2001/747/EC: Council Decision of 27 September 2001 concerning the conclusion of the Agreement on Mutual Recognition between the European Community and Japan
Date: 2001-09-27
Institutions: Council of the European Union
Subjects: Japan, agreement (EU), mutual recognition principle, ratification of an agreement

29.10.2001

EN

Official Journal of the European Communities

L 284/1

II

(Acts whose publication is not obligatory)

COUNCIL

COUNCIL DECISION

of 27 September 2001

concerning the conclusion of the Agreement on Mutual Recognition between the European
Community and Japan

(2001/747/EC)

THE COUNCIL OF THE EUROPEAN UNION,

The texts referred to in the first paragraph are attached to this
Decision.

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

Article 2

Having regard to the proposal of the Commission,

Whereas:

(1)

(2)

The Agreement on Mutual Recognition between the
European Community and Japan was signed, on behalf
of the European Community, on 4 April 2001, subject
to its possible conclusion at a later date, and should be
approved.

internal

procedures

appropriate

be
The
should
established to ensure the proper functioning of
the
Agreement. It is therefore necessary to delegate to the
Commission the power to proceed to amendments of
part B of the Sectoral Annexes to the Agreement and to
take certain decisions for its implementation,

On behalf of the Community, the President of the Council
shall,
the
transmit
Agreement (1).

the note provided for in Article 14 of

Article 3

1.
The Commission, assisted by the special committee
appointed by the Council (hereinafter (cid:145)special committee(cid:146)) shall
represent the Community in the Joint Committee established
under Article 8 of the Agreement and in any subcommittees
established in accordance with paragraph 2 of
the same
Article. The Commission shall proceed, after consultation with
the special committee, to notifications, requests and exchange
of information and to the proposals for:

(a) registration of conformity assessment bodies,

(b) provision of lists of facilities,

HAS DECIDED AS FOLLOWS:

(c)

termination,
assessment bodies,

suspension, or withdrawal of conformity

Article 1

facilities,

(d) non-acceptance of confirmation and of data generated by

The Agreement on Mutual Recognition between the European
Community and Japan,
including its Annexes, together with
the joint declarations and the Exchanges of Letters annexed to
the Final Act, are hereby approved on behalf of the European
Community.

(e) non-acceptance of certificates emanating from suspended

conformity assessment bodies,

(1) The date of entry into force of the Agreement will be published in

the Official Journal of the European Communities.

L 284/2

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Official Journal of the European Communities

29.10.2001

(f) appointments of experts,

(g) definition of emergencies and modalities

in accordance with Article 10(2)(b) of

for visits of
the

facilities
Agreement;

(g) actions taken in the context of verifications, visits or

contestations,

referred to in Articles 5, 6, 7, 8, 9, 10 of the Agreement and
the equivalent provisions of its Sectoral Annexes.

2.
The position to be adopted by the Community in the
Joint Committee or if appropriate in any subcommittees shall
be determined by the Commission following consultation of
the special committee, with regard to:

(a) adoption of the rules of procedure,

in accordance with

Article 8(2) of the Agreement;

(b) establishment of subcommittees in accordance with Article

8(2) of the Agreement;

(c) adoption of the modalities of exchange of information in

accordance with Article 8(3)(c) of the Agreement;

(d) registration

of

conformity

verification and related decisions
Articles 5, 7, 8(3)(a), 8(3)(d) and 9 of the Agreement;

assessment

their
bodies,
in accordance with

(e) establishment and publication of

the lists of registered
conformity assessment bodies and confirmed facilities in
accordance with Article 8(3)(b) of the Agreement;

(f) verification, visit and contestation of confirmed facilities
and related decisions, in accordance with Articles 5, 7 and
10 of the Agreement;

(h) establishment of procedures for implementing the Sectoral
in
on good manufacturing practice
Annex
accordance with points 7(b), 7(c) and 9(b) of this Sectoral
Annex.

(GMP)

and approve

shall manage

The Commission, following consultation of the special
3.
transitional
committee,
arrangements associated with implementation of the Sectoral
Annex on GMP, and shall send the other party, on behalf of
the European Community, the diplomatic note confirming that
the preparatory work is completed (in accordance with point
9(a) of the Sectoral Annex on GMP).

the

The Commission shall approve all modifications of part
4.
B of the Sectoral Annexes,
in consultation with the special
committee and shall send the other party, on behalf of the
European Community,
the diplomatic note referred to in
Article 15(3)(b) of the Agreement.

5.
In all other cases the position to be adopted by the
Community in the Joint Committee or a subcommittee shall be
determined by the Council, acting by a qualified majority on a
proposal from the Commission.

Done at Brussels, 27 September 2001.

For the Council

The President

M. VERWILGHEN