The MHRA has posted information on new pharmacovigilance legislation coming into effect across the EU in July 2012. The changes introduced by the EU Directive will be transposed into UK law in the Human Medicines Regulations 2012, which will also consolidate nearly all other UK medicines legislation.
The legislation will be underpinned by an EC Implementing Measures Regulation and a series of modules on Good Pharmacovigilance Practice.
More information can be found on the MHRA’s website as well as a series of questions and answers on the new requirements. This information will be developed over the coming weeks and months, and Marketing Authorisation Holders are advised to check the MHRA’s site for updated information.