified by the Member States of the Community in accordance with the Community law of
Section I and notified to Hungary in accordance with Article 10 of this Protocol.

Hungary

Bodies which have been designated by Hungary in accordance with the Hungarian national
notified to the Community in accordance with Article 10 of this Protocol.

law of Section I and

S e c t i o n I V

Specific arrangements

Safeguard clauses

A. Safeguard clause relating to industrial products:

1. Where a Party has taken a measure to deny free access to its market for industrial products bearing the CE
marking, subject to this Annex, it shall immediately inform the other Party, indicating the reasons for its
decision and how non compliance has been assessed.

2. The Parties shall consider the matter and the evidence brought to their knowledge, and shall report to each

other the results of their investigations.

3.

4.

In case of agreement, the Parties shall take appropriate measures to ensure that such products are not placed
on the market.

In case of disagreement on the outcome of such investigations the matter shall be forwarded to the
Association Council who may decide to have an expertise carried out.

5. Where the Association Council finds that the measure is:

(a) unjustified, the national authority of the Party who has taken the measure shall withdraw it;

(b)

justified, the Parties shall take appropriate measures to ensure that such products are not placed on the
market.

B.

Safeguard clause relating to harmonised standards:

1. Where Hungary considers that a harmonised standard referred to in the legislation defined in this Annex does
not meet the essential requirements of such legislation, it shall inform the Association Council giving the
reasons thereof.

2. The Association Council shall consider the matter and may request the Community to proceed in accordance

with the procedure provided for in the Community legislation identified in this Annex.

3. The Community shall keep the Association Council and the other Party informed of the proceedings.

4. The outcome of the procedure shall be notified to the other Party.

L 135/48

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Official Journal of the European Communities

17.5.2001

Community law:

National law:

ANNEX ON MUTUAL RECOGNITION OF RESULTS OF CONFORMITY ASSESSMENT

ELECTROMAGNETIC COMPATIBILITY

S e c t i o n I

Community and national law

Council Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of the
Member States relating to electromagnetic compatibility (OJ L 139, 23.5.1989, p. 19), as
last amended by Council Directive 93/68/EEC of 22 July 1993 (OJ L 220, 30.8.1993,
p. 1).

Joint Decree 31/1999 (VI. 11) GM-KHVM of the Ministers of Economic Affairs and
Transport, Telecommunication and Water Management on electromagnetic compatibility
(Magyar K(cid:246)zl(cid:246)ny 51, 11.6.1999, p. 3302), as amended by Joint Decree 58/1999 (X.27)
GM-KHVM (Magyar K(cid:246)zl(cid:246)ny 93, 27.10.1999, p. 5840).

Decree 4/1999 (II.24) GM of MEA on the detailed rules on the designation of testing,
inspection and certification bodies for conformity assessment of
technical products
(Magyar K(cid:246)zl(cid:246)ny 14, 24.2.1999, p. 1036).

Decree 22/1999 (VIII.4) KHVM of MTCWM on the detailed rules on the designation of
for conformity assessment of certain
testing,
telecommunication and information technology products (Magyar K(cid:246)zl(cid:246)ny 69, 4.8.1999,
p. 4466).

inspection and certification bodies

S e c t i o n I I

Notifying authorities

European Community

(cid:151) Belgium:

MinistŁre des Affaires Economiques/Ministerie van Economische Zaken.

(cid:151) Denmark:

Telestyrelsen.

(cid:151) Germany:

Bundesministerium f(cid:252)r Arbeit und Sozialordnung.

(cid:151) Greece:

Tpotqce(cid:223)o Am(cid:220)pstngy. Cemij(cid:222) Cqallase(cid:223)a Biolgvam(cid:223)ay

(cid:151) Spain:

(cid:151) France:

(cid:151) Ireland:

(cid:151) Italy:

(Ministry of Development. General Secretariat of Industry).

Ministerio de Ciencia y Tecnolog(cid:237)a.

MinistŁre de l’Øconomie, des finances et de l’industrie, Direction GØnØrale de l’Industrie,
des Technologies de l’Information et des Postes (DIGITIP), SQUALPI.

Department of Enterprise and Employment.

Ministero dell’Industria, del Commercio e dell’Artigianato.

(cid:151) Luxembourg:

MinistŁre de l’Economie- Service de l’Energie de l’Etat.

(cid:151) Netherlands:

Ministerie van Verkeer en Waterstaat.

(cid:151) Austria:

Bundesministerium f(cid:252)r Wirtschaft und Arbeit.

(cid:151) Portugal:

Under the authority of the Government of Portugal: Instituto PortuguŒs da Qualidade.

(cid:151) Finland:

(cid:151) Sweden:

Kauppa-ja teollisuusministeri(cid:246) / Handels-och industriministeriet. For EMC aspects of
telecommunications
ja
viestint(cid:228)ministeri(cid:246)/Kommunikationsministeriet.

equipment:

Liikenne-

radio

and

Under the authority of
teknisk kontroll (SWEDAC).

the Government of Sweden: Styrelsen f(cid:246)r ackreditering och

(cid:151) United Kingdom:

Department of Trade and Industry.

17.5.2001

EN

Official Journal of the European Communities

L 135/49

Hungary

GazdasÆgi MinisztØrium (Ministry of Economic Affairs (cid:151) MEA).

K(cid:246)zlekedØsi, H(cid:237)rk(cid:246)zlØsi Øs V(cid:237)z(cid:252)gyi MinisztØrium (Ministry of Transport, Communication and Water Management (cid:151)
MTCWM).

S e c t i o n I I I

Notified and competent bodies

European Community

Bodies which have been notified by the Member States of the Community in accordance with the Community law of
Section I and notified to Hungary in accordance with Article 10 of this Protocol.

