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 Republic of Hungary, of the other part on conformity assessment and acceptance of industrial products
Date: 2000-11-30
Institutions: European Commission
Subjects: Hungary, association agreement (EU), cooperation policy, industrial product, standardisation

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 30.11.2000
COM(2000) 741 final

2000/0302 (ACC)
2000/0303 (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 Republic of
Hungary, 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 Republic of Hungary, 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 Hungary (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
trade with respect to industrial products. To this end, 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.

The first mechanism, i.e. the mutual acceptance of industrial products, confirms that Articles
9.4 and 10.4 of the Europe Agreement with Hungary apply without other restriction as
referred to in Article 35 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 Hungarian
market without having to undergo any further approval procedures, and vice-versa. The
following sectors are covered: machinery, electrical safety, electromagnetic compatibility, gas
appliances, hot water boilers, medical devices, good laboratory practice (GLP) for medicinal

1

COM (96) 564 - final. 13.11.96.

2

products for human use and medicinal products good manufacturing practice (GMP)
inspection and batch certification.

Hungary 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 as referred to above. A
unilateral Community declaration inviting the Hungarian representatives to experts meetings
and committees established under the Community law referred to in the annexes is attached to
the Final Act, making it clear that this will not entail any participation in the Community
decision-making process. 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.

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.

is

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

self-explanatory. Definitions of

Article 3: Alignment of legislation. This contains a commitment for Hungary 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 by 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.

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 appropriate 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 of 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 will be responsible for its
effective functioning and may delegate its duties in conformity with the relevant Articles 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.

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

4

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:

the overall consistency with the Community policy objectives

a)
standardisation, certification and conformity assessment
products covered;

for

in the field of
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, Electrical Safety, Electromagnetic Compatibility, Hot Water
Boilers, Gas Appliances and Medical Devices.

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

In the medical devices annex, Section IV includes three additional provisions which provide
for the registration of the person responsible for placing devices on the market, for the
labelling of medical devices and for specific exchanges of information between the Parties.

Annex on good laboratory practice (GLP) for medicinal products.

This annex establishes the mutual recognition of each Party's compliance monitoring
programmes on good laboratory practice (GLP) that are in accordance with the OECD
decisions and recommendations, and the mutual acceptance of studies, data generated, study
audits and test facility inspections of the other Party.

5

The Parties also recognise the equivalence of each other's compliance monitoring
programmes. Recognition of inspection results and the ensuing compliance with the GLP
principles remove the need for companies in each Party to be inspected by the authorities of
the other Party. Both Parties have accepted the decisions and recommendations of the OECD
Council on the definition of terms and on compliance monitoring procedures for Good
Laboratory Practice.

This annex applies to the non-clinical testing of medicinal products, being either substances or
preparations, which are explicitly covered by the legislative, regulatory and administrative
requirements, listed in Section I.

In this annex, "notified test facilities" means the test facilities recognised under each Party's
GLP monitoring programme. Section II, on notified test facilities, establishes the notification
procedure of test facilities for which GLP compliance has been established. The Notifying
Authorities listed in Section III are the GLP monitoring authorities of each Member State and
Hungary.

Section IV, on specific arrangements, contains clauses on test facility inspections, safeguard
mechanisms, and cooperation between the Parties.

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

The Annex gives industry the necessary predictability in terms of acceptance of their data and
removes needless duplication of inspections.

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 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 Hungary.

Section III include 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 analysis costs for each imported batch. In addition, recognition of inspections will

6

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 Declaration

This is attached to the Final Act and is annexed to this Communication.

a) Unilateral Community Declaration relating to attendance of
the Hungarian
representatives to Committees. Through this declaration, Hungary is invited to send
observers to the meetings of the Committees established or referred to under the 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"2.

I.1.3 Relations with EFTA /EEA Member Countries

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

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 Hungary has taken over the Community legislation in certain sectors
before its accession. 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 always been able to quantify the
costs or time taken to obtain conformity assessment of their industrial products in Hungary.
The precise extent of savings in time, cost and market opportunity of this Protocol is therefore
not feasible in every case to determine. This may only be possible once the Protocol has been
in operation for some time. However, on the basis of a rough calculation, it is estimated3 that

Point 4.2.b). COM (99) 710 - final. 20.12.1999.

2
3 Working hypothesis that certification and other related costs amount to an average of 1% of trade.

7

this Protocol would create cost saving opportunities for the exporting industry of around
millions and about
which will be passed on to European importers and consumers.

67
83 millions in terms of cost savings to exporters to the EC, some part of

€

€

Trade figures between the EC and Hungary are attached for information. The general trade
balance in sectors covered by this Protocol shows a trade surplus for Hungary (factor of 1,2:1,
varying from 1,4:1 in the machinery sector to 1,1:1 in the electrical sector). However, there
are sectors such as pharmaceuticals, gas appliances and medical devices where the
Community has a trade surplus with Hungary (factors of 5,7:1, 22:1 and 1,9:1). It is expected
that trade will increase further when the PECA is in force.

