2001/365/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 Czech Republic, of the other part, on Conformity Assessment and Acceptance of Industrial Products (PECA)
Date: 2001-04-04
Institutions: Council of the European Union
Subjects: Czechia, association agreement (EU), committee (EU), industrial product, product safety, protocol to an agreement

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II

(Acts whose publication is not obligatory)

COUNCIL

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 Czech Republic, of the
other part, on Conformity Assessment and Acceptance of Industrial Products (PECA)

(2001/365/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,

Whereas:

(1)

(2)

(3)

(4)

The Europe Agreement
establishing an association
between the European Communities and their Member
States, of the one part, and the Czech Republic of the
other part (1), hereinafter referred to as the (cid:145)Europe
Agreement(cid:146), entered into force on 1 February 1995.

Article 75(2) of the Europe Agreement provides that
standardisation and
fields of
cooperation in the
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 94/910/ECSC, EC, Euratom of the
Council and the Commission of 19 December 1994 on
the conclusion of the Europe Agreement (2), provides
for the Community decision-making procedures and for
the Community position in the
the presentation of
Association Council and in the Association Committee.

(1) OJ L 360, 31.12.1994, p. 2.
(2) OJ L 360, 31.12.1994, p. 1.

(5)

(6)

(7)

(8)

(9)

Article 14 of Decision No 1/95 of
the Association
Council between the European Communities and their
Member States, of the one part, and the Czech Republic,
of
the other part of 4 April 1995 on its rules of
procedure provides that the Association Committee may
set up further subcommittees or groups to assist
in
carrying out its duties.

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
upon the Association Council and,
the
power to amend the Annexes to the Protocol.

in particular,

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,

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 declarations
annexed to the Final Act
thereto, are hereby approved on
behalf of the Community.

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2.
Following consultation of the special committee referred
the Commission shall determine the
to in paragraph 1,
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(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;

the Annexes of

(c) any measures taken in the application of the safeguard
the Protocol
clauses in Section IV of
concerning machinery, lifts, personal protective equipment,
electrical safety, electromagnetic compatibility, equipment
and protective systems intended for use in potentially
explosive atmospheres, hot-water boilers, gas appliances,
and pressure equipment;

(d) 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;

(e) 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,

3.
the position to be taken by the
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

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

Article 2

The President of
Community,
Article 17 of the Protocol (1).

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

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 III
of the Good Manufacturing Practice (GMP) Annex to the
Protocol;

team or teams of experts,

(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 Sections III and IV of the Annexes to the Protocol
concerning machinery, lifts, personal protective equipment,
electrical safety, electromagnetic compatibility, equipment
and protective systems intended for use in potentially
explosive atmospheres, hot water boilers, gas appliances,
pressure equipment and GMP;

(c)

if necessary, reply to requests in accordance with Article
11, Sections III and IV of the Annexes to the Protocol
concerning machinery, lifts, personal protective equipment,
electrical safety, electromagnetic compatibility, equipment
and protective systems intended for use in potentially
explosive atmospheres, hot-water boilers, gas appliances,
pressure equipment and GMP.

(1) The date of entry into force of the Protocol will be published in the
the European Communities by the General

Official
Journal of
Secretariat of the Council.

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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 Czech Republic, of the other part, on Conformity
Assessment and Acceptance of Industrial Products (PECA)

PROTOCOL

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

WHEREAS the Czech Republic 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 the Czech Republic provides
the opportunity to extend certain benefits of the internal market and to ensure its effective operation in certain sectors
before accession,

CONSIDERING THAT, in the sectors covered by this Protocol, Czech national law substantially takes over Community
law,

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 75 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 the Czech Republic 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 and to the equivalent Czech national law, both listed
in the Annexes on mutual
results of
conformity assessment.

recognition of

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 the Czech Republic 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
9 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,

(cid:151) (cid:145)national

law(cid:146) means any legal act and implementing
practice by which the Czech Republic
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 Czech national law.

with its intended use, may compromise the safety or health of
legitimate concern
users or other persons, or any other
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.

Article 7

Extension of coverage

Article 3

Alignment of legislation

As the Czech Republic 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.

appropriate measures,

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

consultation with

in

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
the requirements to be
of
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 36 of
the Europe
Agreement.