Hungary

Bodies which have been designated by Hungary in accordance with the Hungarian national
notified to the Community in accordance with Article 10 of this Protocol.

law of Section I and

S e c t i o n I V

Specific arrangements

Safeguard clauses

A. Safeguard clause relating to industrial products:

1. Where a Party has taken a measure to deny free access to its market for industrial products bearing the CE
marking, subject to this Annex, it shall immediately inform the other Party, indicating the reasons for its
decision and how non compliance has been assessed.

2. The Parties shall consider the matter and the evidence brought to their knowledge, and their knowledge, and

shall report to each other the results of their investigations.

3.

4.

In case of agreement, the Parties shall take appropriate measures to ensure that such products are not placed
on the market.

In case of disagreement on the outcome of such investigations the matter shall be forwarded to the
Association Council who may decide to have an expertise carried out.

5. Where the Association Council finds that the measure is:

(a) unjustified, the national authority of the Party who has taken the measure shall withdraw it;

(b)

justified, the Parties shall take appropriate measures to ensure that such products are not placed on the
market.

B.

Safeguard clause relating to harmonised standards:

1. Where Hungary considers that a harmonised standard referred to in the legislation defined in this Annex does
not meet the essential requirements of such legislation, it shall inform the Association Council giving the
reasons thereof.

2. The Association Council shall consider the matter and may request the Community to proceed in accordance

with the procedure provided for in the Community legislation identified in this Annex.

3. The Community shall keep the Association Council and the other Party informed of the proceedings.

4. The outcome of the procedure shall be notified to the other Party.

L 135/50

EN

Official Journal of the European Communities

17.5.2001

ANNEX ON MUTUAL RECOGNITION OF RESULTS OF CONFORMITY ASSESSMENT

HOT-WATER BOILERS

S e c t i o n I

Community and national law

Community law:

National law:

Council Directive 92/42/EEC of 21 May 1992 on efficiency requirements for new
hot-water boilers fired with liquid or gaseous fuels (OJ L 167, 22.6.1992 p. 17), as
amended by Council Directive 93/68/EEC of 22 July 1993 (OJ L 220, 30.8.1993, p. 1).

Industry, Trade and Tourism on
the Minister of
Decree 20/1998 (IV.17)
efficiency requirements for hot-water boilers fired with liquid or gaseous fuels and
assessment of their conformity (Magyar K(cid:246)zl(cid:246)ny 32, 17.4.1998, p. 2603).

IKIM of

Decree 4/1999 (II.24) GM of MEA on the detailed rules on the designation of testing,
technical products
inspection and certification bodies for conformity assessment of
(Magyar K(cid:246)zl(cid:246)ny 14, 24.2.1999, p. 1036).

S e c t i o n I I

Notifying authorities

European Community

(cid:151) Belgium:

MinistŁre des Affaires Economiques/Ministerie van Economische Zaken.

(cid:151) Denmark:

Boligministeriet.

(cid:151) Germany:

Bundesministerium f(cid:252)r Wirtschaft und Technologie.

(cid:151) Greece:

Tpotqce(cid:223)o Am(cid:220)pstngy. Cemij(cid:222) Cqallase(cid:223)a Biolgvam(cid:223)ay

(cid:151) Spain:

(cid:151) France:

(Ministry of Development. General Secretariat of Industry).

Ministerio de Ciencia y Tecnolog(cid:237)a.

MinistŁre de l’Øconomie, des finances et de l’industrie, Direction de l’Action RØgionale et
de la Petite et Moyenne Industrie (DARPMI). Sous-direction de la sØcuritØ industrielle.

(cid:151) Ireland:

Department of Enterprise and Employment.

(cid:151) Italy:

Ministero dell’Industria, del Commercio e dell’Artigianato.

(cid:151) Luxembourg:

MinistŁre de l’Environnement.

(cid:151) Netherlands:

Ministerie van Economische Zaken.

(cid:151) Austria:

Bundesministerium f(cid:252)r Wirtschaft und Arbeit.

(cid:151) Portugal:

Under the authority of the Government of Portugal: Instituto PortuguŒs da Qualidade.

(cid:151) Finland:

(cid:151) Sweden:

Ymp(cid:228)rist(cid:246)ministeri(cid:246)/Milj(cid:246)ministeriet.

Under the authority of
teknisk kontroll (SWEDAC).

the Government of Sweden: Styrelsen f(cid:246)r ackreditering och

(cid:151) United Kingdom:

Department of the Environment, Transport and the Regions.

Hungary

GazdasÆgi MinisztØrium (Ministry of Economic Affairs ﬂ MEA).

17.5.2001

EN

Official Journal of the European Communities

L 135/51

S e c t i o n I I I

Notified bodies

European Community

Bodies which have been notified by the Member States of the Community in accordance with the Community law of
Section I and notified to Hungary in accordance with Article 10 of this Protocol.

Hungary

Bodies which have been designated by Hungary in accordance with the Hungarian national
notified to the Community in accordance with Article 10 of this Protocol.

law of Section I and

S e c t i o n I V

Specific arrangements

Safeguard clauses

A. Safeguard clause relating to industrial products:

1. Where a Party has taken a measure to deny free access to its market for industrial products bearing the CE
marking, subject to this Annex, it shall immediately inform the other Party, indicating the reasons for its
decision and how non compliance has been assessed.

2. The Parties shall consider the matter and the evidence brought to their knowledge, and shall report to each

other the results of their investigations.

3.

4.

In case of agreement, the Parties shall take appropriate measures to ensure that such products are not placed
on the market.

