Proposal for a Council Decision on the signature on behalf of the Community of an additional 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
Date: 2000-11-28
Institutions: European Commission
Subjects: Czechia, association agreement (EU), cooperation policy, industrial product, standardisation

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 28.11.2000
COM(2000) 748 final

2000/0293 (ACC)
2000/0294 (ACC)

Proposal for a

COUNCIL DECISION

on the signature on behalf of the Community of an additional 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

Proposal for a

COUNCIL DECISION

on the conclusion of an additional 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

(presented by the Commission)

EXPLANATORY MEMORANDUM

I. EXPLANATORY MEMORANDUM

On the basis of negotiating directives adopted by the Council on 21.9.92 and of the specific
decision issued by the Council in June 1997 addressing guidelines to the Commission for the
negotiation of European Conformity Assessment Agreements with Central and Eastern
European Countries, the Commission has negotiated and initialled an additional Protocol to
the Europe Agreement with the Czech Republic (Protocol to the Europe Agreement on
Conformity assessment and Acceptance of industrial products, hereinafter referred to as
"PECA").

The text of this Protocol is attached to this Communication. The following provides an
assessment of the Protocol in the light of the negotiating directives approved by the Council,
and proposes that the Council authorises the signature of the additional Protocol to the Europe
Agreement and decides to approve its conclusion on behalf of the Community.

I.1 ASSESSMENT OF THE AGREEMENT

Considering that this agreement is intended to work only during the pre-accession period, and
that an appropriate legal framework was offered by the Europe Agreement, it was decided, in
consultation with the 133 Committee, to adopt this agreement as a Protocol to the Europe
Agreement rather than an stand alone agreement as foreseen previously.

The draft PECA follows the general principles laid down in the Commission's communication
on Community External Trade Policy in the field of standards and conformity assessment1
under its paragraph 49.

The PECA provides for an extension of certain benefits of the Internal Market in sectors
already aligned. The PECA thus facilitates market access by eliminating technical barriers to
two
trade with respect
mechanisms, a) for the mutual acceptance of industrial products which fulfil the requirements
to be lawfully placed on the market in one of the Parties, and b) the mutual recognition of the
results of conformity assessment of industrial products subject to Community law and to the
equivalent national law.

to industrial products. To this end,

the PECA provides for

The first mechanism, i.e. the mutual acceptance of industrial products, confirms that Articles
10.4 and 11.5 of the Europe Agreement with the Czech Republic apply without other
restriction as referred to in Article 36 of the Europe Agreement. This provision adds the
predictability that is necessary to manufacturers and exporters, confirming in advance that
industrial products under this mechanism may freely move between the Parties. The annexes
making this mechanism operational have still to be negotiated.

The second mechanism is a particular type of mutual recognition agreement (MRA) in which
the mutual recognition operates on the basis of the acquis communautaire. It allows industrial
products certified by Notified bodies in the European Union to be placed on the Czech market
without having to undergo any further approval procedures, and vice-versa. The following
sectors are covered: machinery, personal protective equipment,
lifts, electrical safety,
electromagnetic compatibility, equipment and protective systems intended for use in

1

COM (96) 564 - final. 13.11.96

2

potentially explosive atmosphere, gas appliances, hot water boilers, pressure equipment and
medicinal products Good Manufacturing Practice inspection and batch certification.

The Czech Republic has taken over the Community technical legislation in the sectors
covered by the Protocol and participates in the European organisations in the field of
standards, metrology, testing laboratories and accreditation.

The PECA consists of a framework agreement and a series of annexes. Both a unilateral
declaration and a joint declaration are attached to the Final Act. The unilateral declaration
invites the Czech representatives to committees established under the Community law
referred to in the annexes, making it clear that this will not entail any participation in the
Community decision-making process. The joint declaration is aiming at preparing a further
annex on exchange of information in the area covered by Directive 98/34/EC. An assessment
of the PECA is made in the next paragraphs.

I.1.1 Framework Agreement

An article-by-article assessment follows:

Pre-amble. This sets out the basic objective of the PECA which is that, as the application for
membership of the European Union implies the implementation of the acquis communautaire
by the applicant country, it provides the opportunity to extend certain benefits of the Single
Market in certain sectors already aligned before accession.

Article 1: Purpose. This article establishes the purpose of the PECA, namely the elimination
of technical barriers to trade in respect to industrial products. The PECA provides for two
mechanisms, a) for the mutual acceptance of industrial products which fulfil the requirements
to be lawfully placed on the market in one of the Parties, and b) the mutual recognition of the
results of conformity assessment of industrial products subject to Community law and to the
equivalent national law.

industrial products,
Article 2: Definitions. This
Community and national
legislation and
implementation measures (administrative provisions, guidelines and other means of
implementation of the legislation) are covered by the definitions of Community and national
law.

is self-explanatory. Definitions of
law have been included. All pieces of

Article 3: Alignment of legislation. This contains a commitment for the partner country to
take appropriate measures in order to maintain or complete the take-over of Community law,
namely in the field of technical legislation and for the purpose of the PECA. Together with
the 4th whereas, it means that the alignment is an ongoing process and the Parties agree to iron
out any problems of transposition that could appear later.

Article 4: Mutual acceptance of industrial products. The principle under Article 1.1) is
detailed in this article. It provides that listing industrial products in such annexes will confirm
that these products can freely circulate between the Parties. As already stated, no such annex
has been negotiated yet.

Article 5: Mutual recognition of the results of conformity assessment procedures. This
provision expands the principle under Article 1.2). This kind of recognition is similar to the
one in Mutual Recognition Agreements, with the special feature that all legislation and
standards are aligned. The sectoral annexes will contain the references to the relevant
Community and national legislation.

3

Article 6: Safeguard clause. This sets up the right of each Party to deny market access when
such Party is able to demonstrate that a product might endanger the legitimate concern which
is protected by legislation listed in the annexes (safety and/or public health of users or other
persons mainly). The annexes provide for the detailed procedures to be used in such cases.

Article 7: Extension of coverage. The Parties may modify the scope and coverage of this
Protocol through an amendment of the annexes or the addition of new annexes as soon as all
alignment conditions are met.

Article 8: Origin. This provides that the Protocol will apply to industrial products originating
in the Parties according to non-preferential rules of origin. This origin can be certified by
presentation of a certificate of origin or by a proof of origin according to Protocol 4 of the
Europe Agreement. In case of divergent rules, the rules of the importing Party will be applied.

Article 9: Obligations of Parties as regards their authorities and bodies. This article
obliges the Parties to ensure that
their respective authorities continuously monitor the
technical competence and compliance of the notified bodies and have the necessary power
and expertise for designating, suspending, and withdrawing their bodies. In addition,
it
obliges the Parties to ensure that their respective notified bodies continuously comply with
the requirements of Community or national law and maintain their technical competence to
carry out the tasks for which they have been notified.

Article 10: Notified bodies. This describes the procedure for the notification of bodies to
assess conformity in relation to the legal requirements specified in the corresponding annexes.
The procedure is simplified and similar to the one applied within the Community. The second
paragraph sets out the procedure for the removal of notified bodies.

Article 11: Verification of notified bodies. This article gives the right to one Party to
request a verification of a body notified by the other Party. The verification may be done
either by the authorities which have designated the body or together by the authorities of both
Parties. If the Parties do not agree on the steps to take, they may notify the Chair of the
Association Council of their dissent, and leave to the Association Council to decide on
appropriate action. The notified body would then be suspended from the notification to the
Association Council until a final decision is taken.

Article 12: Exchange of information. A transparency provision to ensure a correct and
uniform application and interpretation of the Protocol. The Parties are advised to encourage
their bodies to cooperate in order to establish mutual recognition agreements in the voluntary
sphere.

Article 13: Confidentiality. A classical provision to avoid disclosing information acquired
under this Protocol.

Article 14: Management of the Protocol. The Association Council is responsible for the
effective functioning of the Protocol and may delegate its duties in conformity the provisions
of the Europe Agreement.

Article 15: Technical cooperation and assistance. This confirms the Community policy on
technical cooperation and assistance with a view to properly implementing this Protocol.

4

Article 16: Agreements with other countries. This confirms that, unless otherwise agreed,
the PECA does not entail any obligation, for one Party, to accept conformity assessments
carried out in another country, even if there is an agreement on recognition of conformity
assessment between the other Party and any other third country.

Article 17: Entry into force. This is a standard provision that provides the arrangement for
the entry into force.

Article 18: Status of the Protocol. This establishes the fact that the PECA is an integral part
of the Europe Agreement.

I.1.2 The Annexes to the Protocol

I.1.2.1 Annexes on Mutual Recognition of Results of Conformity Assessment

There follows an assessment of the content of the annexes in terms of their coverage, and
other implications where relevant. In making this assessment, the Commission has kept in
mind the following elements:

a) the overall consistency with the Community policy objectives
standardisation, certification and conformity assessment
products covered;

in the field of
for the sectors and industrial

b) the overall consistency with Community policy objectives in the field of the removal of
technical barriers to trade;

The sectoral assessment is followed in item I.2 by an overall appreciation of the benefits of
the Protocol.

Annexes on Machinery, Lifts, Personal Protective Equipment, Electrical Safety,
Electromagnetic Compatibility, Equipment and Protective Systems intended for Use in
Potentially Explosive Atmosphere (ATEX), Hot Water Boilers, Gas Appliances and
Pressure Equipment.

These annexes on mutual recognition of results of conformity assessment cover a range of
industrial products subject to third party conformity assessment under the New Approach
directives in the relevant sectors. All these annexes present the same structure.

Coverage is determined by the relevant Community and national law, listed under Section I of
each annex. Section II, on notifying authorities, lists the authorities responsible for the
designation of bodies in the Member Sates and the Czech Republic. Section III, on notified
bodies, makes reference to the notification of all Conformity Assessment Bodies notified by
the Member States and by the Czech Republic. Section IV, on specific arrangements, fixes the
two procedures for the safeguard clause, relating to industrial products and to harmonised
standards.

