WRITTEN QUESTION No. 3417/96 by Jutta HAUG to the Commission. Revision of the Basic Regulation of the Medicines Evaluation Agency
Date: 1996-11-22
Institutions: European Parliament, HAUG
Subjects: EC Regulation, European organisation, budgetary power, exchange of information, medicinal product, payment, report













EUR-Lex - 91996E3417 - EN






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91996E3417

WRITTEN QUESTION No. 3417/96 by Jutta HAUG to the Commission. Revision of the Basic Regulation of the Medicines Evaluation Agency  


Official Journal C 091 , 20/03/1997 P. 0081 





WRITTEN QUESTION P-3417/96 by Jutta Haug (PSE) to the Commission (22 November 1996)Subject: Revision of the Basic Regulation of the Medicines Evaluation AgencyIn the debate on the Regulation on the fees payable to the European Medicines Evaluation Agency, held on 18 January 1995 in Strasbourg ((Debates of the European Parliament no. 4-456 (January 1995). )), Commissioner Martin Bangemann replied as follows to the assertion by the rapporteur of the Committee on Budgets that the Basic Regulation disregarded the budgetary rights of the European Parliament:'...The basic regulation provides for a review in 1997. In 1996, i.e. next year, we will make a proposal on the matter. Then, in the light of any changes or the decision of principle on how such revenue is to be treated, we will be able to draw up a completely new regulation with all the proposals and possibilities to which the rapporteur has referred, as also with a quite different comitology...'At the end of the debate the rapporteur asked for clarification:'...but you are agreeing that the basic regulation will be revised.';to which Commissioner Bangemann replied:'In 1997, to be quite precise. To ensure that this can be done on time, we will be submitting a proposal in 1996.'We are now approaching the end of 1996, and the Commission has not yet fulfilled its promise.1. When does the Commission now propose to submit its proposal for a revision to Parliament?2. Will the Commission make a special effort to ensure that this is done before the end of 1996, as promised by Commissioner Bangemann?Answer given by Mr Bangemann on behalf of the Commission (16 December 1996)Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European agency for the evaluation of medicinal products ((OJ L 35, 15.2.1995. )) is based on Article 235 of the EC Treaty and entered into force on 15 February 1995.Under Article 10, the Commission will submit, within two years at the latest of the entry into force of this Regulation, a report on its implementation and, in the light of that experience, propose a definitive regulation to the Council. The Council, acting by a qualified majority after consulting the Parliament, will adopt provisions on the amounts of the fees and the conditions governing them, to apply as from 1 January 1998.When drafting this proposal, the Commission has to take account in particular of the practical experiences of the European agency for the evaluation of medicinal products. The Commission has therefore asked the Agency to provide it with the necessary information and a report of the Agency to the Commission is expected for December 1996. Based on this report, the Commission will finalise its proposal and forward it to the Council in February 1997.