| Author (Corporate) | European Commission |
|---|---|
| Series Title | COM |
| Series Details | (2013) 472 final (26.6.13) |
| Publication Date | 26/06/2013 |
| Content Type | Policy-making |
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The legal framework of pharmacovigilance for medicinal products for human use marketed within the EU is provided for in Regulation (EC) No 726/2004 and in Directive 2001/83/EC. The EU pharmacovigilance legislation for medicinal products for human use has been subject to a major review and an impact assessment that led to the adoption of a revised legislation in 2010, which strengthens and rationalises the system for safety monitoring of medicines on the European market. This legislation is applicable as of July 2012. It provides for a number of EU-wide procedures to assess pharmacovigilance data which may lead to regulatory action. Some additional amendments to the pharmacovigilance legislation were introduced in 2012 following the 'Mediator' case. Whilst streamlining the EU-wide post-authorisation safety assessment and monitoring of medicines, the revised pharmacovigilance legislation significantly widened the tasks of the European Medicines Agency with regard to pharmacovigilance, irrespective of whether the medicinal products have been authorised via the 'centralised procedure' (in accordance with the Regulation) or via national procedures (in accordance with the Directive). The Agency has therefore acquired pharmacovigilance competences also for nationally authorised medicines, in addition to reinforced competences for centrally authorised medicines. To finance these activities, the revised pharmacovigilance legislation provides for fees to be charged to marketing authorisation holders. These fees should be related to pharmacovigilance activities performed at the level of the EU, notably in the context of the EU-wide assessment procedures. These procedures include scientific assessment carried out by rapporteurs from the national competent authorities of the Member States. These fees are therefore not intended to cover the pharmacovigilance activities of the national competent authorities performed at national level. Member States may accordingly continue to charge fees for the activities performed at national level which should, however, not overlap with the fees laid down in this legal proposal. Since the revised pharmacovigilance legislation only concerns medicinal products for human use, this proposal on fees for pharmacovigilance only covers these medicinal products. |
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| Source Link | http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM:2013:472:FIN |
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| Subject Categories | Health, Politics and International Relations |
| Countries / Regions | Europe |