5

Although the ATEX "Old Approach" directives2 have not been transposed by the Czech
Republic, and thus are not listed in Section I of the ATEX annex, an additional provision in
Section IV of this annex provides for the Czech recognition of the EC valid certificates in
conformity with those directives.

Annex on medicinal products GMP inspection and batch certification

This annex establishes the mutual recognition of the conclusions of each Party's Good
Manufacturing Practice (GMP) inspections, of each Party's manufacturing authorisations, and
of manufacturers' batch certificates. All medicinal products for human and veterinary use are
covered.

Section I lists the relevant Community and national law. Section II lists the official GMP
inspection services of each Member State and the Czech Republic.

Section III includes provisions concerning common definitions of terms in conformity with
their respective legislation, and the scope and coverage of this annex. A pre-operational phase
of 6 months is foreseen. The Association Council will decide on its termination or
prolongation. The operation of this annex will start
immediately after the successful
termination of the pre-operational phase.

Additional provisions include mechanisms for cooperation (transmission of reports, exchange
of information, training of inspectors, joint inspections, alert system, contact points) between
the respective inspection authorities. A safeguard clause for inspections is included to reserve
each Party's right to conduct exceptionally its own inspections for reasons identified in
advance to the other Party. The Parties are supposed to use their best endeavours to resolve
any divergence of views which could occur. Unresolved divergences of views may be
referred to the Association Council.

This annex will remove the need for duplicating batch release procedures and thus save
important costs for each imported batch. In addition, recognition of inspections will permit to
avoid duplication inspections by authorities. This should lead to important savings in terms of
time to access the market and other fees and inspection costs.

I.1.2.2 Annexes on Mutual Acceptance of Industrial Products

No such annexes have been negotiated for the moment. The PECA, in line with the Europe
Agreement, provides nevertheless the basis for such acceptance of products, similar to the one
which operates in the Community.

I.1.2.3 Unilateral and Joint Declarations

These are attached to the Final Act and are annexed to this Communication.

a) Unilateral Community Declaration relating
of Czech
representatives to Committees. Through this declaration, the Czech Republic is invited to
send observers to the meetings of the Committees established or referred to under the

attendance

the

to

2

Directives 76/117/EEC, 79/196/EEC and 82/130/EEC. The "New Approach" directive referred to in
Section I of this annex (94/9/EC) contains a provision saying: "EC certificates of conformity to
harmonised standards obtained in accordance with the procedures laid down in the directives referred to
in paragraph 1 shall continue be valid until 30 June 2003 unless they expire before that date".

6

Community legislation included in the annexes. This declaration follows the principles of the
Commission Communication on "Participation of candidate countries in Community
programmes, agencies and committees"3.

b) Joint Declaration on exchange of information. Through this declaration requested by the
Czech Republic, the Parties agree to negotiate a further annex to the PECA with a view to
determining the conditions of extension of the scope of Article 12 to the non-harmonised
sectors (i.e. participation in a simplified procedure based on Directive 98/34/EC).

I.1.3 Relations with EFTA /EEA Member Countries

In accordance with the general information and consultation procedures set out
in the
Agreement on the European Economic Area and namely its Protocol 12, the Commission has
kept EFTA/EEA Member Countries regularly informed on the progress and final result of the
negotiations. The EFTA/EEA Member Countries are in the initial stage of negotiating a
parallel mutual recognition agreement with the Czech Republic.

I.2 OVERALL APPRECIATION

The Commission considers that the proposed PECA creates an acceptable balance of benefits
for all parties in the pre-accession framework. In all sectors the Community has secured
effective market access - in terms of access to all mandatory procedures of the other party.
The PECA confirms that the Czech Republic has substantially taken over the Community
legislation in the relevant sectors. Both political and commercial benefits are achieved with
the PECA.

The Protocol will allow Community exporters, if they so choose, to test and certify their
industrial products to the same (aligned) requirements prior to export, and then access that
market without any further conformity assessment requirements. The certification procedures
will only need to be carried out one time for both markets and against the same aligned
requirements or standards. The recognition of certification will permit savings and stimulate
exports. European industry federations were consulted and supported unequivocally the
Protocol.

Industrial groups, while supporting the Protocol, have not been able to quantify the costs or
time taken to obtain conformity assessment of their industrial products in the Czech Republic.
The precise extent of savings in time, cost and market opportunity of this Protocol is therefore
not feasible in every case to determine. However, on the basis of a rough calculation, it is
estimated4 that this Protocol would create cost saving opportunities for the exporting industry
of around
45 millions in terms of cost savings to exporters to the
EC, some part of which will be passed on to European importers and consumers.

65 millions and about

€

€

Trade figures between the EC and the Czech Republic are attached for information. The
general trade balance in sectors covered by this Protocol shows a trade surplus for the
Community (factor of 1,4:1, varying from 10:1 in the pharmaceutical sector to 1,1:1 in the
pressure equipment sector). It is expected that trade will increase further when the PECA is in
force.

3

4

Point 4.2.b). COM (99) 710 - final. 20.12.1999.
Working hypothesis that certification and other related costs amount to an average of 1% of trade.

7

In fact, most benefits are clearly not quantifiable, such as reduced time for accessing markets,
less protectionism, and harmonisation of systems. What can be
better predictability,
ascertained is that any agreement provides reciprocal levels of market access, in terms of
conformity assessment.

These advantages outweigh greatly the resources that the Commission will have to engage in
maintenance activities of the Protocol, evaluated at 2.0 person per year and some travel and
other expenses relating to meetings and other activities such as editing guides.

In terms of the benefits to the Czech Republic, the PECA will facilitate access to the
Community market and will give political credit for having aligned its legislation. The Czech
Republic regards the PECA as a means to develop closer industrial relations with the EU and
fully to integrate certain sectors with the Single Market before accession.

II. THE DRAFT COUNCIL DECISIONS

A proposal for two Council decisions is attached.

The first one is concerned with the signature of the Protocol. Signature is required by the
Czech Republic for adoption of any international agreement. It is accordingly proposed that
the President of the Council be authorised to designate the person empowered to sign the
Protocol on behalf of the Community, subject to conclusion later, on the basis of Articles 133
and 300 of the Treaty.

The proposal for a second decision is concerned with the adoption of the PECA. In this
context, the Council should, in line with the previous Council decisions on the conclusion of
mutual recognition agreements establish the appropriate Community procedure for the
implementation and management of the Protocol.

In particular, the Council should confer on the Commission, in consultation with the special
committee appointed by the Council,
the necessary powers for the management and
implementation of the Protocol. Moreover, the Council should delegate to the Commission,
acting in consultation with the special Committee, the necessary powers to determine in
certain cases the Community position with regard to this Protocol in the Association Council,
or where applicable the Association Committee.

In all other cases, the Community position with respect to the Protocol shall be determined by
the Council, acting by qualified majority, on a proposal from the Commission.

The Commission therefore proposes that the Council adopts the attached decisions on the
signature and conclusion of the PECA.

8

2000/0293 (ACC)

Proposal for a

COUNCIL DECISION

on the signature on behalf of the Community of an additional 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

THE COUNCIL OF THE EUROPEAN UNION,

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

Having regard to the proposal from the Commission5,

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, 6entered into force on 1 February 1995;

Article 75(2) of the Europe Agreement provides that co-operation in the fields of
standardisation and conformity assessment shall seek to achieve the conclusion of
agreements on mutual recognition;

The Protocol to the Europe Agreement on Conformity Assessment and Acceptance of
Industrial Products has been negotiated by the Commission on behalf of the
Community;

Subject to its possible conclusion at a later date, the Protocol to the Europe Agreement
on Conformity Assessment and Acceptance of Industrial Products initialled in
Brussels on 10 July 2000 should be signed,

HAS DECIDED AS FOLLOWS:

Subject to a possible conclusion at a later date, the President of the Council is hereby
authorised to designate the person empowered to sign, on behalf of the Community, the
Protocol to the Europe Agreement with the Czech Republic on Conformity Assessment and
Acceptance of Industrial Products.

Done at Brussels, […]

For the Council
The President

5

6

OJ No C […], […], p.[…]
OJ No L 360, 31.12.1994, p.2

9

2000/0294(ACC)

Proposal for a

COUNCIL DECISION

on the conclusion of an additional 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

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article
133 in conjunction Article 300 paragraph 2, first subparagraph, first sentence, paragraph 3,
first subparagraph, first sentence, and paragraph 4 thereof,

Having regard to the proposal from the Commission7,

Whereas:

(1)

(2)

(3)

(4)

(5)

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 part8, entered into force on 1 February 1995;

Article 75(2) of the Europe Agreement provides that co-operation in the fields of
standardisation and conformity assessment shall seek to achieve the conclusion of
agreements on mutual recognition;

Article 108 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/EEC of the Council and the Commission of 19 December
of 1994 on the conclusion of
the Europe Agreement between the European
Communities and their Member States, of the one part, and the Czech Republic, of the
other part9, provides for the Community decision-making procedures and for the
presentation of the Community position in the Association Council and in the
Association Committee;

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;

7

8

9

OJ No C , , p. .
OJ No L 360, 31.12.1994, p.2
OJ No L 360, 31.12.1994, p.1.

10

(6)

(7)

(8)

(9)

The draft Protocol
to the Europe Agreement on Conformity Assessment and
Acceptance of Industrial Products has been signed in Brussels on […2000] on behalf
of the Community; and should be approved;

Certain tasks for implementation have been attributed to the Association Council and
in particular the power to amend certain aspects of the annexes;

The appropriate internal procedures should be established to ensure the proper
functioning of the Protocol; and

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

HAS DECIDED AS FOLLOWS:

Article 1

The additional Protocol to the Europe Agreement between the European Community and the
Czech Republic on Conformity Assessment and Acceptance of
Industrial Products
(hereinafter "the Protocol"), is hereby approved on behalf of the European Community.

The text of the Protocol is attached to this Decision.

The President of the Council shall, on behalf of the Community, transmit the diplomatic note
provided for in Article 17 of the Protocol10.

Article 2

Article 3

1.