In case of disagreement on the outcome of such investigations the matter shall be forwarded to the
Association Council who may decide to have an expertise carried out.

5. Where the Association Council finds that the measure is:

(a) unjustified, the national authority of the Party who has taken the measure shall withdraw it;

(b)

justified, the Parties shall take appropriate measures to ensure that such products are not placed on the
market.

B.

Safeguard clause relating to harmonised standards:

1. Where Hungary considers that a harmonised standard referred to in the legislation defined in this Annex does
not meet the essential requirements of such legislation, it shall inform the Association Council giving the
reasons thereof.

2. The Association Council shall consider the matter and may request the Community to proceed in accordance

with the procedure provided for in the Community legislation identified in this Annex.

3. The Community shall keep the Association Council and the other Party informed of the proceedings.

4. The outcome of the procedure shall be notified to the other Party.

L 135/52

EN

Official Journal of the European Communities

17.5.2001

ANNEX ON MUTUAL RECOGNITION OF RESULTS OF CONFORMITY ASSESSMENT

GAS APPLIANCES

S e c t i o n I

Community and national law

Community law:

National law:

Council Directive 90/396/EEC of 29 June 1990 on the approximation of the laws of the
Member States relating to appliances burning gaseous fuels (OJ L 196, 26.7.1990, p. 15)
as last amended by Council Directive 93/68/EEC of 22 July 1993 (OJ L 220, 30.8.1993,
p. 1).

Decree 22/1998 (IV.17) IKIM of the Minister of Industry, Trade and Tourism on the
design of certain appliances burning gaseous fuels and the assessment of their conformity
(Magyar K(cid:246)zl(cid:246)ny 32, 17.4.1998, p. 2629), as last amended by Decree 67/1999 (XII.15)
GM (Magyar K(cid:246)zl(cid:246)ny 113, 15.12.1999, p. 7506).

Decree 4/1999 (II.24) GM of MEA on the detailed rules on the designation of testing,
inspection and certification bodies for conformity assessment of
technical products
(Magyar K(cid:246)zl(cid:246)ny 14, 24.2.1999, p. 1036).

S e c t i o n I I

Notifying authorities

European Community

(cid:151) Belgium:

MinistŁre des Affaires Economiques/Ministerie van Economische Zaken.

(cid:151) Denmark:

Danmarks Gasmateriel Prłvning.

(cid:151) Germany:

Bundesministerium f(cid:252)r Arbeit und Sozialordnung.

(cid:151) Greece:

Tpotqce(cid:223)o Am(cid:220)pstngy. Cemij(cid:222) Cqallase(cid:223)a Biolgvam(cid:223)ay

(cid:151) Spain:

(cid:151) France:

(Ministry of Development. General Secretariat of Industry).

Ministerio de Ciencia y Tecnolog(cid:237)a.

MinistŁre de l’Øconomie, des finances et de l’industrie, Direction de l’Action RØgionale et
de la Petite et Moyenne Industrie (DARPMI). Sous-direction de la sØcuritØ industrielle.

(cid:151) Ireland:

Department of Enterprise and Employment.

(cid:151) Italy:

Ministero dell’Industria, del Commercio e dell’Artigianato.

(cid:151) Luxembourg:

MinistŁre du Travail (Inspection du Travail et des Mines).

(cid:151) Netherlands:

Ministerie van Economische Zaken.

(cid:151) Austria:

Bundesministerium f(cid:252)r Wirtschaft und Arbeit.

(cid:151) Portugal:

Under the authority of the Government of Portugal: Instituto PortuguŒs da Qualidade.

(cid:151) Finland:

Kauppa-ja teollisuusministeri(cid:246)/Handels-och industriministeriet.

(cid:151) Sweden:

Under the authority of
teknisk kontroll (SWEDAC).

the Government of Sweden: Styrelsen f(cid:246)r ackreditering och

(cid:151) United Kingdom:

Department of Trade and Industry.

17.5.2001

EN

Official Journal of the European Communities

L 135/53

Hungary

GazdasÆgi MinisztØrium (Ministry of Economic Affairs (cid:151) MEA).

S e c t i o n I I I

Notified bodies

European Community

Bodies which have been notified by the Member States of the Community in accordance with the Community law of
Section I and notified to Hungary in accordance with Article 10 of this Protocol.

Hungary

Bodies which have been designated by Hungary in accordance with the Hungarian national
notified to the Community in accordance with Article 10 of this Protocol.

law of Section I and

S e c t i o n I V

Specific arrangements

Safeguard clauses

A. Safeguard clause relating to industrial products:

1. Where a Party has taken a measure to deny free access to its market for industrial products bearing the CE
marking, subject to this Annex, it shall immediately inform the other Party, indicating the reasons for its
decision and how non compliance has been assessed.

2. The Parties shall consider the matter and the evidence brought to their knowledge, and shall report to each

other the results of their investigations.

3.

4.

In case of agreement, the Parties shall take appropriate measures to ensure that such products are not placed
on the market.

In case of disagreement on the outcome of such investigations the matter shall be forwarded to the
Association Council who may decide to have an expertise carried out.

5. Where the Association Council finds that the measure is:

(a) unjustified, the national authority of the Party who has taken the measure shall withdraw it;

(b)

justified, the Parties shall take appropriate measures to ensure that such products are not placed on the
market.

B.

Safeguard clause relating to harmonised standards:

1. Where Hungary considers that a harmonised standard referred to in the legislation defined in this Annex does
not meet the essential requirements of such legislation, it shall inform the Association Council giving the
reasons thereof.

2. The Association Council shall consider the matter and may request the Community to proceed in accordance

with the procedure provided for in the Community legislation identified in this Annex.

