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C 232/60 Official Journal of the European Communities EN 17.8.

2001

Tuesday 12 December 2000

COUNCIL AMENDMENTS
COMMON POSITION BY PARLIAMENT

 the patients participating in the trial have the same


characteristics as those covered by the indication spe-
cified in the abovementioned authorisation.

(Amendment 23)
Article 15(3)(a)

(a) Each Member State shall ensure that all suspected unex- (a) Each Member State shall ensure that all suspected unex-
pected serious adverse reactions to an investigational med- pected serious adverse reactions to an investigational med-
icinal product which are brought to its attention are icinal product which are brought to its attention are
reported immediately to the Agency by the sponsor of the clin- immediately entered in a European database to which,
ical trial. in accordance with Article 9(1), only the competent
authorities of the Member States, the Agency and the
Commission, shall have access.

4. Summer-time ***I

A5-0356/2000

Proposal for a European Parliament and Council directive on summer-time arrangements


(COM(2000) 302  C5-0322/2000  2000/0140(COD))

The proposal was amended as follows:

TEXT PROPOSED AMENDMENTS


BY THE COMMISSION (1) BY PARLIAMENT

(Amendment 3)
Recital 4

(4) The proper functioning of certain sectors, not only trans- (4) The proper functioning of certain sectors, not only trans-
port and communications, but also other sectors of industry, port and communications, but also other sectors of industry,
requires stable, long-term planning. Provisions concerning sum- requires stable, long-term planning. Provisions concerning sum-
mer-time should therefore be laid down for an unlimited period. mer-time should therefore be laid down for an unspecified
Article 4 of Directive 97/44/EC provides, in that respect, that period. Article 4 of Directive 97/44/EC provides, in that
the European Parliament and the Council are to adopt, by 1 Jan- respect, that the European Parliament and the Council are to
uary 2001, the arrangements to apply from 2002 onwards. adopt, by 1 January 2001, the arrangements to apply from
2002 onwards.

(Amendment 4)
Article 5, 2nd paragraph (new)

The Commission shall, if necessary and following the con-


clusions of the report, make appropriate proposals.

(1) OJ C 337 E, 28.11.2000, p. 136.