The Commission, after consultation with the special committee appointed by the
Council, shall:

(a)

proceed to the notifications, acknowledgements, suspensions and withdrawals
of bodies, and appointments of joint team or teams of experts, in accordance
with Articles 10, 11 and 14, indent c) of the Protocol, and Section III of the
Good Manufacturing Practice (GMP) annex to the Protocol;

(b) make the consultations, exchange of information, the requests for verifications
and for participation in verifications, in accordance with Articles 3, 12 and 14,
indents d) and 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 (ATEX), hot water boilers, gas
appliances, pressure equipment and good manufacturing practice (GMP);

10

The date of entry into force of the Protocol will be published in the Official Journal of the European
Communities by the General Secretariat of the Council.

11

(c)

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

equipment,

safety,

2.

The position to be taken by the Community in the Association Council, and where
applicable in the Association Committee shall be determined by the Commission,
following consultation of the special committee referred to in paragraph 1 of this
Article, with regard to:

(a) Amendments of the annexes in accordance with Article 14, indent a) of the

Protocol;

(c) Any decisions regarding disagreements on the results of the verifications and
the suspensions, in part or totally, of any notified body in accordance with
Article 11, paragraphs 2 and 3 of the Protocol;

(d) Any measures taken in the application of the safeguard clauses in Section IV of
the annexes of the Protocol concerning machinery, lifts, personal protective
equipment, electrical safety, electromagnetic compatibility, equipment and
explosive
protective
atmospheres(ATEX), hot water boilers, gas
and pressure
equipment;

appliances,

potentially

intended

systems

use

for

in

(e)

The pre-operational phase and the measures to be taken in accordance with
paragraphs 3.3, 3.4 and 5.1 of Section III of the Good Manufacturing Practice
(GMP) annex of the Protocol;

(e) Any measures concerning the verification, suspension, or withdrawal of
industrial products as having mutual acceptance under Article 4 of the
Protocol.

3.

In all other cases 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 Brussels, […2000]

For the Council
The President

12

ANNEX

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 -

TABLE OF CONTENTS

Framework

Annex on Mutual Recognition of Results of Conformity Assessment

Machinery

Lifts

Personal Protective Equipment

Electrical Safety

Electromagnetic Compatibility

1.

2.

1.

2.

3.

4.

5.

Equipment and Protective Systems intended for Use in

6.
Potentially Explosive Atmosphere

7.

8.

9.

Hot Water Boilers

Gas Appliances

Pressure Equipment

Good Manufacturing Practice (GMP) for Medicinal Products:

10.
inspection and batch certification

13

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 -

The European Community and the Czech Republic, hereinafter referred to as "the
Parties",

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, the Czech national law
substantially takes over the 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 co-operation between them,

the mutual acceptance of

Desiring to conclude a Protocol to the Europe Agreement on Conformity Assessment
and Acceptance of Industrial Products (hereafter the Protocol) providing for the
application of
the
requirements to be 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,

industrial products which fulfil

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:

14

Article 1
Purpose

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 :

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;

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 recognition of results of conformity assessment".

Article 2
Definitions

For the purpose of this Protocol,

"Industrial products" means products, as specified in Article 9 and in Protocol 3 of the
Europe Agreement.

“Community law” means any legal act and implementing practice of the European
Community applicable to a particular situation, risk or category of industrial products,
as interpreted by the Court of Justice of the European Communities.

"National law" means any legal act and implementing practice by which the Czech
Republic takes over the 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
the Czech national law.

Article 3
Alignment of legislation

For the purpose of this Protocol, the Czech Republic agrees to take appropriate
measures, in consultation with the European Commission, to maintain or 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.

15

Article 4
Mutual acceptance of industrial products

The Parties agree that, for the purpose of mutual acceptance, industrial products listed
in the annexes on "mutual acceptance of industrial products", which fulfil
the
requirements to be lawfully placed on the market of a Party, may be placed on the
market of the other Party, without further restriction. This shall be without prejudice
to Article 36 of the Europe Agreement.

Article 5
Mutual recognition of the results of conformity assessment procedures

The Parties agree to recognize 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.

Article 6
Safeguard clause

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

Article 7
Extension of coverage

As the Czech Republic adopts and implements further national law taking over
in
Community law, the Parties may amend the annexes or conclude new ones,
accordance with the procedure laid down in Article 14.

16

Article 8
Origin

The provisions of this Protocol shall apply to industrial products which originate in
the Parties according to non-preferential rules of origin. In the case of divergent rules,
the rules of the Party in whose territory the product is marketed are 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 of the Europe Agreement.

Article 9
Obligations of Parties as regards their authorities and bodies

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,
to notify, suspend, remove suspension and withdraw notification of bodies, to ensure
the conformity of industrial products with Community or national law or to require
their withdrawal from the market.

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

Article 10
Notified bodies

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

Afterwards, the following procedure shall apply for the notification of bodies to
assess conformity in relation to the requirements of Community or national law
specified in the 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 will be
considered as notified and as competent
to assess conformity in relation to the
requirements specified in the annexes from that date.

If a Party decides to withdraw a notified body under its jurisdiction, it shall inform the
other Party in writing. The body will 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.

17

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 will 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 co-operation 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, they may notify
the chairman of the Association Council of their dissent, giving their reasons. The
Association Council may decide on appropriate action.

Unless and until decided otherwise by the Association Council, the notification of the
body and the recognition of its competence to assess conformity in relation to the
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.

Article 12
Exchange of information and cooperation

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 all relevant information concerning implementation of law and practice
including, in particular, on procedure to ensure compliance of notified bodies;

b) take part, as appropriate, in the relevant mechanisms of information, co-ordination
and other related activities of the Parties;

c) encourage their bodies to co-operate with a view to establishing mutual recognition
arrangements in the voluntary sphere.

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.

18

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 technical competence of a
notified body and its compliance with the requirements;

d) exchanging information on proposed and actual modifications of the Community
and national law referred to in the annexes;

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 above responsibilities set out under this
Protocol, in conformity with Articles 108(2) of the Europe Agreement.

Article 15
Technical co-operation and assistance

The European Community may provide technical co-operation and assistance to the
Czech Republic where necessary in order to support the effective implementation and
application of this 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 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.

19

Article 18
Status of the Protocol

This Protocol constitutes an integral part of the Europe Agreement.

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

Done at………….

…….

20

Annexes
on Mutual Recognition of results of Conformity Assessment

Table of contents

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

1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

Good Manufacturing Practice (GMP) for Medicinal Products : inspection and
batch certification

21

Annex on Mutual Recognition of results of Conformity Assessment:

MACHINERY

SECTION 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,
23.07.1998, p.1), as amended by European Parliament and
Council Directive 98/79/EC of 27 October 1998 (OJ L
331, 07.12.1998, p.1).

Act No.22/1997 Coll. (part 6/27.02.1997) on technical
requirements for products and on amendments to some
Acts, as amended by Act No. 71/2000 Coll.
(part
24/03.04.2000).

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 49/29.05.1992),
6/27.02.1997), Act
Act No.
No.110/1997 Coll. (part 38/19.05.1997), and Act No.
71/2000 Coll. (part 24/03.04.2000).

22/1997 Coll.

(part

Order

(part
Government
60/31.07.1997), that lays down the technical requirements
for machinery, as amended by Government Order No.
15/1999 Coll. (part 6/25.01.1999) and …

No.170/1997

Coll.

SECTION II

NOTIFYING AUTHORITIES

European Community:

• Austria:

• Belgium:

• Denmark:

• Finland:

• France:

Bundesministerium für wirtschaftliche Angelegenheiten.

Ministère des Affaires Economiques.
Ministerie van Economische Zaken.

Direktoratet for Arbejdstilsynet.

Sosiaali-ja terveysministeriö/Social-och hälsovårdsministeriet.

Ministère de l'emploi et de la solidarité.

22

Direction des relations du travail, Bureau CT 5.

Ministère de l'économie, des finances et de l' industrie. Secrétariat
d'Etat à l'industrie.

Direction générale de l'industrie, des technologies de l'information
et des postes (DiGITIP) - SQUALPI.

• Germany:

Bundesministerium für Arbeit und Sozialordnung.

• Greece:

•

•

Ireland:

Italy:

• Luxembourg:

• Netherlands:

• Portugal:

• Spain:

• Sweden:

Ministry of Development. General Secretariat of Industry.

Department of Enterprise and Employment.

Ministero dell'Industria, del Commercio e dell'Artiginiato.

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

Minister van Sociale Zaken en Werkgelegenheid.

Under the authority of the Government of Portugal: Instituto
Português da Qualidad.

Ministerio de Industria y Energía.

Under the authority of the Government of Sweden: Styrelsen för
ackreditering och teknisk kontroll (SWEDAC).

• United Kingdom:

Department of Trade and Industry.

Czech Republic:

ř
ad pro technickou normalizaci, metrologii a státní zkušebnictví

Ú
(Czech Office for Standards, Metrology and Testing).

SECTION III

NOTIFIED BODIES

European Community:

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

23

SECTION IV

SPECIFIC ARRANGEMENTS

Safeguard Clauses

A. Safeguard clause relating to industrial products.

1.

2.

3.

4.

5.

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

The 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.

Where the Association Council finds that the measure is:

a)

b)

unjustified,
measure shall withdraw it;

the national authority of the Party who has taken the

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

B. Safeguard clause related relating to harmonised standards.

1.

2.

3.

4.

Where the Czech Republic considers that a harmonised standard referred to
in the legislation defined in the present annex, does not meet the essential
requirements of such legislation, it shall inform the Association Council
giving the reasons thereof.

The Association Council shall consider the matter and may request the
European Community to proceed in accordance with the procedure provided
for in the Community legislation identified in the present annex.

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

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

24

ANNEX ON MUTUAL RECOGNITION OF RESULTS OF CONFORMITY ASSESSMENT:

Community law:

National law:

LIFTS

SECTION I

COMMUNITY AND NATIONAL 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 , 07.09.1995,
p.1).

Act No.22/1997 Coll. (part 6/27.02.1997) on technical
requirements for products and on amendments to some
Acts, as amended by Act No. 71/2000 Coll.
(part
24/03.04.2000).