3. The Community shall keep the Association Council and the other Party informed of the proceedings.

4. The outcome of the procedure shall be notified to the other Party.

L 135/54

EN

Official Journal of the European Communities

17.5.2001

ANNEX ON MUTUAL RECOGNITION OF RESULTS OF CONFORMITY ASSESSMENT

MEDICAL DEVICES

S e c t i o n I

Community and national law

Community law:

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 (OJ L 189, 20.7.1990, p.
17) as last amended by Council Directive 93/68/EEC of 22 July 1993 (OJ L 220,
30.8.1993, p. 1).

Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169,
12.7.1993, p. 1) as last amended by European Parliament and Council Directive
98/79/EC of 27 October 1998 (OJ L 331, 7.12.1998, p. 1).

National law:

Decree 47/1999 (X.6) E(cid:252)M of the Ministry of Health on medical devices (Magyar K(cid:246)zl(cid:246)ny
88, 6.10 1999, p. 5512).

Decree 48/1999 (X.6) E(cid:252)M of MH on the detailed rules on the designation of testing,
inspection and certification bodies for conformity assessment of medical devices (Magyar
K(cid:246)zl(cid:246)ny 88, 6.10.1999, p. 5544).

S e c t i o n I I

Notifying authorities

European Community

(cid:151) Belgium:

MinistŁre de la SantØ Publique, de l’Environment et de l’Integration Sociale. Inspection
Integratie.
Pharmaceutique/Ministerie van Volksgenzondheid, Leefmilieu en Sociale
Farmaceutische Inspectie

MinistŁre des Affaires Economiques/Ministerie van Economische Zaken.

(cid:151) Denmark:

Sundhedsministeriet.

(cid:151) Germany:

Bundesministerium f(cid:252)r Gesundheit.

(cid:151) Greece:

(cid:151) Spain:

(cid:151) France:

Tpotqce(cid:223)o Tce(cid:223)ay (Ministry of Health).

Ministerio de Ciencia y Tecnolog(cid:237)a.

Agence Fran(cid:231)aise de SØcuritØ Sanitaire des Produits de SantØ (AFSSAPS).

MinistŁre de l’Øconomie, des finances et de l’industrie, Direction GØnØrale de l’Industrie,
des Technologies de l’Information et des Postes (DIGITIP), Sous-direction de la chimie, de
la pharmacie et des biotechnologies.

(cid:151) Ireland:

(cid:151) Italy:

Department of Health.

Ministero della Sanit(cid:224).

(cid:151) Luxembourg:

MinistŁre de la SantØ.

(cid:151) Netherlands:

Ministerie van Volksgezondheid, Welzijn en Sport; inspectie Volksgezondheid.

(cid:151) Austria:

Bundesministerium f(cid:252)r soziale Sicherheit und Generationen.

(cid:151) Portugal:

Under the authority of the Government of Portugal: Instituto PortuguŒs da Qualidade.

(cid:151) Finland:

(cid:151) Sweden:

Sosiaali-ja terveysministeri(cid:246)/Social-och h(cid:228)lsov(cid:229)rdsministeriet.

Under the authority of
teknisk kontroll (SWEDAC).

the Government of Sweden: Styrelsen f(cid:246)r ackreditering och

(cid:151) United Kingdom:

Department of Health.

17.5.2001

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Official Journal of the European Communities

L 135/55

Hungary

EgØszsØg(cid:252)gyi MinisztØrium (Ministry of Health (cid:151) MH).

S e c t i o n I I I

Notified bodies

European Community

Bodies which have been notified by the Member States of the Community in accordance with the Community law of
Section I and notified to Hungary in accordance with Article 10 of this Protocol.

Hungary

Bodies which have been designated by Hungary in accordance with the Hungarian national
notified to the Community in accordance with Article 10 of this Protocol.

law of Section I and

S e c t i o n I V

Specific arrangements

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

Any manufacturer who places on the market of one of the Parties the medical devices referred to in Article 14 of
Directive 93/42/EEC and in the relevant Hungarian national law shall inform the competent authorities of the Party
in which he has his registered place of business of the particulars referred to in these provisions. The Parties shall
reciprocally recognise that registration. The manufacturer shall not be obliged to designate a person responsible for
placing devices on the market established in the territory of the other Party.

2.

Labelling of medical devices

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

3.

Information exchanges

In accordance with Article 12 of this Protocol, the Parties shall in particular exchange the information referred to
in the relevant Community law and Hungarian national law, in particular:

(cid:151) data relating to registration of manufacturers and devices,

(cid:151) data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused,

(cid:151) data obtained in accordance with the vigilance procedure.

4.

Safeguard clause

A. Safeguard clause relating to industrial products:

1. Where a Party has taken a measure to deny free access to its market for industrial products bearing the CE
marking, subject to this Annex, it shall immediately inform the other Party, indicating the reasons for its
decision and how non-compliance has been assessed.

2. The Parties shall consider the matter and the evidence brought to their knowledge and shall report to each

other the results of their investigations.

3.

In case of agreement, the Parties shall take appropriate measures to ensure that such products are not
placed on the market.

L 135/56

EN

4.

Official Journal of the European Communities

17.5.2001

In case of disagreement on the outcome of such investigations the matter shall be forwarded to the
Association Council who may decide to have an expertise carried out.

5. Where the Association Council finds that the measure is:

(a) unjustified, the national authority of the Party who has taken the measure shall withdraw it;

(b)

justified, the Parties shall take appropriate measures to ensure that such products are not placed on
the market.

B.