Article 8

Origin

Parties

in the

according

this Protocol

the Party in whose territory the product

shall apply to industrial
The provisions of
products which originate
to
non-preferential rules of origin. In the case of divergent rules,
the rules of
is
marketed shall be determining. 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.

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
in accordance with the
assessment procedures carried out
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

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

to

conformity

competence
assess
the
law specified in the
requirements of Community or national
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.

relation

to

in

Initially, the bodies notified for the purpose of this Protocol
shall be those included in the lists which the Czech Republic
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:

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

(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
shall ensure the full cooperation of bodies under
their
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 body and the recognition of

(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.

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

Article 15

Technical cooperation and assistance

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 the Czech Republic 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,
Italian, Portuguese,
English, Finnish, French, German, Greek,
Spanish, Swedish and Czech 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.

DÆno v Bruselu dne dvacÆtØho (cid:154)estØho œnora roku dvoutis(cid:237)c(cid:237)ho prvn(cid:237)ho.

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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
Za EvropskØ spolec2enstv(cid:237)

Por la Repœblica Checa

For Den Tjekkiske Republik

F(cid:252)r die Tschechischen Republik

Cia sgm Srevij(cid:222) Dglojqas(cid:223)a

For the Czech Republic

Pour la RØpublique tchŁque

Per la Repubblica ceca

Voor de Tsjechische Republiek

Pela Repœblica Checa

T(cid:154)ekin tasavallan puolesta

P(cid:229) Tjeckiska Republikens v(cid:228)gnar

Za C2eskou republiku

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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.

Lifts

3.

Personal protective equipment

4.

Electrical safety

5.

Electromagnetic compatibility

6.

Equipment and protective systems intended for use in potentially explosive atmospheres

7. Hot-water boilers

8. Gas appliances

9.

Pressure equipment

10. Good Manufacturing Practice (GMP) for medicinal products: 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:

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).

National law:

Act No 22/1997 Coll. (part 6/27.2.1997) on technical requirements for products and on
amendments to some Acts, as amended by Act No 71/2000 Coll. (part 24/3.4.2000).

Act No 64/1986 Coll. (part 22/03.11.1986) of the Czech National Council, on the Czech
Trade Inspection, as amended by Act No 240/1992 Coll. (part 49/29.5.1992), Act No
22/1997 Coll. (part 6/27.2.1997), Act No 110/1997 Coll. (part 38/19.5.1997), and Act
No 71/2000 Coll. (part 24/3.4.2000).

Government order No 170/1997 Coll. (part 60/31.7.1997), that lays down the technical
requirements for machinery, as amended by Government order No 15/1999 Coll. (part
6/25.1.1999) and Government order No 283/2000 Coll. (part 82/29.8.2000).

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:

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

(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.

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Czech Republic:

(cid:218)r2ad pro technickou normalizaci, metrologii a stÆtn(cid:237) zku(cid:154)ebnictv(cid:237)
(Czech Office for Standards, Metrology and Testing).

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 the Czech Republic in accordance with Article 10 of this Protocol.

Czech Republic

Bodies which have been authorised by the Czech Republic in accordance with the Czech national law of Section I and
notified to the Community in accordance with Article 10 of this Protocol.

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 the Czech Republic 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:

LIFTS

S e c t i o n I

Community and national law

Community law:

European Parliament and Council Directive 95/16/EC of 29 June 1995 on the
approximation of the laws of the Member States relating to lifts (OJ L 213, 7.9.1995,
p. 1)

National law:

Act No 22/1997 Coll. (part 6/27.2.1997) on technical requirements for products and on
amendments to some Acts, as amended by Act No 71/2000 Coll. (part 24/3.4.2000).

Act No 64/1986 Coll. (part 22/3.11.1986), of the Czech National Council, on the Czech
Trade Inspection, as amended by Act No 240/1992 Coll. (part 49/29.5.1992), Act No
22/1997 Coll. (part 6/27.2.1997), Act No 110/1997 Coll. (part 38/19.5.1997), and Act
No 71/2000 Coll. (part 24/3.4.2000).

Government order No 14/1999 Coll. (part 6/25.1.1999), that lays down the technical
requirements for lifts, as amended by Government order No 227/1999 Coll.
(part
77/14.10.1999), and Government Order No 288/2000 Coll. (part 82/29.8.2000)

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:

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

(cid:151) France:

MinistŁre de l’Øquipement, des
l’urbanisme, de l’habitat et de la construction.

transports et du logement, Direction gØnØrale de

(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 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:

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 135/13

Czech Republic

(cid:218)r2ad pro technickou normalizaci, metrologii a stÆtn(cid:237) zku(cid:154)ebnictv(cid:237)
(Czech Office for Standards, Metrology and Testing).