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 49/29.05.1992),
Act No.22/1997 Coll.
6/27.02.1997), Act
No.110/1997 Coll. (part 38/19.05.1997), and Act No.
71/2000 Coll. (part 24/03.04.2000).

(part

Government Order No.14/1999 Coll. (part 6/25.01.1999),
that lays down the technical requirements for lifts, as
amended by Government Order No. 227/1999 Coll. (part
77/14.10.1999), and …

SECTION II

NOTIFYING AUTHORITIES

European Community

• Austria

• Belgium

• Denmark

• Finland

Bundesministerium für wirtschaftliche Angelegenheiten.

Ministère des Affaires Economiques.

Ministerie van Economische Zaken.

Direktoratet for Arbejdstilsynet.

Kauppa- ja teollisuusministeriö/Handels- och industriministeriet.

25

• France

Ministère de l'emploi et de la solidarité.

Direction des relations du travail, Bureau CT 5.

Ministère de l'économie, des finances et de l' industrie.

Secrétariat d'Etat à l'industrie.

Direction générale de l'industrie, des technologies de l'information et
des postes (DiGITIP) – SQUALPI

• Germany

• Greece

•

•

Ireland

Italy

• Luxembourg

• Netherlands

• Portugal

• Spain

• Sweden

Bundesministerium für Arbeit und Sozialordnung.

Ministry of Development. General Secretariat of Industry.

Department of Enterprise and Employment.

Ministero dell'Industria, del Commercio e dell'Artiginiato.

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

Minister van Sociale Zaken en Werkgelegenheid.

Ministério da Economia. Direcção Geral da Energia.

Ministerio de Industria y Energía.

Under the authority of the Government of Sweden :

Styrelsen för ackreditering och teknisk kontrol (SWEDAC)

• United Kingdom

Department of Trade and Industry.

Czech Republic:

ř

Ú

ad pro technickou normalizaci, metrologii a státní zkušebnictví

(Czech Office for Standards, Metrology and Testing).

SECTION III

NOTIFIED BODIES

European Community:

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

26

SECTION IV

SPECIFIC ARRANGEMENTS

Safeguard Clauses

A. Safeguard clause relating to industrial products.

1.

2.

3.

4.

5.

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

The 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.

Where the Association Council finds that the measure is:

unjustified, the national authority of the Party who has taken the

a)
measure shall withdraw it;

justified, the Parties shall take appropriate measures to ensure that such

b)
products are not placed on the market.

B. Safeguard clause relating to harmonised standards.

1.

2.

3.

4.

Where the Czech Republic considers that a harmonised standard referred to
in the legislation defined in the present annex, does not meet the essential
requirements of such legislation, it shall inform the Association Council
giving the reasons thereof.

The Association Council shall consider the matter and may request the
European Community to proceed in accordance with the procedure provided
for in the Community legislation identified in the present annex.

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

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

27

ANNEX ON MUTUAL RECOGNITION OF RESULTS OF CONFORMITY ASSESSMENT:

PERSONAL PROTECTIVE EQUIPMENT

SECTION I

COMMUNITY AND NATIONAL LAW

Community law:

National 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, 18.09.1996, p.44).

Act No.22/1997 Coll. (part 6/27.02.1997) on technical
requirements for products and on amendments to some
Acts, as amended by Act No. 71/2000 Coll. (part
24/03.04.2000).

Act No. 64/1986 Coll. (part 22/03.11.1986), of the
on the Czech Trade
Czech National Council,
Inspection, as amended by Act No. 240/1992 Coll.
(part
(part 49/29.05.1992), Act No.22/1997 Coll.
(part
6/27.02.1997),
(part
38/19.05.1997), and Act No. 71/2000 Coll.
24/03.04.2000).

No.110/1997

Coll.

Act

Order
that

(part
No.172/1997
Government
61/04.08.1997),
technical
down
lays
requirements for personal protective equipment, as
amended by ….

Coll.

the

SECTION II

NOTIFYING AUTHORITIES

European Community:

• Austria

Bunderministerium für wirtschaftliche Angelegenheiten.

• Belgium

Ministère des Affaires Economiques.

• Denmark

• Finland

Ministerie van Economische Zaken.

Direktoratet for Arbejdstilsynet.

Sosiaali-ja terveyministeriö/Social-och hälsovårdsministeriet.

28

• France

Ministère de l'emploi et de la solidarité.

Direction des relations du travail, Bureau CT 5.

Ministère de l'économie, des finances et de l'industrie.

Secrétariat d'Etat à l'industrie.

Direction générale de l'industrie, des technologies de l'information et
des postes (DiGITIP) – SQUALPI

• Germany

• Greece

•

•

Ireland

Italy

• Luxembourg

• Netherlands

• Portugal

• Spain

• Sweden

Bundesministerium für Arbeit und Sozialordnung.

Ministry of Development. General Secretariat of Industry.

Department of Enterprise and Employment.

Ministero dell'Industria, del Commercio e dell'Artiginiato.

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

Minister van Volksgezondheid, Welzijn en Sport.

Ministério da Economia. Instituto Português da Qualidade.

Ministerio de Industria y Energía.

Under the authority of the Government of Sweden:

Styrelsen för ackreditering och teknisk kontroll (SWEDAC).

• United Kingdom Department of Trade and Industry.

ř

Czech Republic:

ad pro technickou normalizaci, metrologii a státní zkušebnictví

Ú
(Czech Office for Standards, Metrology and Testing)

SECTION III

NOTIFIED BODIES

European Community:

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

29

SECTION IV

SPECIFIC ARRANGEMENTS

Safeguard Clauses.

A. Safeguard clause relating to industrial products

1.

2.

3.

4.

5.

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

The 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.

Where the Association Council finds that the measure is:

unjustified, the national authority of the Party who has taken the

a)
measure shall withdraw it;

justified, the Parties shall take appropriate measures to ensure that such

b)
products are not placed on the market.

B. Safeguard clause relating to harmonised standards.

1.

2.

3.

4.

Where the Czech Republic considers that a harmonised standard referred to
in the legislation defined in the present annex, does not meet the essential
requirements of such legislation, it shall inform the Association Council
giving the reasons thereof.

The Association Council shall consider the matter and may request the
European Community to proceed in accordance with the procedure provided
for in the Community legislation identified in the present annex.

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

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

30

ANNEX ON MUTUAL RECOGNITION OF RESULTS OF CONFORMITY ASSESSMENT:

Community law:

National law:

ELECTRICAL SAFETY

SECTION I

COMMUNITY AND NATIONAL 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, 26.03.1973, p. 29), as last amended by
Directive 93/68/EEC of 22 July 1993 (OJ L 220, 30.08.1993,
p.1).

(part 6/27.02.1997) on technical
Act No.22/1997 Coll.
requirements for products and on amendments to some Acts,
as amended by Act No. 71/2000 Coll. (part 24/03.04.2000).

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 49/29.05.1992),
Act No.22/1997 Coll. (part 6/27.02.1997), Act No.110/1997
Coll. (part 38/19.05.1997), and Act N° 71/2000 Coll. (part
24/03.04.2000).

Government Order No.168/1997 Coll. part 60/31.07.1997),
that lays down the technical requirements for low voltage
electrical equipment, as amended by …

• Austria:

• Belgium:

• Denmark:

• Finland:

SECTION II

NOTIFYING AUTHORITIES

Bundesministerium für wirtschaftliche Angelegenheiten.

Ministère des Affaires Economiques.

Ministerie van Economische Zaken.

Boligministeriet.

Kauppa ja teollisuusministeriö.

Handels och industriministeriet.

• France:

Ministère de l'économie, des finances et de l'industrie.

Secrétariat d'Etat à l'industrie.

31

Direction générale de l'industrie, des technologies de l'information
et des postes (DiGITIP) – SQUALPI.

• Germany:

Bundesministerium für Arbeit und Sozialordung.

• Greece:

•

•

Ireland:

Italy:

Ministry of Development. General Secretariat of Industry.

Department of Enterprise and Employment.

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

• Luxembourg:

Ministère de l'Economie- Service de l'Energie de l'Etat.

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

• Netherlands:

Minister van Volksgezondheid, Welzijn en Sport
goods).

(consumer

Minister van Sociale Zaken en Werkgelegenheid (others).

• Portugal:

• Spain:

• Sweden:

Under
Instituto Português da Qualidade.

authority

the

of

the Government

of

Portugal:

Ministerio de Industria y Energía.

Under
Styrelsen för ackreditering och teknisk kontrol (SWEDAC).

the Government

authority

of Sweden

the

of

:

• United Kingdom

Department of Trade and Industry.

Czech Republic:

ř

Ú

ad pro technickou normalizaci, metrologii a státní zkušebnictví

(Czech Office for Standards, Metrology and Testing).

SECTION III

NOTIFIED AND COMPETENT BODIES

European Community:

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

32

SECTION IV

SPECIFIC ARRANGEMENTS

Safeguard Clauses

A. Safeguard clause relating to industrial products.

1.

2.

3.

4.

5.

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

The 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.

Where the Association Council finds that the measure is:

unjustified, the national authority of the Party who has taken the measure

a)
shall withdraw it;

justified, the Parties shall take appropriate measures to ensure that such

b)
products are not placed on the market.

B. Safeguard clause relating to harmonised standards.

1.

2.

3.

4.

Where the Czech Republic considers that a harmonised standard referred to in the
legislation defined in the present annex, does not meet the essential requirements of
such legislation, it shall inform the Association Council giving the reasons thereof.

The Association Council shall consider the matter and may request the European
Community to proceed in accordance with the procedure provided for in the
Community legislation identified in the present annex.

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

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

33

ANNEX ON MUTUAL RECOGNITION OF RESULTS OF CONFORMITY ASSESSMENT:

ELECTROMAGNETIC COMPATIBILITY

SECTION I

COMMUNITY AND NATIONAL LAW

Community law:

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, 23.05.1989, p. 19),
as last amended by Directive 93/68/EEC of 22 July 1993 (OJ
L 220, 30.08.1993, p.1).

