Activites

• 2005/11/23 Final act published in Official Journal
  • Regulation 2005/1905
  • OJ L 304 23.11.2005, p. 0001-0009
• #2689
• 2005/11/14 Council Meeting
• 2005/11/14 End of procedure in Parliament
• 2005/11/14 Act adopted by Council after consultation of Parliament
• 2005/09/27 Results of vote in Parliament
  • Results of vote in Parliament
  • T6-0345/2005 summary

    The European Parliament adopted a resolution drafted by Karl-Heinz FLORENZ (EPP-ED, DE) Approving the proposal, subject to a few amendments. (Please see the document dated 14/09/2005.) The amendments were as follows: -In order to respect the principle of proportionality, medicinal products in which the active substances have been in well-established medicinal use within the Community for at least ten years should benefit from a reduced annual fee.-In exceptional cases, where an extensive workload relating to the evaluation of an application for marketing authorisation pursuant to Article 10a of Directive 2001/83/EC can be demonstrated, a fee of up to EUR 232 000 may be determined.-When it concerns the evaluation of traditional herbal medicinal products, the fee will be not more than EUR 25 000.-A reduced scientific service fee falling within the range of EUR 2 500 to EUR 25 000 shall apply for certain scientific opinions or services concerning traditional herbal medicinal products.

• 2005/09/16 Committee report tabled for plenary, 1st reading/single reading
  • A6-0264/2005
• 2005/09/14 Vote in committee, 1st reading/single reading
• 2005/05/26 Committee referral announced in Parliament, 1st reading/single reading
• 2005/03/31 Legislative proposal published
  • COM(2005)0106 summary

    PURPOSE : to amend some of the rules regarding fees payable to the European Medicines Agency and to amend Regulation 297/95/EC.PROPOSED ACT : Council Regulation.CONTENT : the pharmaceutical legislation has recently been revised and in this context  Regulation 726/2004/EC established a European Medicines Agency. The Agency's revenue consists of a contribution from the Community and fees paid by undertakings for obtaining and maintaining Community marketing authorisations and for other services provided by the Agency. The current fee scheme, as laid down in Council Regulation 297/95/EC on fees payable to the EMEA, does neither take into account the new tasks of the Agency, nor the modifications of existing tasks introduced by the revised legislation. It is therefore necessary to amend it.The main objectives of the proposal are:- to adapt the existing fee scheme to the revised pharmaceutical legislation and the new responsibilities conferred to the EMEA, taking in consideration the experience with the current system;- to ensure proportionality between the amount of the fees and the nature of the service actually provided by the Agency;- to alleviate the financial pressure put on applicants, without undermining the Agency’s ability to perform its tasks.The proposal’s objectives contribute to the three strategic goals of the Community framework for the authorisation, supervision and surveillance of medicinal products, and the establishment of the European Medicines Agency, i.e.:- protecting public health across the Community;- maintaining a reliable and independent source of scientific advice and information on medicinal products;- supporting the achievement of the internal market for the pharmaceutical sector.FINANCIAL IMPLICATIONS : Budget lines and headings : 02.040201 and 02.040202.The proposed Regulation should apply from 20 November 2005. The overall impact on revenues has been calculated for 2005-2010 and indicates a rough increase of the gross revenues of the Agency from 2 to 4 million euro per year. Nevertheless, additional costs resulting from the new tasks provided to the Agency by Regulation 726/2004/EC have not yet been fully assessed. As a consequence, the effect on the level of subsidy from the UE budget can only be evaluated in a further stage. The forecast shows that the overall impact of the fees changes:- represents 2.8 to 3% of the Agency’s annual revenues from fees;- represents 1.9 to 2.5% of the Agency’s total annual revenues (fees + Community contribution);Given that the error margin for the revenues forecasts is about 5-10%, and that the calculation does not take into account inflation, which at present is around 2.1% in the EU, the overall impact of the fees changes, compared to the Agency’s total revenues, is relatively moderate (less than 2.5%).However, in absolute numbers, this still represents 2 to 4 millions Euros per year and 9% to 15% of the general subsidy entered in budget 2005, which cannot be considered entirely negligible.This should therefore be taken into account in the next budgetary procedures, when reviewing the Community contribution to the EMEA for the 2005-2010 time period.

  • DG [{'url': 'http://ec.europa.eu/enterprise/', 'title': 'Enterprise and Industry'}],

Documents

• Legislative proposal published: COM(2005)0106
• Committee report tabled for plenary, 1st reading/single reading: A6-0264/2005
• Results of vote in Parliament: Results of vote in Parliament
• Decision by Parliament, 1st reading/single reading: T6-0345/2005
• : Regulation 2005/1905
• : OJ L 304 23.11.2005, p. 0001-0009

History

(these mark the time of scraping, not the official date of the change)