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 1.6 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 Hungary, the PECA will facilitate access to the Community market
and will give political credit for having aligned its legislation. Hungary 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
Hungary for the adoption of this Protocol. 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 agreementsestablish the appropriate Community procedure for
the
implementation and management of the Protocol.

In particular, the Council should confer on the Commission, after consultations 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 decision on the
signature and conclusion of the PECA.

8

2000/0302 (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 Republic of
Hungary, 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 Commission4,

Whereas:

(1)

(2)

(3)

(4)

establishing an association between the European
The Europe Agreement
Communities and their Member States, of the one part, and the Republic of Hungary
of the other part5, entered into force on 1 February 1994.

Article 73(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:

4

5

OJ C …, …, p. …
OJ L 347, 31.12.1993, p.2.

9

Sole Article

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 Hungary on Conformity Assessment and Acceptance
of Industrial Products.

Done at Brussels, […]

For the Council
The President
[…]

10

2000/0303 (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 Republic of Hungary, 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 Commission6,

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 Republic of Hungary
of the other part7, entered into force on 1 February 1994.

Article 73(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 93/742/EEC of the Council and the Commission of 13 December
of 1993 on the conclusion of
the Europe Agreement between the European
Communities and their Member States, of the one part, and the Republic of Hungary,
of the other part8, 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 1/94 of the Association Council between the European
Communities and their Member States, of the one part, and the Republic of Hungary,
of the other part of 7 March 1994 on its rules of procedure9 provides that
the
in
Association Committee may set up further subcommittees or groups to assist
carrying out its duties.

6

7

8

9

OJ C …, …, p. …
OJ L 347, 31.12.1993, p.2.
OJ L 347, 31.12.1993, p.1.
OJ L 242, 17.9.1994, p. 23.

11

(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 with the Republic of Hungary on
Conformity Assessment and Acceptance of Industrial Products between the European
Community and the Republic of Hungary (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

1.

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

Article 3

(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 IV of the
Good Laboratory Practice (GLP) annex 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), Section II of the Good Laboratory Practice (GLP) annex to
this Protocol, and Sections III and IV of the annexes to the Protocol concerning
machinery, electrical safety, electromagnetic compatibility, hot water boilers,
gas appliances, medical devices, good laboratory practice (GLP), 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.

12

(c)

if necessary, reply to requests in accordance with Article 11, Sections III and
IV of the annexes to the Protocol concerning machinery, electrical safety,
electromagnetic compatibility, hot water boilers, gas appliances, medical
devices, good laboratory practice (GLP), and good manufacturing practice
(GMP).

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;

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

(c) Any measures taken in the application of the safeguard clauses in Section IV of
safety,
the annexes of
electromagnetic compatibility, hot water boilers, gas appliances, medical
devices, and good laboratory practice (GLP);

the Protocol concerning machinery, electrical

(d) 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,

For the Council
The President

13

ANNEX

PROTOCOL

TO THE EUROPE AGREEMENT ESTABLISHING AN ASSOCIATION BETWEEN
THE EUROPEAN COMMUNITIES AND THEIR MEMBER STATES, OF THE ONE PART,
AND THE REPUBLIC OF HUNGARY, OF THE OTHER PART, ON CONFORMITY
ASSESSMENT AND ACCEPTANCE OF INDUSTRIAL PRODUCTS – PECA

TABLE OF CONTENTS

1.Framework

2.Annexes on Mutual Recognition of results of conformity assessment

1. Machinery

2. Electrical Safety

3. Electromagnetic Compatibility

4. Hot water boilers

5. Gas Appliances

6. Medical Devices

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

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

14

The European Community and Hungary,

hereinafter referred to as "the Parties",

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

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

Considering that, in the sectors covered by this Protocol, the Hungarian 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,

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 mutual acceptance of industrial products which fulfil 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 73 of the Europe Agreement provides, where
appropriate, for the conclusion of an agreement on mutual recognition,

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

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

HAVE AGREED AS FOLLOWS:

Article 1
Purpose

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

law, which is equivalent

15

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 Hungarian 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 8 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 Hungary 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
Hungarian national law.

Article 3
Alignment of legislation

For the purpose of this Protocol, Hungary 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.

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 35 of the
Europe Agreement.

16

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

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. 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,
to ensure the
conformity of industrial products with Community or national law or to require their
withdrawal from the market.

remove suspension and withdraw notification of bodies,

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.

17

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 Hungary 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.

Article 11
Verification of notified bodies

the other Party to verify the technical competence and
Each Party may request
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 theAssociation Council.