(part 6/27.02.1997) on technical
Act No. 22/1997 Coll.
requirements for products and on amendments to some Acts,
as amended by Act N°. 71/2000 Coll. (part 24/03.04.2000).

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 49/29.05.1992), Act No.
22/1997 Coll. (part 6/27.02.1997), Act No. 110/1997 Coll.
(part 38/19.05.1997), and Act N°. 71/2000 Coll.
(part
24/03.04.2000).

Government Order No. 169/1997 Coll. (part 60/31.07.1997),
that lays down the technical requirements for products relating
to their electromagnetic compatibility, as amended by …

SECTION II

NOTIFYING AUTHORITIES

European Community:

• Austria:

• Belgium:

• Denmark:

• Finland:

Bundesministerium für wirtschaftliche Angelegenheiten.

Ministère des Affaires Economiques.

Ministerie van Economische Zaken.

Telestyrelsen.

Kauppa-ja teollisuusministeriö/Handels-och industriministeriet.

For EMC aspects
equipment:Liikenneministeriö/Trafikministeriet.

telecommunications

of

and

radio

• France:

Ministère de l'économie, des finances et de l'industrie.

Secrétariat d'Etat à l'industrie.

34

de
Direction
l'information et des postes (DiGITIP) - SQUALPI.

l'industrie,

générale

des

technologies

de

• Germany:

• Greece:

•

•

Ireland:

Italy:

• Luxembourg:

• Netherlands:

• Portugal:

Bundesministerium für Wirtschaft und Technologie.

Ministry of Development. General Secretariat of Industry.

Department of Enterprise and Employment.

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

Ministère de l'Economie- Service de l'Energie de l'Etat.

Minister van Verkeer en Waterstaat.

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

• Spain:

Ministerio de Industria y Energía.

For EMC aspects of telecommunications and radio equipment:
Ministerio de Fomento.

• Sweden:

Under the authority of the Government of Sweden : Styrelsen för
ackreditering och teknisk kontrol (SWEDAC).

• United Kingdom: Department of Trade and Industry.

Czech Republic:

technickou

normalizaci, metrologii

a

státní

ř

ad

pro

Ú
zkušebnictví

(Czech Office for Standards, Metrology and Testing).

SECTION III

NOTIFIED AND COMPETENT BODIES

European Community:

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

35

SECTION IV

SPECIFIC ARRANGEMENTS

Safeguard Clauses

A. Safeguard clause relating to industrial products.

1.

2.

3.

4.

5.

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

The 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.

Where the Association Council finds that the measure is:

unjustified, the national authority of the Party who has taken the

a)
measure shall withdraw it;

justified, the Parties shall take appropriate measures to ensure that such

b)
products are not placed on the market.

B. Safeguard clause relating to harmonised standards.

1.

2.

3.

4.

Where the Czech Republic considers that a harmonised standard referred to
in the legislation defined in the present annex, does not meet the essential
requirements of such legislation, it shall inform the Association Council
giving the reasons thereof.

The Association Council shall consider the matter and may request the
European Community to proceed in accordance with the procedure provided
for in the Community legislation identified in the present annex.

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

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

36

ANNEX ON MUTUAL RECOGNITION OF RESULTS OF CONFORMITY ASSESSMENT:

EQUIPMENT AND PROTECTIVE SYSTEMS INTENDED FOR USE

IN POTENTIALLY EXPLOSIVE ATMOSPHERES

Community law:

National law:

SECTION I

COMMUNITY AND NATIONAL 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, 19.04.1994, p.1).

Act No. 22/1997 Coll. (part 6/27.02.1997) on technical
requirements for products and on amendments to some
Acts, as amended by Act N°. 71/2000 Coll; (part
24/03.04.2000).

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 49/29.05.1992), Act No. 22/1997. Coll. (part
(part
110/1997 Coll.
6/27.02.1997), Act No.
38/19.05.1997), and Act N°. 71/2000 Coll.
(part
24/03.04.2000).

176/1997 Coll.

(part
Government Order No.
63/08.08.1997),
technical
lays
requirements for equipment and protective systems
intended for use in potentially explosive atmospheres,
as amended by …

down

that

the

SECTION II

NOTIFYING AUTHORITIES

European Community

• Austria

• Belgium

Bundesministerium für wirtschaftliche Angelegenheiten.

Ministère des Affaires Economiques.

Ministerie van Economische Zaken.

• Denmark

Elektricitetsrådet.

37

• Finland

• France

• Germany

• Greece

•

•

Ireland

Italy

• Luxembourg

• Netherlands

• Portugal

• Spain

• Sweden

Kauppa-ja teollisuusministeriö/Handels-och industriministeriet.

Ministère de l'économie, des finances et de l'industrie.

Secrétariat d'Etat à l'industrie.

Direction de l'action régionale et de la petite et moyenne industrie
(DARPMI). Sous-direction de la sécurité industrielle.

Direction générale de l'industrie, des technologies de l'information
et des postes (DiGITIP) – SQUALPI

Bundesministerium für Arbeit und Sozialordnung.

Ministry of Development. General Secretary of Industry.

Department of Enterprise and Employment.

Ministero dell'Industria, del Commercio e dell'Artiginiato.

Ministère de l'Economie- Service de l'Energie de l'Etat.

Minister van Sociale Zaken en Werkgelegenheid.

Ministério da Economia. Direcção Geral da Energia.

Ministerio de Industria y Energía.

Under the authority of the Government of Sweden :

Styrelsen för ackreditering och teknisk kontrol (SWEDAC)

• United Kingdom Department of Trade and Industry.

Czech Republic:

ř

ad pro technickou normalizaci, metrologii a státní zkušebnictví

Ú
(Czech Office for Standards, Metrology and Testing).

SECTION III

NOTIFIED BODIES

European Community:

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

38

SECTION IV

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. 22/197 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
to the
Republic will
applicable requirements referred to in this paragraph.

issue a declaration of conformity of the relevant product

2.

Safeguard Clauses

A. Safeguard clause relating to industrial products.

1.

2.

3.

4.

5.

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

The 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.

Where the Association Council finds that the measure is:

unjustified, the national authority of the Party who has taken the

a)
measure shall withdraw it;

justified, the Parties shall take appropriate measures to ensure that such

b)
products are not placed on the market.

B. Safeguard clause relating to harmonised standards.

1.

2.

Where the Czech Republic considers that a harmonised standard referred to
in the legislation defined in the present annex, does not meet the essential
requirements of such legislation, it shall inform the Association Council
giving the reasons thereof.

The Association Council shall consider the matter and may request the
European Community to proceed in accordance with the procedure provided
for in the Community legislation identified in the present annex.

39

3.

4.

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

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

40

ANNEX ON MUTUAL RECOGNITION OF RESULTS OF CONFORMITY ASSESSMENT:

HOT WATER BOILERS

SECTION 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 No L 167, 22.06.1992 p.17), as amended by
Council Directive 93/68/EEC of 22 July 1993 (OJ L 220,
30.08.1993, p.1).

National law:

Act No. 22/1997 Coll.
(part 6/27.02.1997) on technical
requirements for products and on amendments to some Acts, as
amended by Act N°. 71/2000 Coll. (part 24/03.04.2000).

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 49/29.05.1992), Act No.
22/1997 Coll. (part 6/27.02.1997), Act No. 110/1997 Coll. (part
(part
38/19.05.1997),
24/03.04.2000).

and Act N°.

71/2000

Coll.

Government Order No. 180/1999 Coll. (part 61/17.08.1999),
that lays down the technical requirements for new hot-water
boilers fired with liquid or gaseous fuels, as amended by….

SECTION II

NOTIFYING AUTHORITIES

European Community:

• Austria

• Belgium

• Denmark

• Finland

• France

Bunderministerium für wirtschaftliche Angelegenheiten.

Ministère des Affaires Economiques.

Ministerie van Economische Zaken.

Boligministeriet.

Ympäristöministeriö/Miljöministeriet.

Ministère de l'économie, des finances et de l'industrie.

Secrétariat d'Etat à l'industrie.

41

Direction de l'action régionale et de la petite et moyenne
industrie (DARPMI). Sous-direction de la sécurité industrielle.

Direction
de
l'information et des postes (DiGITIP) - SQUALPI.

l'industrie,

générale

des

technologies

de

• Germany

• Greece

•

•

Ireland

Italy

• Luxembourg

• Netherlands

• Portugal

• Spain

• Sweden

• United Kingdom

Czech Republic:

Bundesministerium für Wirtschaft und Technologie.

Ministry of Development. General Secretary of Industry.

Department of Enterprise and Employment.

Ministero dell'Industria, del Commercio e dell'Artiginiato.

Ministère de l'Environnement.

Ministerie van Economische Zaken.

Ministério da Economia. Instituto Português da Qualidade.

Ministerio de Industria y Energia.

Under the authority of the Government of Sweden: Styrelsen för
ackreditering och teknisk kontroll (SWEDAC).

Department of the Environment, Transport and the Regions.

ř

ad pro technickou normalizaci, metrologii a státní zkušebnictví

Ú
(Czech Office for Standards, Metrology and Testing).

SECTION III

NOTIFIED BODIES

European Community:

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

Czech Republic:

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

42

SECTION IV

SPECIFIC ARRANGEMENTS

Safeguard Clauses

A. Safeguard clause relating to industrial products.

1.

2.

3.

4.

5.

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

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

to their

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.

Where the Association Council finds that the measure is:

unjustified, the national authority of the Party who has taken the

a)
measure shall withdraw it;

justified, the Parties shall take appropriate measures to ensure that such

b)
products are not placed on the market.

B. Safeguard clause relating to harmonised standards.

1.

2.

3.

4.

Where the Czech Republic considers that a harmonised standard referred to
in the legislation defined in the present annex, does not meet the essential
requirements of such legislation, it shall inform the Association Council
giving the reasons thereof.

The Association Council shall consider the matter and may request the
European Community to proceed in accordance with the procedure provided
for in the Community legislation identified in the present annex.