Safeguard clause relating to harmonised standards:

1. Where Hungary considers that a harmonised standard referred to in the legislation defined in this Annex
does not meet the essential requirements of such legislation, it shall inform the Association Council giving
the reasons thereof.

2. The Association Council shall consider the matter and may request

the Community to proceed in

accordance with the procedure provided for in the Community legislation identified in this Annex.

3. The Community shall keep the Association Council and the other Party informed of the proceedings.

4. The outcome of the procedure shall be notified to the other Party.

17.5.2001

EN

Official Journal of the European Communities

L 135/57

ANNEX ON MUTUAL RECOGNITION OF RESULTS OF CONFORMITY ASSESSMENT

GOOD LABORATORY PRACTICE FOR MEDICINAL PRODUCTS FOR HUMAN USE

S e c t i o n I

Community and national law

Community law:

Good laboratory practice

Council Directive 87/18/EEC of 18 December 1986 on the harmonisation of
laws,
regulations and administrative provisions relating to the application of the principles of
good laboratory practice and the verification of their applications for tests on chemical
substances (OJ L 15, 17.1.1987, p. 29), as last amended by Commission Directive
1999/11/EC of 8 March 1999 (OJ L 77, 23.3.1999, p. 8).

Monitoring of good laboratory practice

Council Directive 88/320/EEC of 9 June 1988 on the inspection and verification of Good
Laboratory Practice (OJ L 145, 11.6.1988, p. 35), as last amended by Commission
Directive1999/12/EC of 8 March 1999 (OJ L 77, 23.3.1999, p. 22).

Medicinal products

approximation of

Council Directive 87/19/EEC of 22 December 1986 amending Directive 75/318/EEC on
the
relating to analytical,
pharmaco-toxicological and clinical standards and protocols in respect of the testing of
proprietary medicinal products (OJ L 5, 17.1.1987, p. 31).

the Member States

laws of

the

Council Directive 87/21/EEC of 22 December 1986 amending Directive 65/65/EEC on
the approximation of provisions laid down by law, regulation or administrative action
relating to proprietary medicinal products (OJ L 15, 17.1.1987, p. 36).

Commission Directive 91/507/EEC of 19 July 1991 modifying the Annex to Council
Directive 75/318/EEC on the approximation of the laws of Member States relating to
analytical, pharmaco-toxicological and clinical standards and protocols in respect of the
testing of propietary medicinal products (OJ L 270, 26.9.1991, p. 32).

National law:

Good laboratory practice and monitoring of good laboratory practice

Joint Decree 31/1999 (VIII.6.) E(cid:252)M (cid:151) FVM of the Minister of Health and the Minister of
Agriculture and Rural Development on the application and monitoring of good
laboratory practice relating to human medicines and pesticides (Magyar K(cid:246)zl(cid:246)ny 70,
6.8.1999, S. 4521).

Medicinal Products

Act XXV of 1998 on medicines for human use (Magyar K(cid:246)zl(cid:246)ny 28, 1.4.1998, S. 2385).

S e c t i o n I I

Notified Test facilities

For the purpose of this Annex, the term (cid:145)Notified Test facilities(cid:146) means the test facilities recognised under each Party’s
GLP monitoring programme.

Each Party shall provide the other Party at least annually with a list of the test facilities which, in the light of the results
of the inspections and study audits conform to the GLP principles as well as of the dates of inspection or study audit,
their GLP compliance status, and the area of expertise in accordance with point 4 of the Appendix to Annex III of the
OECD Decision-Recommendation of 2 October 1989 C(89)87(Final).

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Each Party shall notify without delay the other Party when a listed test facility under its jurisdiction fails to conform to
the GLP principles to an extent which may jeopardise the integrity or authenticity of any such studies it conducts. The
test facility will be deleted from the list established in accordance with the preceding paragraph.

S e c t i o n I I I

Notifying authorities

For the purpose of this Annex, the term (cid:145)Notifying authorities(cid:146) means the GLP monitoring authorities of the Parties.

European Community

(cid:151) Belgium:

(cid:151) Denmark:

(cid:151) Germany:

(cid:151) Greece:

(cid:151) Spain:

(cid:151) France:

MinistŁre de la SantØ Publique.
Pasteur/Ministerie
Volksgezondheid (cid:151) Louis Pasteur.

van

Institut Scientifique pour la SantØ Publique (cid:151) Louis
voor

Volksgezondheid. Wetenschappelijk

Instituut

L(cid:230)gemiddelstyrelsen (D(cid:228)nische Arzneimittelbeh(cid:246)rde).

Bundesministerium f(cid:252)r Umwelt, Naturschutz und Reaktorsicherheit.

Cemij(cid:252) Vgle(cid:223)o sot Jq(cid:220)soty (General Chemical State Laboratory).

Tpotqce(cid:223)o Tce(cid:223)ay jai Pq(cid:252)moiay, Ehmij(cid:252)y Oqcamirl(cid:252)y Uaql(cid:220)jot) Ministry of Health and
Welfare, National Drug Organisation).

Agencia Espaæola del Medicamento.

chemical products other

For
interministØriel des produits chimiques (GIPC).

than medicinal products

and cosmetics: Groupe

For medicinal products for human use and cosmetics: Agence Fran(cid:231)aise de SØcuritØ
Sanitaire des Produits de SantØ (AFSSAPS).

(cid:151) Ireland:

(cid:151) Italy:

Irish Laboratory Accreditation Board (ILAB).

Ministero della Sanit(cid:224) (cid:151) Dipartimento della Prevenzione.

(cid:151) Netherlands:

Ministerie van Volksgezondheid, Welzijn en Sport; Inspectie Volkgezondheid.

