Notification according to Article 95(4) of the EC Treaty — Approval to maintain national legislation derogating from the provisions of a Community harmonisation measure (Text with EEA relevance)
Date: 2001-05-01
Institutions: European Commission
Subjects: Germany, approximation of laws, drug surveillance, pharmaceutical legislation, pharmacology, public health

C 130/2

EN

Official Journal of the European Communities

1.5.2001

Notification according to Article 95(4) of the EC Treaty (cid:151) Approval to maintain national legis-
lation derogating from the provisions of a Community harmonisation measure

(2001/C 130/02)

(Text with EEA relevance)

1. On 25 January 2001 the Federal Republic of Germany
notified national
legislation to be maintained despite the
2000/38/EC (1)
adoption
Commission
amending Chapter Va of Council Directive 75/319/EEC (2)
regarding pharmacovigilance.

Directive

of

2. Article 95(4) stipulates that if, after the adoption by the
Council or by the Commission of
a harmonisation
measure, a Member State deems it necessary to maintain
national provisions on grounds of major needs referred to
in Article 30, or
the
it shall notify
environment or the working environment,
the Commission of
the
grounds for maintaining them.

relating to the protection of

these provisions as well as

a reporting obligation is established only for unexpected
reactions.

5. The German authorities justify their request by referring to
the highest possible level of protecting public health in the
use of medicinal products which could not be ensured after
implementation of Directive 2000/38/EC. They further
claim that the national provisions do not involve arbitrary
discrimination, or a disguised barrier
to trade between
Member States, nor do they obstruct the operation of the
internal market.

6. Further information regarding the request from the Federal

Republic of Germany can be obtained from:

3. The Commission shall, within six months of the notification
the national provisions involved after
approve or reject
having verified whether or not
they are a means of
arbitrary discrimination or a disguised restriction to trade
between Member States and whether or not
they shall
constitute an obstacle to the functioning of the internal
market.

4. The national legislation notified obliges the pharmaceutical
entrepreneur to inform the competent federal authority in
Germany within 15 days of all suspected serious adverse
reactions irrespective of whether or not the reactions are
expected and whether it occurs within or outside of the
Community.
In contrast to that, the amended provisions
of Directive 75/319/EEC oblige the marketing authorisation
holder to report suspected serious adverse reactions only to
the competent authority of that Member State in whose
territory the incident occurred.
the suspected serious
adverse reactions occur in the territory of a third country,

If

RD Dr. Heinz Haage
Bundesministerium f(cid:252)r Gesundheit
Referat 112
D-53108 Bonn
Tel. (49-228) 941 11 21 or (49-1888) 441 11 21
Fax (49-228) 941 48 43 or (49-1888) 441 48 43
E-mail: Haage@bmg.bund.de

Contact point in the European Commission:

European Commission
Directorate-General for Enterprise
Unit F-2 Pharmaceuticals
Rue d’Arlon/Aarlenstraat 88 (1/39)
B-1040 Brussels
Tel. (32-2) 295 35 39
Fax (32-2) 296 15 20
E-mail: nils.behrndt@cec.eu.int

(1) OJ L 139, 10.6.2000, p. 28.
(2) OJ L 147, 9.6.1975, p. 13.