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

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

43

ANNEX ON MUTUAL RECOGNITION OF RESULTS OF CONFORMITY ASSESSMENT:

Community law:

National law:

European Community

• Austria

• Belgium

• Denmark

• Finland

• France

GAS APPLIANCES

SECTION I

COMMUNITY AND 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, 26.07.1990, p. 15)
, as last amended by Council Directive 93/68/EEC of 22 July
1993 (OJ No L 220, 30.08.1993, p. 1).

(part 6/27.02.1997) on technical
Act No. 22/1997 Coll.
requirements for products and on amendments to some Acts,
as amended by Act N°. 71/2000 Coll. (part 24/03.04.2000).

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 49/29.05.1992), Act No.
22/1997 Coll. (part 6/27.02.1997), Act No.110/1997 Coll.
(part 38/19.05.1997), and Act N°. 71/2000 Coll.
(part
24/03.04.2000).

Government Order No. 177/1997 Coll. (part 64/12.08.1997),
that
lays down the technical requirements for appliances
burning gaseous fuels, as amended by….

SECTION II

NOTIFYING AUTHORITIES

Bundesministerium für wirtschaftliche Angelegenheiten.

Ministère des Affaires Economiques.

Ministerie van Economische Zaken.

Danmarks Gasmaterial Prøvning.

Kauppa-ja teollisuusministeriö/Handels-och industriministeriet.

Ministère de l'économie, des finances et de l'industrie.

Secrétariat d'Etat à l'industrie.

Direction de l'action régionale et de la petite et moyenne
industrie (DARPMI). Sous-direction de la sécurité industrielle.

Direction

générale

de

l'industrie,

des

technologies

de

44

• Germany

• Greece

•

•

Ireland

Italy

• Luxembourg

• Netherlands

• Portugal

• Spain

• Sweden

• United Kingdom

Czech Republic:

l'information et des postes (DiGITIP) - SQUALPI

Bundesministerium für Arbeit und Sozialordnung.

Ministry of Development. General Secretary of Industry.

Department of Enterprise and Employment.

Ministero dell'Industria, del Commercio e dell'Artiginiato.

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

Ministerie van Economische Zaken.

Ministério da Economia. Instituto Português da Qualidade.

Ministerio de Industria y Energía.

Under the authority of the Government of Sweden: Styrelsen för
ackreditering och teknisk kontroll (SWEDAC)

Department of Trade and Industry.

ř

ad pro technickou normalizaci, metrologii a státní zkušebnictví

Ú
(Czech Office for Standards, Metrology and Testing).

SECTION III

NOTIFIED BODIES

European Community:

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

SECTION IV

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 the present annex, it

45

2.

3.

4.

5.

shall immediately inform to the other Party, indicating the reasons for its
decision and how non compliance has been assessed.

The 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.

Where the Association Council finds that the measure is:

unjustified, the national authority of the Party who has taken the

a)
measure shall withdraw it;

justified, the Parties shall take appropriate measures to ensure that such

b)
products are not placed on the market.

B. Safeguard clause relating to harmonised standards.

1.

2.

3.

4.

Where the Czech Republic considers that a harmonised standard referred to
in the legislation defined in the present annex, does not meet the essential
requirements of such legislation, it shall inform the Association Council
giving the reasons thereof.

The Association Council shall consider the matter and may request the
European Community to proceed in accordance with the procedure provided
for in the Community legislation identified in the present annex.

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

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

46

ANNEX ON MUTUAL RECOGNITION OF RESULTS OF CONFORMITY ASSESSMENT

Community law:

PRESSURE EQUIPMENT

SECTION I

COMMUNITY AND NATIONAL 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, 08.08.1987, p. 48), as last
amended by Council Directive 93/68/EEC of 22 July 1993
(OJ L 220, 30.08.1993, 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, 09.07.1997,
p. 1).

National law:

Act No. 22/1997 Coll. (part 6/27.02.1997) on technical
requirements for products and on amendments to some Acts,
as amended by Act N°. 71/2000 Coll. (part 24/03.04.2000).

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 49/29.05.1992),
Act No. 22/1997 Coll. (part 6/27.02.1997), Act No. 110/1997
Coll. (part 38/19.05.1997), and Act N°. 71/2000 Coll. (part
24/03.04.2000).

Government Order No. 175/1997 Coll. (part 63/08.08.1997),
that lays down the technical requirements for simple pressure
vessels, as amended by Government Order No. 80/1999 Coll.
(part 30/04.05.1999) and …

Government Order No. 182/1999 Coll. (part 62/24.08.1999),
that
requirements for pressure
equipment, as amended by ….

lays down the technical

SECTION II

NOTIFYING AUTHORITIES

European Community:

• Austria

• Belgium

Bundesministerium für Wirtschaftliche Angelegenheiten.

Ministère des Affaires Economiques.

Ministerie van Economische Zaken.

47

• Denmark

• Finland

• France

• Germany

• Greece

• Ireland

• Italy

• Luxembourg

• Netherlands

• Portugal

• Spain

• Sweden

• United

Kingdom

Czech Republic:

Direktoratet for Arbejdstilsynet.

Kauppa-ja teollisuusministeriö/Handels- och industriministeriet.

Ministère de l'économie, des finances et de l'industrie.

Secrétariat d'Etat à l'industrie.

Direction de l'action régionale de la petite et moyenne industrie
(DARPMI).Sous-direction de la sécurité industrielle.

Direction générale de l'industrie, des technologies de l'information
et des postes (DiGITIP) – SQUALPI.

Bundesministerium für Arbeit und Sozialordnung.

Ministry of Development. General Secretariat of Industry.

Department of Enterprise and Employment.

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

Ministère du Travail et de l'Emploi.

Minister van Sociale Zaken en Werkgelegenheid.

Under the authority of the Government of Portugal:

Instituto Português da Qualidade.

Ministerio de Industria y Energía.

Under the authority of the Government of Sweden:

Styrelsen för ackreditering och teknisk kontroll (SWEDAC).

Department of Trade and Industry.

ř

ad pro technickou normalizaci, metrologii a státní zkušebnictví

Ú
(Czech Office for Standards, Metrology and Testing).

48

SECTION III

NOTIFIED BODIES

European Community:

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

SECTION IV

SPECIFIC ARRANGEMENTS

Safeguard Clauses

A. Safeguard clause relating to industrial products.

1.

2.

3.

4.

5.

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

The 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.

Where the Association Council finds that the measure is:

unjustified, the national authority of the Party who has taken the

a)
measure shall withdraw it;

justified, the Parties shall take appropriate measures to ensure that such

b)
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 the present annex, does not meet the essential

49

requirements of such legislation, it shall inform the Association Council
giving the reasons thereof.

The Association Council shall consider the matter and may request the
European Community to proceed in accordance with the procedure provided
for in the Community legislation identified in the present annex.

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

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

2.

3.

4.

50

Annex on Mutual Recognition of results of Conformity Assessment:

GOOD MANUFACTURING PRACTICE (GMP) FOR MEDICINAL PRODUCTS : INSPECTION AND
BATCH CERTIFICATION

Community law:

SECTION I

COMMUNITY AND NATIONAL 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,
09.02.1965), as last amended by Council Directive 93/39/EEC
of 14 June 1993 (OJ L 214, 24.08.1993, p.22).

Council Directive 75/318/EEC of 20 May 1975 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 medicinal products (OJ L
last amended by Commission
147, 09.06.1975, p.1), as
Directives 1999/82/EC and 1999/83/EC of 8 September 1999
(OJ L 243, 15.09.1999, 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,
09.06.1975, p. 13), as last amended by Council Directive
93/39/EEC of 14 June 1993 (OJ L 214, 24.08.1993, 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, 06.11.1981, p.1), as
last amended by Council Directive 90/676/EEC of 13 December
1990 (OJ L 373, 31.12.1990, p.15).

Council 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, 06.11.1981, p.16), as last amended by
Commission Directive 1999/104/EC of 22 December 1999 (OJ
L 3, 06.01.2000, 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,
17.07.1991, p.30).

Commission Directive 91/412/EEC of 23 July 1991 laying
down the principles and guidelines of good manufacturing
practice
(OJ L 228,
17.08.1991, p.70).

for veterinary medicinal products

51

Council Regulation (EEC) N° 2309/93 of 22 July 1993 laying
authorisation and
down Community procedures
supervision of medicinal products for human and veterinary use
and establishing a European Agency for the Evaluation of
Medicinal Products (OJ L, 214, 24.08.1993, p.1) as last
amended by Commission Regulation (EC) N° 649/98 of 23
March 1998 (OJ L 88, 24.03.1998, p. 7).

the

for

Council Directive 92/25/EEC of 31 March 1992 on the
wholesale distribution of medicinal products for human use (OJ
L 113, 30.04.1992. p.1) & 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 Procedures on Administrative
Collaboration and Harmonisation of Inspections (III/5698/94-
EN).

National law:

Act No. 79/1997 Coll. (part 26/15.04.1997) on pharmaceuticals
and on amendments to some Acts as amended by Act No.
149/2000 Coll. (part 47/13.06.2000).

355/1997 Coll.

Decree of the Ministry of Health and Ministry of Agriculture
No.
on Good
Manufacturing Practice, Good Distribution Practice and More
Detailed Conditions
and
Distribution of Pharmaceuticals as amended by Decree No. …
(part …).

for Licensing of Manufacture

115/31.12.1997)

(part

Implementation of Good
for
Recommended Procedures
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
and
(GMP)
Manufacturing Practice
Distributors of Pharmaceuticals, Official Journal of SUKL No.
3/1998, (VYR-8).

for Manufacturers

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

General Requirements of SUKL on Validation of Aseptic

52

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 the Institute for State Control of Veterinary
Immunologicals and Medicaments, Brno (USKVBL)

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

SECTION II

OFFICIAL GMP INSPECTION SERVICES OF EACH PARTY

European Community

• Austria

• Belgium

• Denmark

• Finland

• France

• Germany

• Greece

•

•

Ireland

Italy

Bundesministerium für Arbeit, Gesundheit und Soziales.

Ministère de la Santé Publique, de l'Environment et de l'Intégration
Sociale. Inspection Pharmaceutique.

Ministerie van Volksgenzondheid, Leefmilieu en Sociale Integratie.
Farmaceutische Inspectie.