(cid:151) Austria:

(cid:151) Portugal:

(cid:151) Finland:

(cid:151) Sweden:

Bundesministerium f(cid:252)r Umwelt, Jugend und Familie.

Under the authority of the Government of Portugal: Instituto PortuguŒs da Qualidade.

Sosiaali- ja terveysministeri(cid:246) / Social- och h(cid:228)lsov(cid:229)rdsministeriet.

L(cid:228)kemedelsverket (Arzneimittelagentur).

(cid:151) United Kingdom:

Department of Health. GLP Monitoring Authority.

Hungary

OrszÆgos Gy(cid:243)gyszerØszeti IntØzet (cid:151) OGYI (National Institute of Pharmacy).

S e c t i o n I V

Specific arrangements

The provisions of this Annex apply to the non-clinical testing of medicinal products according to Good Laboratory
Practice (GLP), being either substances or preparations, covered by the legislative, regulatory and administrative
requirements listed in Section I.

to OECD Council Decision of 12 May 1981 C(81)30(Final),

Unless specific definitions are given, the definition of terms in the OECD Principles of Good Laboratory Practice as
the Guides for Compliance
contained in Annex II
Monitoring Procedures for Good Laboratory Practice as contained in Annex I to Council Decision-Recommendation of
2 October 1989 C(89)87(Final), the GLP Consensus Document (cid:145)The Application of the GLP Principles to Field Studies(cid:146)
(OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring, Number 6), and all amendments
made thereto, shall apply.

The Parties recognise the equivalence of each other’s GLP compliance programmes that are in accordance with the
legislative, regulatory, and administrative requirements listed in Section I, which requirements are consistent with the
OECD Decision-Recommendation of 2 October 1989 C(89)87(Final). The Parties mutually accept the conclusions of
study audits and test facility inspections on the GLP compliance status performed by the competent authorities referred
to in Section III.

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Test facility inspections and/or study audits shall be carried out in accordance with the legislative, regulatory, and
administrative requirements of the Party under the jurisdiction of which the studies and data generated therefrom are
produced.

Each Party recognises studies and data generated therefrom produced by a test facility of the other Party as studies and
data generated therefrom produced by the test facilities complying with the GLP principles under its own jurisdiction,
provided that the test facility is included in the list established in accordance with Section II.

The provisions of this Annex shall enter into operation upon decision of the Association Council. This decision will be
taken in the light of the Mutual Joint Visits (MJV) carried out in Hungary according to the OECD Pilot Project on
Examination of National GLP Compliance Monitoring Programmes.

Safeguard clause procedure

1.

Each Party may request further test facility inspections or study audits if there is a documented doubt as to
whether a study was conducted in accordance with GLP.

2. The Party from which the data are originating shall consider the matter and the evidence brought to its knowledge.

It shall report to the other Party the results of its investigations.

3.

4.

In case of agreement, the Party from which the data are originating shall take appropriate measures to rectify the
situation of the test facility.

If, in exceptional cases, doubts persist and the requesting Party can justify a special concern, it may designate one
or more experts of its authorities listed in Section III to participate in a laboratory inspection or an audit of a study
conducted jointly by the authorities of the Parties upon decision of the Association Council.

Cooperation

Each Party may, on request, participate as an observer in an inspection of a test facility conducted by the competent
authorities of the other Party with the consent of the test facility concerned in order to maintain a continuing
understanding of the other Party’s inspection procedures.

The Parties shall supply each other with additional information on a test facility inspection or study audit in response
to a reasonable request from the other Party.

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ANNEX ON MUTUAL RECOGNITION OF RESULTS OF CONFORMITY ASSESSMENT

GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS FOR HUMAN USE: INSPECTION AND
BATCH CERTIFICATION

S e c t i o n I

Community and national law

Community law:

Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid
down by law, regulation or administrative action relating to medicinal products (OJ L 22,
9.2.1965, p. 369) as last amended by Council Directive 93/39/EEC of 14 June 1993 (OJ
L 214, 24.8.1993, p. 22).

Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of
Member States relating to analytical, pharmaco-toxicological and clinical standards and
protocols in respect of the testing of proprietary medicinal products (OJ L 147, 9.6.1975,
p. 1) as last amended by Commission Directives 1999/82/EEC and 1999/83/EEC of 8
September 1999 (OJ L 243, 15.9.1999, pp. 7 and 9).

Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid
down by law, regulation on administrative action relating to medicinal products (OJ L
147, 9.6.1975, p. 13) as last amended by Council Directive 93/39/EEC of 14 June 1993
(OJ L 214, 24.8.1993, p. 22).

Commission Directive 91/356/EEC of 13 June 1991 laying down the principles and
guidelines of good manufacturing practice for medicinal products for human use (OJ L
193, 17.7.1991, p. 30).

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 (OJ L 214, 24.8.1993, p. 1) as last amended by Commission Regulation (EC) No
649/98 of 23 March 1998 (OJ L 88, 24.3.1998, p. 7).

Council Directive 92/25/EEC of 31 March 1992 on the wholesale distribution of
medicinal products for human use (OJ L 113, 30.4.1992, p. 1) and Guide to Good
Distribution Practice.

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

National law:

Decree 37/2000(III.23) Korm. of
requirements of manufacture of medicines
23.3.2000, p. 1206).

the Government on the subjective and objective
for human use (Magyar K(cid:246)zl(cid:246)ny 25,

Act XXV of 1998 on medicines for human use (Magyar K(cid:246)zl(cid:246)ny 28, 1.4.1998, p. 2385).

Law Decree 31/1976, which is based on the proclamation of the international treaty
came into force on 9-11 October 1970 in Geneva, dealing with the subject of mutual
acknowledgement of supervision during the manufacturing of pharmaceutical products
(Magyar K(cid:246)zl(cid:246)ny 94, 11.12.1976, p. 1139).