18

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.

Article 14
Management of the Protocol

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

in conformity with Article 106 of

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.

19

Article 15
Technical co-operation and assistance

The European Community may provide technical co-operation and assistance to Hungary
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.

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 Hungarian, 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

1. Machinery

2. Electrical Safety

3. Electromagnetic Compatibility

4. Hot water Boilers

5. Gas Appliances

6. Medical Devices

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

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

and batch certification

21

ANNEX ON MUTUAL RECOGNITION OF RESULTS OFCONFORMITY
ASSESSMENT:

MACHINERY

SECTION I
COMMUNITY AND NATIONAL LAW

Community 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).

Hungarian
national law:

Decree 21/1998. (IV.17.) IKIM of the Minister of Industry,
Trade and Tourism on the safety requirements of machinery
and assessment of their conformity (Magyar Közlöny 32,
17.04.1998, p. 2606) as last amended by Decree 60/1999.
(XII.1.) GM (Magyar Közlöny 107, 01.12.1999, p. 6897).

Decree 4/1999. (II.24.) GM of MEA on the detailed rules on
the designation of testing, inspection and certification
bodies for conformity assessment of technical products
(Magyar Közlöny 14, 24.02.1999, p. 1036).

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.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.

22

• 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.

Hungary:

Gazdasági Minisztérium (Ministry of Economic Affairs - MEA)

European
Community:

Hungary:

SECTION III
NOTIFIED BODIES

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.

Bodies which have been designated by Hungary in accordance
with the Hungarian 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.

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

to the present annex,

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

23

3.

4.

5.

1.

2.

3.

4.

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

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

Where the Association Council finds that the measure is:

a)

b)

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

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

B. Safeguard clause relating to harmonised standards.

Where Hungary 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:

Hungarian 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).

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

Decree 4/1999. (II.24.) GM of MEA on the detailed rules on
the designation of testing, inspection and certification bodies
for conformity assessment of technical products (Magyar
Közlöny 14, 24.02.1999, p. 1036).

SECTION II
NOTIFYING AUTHORITIES

• Austria:

• Belgium:

Bundesministerium für wirtschaftliche Angelegenheiten.

Ministère des Affaires Economiques.

-Ministerie van Economische Zaken.

• Denmark:

Boligministeriet.

• Finland:

• France:

• Germany:

• Greece:

•

Ireland:

Kauppa ja teollisuusministeriö/Handels och industriministeriet.

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.

Bundesministerium für Arbeit und Sozialordung

Ministry of Development. General Secretariat of Industry.

Department of Enterprise and Employment.

25

•

Italy:

• Luxembourg:

• Netherlands:

• Portugal:

• Spain:

• Sweden:

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

Ministère de l'Economie- Service de l'Energie de l'Etat.
Ministère du Travail (Inspection du Travail et des Mines).

Minister van Volksgezondheid, Welzijn en Sport (consumer
goods).
Minister van Sociale Zaken en Werkgelegenheid (others).

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 kontrol (SWEDAC).

• United Kingdom: Department of Trade and Industry

Hungary:

Gazdasági Minisztérium (Ministry of Economic Affairs- MEA)

European
Community:

Hungary:

SECTION III
NOTIFIED BODIES

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.

Bodies which have been designated by Hungary in accordance
with the Hungarian 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.

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

to the present annex,

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

26

3.

4.

5.

1.

2.

3.

4.

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

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

Where the Association Council finds that the measure is:

a)

b)

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

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

B. Safeguard clause relating to harmonised standards.

Where Hungary 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 RECOGNITIONOf RESULTS OFCONFORMITY
ASSESSMENT:

Community law:

Hungarian national
law:

ELECTROMAGNETIC COMPATIBILITY

SECTION I
COMMUNITY AND NATIONAL LAW

Council Directive 89/336/EEC of 3 May 1989 on the
approximation of the laws of the Member States relating to
electromagnetic compatibility (OJ L 139, 23.05.1989, p. 19), as
last amended by Council Directive 93/68/EEC of 22 July 1993
(OJ L 220, 30.08.1993, p.1).

Joint Decree 31/1999. (VI. 11.) GM-KHVM of the Ministers of
Economic Affairs and Transport, Telecommunication and Water
Management on electromagnetic compatibility (Magyar
Közlöny 51,11.06. 1999, p. 3302), as amended by Joint Decree
58/1999. (X.27) GM-KHVM (Magyar Közlöny 93, 27.10.1999,
p. 5840).

Decree 4/1999. (II.24) GM of MEA on the detailed rules on the
designation of testing, inspection and certification bodies for
conformity assessment of technical products (Magyar Közlöny
14, 24.02.1999, p. 1036).