Lægemiddelstyrelsen (Danish Medicines Agency).

Sosiaali-ja terveyministeriö/Social-och hälsovardsministeriet.

Ministère de l'emploi et de la solidarité. Direction générale de la
santé.

Agence française de sécurité sanitaire des produits de santé (human
medicinal products).

Agence française de sécurité sanitaire des aliments (veterinary
medicinal products).

Bundesministerium für Gesundheit.

Ministry of Health and Welfare, National Drug Organization
(E.O.F.).

Irish Medicines Board.

Ministero della Sanità. Dipartimento Farmaci e Farmacovigilanza
(human medicinal products).

Ministero della Sanità. Dipartimento alimenti e nutrizione e sanità
pubblica veterinaria – Div IX (veterinary medicinal products).

• Luxembourg Direction de
Médicaments.

la Santé, Division de

la Pharmacie

et des

• Netherlands Ministerie van Volksgezondheid, Welzijn en Sport;

inspectie

Volksgezondheid.

53

• Portugal

• Spain

• Sweden

• United

Kingdom

Instituto da Farmácia e do Medicamento (INFARMED).

Agencia Española del Medicamento.

Läkemedelsverket (Medical Products Agency).

Medicines Control Agency.

Veterinary Medicines Directorate.

č
Czech Republic: Státní ústav pro kontrolu lé

iv - SUKL (State Institute for Drug

Control) Praha.

Ústav pro státní kontrolu veterinárních biopreparát
USKVBL.
for
Immunologicals and Medicaments) Brno.

State Control

(Institute

ů

č
iv –
a lé
of Veterinary

SECTION III

SPECIFIC ARRANGEMENTS

1.

DEFINITION

"Medicinal products": means all products regulated by the pharmaceutical legislation in the
European Community and the Czech Republic as listed in Section I above.

"Good Manufacturing Practice (GMP)": as defined in Council Directive 91/356/EEC and
Council Directive 91/412/EEC and the relevant legislation of the Czech Republic as listed in
Section I above.

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

"Inspection Report": means the written observations and Good Manufacturing Practice
compliance assessment completed by an authority listed in Section II above.

2.

2.1

2.2

2.3

SCOPE AND COVERAGE

The provisions of this Sectoral Annex cover all medicinal products for human and
veterinary use which are industrially manufactured in the Czech Republic and the
European Community, and to which the GMP requirements apply.

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

In addition, the manufacturer's certification of the conformity of each batch to its
specifications shall be recognised by the other Party without re-control at import.

54

3.

3.1

3.2

3.3

3.4

PRE-OPERATIONAL PHASE

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

effective

regulatory and administrative
The
requirements of the European Community on GMP by the Czech Republic will be
determined according to a procedure established by the European Community.

implementation of

legislative,

The practical implementation of the requirements of the European Community on
GMP will be determined through joint inspections, examination of inspection reports
and other documents linked to an inspection.

The length of the pre-operational phase will be 6 month.

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
Association Council. The operational phase will start
the
successful termination of the pre-operational phase.

immediately after

The Parties may decide, in the Association Council, to renounce the pre-operational
implementation and
phase at any time in the light of the demonstration of
maintenance of Good Manufacturing Practice in the Czech Republic.

4.

OPERATIONAL PHASE

Certification of manufacturers

4.1

At the request of an exporter, importer or the Competent Authority of the other party,
the authorities 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:

is appropriately authorised to manufacture and/or control

a)
medicinal product or to carry out the relevant specified operations;

the relevant

complies with the European Community and Czech Republic GMP

b)
requirements; and,

c)

is regularly inspected by the competent inspection service.

4.2

4.3

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

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

55

Batch certification

4.4

4.5

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
in accordance with the requirements of the
ensure the quality of the product
marketing authorisation. This certificate shall attest
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.

that

When issuing a certificate, the manufacturer shall take account of the provisions of
the current European Community certification. The batch certificate shall be signed
by the person responsible for releasing the batch for export, i.e. the "qualified
person" 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 (e.g. 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:

General or System Inspections: carried out to verify whether a manufacturer
routine inspection covering

a)
complies generally with GMP requirements (e.g.
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 (e.g. 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 (e.g. "pre-marketing" 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 of inspection/establishment fees is determined by the manufacturer's
location. Inspection/establishment fees will not be charged to manufacturers located
on the territory of the other Party for products covered by this Protocol.

56

Transmission of inspection reports

4.10

4.11

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.

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

4.13

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.

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
requirements

information between authorities and approximation of quality

4.14

4.15

In accordance with the general provisions of the Protocol, the Parties shall exchange
any information necessary for the mutual recognition of inspections.

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
their
approximation.

to proceed towards

Inspectors training

4.16

In accordance with the general provisions of the 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 the 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.

57

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

for the European Community:

the Director of the European Agency for the Evaluation of Medicinal Products.

for the Czech Republic:

in case of human medicinal product - the Director of the State Institute for Drug
Control,

in case of 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.

5.1

5.2

SAFEGUARD MECHANISMS

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.

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.

58

DECLARATION ON EXCHANGE OF INFORMATION

The Parties see the merit of adopting a further annex to this PECA, concerned with exchange
of information referred to in Article 12. 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 22 June 1998, laying down a procedure for the provision
of information in the field of technical standards and regulations, as amended by Directive
98/48/EC of 20 July 1998. To this effect, a simplified procedure will be prepared as a new
annex to this Protocol.

59

DECLARATION BY THE EUROPEAN COMMUNITY ON THE ATTENDANCE OF
THE CZECH REPRESENTATIVES TO COMMITTEES

In order to ensure a better understanding of the practical aspects of the application of the
acquis communautaire, the European 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.

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

This invitation may be extended, on a case-by-case basis, to groups of experts convened by
the European Commission.

60

FINANCIAL STATEMENT 2001-2005

External trade relations - Protocol to the Europe Agreement between the European
Community and the Czech Republic on Conformity Assessment and Acceptance of
Industrial Products (PECA)

1. TITLE

External Trade Relations-

Protocol to the Europe Agreement between the European Communities and the Czech
Republic on Conformity Assessment and Acceptance of Industrial Products (PECA)

2. BUDGETARY HEADINGS: B7-8500

3. LEGAL BASIS

Article 133 of the Treaty establishing the European Community.

Proposal for a Council decision N°.... on the conclusion by the European Community of an
additional Protocol to the Europe Agreement between the European Community and the
Czech Republic on Conformity Assessment and Acceptance of Industrial Products (PECA).

4. DESCRIPTION OF OPERATION:

4.1 General objective:

The main objective of the PECA is to facilitate trade by means of the elimination of technical
barriers in respect of industrial products in certain sectors in which the candidate country has
aligned its legislation on the acquis communautaire.

The purpose of this PECA is to establish the mutual acceptance of industrial products which
fulfil the requirements to be lawfully placed on the market and the mutual recognition of the
results of conformity assessment of industrial products subject to the Community technical
regulations and to the equivalent Czech national legislation.

The major actions, which will be pursued by the Commission under this budget line, will be
the following:

• Confidence-building activities to facilitate the proper implementation of the PECA.

• Management of the PECA and maintenance of the necessary degree of confidence.

• Extension of the PECA to new sectors.

The Commission will be assisted by experts, particularly in regard to sectoral activities. It will
however remain the final arbiter in the management of this PECA.

4.2 Duration of the action; means foreseen for its renewal:

The general action undertaken will be of a definite duration. The PECA has a lifetime limited
to the pre-accession period of the Czech Republic. The initial period of confidence building
will require a more intensive effort but the expenditure should be substantially less after 1

61

year. However, during the life of the PECA a continued effort will be needed to ensure
management and maintenance of confidence.

5. CLASSIFICATION OF EXPENDITURE/REVENUE

5.1 Non-compulsory expenditure ("DNO")

5.2 Differentiated appropriation ("CD")

5.3 Type of revenue involved:

None

6. TYPE OF EXPENDITURE/REVENUE

-

-

100% subsidy: No

subsidy for co-financing with other sources in the public or private sector?

Yes, this may be envisaged as a method of funding. Subsidies will be awarded according to
the Commission's "Vademecum on grant management". Grant can be provided to professional
associations and other responsible organisations for activities related to the implementation of
the PECA.

-

-

Interest subsidy: No

Others

Financing of events, acquisition of studies, publications and conferences.

Should the action prove an economic success, is there provision for all, or part of, the

-
Community contribution to be reimbursed? Not relevant

- Will the proposed operation cause any changes in the level of revenue? No

7. FINANCIAL IMPACT ON APPROPRIATIONS FOR OPERATIONS

7.1 Method of calculating the total cost of the operation:

The estimation of costs is based on the anticipated requirements in terms of expenses related
to seminars, workshops, travel of experts, verification of conformity assessment bodies,
information and studies. The total estimated cost is based on the sum of the individual actions.

A range of different actions is foreseen to meet the objectives of the budget-line and costs will
vary depending on the nature of action undertaken. Even for similar types of action (e.g.
seminars) costs will vary depending on the scope of the action and the degree of specialisation
needed.

The costs of specific actions will be determined either:

• by the Commission when it organises activities itself, e.g. seminars

• following invitations to tender issued by the Commission

62

• following requests for subsidies. In such cases, projects are selected according to how well
they meet the criteria that have been established for selection. Subsidies will be awarded
and managed according to the rules of the "Vademecum on grant management".

Attendance at the Association Council, the Association Committee or any special

A.
subcommittee or group to which has been delegated the management of the PECA.

This will be attended by Commission officials and some experts from the Member States.
Travel and per diem expenses should be foreseen within the normal range of such expenses.
The travel expenditure for officials will be covered by the "Mission budget" (A-7010). The
reimbursement of travel and related expenses for experts will be made on line B7-8500.

B.

Workshops and Seminars

These will be held to familiarise economic and other operators with the requirements of the
PECA. The cost of these seminars will vary according to the subject matter and location, and
will include travel and organisational costs (when in the EC) and substantial travel costs when
in the Czech Republic. Organisational costs will cost c. 3000 Euro each. The number of
seminars will vary depending on the individual industrial sectors covered by the PECA.