Decree 13/1987 E(cid:252)M (VIII.19) of the Minister of Health on the registration and placing
on the market of pharmaceutical products (Magyar K(cid:246)zl(cid:246)ny 36, 19.8.1987, p. 698).

S e c t i o n I I

Official GMP inspection services of each party

European Community

(cid:151) Belgium:

MinistŁre de la SantØ Publique, de l’Environment et de l’IntØgration Sociale. Inspection
Pharmaceutique/Ministerie
Integratie.
Farmaceutische Inspectie.

van Volksgezondheid, Leefmilieu en Sociale

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(cid:151) Denmark:

L(cid:230)gemiddelstyrelsen (Danish Medicines Agency).

(cid:151) Germany:

Bundesministerium f(cid:252)r Gesundheit.

(cid:151) Greece:

Tpotqce(cid:223)o Tce(cid:223)ay jai Pq(cid:252)moiay, Ehmij(cid:252)y Oqcamirl(cid:252)y Uaql(cid:220)jot

(Ministry of Health and Welfare, National Drug Organisation).

(cid:151) Spain:

(cid:151) France:

Agencia Espaæola del Medicamento.

MinistŁre de l’emploi et de la solidaritØ, Direction gØnØrale de la santØ.

Agence Fran(cid:231)aise de SØcuritØ Sanitaire des Produits de SantØ (AFSSAPS).

(cid:151) Ireland:

Irish Medicines Board.

(cid:151) Italy:

Ministero della Sanit(cid:224). Dipartimento Farmaci e Farmacovigilanza.

(cid:151) Luxembourg:

Direction de la SantØ, Division de la Pharmacie et des MØdicaments.

(cid:151) Netherlands:

Ministerie van Volksgezondheid, Welzijn en Sport; inspectie Volksgezondheid.

(cid:151) Austria:

Bundesministerium f(cid:252)r soziale Sicherheit und Generationen.

(cid:151) Portugal:

Under the authority of the Government of Portugal: Instituto PortuguŒs da Qualidade.

(cid:151) Finland:

Sosiaali (cid:151) ja terveysministeri(cid:246) / Social (cid:151) och h(cid:228)lsov(cid:229)rdsministeriet.

(cid:151) Sweden:

L(cid:228)kemedelsverket (Medical Products Agency).

(cid:151) United Kingdom:

Medicines Control Agency.

Hungary

OrszÆgos Gy(cid:243)gyszerØszeti IntØzet (cid:150) OGYI (National Institute of Pharmacy).

S e c t i o n I I I

Specific arrangements

1.

DEFINITIONS

(cid:145)Medicinal products(cid:146) means all products regulated by the pharmaceutical
Hungary as listed in Section I.

legislation in the Community and

(cid:145)Good Manufacturing Practice (GMP)(cid:146): as defined in Commission Directive 91/356/EEC and the relevant legislation
of Hungary as listed in Section I.

(cid:145)Inspection(cid:146): means an on-site evaluation of a manufacturing facility carried out by an inspection service listed in
Section II to determine whether such manufacturing facility is operating in compliance with Good Manufacturing
Practice or commitments made as part of the marketing authorisation.

(cid:145)Inspection Report(cid:146): means the written observations and Good Manufacturing Practice compliance assessment
completed by an authority listed in Section II.

2.

SCOPE AND COVERAGE

2.1. The provisions of this Annex cover all medicinal products for human use which are industrially manufactured in

Hungary and the Community, and to which the Community and Hungarian GMP requirements apply.

2.2.

2.3.

For the medicinal products covered by this Annex, each Party shall recognise the conclusions of inspections
carried out by the relevant inspection services of the other Party and the relevant manufacturing authorisations
granted by the Competent Authorities of the other Party.

In addition,
recognised by the other Party without re-control at import.

the manufacturer’s certification of

the conformity of each batch to its specifications shall be

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3.

PRE-OPERATIONAL PHASE

3.1.

In the pre-operational phase the following activities will be carried out:

(cid:151) the effective implementation of legislative, regulatory and administrative requirements of the Community on

GMP by Hungary will be determined according to a procedure established by the Community,

(cid:151) the practical implementation of the requirements of the Community on GMP will be determined through

joint inspections, examination of inspection reports and other documents linked to an inspection.

3.2. The length of the pre-operational phase will be six months.

3.3. The results of the activities in the pre-operational phase will be discussed in the competent expert group
the competent authorities of
the pre-operational phase in the
the

(European Community inspector’s Working Party) with the participation of
Hungary. The Parties will decide on the prolongation or termination of
Association Council. The operational phase will start
pre-operational phase.

immediately after the successful

termination of

3.4. The Parties may decide, in the Association Council, to renounce the pre-operational phase at any time in the

light of the demonstration of implementation and maintenance of GMP in Hungary.

4.

OPERATIONAL PHASE

Certification of manufacturers

4.1. At

the request of an exporter,

the authorities
importer or the Competent Authority of
responsible for granting manufacturing authorisations and for supervision of the manufacture and control of
medicinal products shall certify that the manufacturer of the medicinal product:

the other party,

(a)

is appropriately authorised to manufacture and/or control the relevant medicinal product or to carry out the
relevant specified operations;

(b) complies with the Community and Hungarian GMP requirements; and

(c)

is regularly inspected by the competent inspection service.

4.2. The certificates shall also identify the site(s) of manufacture. Guidance on a common format for such certificate

will be given.

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

Batch certification

4.4.

