Regulation 2014/658 - Fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use - Main contents
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official title
Regulation (EU) No 658/2014 of the European Parliament and of the Council of 15 May 2014 on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use Text with EEA relevance| Legal instrument | Regulation |
|---|---|
| Number legal act | Regulation 2014/658 |
| Original proposal | COM(2013)472  |
| CELEX number i | 32014R0658 |
| Document | 15-05-2014 |
|---|---|
| Publication in Official Journal | 27-06-2014; OJ L 189 p. 112-127 |
| Effect | 17-07-2014; Entry into force Date pub. +20 See Art 18 |
| End of validity | 31-12-2024; Repealed by 32024R0568 |
27.6.2014 |
EN |
Official Journal of the European Union |
L 189/112 |
REGULATION (EU) No 658/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 15 May 2014
on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 and point (c) of Article 168(4) thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Economic and Social Committee (1),
After consulting the Committee of the Regions,
Acting in accordance with the ordinary legislative procedure (2),
Whereas:
(1) |
The revenue of the European Medicines Agency (the ‘Agency’) consists of a contribution from the Union and fees paid by undertakings for obtaining and maintaining Union marketing authorisations and for other services as referred to in Article 67(3) of Regulation (EC) No 726/2004 of the European Parliament and of the Council (3). |
(2) |
The provisions on pharmacovigilance relating to medicinal products for human use (‘medicinal products’) laid down in Regulation (EC) No 726/2004 and in Directive 2001/83/EC of the European Parliament and of the Council (4) were amended by Directive 2010/84/EU of the European Parliament and of the Council (5), Regulation (EU) No 1235/2010 of the European Parliament and of the Council (6), Directive 2012/26/EU of the European Parliament and of the Council (7) and Regulation (EU) No 1027/2012 of the European Parliament and of the Council (8). Those amendments provide for new pharmacovigilance tasks for the Agency, including pharmacovigilance procedures carried out at Union level, the monitoring of literature cases and the improved use of information technology tools. Furthermore, those amendments provide that the Agency should be enabled to fund those activities from fees charged to marketing authorisation holders. New types of fees should therefore be created to cover the new and specific tasks of the Agency. |
(3) |
In order to enable the Agency to charge fees for those new pharmacovigilance tasks, and pending an overall legislative revision of the fees regimes in the medicinal products sector, this Regulation should be adopted. The fees provided for in this Regulation should be applicable without prejudice to the fees laid down in Council Regulation (EC) No 297/95 (9). |
(4) |
This Regulation should be based on the dual legal basis of Article 114 and point (c) of Article 168(4) of the Treaty on the Functioning of the European Union (TFEU). It is aimed at financing pharmacovigilance activities that contribute to achieving an internal market as regards medicinal products, taking as a basis a high level of protection of health. At the same time, this Regulation aims to ensure financial resources to support the activities addressing common safety concerns, in order to maintain high standards of quality, safety and efficacy of medicinal products. Both objectives are pursued simultaneously and are inseparably linked, so that one is not secondary to the other. |
(5) |
The structure and amounts of the fees for pharmacovigilance collected by the Agency, as well as the rules for their payment, should be established. The structure of the fees should be as simple as possible to apply in order to minimise the related administrative burden. |
(6) |
In line with the Joint Statement of the European Parliament, the Council of the EU and the European Commission of 19 July 2012 on decentralised agencies, for bodies for which the revenue is constituted by fees and charges in addition to the... |
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