Decree 22/1999. (VIII.4) KHVM of MTCWM on the detailed
rules on the designation of testing, inspection and certification
bodies for conformity assessment of certain telecommunication
and information technology products (Magyar Közlöny 69,
04.08.1999, p. 4466).

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 of telecommunications and radio
equipment:Liikenneministeriö/Trafikministeriet.

28

• France:

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 Wirtschaft und Technologie.

• 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.

• Netherlands:

Minister van Verkeer en Waterstaat.

• Portugal:

• Spain:

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

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.

Hungary:

Gazdasági Minisztérium (Ministry of Economic Affairs - MEA)

Közlekedési, Hírközlési és Vízügyi Minisztérium (Ministry of
Transport, Communication and Water Management - MTCWM)

SECTION III
NOTIFIED AND COMPETENT BODIES

European Community:

Hungary:

States
in

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

the
accordance with

Bodies which have been designated by
Hungary in accordance with the Hungarian
national law of Section I and notified to the
European Community in 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.

1.

2.

3.

4.

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

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

the matter and the evidence brought

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, the national authority of the Party who has taken the measure
shall withdraw it;

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

B. Safeguard clause relating to harmonised standards.

Where Hungary considers that a harmonised standard referred to in the
the essential
legislation defined in the present annex, does not meet
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:

HOT WATERBOILERS

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).

Hungarian national
law:

Decree 20/1998. (IV.17.) IKIM of the Minister of Industry,
Trade and Tourism on efficiency requirements for hot water
boilers fired with liquid or gaseous fuels and assessment of their
conformity (Magyar Közlöny 32, 17.04.1998, p. 2603.

Decree 4/1999. (II.24.) GM of MEA on the detailed rules on the
designation of testing, inspection and certification bodies for
conformity assessment of technical products (Magyar Közlöny
14, 24.02.1999, p. 1036).

SECTION II
NOTIFYING AUTHORITIES

European Community

• Austria

• Belgium

Bundesministerium für wirtschaftliche Angelegenheiten.

Ministère
Economische Zaken.

des Affaires

Economiques. Ministerie

van

• Denmark

Boligministeriet.

• Finland

• France

Ympäristöministeriö/Miljöministeriet.

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.

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

l'industrie,

générale

des

technologies

de

• Germany

Bundesministerium für Wirtschaft und Technologie.

31

• Greece

•

•

Ireland

Italy

Ministry of Development. General Secretary of Industry.

Department of Enterprise and Employment.

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

• Luxembourg

Ministère de l'Environnement.

• Netherlands

Ministerie van Economische Zaken.

• Portugal

• Spain

• Sweden

Ministério da Economia. InstitutoPortuguês da Qualidade.

Ministerio de Industria y Energia.

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

• United Kingdom

Department of the Environment, Transport and the Regions.

Hungary:

Gazdasági Minisztérium (Ministry of Economic Affairs - MEA)

SECTION III
NOTIFIED BODIES

European Community:

Hungary:

States
in

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

the
accordance with

Bodies which have been designated by
Hungary in accordance with the Hungarian
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 shall
immediately inform the other Party, indicating the reasons for its decision and
how non compliance has been assessed.

32

2.

3.

4.

5.

1.

2.

3.

4.

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

the matter and the evidence brought

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:

a)

b)

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

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

B. Safeguard clause relating to harmonised standards.

Where Hungary 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:

Community law:

Hungarian national
law:

GAS APPLIANCES

SECTION I
COMMUNITY ANDNATIONAL 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)

Decree 22/1998. (IV.17.) IKIM of the Minister of Industry,
Trade and Tourism on the design of certain appliances burning
gaseous fuels and the assessment of their conformity (Magyar
Közlöny 32, 17.04.1998, p. 2629), as last amended Decree
67/1999. (XII.15.) GM (Magyar Közlöny 113, 15.12.1999, p.
7506).
Decree 4/1999.(II.24.) GM of MEA on the detailed rules on the
designation of testing, inspection and certification bodies for
conformity assessment of technical products (Magyar Közlöny
14, 24.02.1999, p. 1036).

SECTION II
NOTIFYING AUTHORITIES

European Community

• Austria

• Belgium

• Denmark

• Finland

• France

Bundesministerium für wirtschaftliche Angelegenheiten.

Ministère
Economische Zaken.

des Affaires

Economiques. Ministerie

van

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
de
l'industrie,
de
l'information et des postes (DiGITIP) - SQUALPI

technologies

générale

des

• Germany

Bundesministerium für Arbeit und Sozialordnung

34

• Greece

•

•

Ireland

Italy

• Luxembourg

• Netherlands

• Portugal

• Spain

• Sweden

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. InstitutoPortuguês 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.

Hungary:

Gazdasági Minisztérium (Ministry of Economic Affairs -MEA)

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.

