Archive for 2011

UK: Consultation on pharmacovigilance

Tuesday, December 6th, 2011 in News

The MHRA launched a public consultation on the transposition of the Pharmacovigilance Directive 2010/84/EU in the UK . The consultation period ends on February 28. EMIG will respond to the consultation. Please send your responses to Matt Keirle (Matt.Keirle@lexcomm.co.uk) by January 31, 2012. On the basis of the EUCOPE synopsis you ... read more...

Germany: 16. AMG Amendment

Friday, December 2nd, 2011 in News

In Germany the Directives on Pharmacovigilance and Falsified Medicines (2011/62/EU) are transposed into national law. On 2 December the proposal for the 16. Amendment of the AMG (German Drug Act) was sent to the associations. The foreseen changes include: Pharmacovigilance : • ... read more...