C.

Verification actions

The competence of the notified bodies will in some cases have to be checked, more so in the
initial period of the PECA, but as a matter of course throughout the life of the PECA to
maintain confidence in the system.

This will involve on-site assessment by teams of experts of notified bodies in the partner
country in the initial stages, and subsequently investigation of complaints. This expenditure
will cover all sectors of the PECA and may involve several notified bodies in each sector.

D.

Production and dissemination of information

Certain costs may need to be incurred for the dissemination of information. Guides to
regulations and assessment procedures may be needed typically at a cost of 10000 Euro.

63

7.2

Breakdown by elements of the operation

Breakdown

A. Committee

C. Seminars

Year

2001

9.136

9.854

D. Verifications

6.936

E. Information

20.000

Year

2002

9.136

9.854

6.936

5.000

2003

9.136

3.468

5.000

In Euro
(current prices)

Total

2004

2005

2001-2005

9.136

9.136

45.680

3.468

3.468

19.708

24.276

30.000

Total

45.926

30.926

17.604

12.604

12.604

119.664

From the year 2002 on the estimates are for information. The year number and the total
amount will depend on the accession year of the Czech Republic.

7.3

Indication of the timetable for commitment and payment appropriations

Year

2001

2002

2003

2004

2005

and

2005
following
years

of

46

31

18

13

13

13

46

31

18

13

46

31

18

13

13

13

13

13

Schedule
Commitment

Payment
appropriations

2001

2002

2003

2004

2005

2006

Total

1000 Euro

Total

132

46

31

18

13

13

13

132

The year number and the total amount will depend on the accession year of the Czech
Republic.

64

8. WHAT ANTI-FRAUD MEASURES ARE PLANNED IN THE PROPOSAL FOR
THE OPERATION?

Methods of control (submission of reports, etc.) will be included in all contracts or grant
agreements between the Commission and beneficiaries.

A close co-operation with the delegations of the Commission and the participation of a
representative of the Commission at events in third countries will check on the spot the work
to ensure that it corresponds with the terms of reference, contract provisions and required
professionalism.

The checks take place before the final payment. The same rule applies to the financial
incentives paid to participating companies. Where appropriate, agreements also require
organisations to submit financial accounts certified by their auditors.

9. ELEMENTS OF COST-EFFECTIVENESS ANALYSIS

9.1. Specific objectives of the proposed operation, population targeted

- The specific objectives of Protocols on Conformity Assessment and Acceptance of
Industrial Products are:

• to avoid duplication of certification by economic operators.

• to promote exports, employment, competitivity and investment.

• to reduce costs, in particular for small and medium-sized enterprises and ultimately for the

consumer,

• to extend certain benefits of the Internal Market to the Czech Republic

• to ensure the effective operation of the Internal Market in certain sectors before accession

of the Czech Republic.

- Target population

The target population are the exporting companies, business associations, chambers of
commerce and public institutions of the European Union and the general consumer which will
benefit, or have an interest in, the mutual acceptance of industrial products and recognition of
results of conformity assessment certification.

9.2. Reasons for the operation

- Need for intervention from the Community budget

Under Article 133 of the Treaty the Community has exclusive competence for commercial
policy and this agreement have been negotiated in accordance with a mandate of the Council
of Ministers and in consultation with the 133 Committee. The Commission will be
responsible for implementation and management of this Protocol.

- Choice of methods of intervention

• advantages over alternative measures (comparative advantages)

65

• analysis of similar operations at Community or national level

• results and expected multipliers

The choice of management method (Association Council) has been set out in the PECA and
constitute a minimum necessary for the proper functioning of the PECA. The use of seminars
in the initial phases will allow ensuring familiarity with other systems.

These seminars and verifications are also designed to build mutual confidence; verifications
will also be required to ensure this confidence is maintained throughout the life of the PECA.
Confidence and its maintenance are keys to the successful operation of the PECA.

The importance of this budget is justified when put in perspective with the trade involved in
this PECA and the yearly savings for EU exporters which are expected (estimated on a yearly
basis at

63 million for EU exporters to the Czech Republic).

€

- Main factors of uncertainty which could affect the specific results of the operation.

* None

9.3 Monitoring and evaluation of the operation

- Performance indicators selected

* Output indicators

* indicators of impact, following the objectives chosen

In the case of this PECA, success can be quantified by trade facilitation through avoidance of
duplication of testing and certification and costs. Yearly estimated savings for the European
Community are indicated above (9.2).

Success can also be measured by increased EU exports and this factor will be taken into
consideration although export performance is subject to such a wide range of variables (e.g.
changes in exchange rates) that this can never be the sole factor for evaluation.

- Evaluation of results

Progress in the attainment of the PECA objectives will be monitored by Commission officials,
the Association Council and by the economic operators concerned.

Details and frequency of the planned evaluation

The evaluation of the effectiveness and usefulness of the PECA will be regularly monitored
by the Commission, by the Association Council at its annual meeting, by the Association
Committee at its annual meeting, or by any special subcommittee or group to which the
Association Council has delegated the management of the PECA. At least, the first major
evaluation will be two years after the entry into force.

66

10.

ADMINISTRATIVE EXPENSES

Human resources and administrative means are to be covered by the credits already allocated
to the managing service. There is no request for additional staff.

Effect on the number of posts (considering that 10 industrial sectors are covered by the

10.1
PECA).

Type of post

Staff to be assigned to managing
the operation

Source

Duration

Permanent posts

Temporary
posts

DG
+
sectoral DGs

I

Additional
resources

Existing resources in
the DGs (DG Trade,
and
Enlarge, Enter
Trend)
or
departments
concerned

Officials

A

1.5

None

1.5

None

Permanent

B

C

0.5

0.5

Other
resources

None

Total

2.0

2.0

10.2 Overall financial impact of additional human resources: 2.0 staff ( 108.000 Euro per
staff member per year = 216.000 Euro). (Headings A1, A2, A4, A5 and A7)

Increase in other administrative expenditure as a result of the operation (A-7010:

10.3
missions)

The expenses set out below relate to travel expenses for officials of the Commission attending
meetings of the Association Council, the Association Committee or any special subcommittee
or group to which has been delegated the management of the PECA; seminars and
verifications, when these are outside Brussels. These will be taken care of by the relevant
budget allocations of various Directorates Generals involved.

67

For 2001 this involves the following calculation (the additional missions will be covered by
the allocation on A-7010):

Budget heading Amounts (Euro)

Method of calculation

No. of missions

Mission Unit cost

Committee

4.624 Czech Republic: 4

Brussels: Travel: 800 Euro;
per diem: 150 Euro

A-7010

Seminars

A-7010

1.526 Czech Republic: 1

Czech Republic: Travel 786
Euro; per diem: 185 Euro

Verifications

2.312 Czech Republic: 2

A-7010

A-7010: Total

8.462

7

Year

2001

Year

2002

In Euro

Total

2003

2004

2005

2001-2005

A. Committee

4.624

4.624

4.624

4.624

4.624

23.120

B. Seminars

1.526

1.526

3.052

C. Verifications

2.312

2.312

1.156

1.156

1.156

9.092

TOTAL

8.462

8.462

5.780

5.780

5.780

39.468

The above-mentioned figures are for information only. The impact on staff and missions will
be covered by the allocations on the A-7 budget starting in the year 2001, and will depend on
the accession date of the Czech Republic.

68

IMPACT ASSESSMENT FORM

THE IMPACT OF THE PROPOSAL ON BUSINESS
with special reference to small and medium-sized enterprises

Title of proposal

Proposal for Council Decisions on the signature and on the conclusion of an additional
Protocol to the Europe Agreement between the European Community and the Czech Republic
on Conformity Assessment and Acceptance of Industrial Products (PECA).

Reference number

The proposals

These decisions are necessary to conclude the Protocol to the Europe Agreement between the
European Community and the Czech Republic on Conformity Assessment and Acceptance of
Industrial Products. The Commission negotiated the draft Protocol in accordance with the
negotiating guidelines for the negotiation of European Conformity Assessment Agreement
with the Central Eastern European Countries, adopted by the Council in June 1997.

The impact on business

The business sectors affected are machinery, personal protective equipment, lifts, electrical
safety, electromagnetic compatibility, equipment and protective systems intended for use in
potentially explosive atmosphere, gas appliances, hot water boilers, pressure equipment and
medicinal products Good Manufacturing Practice inspection and batch certification.

The PECA provides to extend certain benefits of the Internal Market in industrial sectors
already aligned. The PECA permits certification of conformity with technical regulations on
product safety, etc, to be conducted in the European Union for exports destined the Czech
Republic. This avoids the need for further certification by Czech conformity assessment
bodies before putting them on the Czech market. The certification procedure and the technical
regulations are the same as the Community one.

The PECA also envisages acceptance of industrial products that fulfil the requirements to be
legally placed on the EU market by the Czech Republic without subject further requirement.
Annexes under this mechanism have still to be negotiated.

The PECA therefore presents important advantages from the point of view of transparency,
market access, avoidance of duplication especially of cost, effective operation in certain
sectors before accession and general facilitation of trade. This is of particular importance for
small and medium-sized enterprises. The PECA covers a wide range of sectors and therefore
affects an extensive range of firms both large and small. The advantages are not limited to
specific geographical areas in the Community.

Businesses will have to apply Czech regulations and procedures. However, these are aligned
on the EC ones in sectors covered by the PECA. Furthermore, certification, as stated above,
will be conducted by conformity assessment bodies located and already designated by the
in the Czech Republic. The PECA will
Member States in the Community, and not
substantially reduce certification costs and improve prospects for exports, employment,
investment and competitiveness by Community firms.

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The PECA does not contain measures to take account of the specific situation of small and
medium-sized firms, but by its nature and by reducing certification costs which are the same
for all firms, the agreement will benefit small and medium sized enterprises to a greater extent
proportionately than larger firms.

Consultation

The main industry organisations (e.g. EFPIA, Eurobit, and Orgalime) have been consulted
and have declared their support for this Protocol.

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