WRITTEN QUESTION No. 569/98 by Kenneth COLLINS to the Commission. Legal base of the regulation establishing the European Medicines Evaluation Agency
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 Santerís 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 Unionís 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