Hungary:

Bodies which have been designated by Hungary in accordance with the Hungarian
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 shall
immediately inform the other Party, indicating the reasons for its decision and
how non compliance has been assessed.

35

2.

3.

4.

5.

1.

2.

3.

4.

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

the matter and the evidence brought

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:

a)

b)

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

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

B. Safeguard clause relating to harmonised standards.

Where Hungary 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:

Community law:

Hungarian national
law:

MEDICAL DEVICES

SECTION I
COMMUNITY AND NATIONAL LAW

Council Directive 90/385/EEC of 20 June 1990 on the
approximation of the laws of the Member States relating to
active implantable medical devices (OJ L 189, 20.07.1990, p.
17), as last amended by Council Directive 93/68/EEC of 22
July 1993 (OJ L 220, 30.08.1993, p. 1)

Council Directive 93/42/EEC of 14 June 1993 concerning
medical (OJ L 169, 12.07.1993, p. 1), as last amended by
European Parliament and Council Directive 98/79/EC of 27
October 1998 (OJ L 331, 07.12.1998, p.1).

Decree 47/1999. (X.6.) EüM of the Ministry of Health on
medical devices (Magyar Közlöny 88, 06.10 1999, p. 5512).
Decree 48/1999 (X.6) EüM of MH on the detailed rules on the
designation of testing, inspection and certification bodies for
conformity assessment of medical devices (Magyar Közlöny
88, 06.10.1999, p. 5544).

SECTION II
NOTIFYING AUTHORITIES

European Community:

• Austria:

• Belgium:

• Denmark:

• Finland:

Bundesministerium für Arbeit, Gesundheit und Soziales

Ministère de la Santé Publique, de l'Environment et de
l'IntegrationSociale. Inspection Pharmaceutique. /Ministerie van
Volksgenzondheid, Leefmilieu en Sociale Integratie.
Farmaceutische Inspectie.
Ministère des Affaires Economiques/Ministerie van
Economische Zaken.

Sundhedsministeriet.

Sosiaali-ja terveysministeriö/Social-och hälsovårdsministeriet

37

• France:

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

• Greece:

•

•

Ireland:

Italy:

Ministry of Health.

Department of Health.

Ministero della Sanità.

• Luxembourg:

Ministère de la Santé.

• Netherlands:

Ministerie van Volksgezondheid, Welzijn en Sport; inspectie
Volksgezondheid.

• Portugal:

• Spain:

• Sweden:

Ministerio da Saude.

Ministerio Sanidad y Consumo.

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

• United Kingdom: Department of Health.

Hungary:

Egészségügyi Minisztérium (Ministry of Health – MH)

SECTION III
NOTIFIED BODIES

European
Community:

Hungary:

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.

Bodies which have been designated by Hungary in accordance
with the Hungarian 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. Registration of the person responsible for placing devices on the market

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

2. Labelling of medical devices

Manufacturers of both Parties shall indicate their name or trade name and address on the
label of medical devices as specified in Annex 1, point 13.3(a) to Directive 93/42/EEC
and in the relevant Hungarian national law. They shall not be obliged to indicate the
name and address of the person responsible for placing the device on the market, of the
representative or of the importer established within the territory of the other Party on the
label, outer packaging or instructions for use.

3. Information exchanges

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

–

–

–

data relating to registration of manufacturers and devices;

data relating to certificates issued, modified, supplemented, suspended,
withdrawn or refused;

data obtained in accordance with the vigilance procedure.

4. Safeguard clause

A. Safeguard clause relating to industrial products in products.;

1.

2.

3.

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
knowledge and shall report to each other the results of their investigations.

the matter and the evidence brought

to their

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

39

4.

5.

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, the national authority of the Party who has taken the measure
shall withdraw it;

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

B. Safeguard clause relating to harmonised standards.

1.

2.

3.

4.

Where Hungary 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.

40

ANNEX ON MUTUAL RECOGNITIONOF RESULTS OF CONFORMITY
ASSESSMENT:

GOODLABORATORY PRACTICEFOR MEDICINALPRODUCTS FOR HUMAN USE

SECTION I
COMMUNITY AND NATIONAL LAW

Community law:

Good Laboratory Practice:

Council Directive 87/18/EEC of 18 December 1986 on the
harmonisation of laws, regulations and administrative
provisions relating to the application of the principles of good
laboratory practice and the verification of their applications for
tests on chemical substances(OJ N° L 15, 17.01.87, p. 29) as
last amended by Commission Directive 1999/11/EC of 8
March 1999 (OJ L 77, 23.03.99, p. 8).

