Activites

• 1998/12/19 Final act published in Official Journal
  • Regulation 1998/2743
  • OJ L 345 19.12.1998, p. 0003
• #2151
• 1998/12/14 Council Meeting
• 1998/12/14 End of procedure in Parliament
• 1998/12/14 Act adopted by Council after consultation of Parliament
• 1998/11/11 Modified legislative proposal published
  • COM(1998)0648 summary

    The Commission accepts, in part or in full, those of the European Parliament's amendments covering the following areas: - if the fee is increased on initiation of the arbitration procedure in respect of a marketing authorisation for a veterinary medicinal product, such an increase is to remain pegged within a ceiling of ECU 20,000 ; - any increase in the additional fee for an application to amend or extend an existing MLR is to remain pegged within a ceiling of ECU 15,000 ; - introduction of the principle of maximum fees for applications for scientific advice ; - future reviews of fees shall be based on a full cost evaluation of the costs of the Agency, including expenditure relating to Member States' rapporteurs. The Commission rejects those amendments covering the following areas: - a change in the legal basis of the proposed text, as the derived legal basis is perfectly appropriate ; - the budget rules applicable to the Agency, as this does not specifically concern the levels and structure of the fees payable to the Agency for the evaluation of medicinal products and these aspects are in any case subject to a draft horizontal regulation covering all agencies under discussion; - the replacement of the ecu with the euro, as this will need to be covered by a horizontal text covering all Community texts ; - the reintroduction of ceilings for fees directly linked to the granting of marketing authorisations under the centralised procedure as this cannot be justified either in terms of the service provided by the Agency or on public health grounds and the principles governing the rational use of medicinal products preclude the proliferation of different pharmaceutical forms of the same medicinal product.�

• #2130
• 1998/11/09 Council Meeting
• 1998/10/07 Decision by Parliament, 1st reading/single reading
  • T4-0557/1998 summary

    In adopting the report by Mr Michael TAPPIN (PSE, UK) on the European Agency for the Evaluation of Medicinal Products, the European Parliament adopted a number of amendments to render more stringent the obligation to consult Parliament about the fees payable to the Agency. The general principle of own resources is recalled, and the link between the Agency's resources and the EU budget is confirmed (Parliament particularly stresses that the fees charged by the Agency must be regarded as Community revenue and entered in the budget as preallocated resources for the Agency). Parliament seeks to give the Agency the flexibility it needs as regards the granting of EU funds. �

• 1998/10/06 Debate in Parliament
  • Debate in Parliament
• 1998/09/22 Vote in committee, 1st reading/single reading
  • A4-0338/1998
• 1998/05/27 Committee referral announced in Parliament, 1st reading/single reading
• 1998/01/21 Legislative proposal published
  • COM(1998)0021 summary

    OBJECTIVE: to amend Regulation (EC) No 297/95 on fees payable to the European Agency for the Evaluation of Medicinal Products (EMEA). SUBSTANCE: in the light of experience since 1995, it is deemed appropriate to retain the general principles and overall structure of the fee system, as well as the main operational and procedural provisions laid down by Regulation (EC) No 297/95. However, in the case of certain fees, the proposal seeks to define more precisely the services to which they relate in order to facilitate their recovery and improve the transparency and practical implementation of the Regulation. The Commission proposal includes three new initiatives: - the possibility for the EMEA Management Board, on a proposal by the Executive Director, to determine those cases in which the fee payable for a variation of major importance (type II) may be halved; - the introduction of an annual fee to cover costs of supervision of medicinal products whose marketing has been authorised by the Community and the maintenance of these authorisations; - the introduction of a fee for scientific advice and protocol assistance given to future applicants in the design of their research and development programmes. The proposed new provisions also include initiatives for a fee for the establishment of maximum residue limits for clinical trials, administrative charges and the introduction of differentiated fees for the initiation of Community referral procedures under Directives 75/319/EEC and 81/851/EEC. �

Documents

• Legislative proposal published: COM(1998)0021
• Committee report tabled for plenary, 1st reading/single reading: A4-0338/1998
• Debate in Parliament: Debate in Parliament
• Decision by Parliament, 1st reading/single reading: T4-0557/1998
• Modified legislative proposal published: COM(1998)0648
• : Regulation 1998/2743
• : OJ L 345 19.12.1998, p. 0003

History

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