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 the Czech Republic in accordance with Article 10 of this Protocol.

Czech Republic

Bodies which have been authorised by the Czech Republic in accordance with the Czech national law of Section I and
notified to the Community in accordance with Article 10 of this Protocol.

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 the Czech Republic 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 135/14

EN

Official Journal of the European Communities

17.5.2001

ANNEX ON MUTUAL RECOGNITION OF RESULTS OF CONFORMITY ASSESSMENT

PERSONAL PROTECTIVE EQUIPMENT

S e c t i o n I

Community and national law

Community law:

Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws
of the Member States relating to personal protective equipment (OJ L 399, 30.12.1989,
p. 18), as last amended by Parliament and Council Directive 96/58/EC of 3 September
1996 (OJ L 236, 18.9.1996, p. 44).

National law:

Act No 22/1997 Coll. (part 6/27.2.1997) on technical requirements for products and on
amendments to some Acts, as amended by Act No 71/2000 Coll. (part 24/3.4.2000).

Act No 64/1986 Coll. (part 22/3.11.1986), of the Czech National Council, on the Czech
Trade Inspection, as amended by Act No 240/1992 Coll. (part 49/29.5.1992), Act No
22/1997 Coll. (part 6/27.2.1997), Act No 110/1997 Coll. (part 38/19.5.1997), and Act
No 71/2000 Coll. (part 24/3.4.2000).

Government order No 172/1997 Coll. (part 61/4.8.1997), that lays down the technical
requirements for personal protective equipment, as amended by Government order No
284/2000 Coll. (part 82/29.8.2000).

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:

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

(cid:151) France:

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

MinistŁre de l’Øconomie, des finances et de l’industrie, Direction GØnØrale de l’Industrie,
des Technologies de l’Information et des Postes (DiGITIP) (cid:151) SQUALPI.

(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 Volksgezondheid, Welzijn en Sport.

(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:

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

(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 135/15

Czech Republic

(cid:218)r2ad pro technickou normalizaci, metrologii a stÆtn(cid:237) zku(cid:154)ebnictv(cid:237)
(Czech Office for Standards, Metrology and Testing).

S e c t i o n I I I

Notified bodies

European Community

Bodies which have been authorised by the Czech Republic in accordance with the Czech national law of Section I and
notified to the Community in accordance with Article 10 of this Protocol.

Czech Republic

Bodies which have been authorised by the Czech Republic in accordance with the Czech national law of Section I and
notified to the Community in accordance with Article 10 of this Protocol.

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.

3.

4.

Parties shall consider the matter and the evidence brought to their knowledge, and shall report to each other
the results of their investigations.

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) ustified, 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 the Czech Republic 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 135/16

EN

Official Journal of the European Communities

17.5.2001

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:

Act No 22/1997 Coll. (part 6/27.2.1997) on technical requirements for products and on
amendments to some Acts, as amended by Act No 71/2000 Coll. (part 24/3.4.2000).

Act No 64/1986 Coll. (part 22/3.11.1986), of the Czech National Council, on the Czech
Trade Inspection, as amended by Act No 240/1992 Coll. (part 49/29.5.1992), Act No
22/1997 Coll. (part 6/27.2.1997), Act No 110/1997 Coll. (part 38/19.5.1997), and Act
No 71/2000 Coll. (part 24/3.4.2000).

Government order No 168/1997 Coll. (part 60/31.7.1997), that lays down the technical
requirements for low voltage electrical equipment, as amended by Government order No
281/2000 Coll. (part 82/29.8.2000).

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 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:

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) (cid:151) 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 (Verbrauchsg(cid:252)ter).

Ministerie van Sociale Zaken en Werkgelegenheid (Sonstige).

(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 135/17

Czech Republic

(cid:218)r2ad pro technickou normalizaci, metrologii a stÆtn(cid:237) zku(cid:154)ebnictv(cid:237)
(Czech Office for Standards, Metrology and Testing).

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 the Czech Republic in accordance with Article 10 of this Protocol.