Monitoring of Good Laboratory Practice

Council Directive 88/320/EEC of 9 June 1988 on the
inspection and verification of Good Laboratory Practice (GLP)
(OJ L 145, 11.06.88, p. 35) , as last amended by Commission
Directive1999/12/EC of of 8 March 1999 (OJ L 77, 23.03.99,
p. 22)

Medicinal Products :

Council Directive 87/21/EEC of 22 December 1986 amending
Directive 65/65/EEC on the approximation of provisions laid
down by law, regulation or administrative action relating to
proprietary medicinal products(OJ N° L 15, 17.01.87, p. 36).

Council Directive 87/19/EEC of 22 December 1986 amending
Directive 75/318/EEC on the approximation of the laws of the
Member States relating to analytical, pharmaco-toxicological
and clinical standards and protocols in respect of the testing of
proprietary medicinal products (OJ N° L 15, 17.01.87, p. 31).
Commission Directive 91/507/EEC of 19 July 1991 modifying
the Annex to Council Directive 75/318/EEC on the
approximation of the laws of Member States relating to
analytical, pharmaco-toxicological and clinical standards and
protocols in respect of the testing of propietary medicinal
products(OJ N°L 270, 26.09.91, p. 32)

Hungarian national
law:

Good Laboratory Practice and Monitoring of Good Laboratory
Practice:

41

Joint Decree 31/1999 (VIII.6.) EüM - FVM of the Minister of
Health and the Minister of Agriculture and Rural Development
on the application and monitoring of good laboratory practice
relating to human medicines and pesticides (Magyar Közlöny
70, 06.08.1999, p. 4521).

Medicinal Products:
Act XXV of 1998 on medicines for human use (Magyar
Közlöny 28, 01.04.1998, p. 2385).

SECTION II
NOTIFIED TEST FACILITIES

For the purpose of this Sectoral Annex, the term “Notified Test facilities” means the test
facilities recognised under each Party’s GLP monitoring programme.

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

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

SECTION III
NOTIFYING AUTHORITIES

For the purpose of this Sectoral Annex, the term “Notifying Authorities” means the GLP
Monitoring Authorities of the Parties.

European Community

• Austria

• Belgium

• Denmark

• Finland

• France

Bundesministerium für Umwelt, Jugend und Familie.

Ministère de la Santé Publique. Institut Scientifique pour la
Santé Publique - Louis Pasteur. Ministerie van
Volksgezondheid. Wetenschappelijk Instituut voor
Volksgezondheid.– Louis Pasteur.

Lægemiddelstyrelsen (Danish Medicines Agency).

Sosiaali- ja terveysministeriö/Social- och hälsovårdsministeriet

Ministère de l'emploi et de la solidarité. Direction générale de la
santé. Agence française de sécurité sanitaire des produits de
santé (AFSSAPS). 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

42

• Germany

• Greece

•

•

Ireland

Italy

(DiGITIP).

Bundesministerium für Umwelt, Naturschutz und
Reaktorsicherheit

General Chemical State Laboratory.

Irish Laboratory Accreditation Board (ILAB)

Ministry of Health. Department of Prevention. GLP Compliance
Monitoring Unit.

• Netherlands

Ministerie van Volksgezondheid, Welzijn en Sport;

• Portugal

• Spain

• Sweden

inspectie Volksgezondheid.

Instituto National de Farmacia e do
Medicamento(INFARMED).

Agencia Española del Medicamento.

Läkemedelsverket (Medical Products Agency).

• United Kingdom Department of Health. GLP Monitoring Authority.

Hungary:

Országos Gyógyszerészeti Intézet - OGYI (National Institute of
Pharmacy)

SECTION IV
SPECIFIC ARRANGEMENTS

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

Unless specific definitions are given, the definition of terms in the OECD Principles of
Good Laboratory Practice as contained in Annex II to OECD Council Decision of 12
May 1981 C(81)30(Final), the Guides for Compliance Monitoring Procedures for Good
Laboratory Practice as contained in Annex I to Council Decision-Recommendation of 2
October 1989 C(89)87(Final), the GLP Consensus Document ’The Application of the
GLP Principles to Field Studies’ (OECD Series on Principles of Good Laboratory
Practice and Compliance Monitoring, Number 6), and all amendments made thereto,
shall apply.

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

43

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

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

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

Procedure for application of the safeguard clause

1.

2.

3.

4.

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

The Party from which the data are originating shall consider the matter and the
evidence brought to its knowledge. It shall report to the other Party the results of
its investigations.

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

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

Co-operation

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

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

information on a test facility

44

ANNEX ON MUTUAL RECOGNITION OF RESULTS OF CONFORMITY ASSESSMENT:

GOOD MANUFACTURINGPRACTICE FOR MEDICINAL PRODUCTS
FOR HUMANUSE : INSPECTION AND BATCH CERTIFICATION

SECTION I
COMMUNITY AND NATIONAL LAW

Community law:

Council Directive 65/65/EEC, of 26 January 1965 on the
approximation of provisions laid down by law, regulation or
administrative action relating to medicinal products (OJ L 22,
09.02.1965, p.369), 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
147, 09.06.1975, p.1), as last amended by Commission 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 on
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).

