National Legislation transposing 2010/84/EU now published
27 August 2012
The national legislation transposing the EU pharmacovigilance legislation was signed by the Minister of Health Dr. James Reilly on 25/07/2012. This legislation has now been officially published in the Irish Statute Book, and is available via the below links:
SI 272 of 2012 (Medicinal Products (Control of Placing on the Market)(Amendment) Regulations2012)
SI 273 of 2012 (Medicinal Products (Control of Manufacture) (Amendment)Regulations 2012)
SI 274 of 2012 (Medicinal Products (Control of Wholesale Distribution)(Amendment) Regulations 2012)