Czech Republic

Bodies which have been authorised by the Czech Republic in accordance with the Czech national law of Section I and
notified to the Community in accordance with Article 10 of this Protocol.

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 the Czech Republic 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 135/18

EN

Official Journal of the European Communities

17.5.2001

ANNEX ON MUTUAL RECOGNITION OF RESULTS OF CONFORMITY ASSESSMENT

ELECTROMAGNETIC COMPATIBILITY

S e c t i o n I

Community and national law

Community 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 Directive 93/68/EEC of 22 July 1993 (OJ L 220, 30.8.1993, p. 1)

National law:

Act No 22/1997 Coll. (part 6/27.2.1997) on technical requirements for products and on
amendments to some Acts, as amended by Act No 71/2000 Coll. (part 24/3.4.2000).

Act No 64/1986 Coll. (part 22/3.11.1986), of the Czech National Council, on the Czech
Trade Inspection, as amended by Act No 240/1992 Coll. (part 49/29.5.1992), Act No
22/1997 Coll. (part 6/27.2.1997), Act No 110/1997 Coll. (part 38/19.5.1997), and Act
No 71/2000 Coll. (part 24/3.4.2000).

Government order No 169/1997 Coll. (part 60/31.7.1997), that lays down the technical
requirements for products relating to their electromagnetic compatibility, as amended by
Government order No 282/2000 Coll. (part 82/29.8.2000).

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 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

(Ministry of Development. General Secretariat of Industry).

(cid:151) Spain:

(cid:151) France:

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) (cid:151) 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.

(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:

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

EMC aspects

For
of
viestint(cid:228)ministeri(cid:246)/Kommunikationsministeriet.

telecommunications

and

radio

equipment:

Liikenne-ja

(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 135/19

Czech Republic:

(cid:218)r2ad pro technickou normalizaci, metrologii a stÆtn(cid:237) zku(cid:154)ebnictv(cid:237) (Czech Office for Standards, Metrology and Testing).

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 the Czech Republic in accordance with Article 10 of this Protocol.

Czech Republic

Bodies which have been authorised by the Czech Republic in accordance with the Czech national law of Section I and
notified to the Community in accordance with Article 10 of this Protocol.

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 the Czech Republic 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 135/20

EN

Official Journal of the European Communities

17.5.2001

ANNEX ON MUTUAL RECOGNITION OF RESULTS OF CONFORMITY ASSESSMENT:

EQUIPMENT AND PROTECTIVE SYSTEMS INTENDED FOR USE IN POTENTIALLY EXPLOSIVE
ATMOSPHERES

S e c t i o n I

Community and national law

Community law:

European Parliament and of the Council Directive 94/9/EC of 23 March 1994, on the
approximation of the laws of the Member States concerning equipment and protective
systems intended for use in potentially explosive atmospheres (OJ L 100, 19.4.1994, p. 1)

National law:

Act No 22/1997 Coll. (part 6/27.2.1997) on technical requirements for products and on
amendments to some Acts, as amended by Act No 71/2000 Coll; (part 24/3.4.2000).

Act No 64/1986 Coll. (part 22/3.11.1986), of the Czech National Council, on the Czech
Trade Inspection, as amended by Act No 240/1992 Coll. (part 49/29.5.1992), Act No
22/1997. Coll. (part 6/27.2.1997), Act No 110/1997 Coll. (part 38/19.5.1997), and Act
No 71/2000 Coll. (part 24/3.4.2000).

Government order No 176/1997 Coll. (part 63/8.8.1997), that lays down the technical
requirements for equipment and protective systems intended for use in potentially
explosive atmospheres, as amended by Government order No 286/2000 Coll.
(part
82/29.8.2000).

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:

Elektricitetsr(cid:229)det.

(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:

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

(cid:151) France:

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

(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:

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 135/21

Czech Republic

(cid:218)r2ad pro technickou normalizaci, metrologii a stÆtn(cid:237) zku(cid:154)ebnictv(cid:237)
(Czech Office for Standards, Metrology and Testing).

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 the Czech Republic in accordance with Article 10 of this Protocol.

Czech Republic

Bodies which have been authorised by the Czech Republic in accordance with the Czech national law of Section I and
notified to the Community in accordance with Article 10 of this Protocol.