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).

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

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.

Decree 37/2000 .(III.23.) Korm. of the Government on the
subjective and objective requirements of manufacture of
medicines for human use (Magyar Közlöny 25, 23.03.2000,
p.1206).

Act XXV of 1998 on medicines for human use (Magyar

45

Hungarian national
law:

Közlöny 28,01.04.1998, p. 2385).

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

Decree 13/1987 EüM (VIII.19) of the Minister of Health on the
registration and placing on the market of pharmaceutical
products (Magyar Közlöny 36, 19.08.1987, p. 698).

SECTION II
OFFICIAL GMP INSPECTION SERVICES OF EACH PARTY

European Community

• Austria

• Belgium

• Denmark

• Finland

• France

• Germany

• Greece

•

•

Ireland

Italy

• Luxembourg

• Netherlands

• Portugal

• Spain

• Sweden

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.

Bundesministerium für Gesundheit.

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

Irish Medicines Board.

Ministero della Sanità. Dipartimento Farmaci e Farmacovigilanza.

Direction de la Santé, Division de la Pharmacie et des Médicamen

Ministerie van Volksgezondheid, Welzijn en Sport; inspectie
Volksgezondheid.

Instituto da Farmácia e do Medicamento (INFARMED).

Agencia Española del Medicamento.

Läkemedelsverket (Medical Products Agency).

46

• United Kingdom Medicines Control Agency.

Hungary:

Országos Gyógyszerészeti Intézet - OGYI (National Institute of
Pharmacy).

SECTION III
SPECIFIC ARRANGEMENTS

1. Definitions

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

"Good Manufacturing Practice (GMP)": as defined in Council Directive 91/356/EEC and the
relevant legislation of Hungary 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. Scope and Coverage

The provisions of this Sectoral Annex cover all medicinal products for human use

2.1
which are industrially manufactured in Hungary and the European Community, and to which
the European Community and Hungarian GMP requirements apply.

For the medicinal products covered by this Sectoral Annex, each Party shall recognise

2.2
the conclusions of inspections carried out by the relevant inspection services of the other
Party and the relevant manufacturing authorisations granted by the Competent Authorities of
the other Party.

In addition, the manufacturer's certification of the conformity of each batch to its

2.3
specifications shall be recognised by the other Party without re-control at import.

3. Pre-Operational phase

3.1

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

–

–

The effective implementation of legislative, regulatory and administrative
requirements of the European Community on GMP by Hungary will be
determined according to a procedure established by the European Community.

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

3.2

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

3.3
competent expert group (European Community inspector's Working Party) with the

47

participation of the competent authorities of Hungary.The Parties will decide on the
prolongation or termination of the pre-operational phase in the Association Council. The
operational phase will start immediately after the successful termination of the pre-operational
phase.

The Parties may decide, in the Association Council, to renounce the pre-operational

3.4
phase at any time in the light of the demonstration of implementation and maintenance of
Good Manufacturing Practice in Hungary.

4.Operational phase

Certification of manufacturers

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

4.1
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:

a)

b)

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

the relevant

complies with the European Community and Hungarian GMP requirements;
and,

c)

is regularly inspected by the competent inspection service.

The certificates shall also identify the site(s) of manufacture. Guidance on a common

4.2
format for such certificate will be given.

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

Batch certification

Each batch exported shall be accompanied by a batch certificate issued by the
4.4
manufacturer (self certification) after a full qualitative analysis, a quantitative analysis of all
the active constituents and all the other tests or checks necessary to ensure the quality of the
product in accordance with the requirements of the marketing authorisation. This certificate
shall attest that the batch meets its specification and has been manufactured in accordance
with the relevant marketing authorisation. This certificate shall be retained by the importer of
the batch and will be made available upon request of the Competent Authority.

4.5 When issuing a certificate, the manufacturer shall take account of the provisions of the
current 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 in Article 24(2) i) of Act XXV of 1998 on medicines for
human use.

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

48

competent authorities before the distribution of each batch of product. This Protocol does not
encompass mutual recognition of these official batch releases.

Inspections

GMP inspections shall be carried out by the locally competent inspection service

4.7
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 complies

a)
generally with GMP requirements (e.g. routine inspection covering especially the
fundamental requirements of GMP).

Process inspections: carried out to verify whether a manufacturer conducts a certain

b)
process (es) according to GMP requirements (e.g. production of sterile water).

Product inspection: carried out to verify whether a manufacturer produces certain

c)
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).

