EU Pharmacovigilance Legislation

The legal basis for pharmacovigilance for medicines for human use in the EU is laid down in Directive 2001/83/EC and Regulation (EC) No 726/2004, as amended. The most recent amendments to this legislation in 2010 were implemented to further protect public health by strengthening the European-wide system for monitoring the safety of medicines.

The legislation is accompanied by the implementing regulation which was published by the European Commission in June 2012. Implementing Regulation (EU) No 520/2012 provides details on some of the operational aspects for the revised legislation. In addition, detailed guidance in the form of a number of good pharmacovigilance practice (GVP) modules to facilitate the performance of pharmacovigilance in the European Union (EU) are available.

The revised EU legislation was transposed into Irish law on 25 July 2012. This legislation has been officially published in the Irish Statute Book and comprises:

• S.I. No. 272 of 2012 (Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2012)
• S.I. No. 273 of 2012 (Medicinal Products (Control of Manufacture) (Amendment) Regulations 2012)
• S.I. No. 274 of 2012 (Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2012)

Good Vigilance Practices (GVP)

Good pharmacovigilance practices (GVP) are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU). GVP applies to marketing-authorisation holders, the European Medicines Agency and medicines regulatory authorities in EU Member States. Further information relating to Good Vigilance Practice, including the modules themselves, are available from the European Medicines Agency website.