S e c t i o n I V

Specific arrangements

1. Transitional arrangements

The certificates issued in the EC Member States in conformity with Directives 76/117/EEC, 79/196/EEC and
82/130/EEC will be recognised as a proof of the conformity assessment under the Article 17 of Act No 22/1997
Coll., on technical requirements for products and on amendments to some acts, as amended by Act No 71/2000
Coll. Based on these certificates, the importer of these products in the Czech Republic will issue a declaration of
conformity of the relevant product to the applicable requirements referred to in this paragraph.

2.

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 the Czech Republic 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 135/22

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:

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)

National law:

Act No 22/1997 Coll. (part 6/27.2.1997) on technical requirements for products and on
amendments to some Acts, as amended by Act No 71/2000 Coll. (part 24/3.4.2000).

Act No 64/1986 Coll. (part 22/3.11.1986), of the Czech National Council, on the Czech
Trade Inspection, as amended by Act No 240/1992 Coll. (part 49/29.5.1992), Act No
22/1997 Coll. (part 6/27.2.1997), Act No 110/1997 Coll. (part 38/19.5.1997), and Act
No 71/2000 Coll. (part 24/3.4.2000).

Government order No 180/1999 Coll. (part 61/17.8.1999), that lays down the technical
requirements for new hot-water boilers fired with liquid or gaseous fuels, as amended by
Government order No 289/2000 Coll. (part 89/29.8.2000).

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

(Ministry of Development. General Secretariat of Industry).

(cid:151) Spain:

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

(cid:151) France:

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:

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

(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 the Environment, Transport and the Regions.

17.5.2001

EN

Official Journal of the European Communities

L 135/23

Czech Republic

(cid:218)r2ad pro technickou normalizaci, metrologii a stÆtn(cid:237) zku(cid:154)ebnictv(cid:237)
(Czech Office for Standards, Metrology and Testing).

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 the Czech Republic in accordance with Article 10 of this Protocol.

Czech Republic

Bodies which have been authorised by the Czech Republic in accordance with the Czech national law of Section I and
notified to the Community in accordance with Article 10 of this Protocol.

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 the Czech Republic 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 135/24

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:

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)

National law:

Act No 22/1997 Coll. (part 6/27.2.1997) on technical requirements for products and on
amendments to some Acts, as amended by Act No 71/2000 Coll. (part 24/3.4.2000).

Act No 64/1986 Coll. (part 22/3.11.1986), of the Czech National Council, on the Czech
Trade Inspection, as amended by Act No 240/1992 Coll. (part 49/29.5.1992), Act No
22/1997 Coll. (part 6/27.2.1997), Act No 110/1997 Coll. (part 38/19.5.1997), and Act
No 71/2000 Coll. (part 24/3.4.2000).

Government order No 177/1997 Coll. (part 64/12.8.1997), that lays down the technical
requirements for appliances burning gaseous fuels, as amended by Government Order No
287/2000 Coll. (part 82/29.8.2000).

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

(Ministry of Development. General Secretariat of Industry).

(cid:151) Spain:

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

(cid:151) France:

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 135/25

Czech Republic

(cid:218)r2ad pro technickou normalizaci, metrologii a stÆtn(cid:237) zku(cid:154)ebnictv(cid:237)
(Czech Office for Standards, Metrology and Testing).

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 the Czech Republic in accordance with Article 10 of this Protocol.

Czech Republic

Bodies which have been authorised by the Czech Republic in accordance with the Czech national law of Section I and
notified to the Community in accordance with Article 10 of this Protocol.

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 the Czech Republic 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 135/26

EN

Official Journal of the European Communities

17.5.2001

ANNEX ON MUTUAL RECOGNITION OF RESULTS OF CONFORMITY ASSESSMENT

PRESSURE EQUIPMENT

S e c t i o n I

Community and national law

Community law:

Council Directive 87/404/EEC of 25 June 1987 on the approximation of the laws of the
Member States relating to simple pressure vessels (OJ L 220, 8.8.1987, p. 48), as last
amended by Council Directive 93/68/EEC of 22 July 1993 (OJ L 220), 30.8.1993, p. 1)

European Parliament and Council Directive 97/23/EC of 29 May 1997 on the
approximation of the laws of the Member States concerning pressure equipment (OJ L
181, 9.7.1997, p. 1)

National law:

Act No 22/1997 Coll. (part 6/27.2.1997) on technical requirements for products and on
amendments to some Acts, as amended by Act No 71/2000 Coll. (part 24/3.4.2000).