The regime of inspection/establishment fees is determined by the manufacturer's

4.9
location. Inspection/establishment fees will not be charged to manufacturers located on the
territory of the other Party for products covered by this Protocol.

Transmission of inspection reports

4.10 Upon reasoned request, the relevant inspection services shall forward a copy of the
last inspection report of the manufacturing or control site, in case analytical 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

4.11
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

The Competent Authorities will inform the authorities of the other Party with the

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

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

49

Exchange of
requirements

information between authorities and approximation of quality

In accordance with the general provisions of this Protocol, the Parties shall exchange

4.14
any information necessary for the mutual recognition of inspections.

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

Inspectors training

In accordance with the general provisions of this Protocol, training sessions for

4.16
inspectors, organised by the Authorities, shall be accessible to inspectors of the other Party.
The Parties will keep each other informed of these sessions.

Joint inspections

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

Contact points

For the purpose of this Protocol, the contact points for the alert system, any technical

4.18
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 Hungary:

ő
Országos Gyógyszerészeti Intézet, f
General).

Divergence of views

igazgató (National Institute of Pharmacy, Director

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

5. SAFEGUARD CLAUSES

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

Each Party reserves the right to conduct its own inspection for reasons identified to the

5.2
other Party. Such inspections are to be notified in advance to the other Party, which has the

50

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.

51

DECLARATION BY THE EUROPEAN COMMUNITY ON THE ATTENDANCE OF
HUNGARIAN 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 Hungary is invited, under the
following conditions, to the meetings of the committees established or referred to under the
Community law on machinery, electromagnetic compatibility, gas appliances, and medical
devices.

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.

52

FINANCIAL STATEMENT 2001-2005

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

1. TITLE

External Trade Relations-

Protocol to the Europe Agreement between the European Communities and Hungary 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 Hungary
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 Hungarian 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 Hungary. The initial period of confidence building will require
a more intensive effort but the expenditure should be substantially less after 1 year. However,

53

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

54

• 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 Hungary. 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.

55

7.2

Breakdown by elements of the operation

In Euro

(current prices)

Breakdown

Year

2001

Year

2002

2003

2004

2005

Total

2001-
2005

A. Committee

11.128

11.128

11.128

11.128

11.128

55.640

C. Seminars

11.422

D. Verifications

8.928

E. Information

20.000

7.672

8.928

5.000

4.464

5.000

4.464

4.464

19.094

31.248

30.000

Total

51.478

32.728

20.592

15.592

15.592

135.982

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

56

7.3

Indication of the timetable for commitment and payment appropriations

Year

2001

2002

2003

2004

2005

and

2005
following
years

51

33

20

16

16

16

51

33

20

16

16

51

33

20

16

16

16

16

Schedule of
Commitment

Payment
appropriations

2001

2002

2003

2004

2005

2006

Total

1000 Euro

Total

151

51

33

20

16

16

16

151

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

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.

57

• 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 Hungary

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

of Hungary.

- 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)

• 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

67 million for EU exporters to Hungary).

€

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

* None

58

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.

59

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 8 industrial sectors are covered by the

10.1
PECA).

Type of post

to be

Staff
managing the operation

assigned to

Source

Duration

Permanent
posts

Temporary
posts

DG I
+
sectoral DGs

Additional
resources

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

Officials

A

1.2

None

1.2

None

Permanent

B

C

0.4

0.4

Other resources

None

Total

1.6

1.6

10.2 Overall financial impact of additional human resources: 1.6 staff ( 108.000 Euro per
staff member per year = 172.800 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.

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

60

Budget heading

Amounts (Euro) Method of calculation

No. of missions

Mission Unit cost

Committee

5.952 Hungary: 4

A-7010

Seminars

A-7010

1.918 Hungary: 1

Verifications

2.976 Hungary: 2

A-7010

A-7010: Total

10.846

7

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

Hungary: Travel 1058
Euro; per diem: 215 Euro

In Euro

Year

Year

2001

2002

2003

2004

2005

Total

2001-
2005

A. Committee

5.952

5.952

5.952

5.952

5.952

29.760

B. Seminars

1.918

1.918

C. Verifications

2.976

2.976

1.488

1.488

1.488

10.416

TOTAL

10.846

8.928

7.440

7.440

7.440

42.094

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 Hungary.

61

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 Hungary 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 Hungary 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, electrical safety, electromagnetic compatibility,
gas appliances, hot water boilers, medical devices, good laboratory practice (GLP) for
medicinal products for human use 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 Hungary. This
avoids the need for further certification by Hungarian conformity assessment bodies before
putting them on the Hungarian 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 Hungary 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 Hungarian 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 Member States in the Community, and not in Hungary. The PECA will substantially
reduce certification costs and improve prospects for exports, employment, investment and
competitiveness by Community firms.

62

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.

63