Each batch exported shall be accompanied by a batch certificate issued by the manufacturer (self certification)
after a full qualitative analysis, a quantitative analysis of all the active constituents and all the other tests or
checks necessary to ensure the quality of the product in accordance with the requirements of the marketing
authorisation. This certificate shall attest that the batch meets its specification and has been manufactured in
accordance with the relevant marketing authorisation. This certificate shall be retained by the importer of the
batch and will be made available upon request of the Competent Authority.

4.5. When issuing a certificate, the manufacturer shall take account of the provisions of the current Community
certification system. The batch certificate shall be signed by the person responsible for releasing the batch for
export, i.e. the (cid:145)qualified person(cid:146) referred to in Article 17 of Directive 75/319/EEC and in Article 24(2)(i) of Act
XXV of 1998 on medicines for human use.

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Official batch release

4.6. The official batch release procedure is an additional verification of safety and efficacy of immunological medicinal
products (for example vaccines) and blood derivatives, carried out by the competent authorities before the
distribution of each batch of product. This Protocol does not encompass mutual recognition of these official
batch releases.

Inspections

4.7. GMP inspections shall be carried out by the locally competent inspection service against the GMP requirements

as listed in Section I.

4.8. The following types of inspections may be carried out:

(a) General or system inspections: carried out to verify whether a manufacturer complies generally with GMP
requirements (for example routine inspection covering especially the fundamental requirements of GMP).

(b) Process inspections: carried out to verify whether a manufacturer conducts a certain process(es) according to

GMP requirements (for example production of sterile water).

(c) Product inspection: carried out to verify whether a manufacturer produces certain medicinal product or a
series of product(s) according to GMP requirements. It focuses on the validation of compliance with specific
process or control aspects as described in the marketing authorisation (for example (cid:145)pre-marketing(cid:146)
inspections) and therefore the inspector shall have available and be conversant with the relevant information
(the quality dossier and an application/authorisation dossier).

4.9. The

regime

location.
is
Inspection/establishment fees will not be charged to manufacturers located on the territory of the other Party for
products covered by this Protocol.

inspection/establishment

the manufacturer’s

determined

fees

by

of

Transmission of inspection reports

4.10. Upon reasoned request, the relevant inspection services shall forward a copy of the last inspection report of the
manufacturing or control site, in case control operations are contracted out. Each Party shall deal with these
inspection reports with the degree of confidentiality requested by the Party of origin.

4.11. If the manufacturing operations of the medicinal product in question have not been inspected recently, i.e. when
the last inspection dates back to more than two years, or a particular need to inspect has been identified, a
specific and detailed inspection may be requested. The Parties will ensure that inspection reports are forwarded in
no more than 30 calendar days, this period being extended to 60 days should a new inspection be carried out.

Alert system

4.12. The competent authorities will inform the authorities of the other Party with the appropriate speed in case of
quality defect, batch recalls, counterfeiting and other problems concerning quality, which could necessitate
additional controls or suspension of the distribution of the batch. A detailed alert procedure shall be agreed
between the Parties.

4.13. The Parties shall ensure that any suspension or withdrawal (total or partial) of a manufacturing authorisation,
based on non compliance with GMP and which could affect the protection of public health, is communicated to
each other with the appropriate degree of urgency.

Exchange of information between authorities and approximation of quality requirements

4.14. In accordance with the general provisions of this Protocol, the Parties shall exchange any information necessary

for the mutual recognition of inspections.

4.15. In addition, the Competent Authorities shall keep each other informed of any new technical guidance or
inspection procedure. Each Party shall consult the other before their adoption and will endeavour to proceed
towards their approximation.

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Inspectors training

4.16. In accordance with the general provisions of this Protocol, training sessions for inspectors, organised by the
Authorities, shall be accessible to inspectors of the other Party. The Parties will keep each other informed of these
sessions.

Joint inspections

4.17. In accordance with the general provisions of this Protocol, and by mutual agreement between the Parties, joint
inspections may be authorised. These inspections are intended to develop common understanding and
interpretation of practice and requirements. The setting up of these inspections and their form shall be agreed
through procedures approved by the Parties.

Contact points

4.18. For the purpose of this Protocol, the contact points for the alert system, any technical question, such as exchange

of inspection reports, inspectors training sessions, technical requirements are:

(a)

for the Community:

(cid:151) the Director of the European Agency for the Evaluation of Medicinal Products

(b)

for Hungary:

(cid:151) OrszÆgos Gy(cid:243)gyszerØszeti IntØzet, fo0igazgat(cid:243) (National Institute of Pharmacy, Director General).

Divergence of views

4.19. Both Parties shall use their best endeavours to resolve any divergence of views concerning inter alia compliance of
manufacturers and conclusions of inspection reports. Unresolved divergences of view will be referred to the
Association Council.

5.

SAFEGUARD CLAUSES

5.1. Where a party establishes in writing and in an objective and reasoned manner that the other Party is failing to
comply with the conditions of this Annex, it may consult the Association Council. The Association Council may
decide on measures to be taken.

5.2.

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

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Declaration by the Community on the attendance of Hungarian representatives at committee
meetings

In order to ensure a better understanding of
the acquis
communautaire, the Community declares that Hungary is invited, under the following conditions, to the
meetings of
the committees established or referred to under the Community law on machinery,
electromagnetic compatibility, gas appliances and medical devices.

the practical aspects of

the application of

This participation shall be limited to meetings or parts thereof during which the application of the acquis
it shall not entail attendance at meetings intended to prepare and issue opinions on
is discussed;
implementation or management powers delegated to the Commission by the Council.

This invitation may be extended, on a case-by-case basis,
Commission.

to groups of experts convened by the