WRITTEN QUESTION No. 569/98 by Kenneth COLLINS to the Commission. Legal base of the regulation establishing the European Medicines Evaluation Agency
Date: 1998-03-04
Institutions: COLLINS KENNETH, European Parliament
Subjects: European Medicines Agency, animal disease, cattle, health policy, health risk, legal basis, medicinal product, pharmaceutical legislation, public health, veterinary drug

9. 10. 98

EN

Official Journal of the European Communities

C 310/91

Ethical aspects on animals experimentation are becoming increasingly important. The Commission is strongly
encouraging Member States to set up ethical committees for animal experimentation on a voluntary basis as part
of their regular review process.

(98/C 310/121)

WRITTEN QUESTION E-0569/98

by Kenneth Collins (PSE) to the Commission

(4 March 1998)

Subject: Legal base of the regulation establishing the European Medicines Evaluation Agency

Does the Commission accept, as a consequence of the Amsterdam Treaty and President Santer(cid:146)s statement to
Parliament in February 1997 on EU health policy following the BSE crisis, that the review which is required of
the regulation establishing the European Medicines Evaluation Agency will be conducted on the basis of Article
100a of the Treaty, rather than Article 235?

Answer given by Mr Santer on behalf of the Commission

(8 April 1998)

According  to  Article  71  of  Council  Regulation  (EEC)  No  2309/93  of  22  July  1993  laying  down  Community
procedures  for  the  authorization  and  supervision  of  medicinal  products  for  human  and  veterinary  use  and
establishing  a  European  agency  for  the  evaluation  of  medicinal  products (1)  the  Commission  shall  publish  a
general  report  on  the  experience  acquired  as  a  result  of  the  operation  of  the  procedures  laid  down  in  the
Regulation within six years. As the Regulation entered into force on 1 January 1995 the Commission will present
the report mentioned in Article 71 in the year 2001.

Based on that report it will be considered whether amendments of the Regulation are required. It is established
case law that the legal base of a Community act should reflect the content of the act. If the Commission on the
basis of the report proposes amendments to the Regulation, the legal base of the proposal would thus reflect the
content of such a proposal.

(1)  OJ L 214, 24.8.1993.

(98/C 310/122)

WRITTEN QUESTION E-0570/98

by Eryl McNally (PSE) to the Commission

(4 March 1998)

Subject: Plutonium storage

It has been suggested by the Royal Society that the rising stocks of plutonium in Britain pose the threat not only
of environmental damage but also that of being stolen for use in illicit nuclear weapons.

What  extra  difficulties  does  the  Commission  envisage,  inn  light  of  the  above,  for  the  European  Union(cid:146)s
responsibilities for nuclear safeguards and the monitoring of fissile material?

Answer given by Mr Papoutsis on behalf of the Commission

(7 April 1998)

The Commission in the framework of its obligation under Chapter VII of the Euratom Treaty already invests
substantial financial and human resources in safeguarding plants handling large amounts of plutonium to ensure
that the material is not diverted from its intended use.