Act No 64/1986 Coll. (part 22/3.11.1986), of the Czech National Council, on the Czech
Trade Inspection, as amended by Act No 240/1992 Coll. (part 49/29.5.1992), Act No
22/1997 Coll. (part 6/27.2.1997), Act No 110/1997 Coll. (part 38/19.5.1997), and Act
No 71/2000 Coll. (part 24/3.4.2000).

Government order No 175/1997 Coll. (part 63/8.8.1997), that lays down the technical
requirements for simple pressure vessels, as amended by Government order No 80/1999
Coll. (part 30/4.5.1999) and Government order No 285/2000 Coll. (part 82/29.8.2000).

Government order No 182/1999 Coll. (part 62/24.8.1999) that lays down the technical
requirements for pressure equipment, as amended by Government order No 290/2000
Coll. (part 82/29.8.2000).

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:

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

MinistŁre de l’Øconomie, des finances et de l’industrie, Direction de l’Action RØgionale 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 et de l’Emploi.

(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:

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 135/27

Czech Republic

(cid:218)r2ad pro technickou normalizaci, metrologii a stÆtn(cid:237) zku(cid:154)ebnictv(cid:237)
(Czech Office for Standards, Metrology and Testing).

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 the Czech Republic in accordance with Article 10 of this Protocol.

Czech Republic

Bodies which have been authorised by the Czech Republic in accordance with the Czech national law of Section I and
notified to the Community in accordance with Article 10 of this Protocol.

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 the Czech Republic 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 the present 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 135/28

EN

Official Journal of the European Communities

17.5.2001

ANNEX ON MUTUAL RECOGNITION OF RESULTS OF CONFORMITY ASSESSMENT

GOOD MANUFACTURING PRACTICE (GMP) FOR MEDICINAL PRODUCTS 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,
1.1.1965, 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/EC and 1999/83/EC of 8
September 1999 (OJ L 243, 15.9.1999, p. 7 and 9)

Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid
down by law, regulation or 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).

Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws
of the Member States relating to veterinary medicinal products (OJ L 317, 6.11.1981, p.
1), as last amended by Council Directive 90/676/EEC of 13 December 1990 (OJ L 373,
31.12.1990, p. 15).

Directive 81/852/EEC of 28 September 1981 on the approximation of the laws of the
Member States relating to analytical, pharmacotoxicological and clinical standards and
protocols in respect of the testing of veterinary medicinal products (OJ L 317, 6.11.1981,
p. 16), as last amended by Commission Directive 1999/104/EC of 22 December 1999
(OJ L 3, 6.1.2000, p. 18).

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).

Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and
guidelines of good manufacturing practice for veterinary medicinal products (OJ L 228,
17.8.1991, p. 70).

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 whole sale 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.

Compilation
of Community
Harmonisation of Inspections (III/5698/94-EN).

Procedures

on Administrative Collaboration

and

National law:

Act No 79/1997 Coll. (part 26/15.4.1997) on pharmaceuticals and on amendments to
some Acts as amended by Act No 149/2000 Coll. (part 47/13.6.2000).

Decree of the Ministry of Health and Ministry of Agriculture No 296/2000 Coll. (part
83/28.8.2000) on Good Manufacturing Practice, Good Distribution Practice and Specific
Conditions for Permitting Drug Manufacturing and Distribution,
including Medicated
Feedingstuffs.

17.5.2001

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Official Journal of the European Communities

L 135/29

Recommended Procedures for Implementation of Good Manufacturing Practice and Good
Distribution Practice, Official Journal of SUKL, Special Issue, February 1998.

General Requirements of the State Institute for Drug Control, Praha (SUKL) on Validation
of Manufacturing Process, Official Journal of SUKL No 12/1995 (VYR-3).

General Requirements of SUKL on Cleaning Procedures and Their Validation, Official
Journal of SUKL No 7/1996 (VYR-5).

Clean Rooms, Official Journal of SUKL No 6/1997 (VYR-7).

Principles of Control Activities of SUKL in the Field of Good Manufacturing Practice
(GMP) for Manufacturers and Distributors of Pharmaceuticals, Official Journal of SUKL No
3/1998 (VYR-8).

Issuing of GMP Certificates, Official Journal of SUKL No 10/1998 (VYR-9).

