Statutory Instruments

Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2014

These Regulations amend the Medicinal Products (Control of Placing on the Market) Regulations 2007 (S.I. No. 540 of 2007).  These Regulations give effect to Directive 2012/26/EU of the European Parliament and of the Council of the 25 October 2012, which amended, as regards pharmacovigilance, Directive 2001/83/EC. The Regulations also give full effect to Regulation (EU) No. 1027/2012 of the European Parliament and of the Council of 25 October 2012 and Commission Implementing Regulation (EU) No. 198/2013. These Regulations may be cited as the Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2014.  Download the PDF here