General Requirements of SUKL on Validation of Aseptic Procedures, Official Journal of
SUKL No 12/1998 (VYR-10).

Requirements of SUKL on Distributors of Medicinal Gases, Official Journal of SUKL No
12/1998 (DIS-5).

Guidelines of
Medicaments, Brno (USKVBL).

the Institute for State Control of Veterinary Immunologicals and

Recommended Procedures for Implementation of Good Distribution Practice, Official
Journal of USKVBL No 1/1998.

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’Environnement et de l’IntØgration Sociale. Inspection
Pharmaceutique/Ministerie
Integratie.
Farmaceutische Inspectie.

van Volksgezondheid, Leefmilieu en Sociale

(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.

Pour les mØdicaments (cid:224) usage humain (human medicinal products): Agence Fran(cid:231)aise de
SØcuritØ Sanitaire des Produits de SantØ (AFSSAPS).

Pour
les mØdicaments (cid:224) usage vØtØrinare (veterinary medicinal products): Agence
Fran(cid:231)aise de SØcuritØ Sanitaire des Aliments (AFSSA, Agence nationale du mØdicament
vØtØrinaire).

(cid:151) Ireland:

Irish Medicines Board.

(cid:151) Italy:

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

Ministero della Sanit(cid:224). Dipartimento alimenti e nutrizione e sanit(cid:224) pubblica veterinaria (cid:151)
(veterinary medicinal products).

(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:

L 135/30

EN

Official Journal of the European Communities

17.5.2001

(cid:151) Finland:

Sosiaali-ja terveysministeri(cid:246) / Social-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.

Veterinary Medicines Directorate.

Czech Republic

StÆtn(cid:237) œstav pro kontrolu lØc2iv (cid:150) SUKL (State Institute for Drug Control) Praha.

(cid:218)stav pro stÆtn(cid:237) kontrolu veterinÆrn(cid:237)ch biopreparÆtu5 a lØc2iv (cid:150)USKVBL.
Immunologicals and Medicaments) Brno.

(Institute for State Control of Veterinary

S e c t i o n I I I

Specific arrangements

1.

DEFINITION

(cid:145)Medicinal products(cid:146): means all products regulated by the pharmaceutical legislation in the Community and the
Czech Republic as listed in Section I.

(cid:145)Good Manufacturing Practice (GMP)(cid:146): as defined in Commission Directive 91/356/EEC and Commission Directive
91/412/EEC and the relevant legislation of the Czech Republic 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 and veterinary use which are industrially

manufactured in the Czech Republic and the Community, and to which the 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

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 the Czech Republic 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.

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Official Journal of the European Communities

L 135/31

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
(European Community inspector’s Working Party) with the participation of the Competent Authorities of the
Czech Republic. The Parties will decide on the prolongation or termination of the pre-operational phase in the
the
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 the Czech Republic.

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 Czech Republic 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 Article 29 of Directive
81/851/EEC, and in Sections 4 and 19 of Act 79/1997 Coll.

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).

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(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 relevant 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.

Inspectors training

4.16. In accordance with the general provisions of this Protocol, training sessions for inspectors, organised by the
Competent 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.

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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 the Czech Republic:

(cid:151) in the case of a human medicinal product: the Director of the State Institute for Drug Control;

(cid:151) in the case of a veterinary medicinal product: the Director of the Institute for State Control of Veterinary

Immunologicals and Medicaments.

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 on exchange of information

The Parties see the merit of adopting a further Annex to the Protocol, concerned with exchange of
information referred to in Article 12 thereof. The objective is to prevent any potential new technical
barrier through an extension to the Czech Republic of some of the principles contained in Directive
98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for
information in the field of technical standards and regulations (1). To that end, a
the provision of
simplified procedure will be prepared as a new Annex to the Protocol.

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

In order to ensure a better understanding of
the acquis
communautaire, the Community declares that the Czech Republic is invited, under the following conditions,
to the meetings of the committees established or referred to under the Community law on machinery,
lifts, personal protective equipment, electromagnetic compatibility, equipment and protective systems
intended for use in potentially explosive atmosphere, gas appliances, simple pressure vessels and pressure
equipment.

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

(1) OJ L 204, 21.7.1998, p. 37. Directive as amended by Directive 98/48/EC (OJ L 217, 5.8.1998, p. 18).