On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...24 January 2017
EU extends the suspension of Belarus sanctions
Since the current suspension expires on 29 February 2016, we expect the new Council Decision to be published in the coming week.
The easing of EU Belarus sanctions follows the overall rapprochement between the EU and Belarus, taking into account some of the achievements made by this country in the last 2 years, such as the release of all political prisoners back in August 2015 and the presidential elections of October 2015 that were allegedly held in an environment free from violence.
Nonetheless, it must be noted that the arms embargo on Belarus is still in force and so are restrictive measures taken against a small number of parties linked to unresolved disappearances of two opposition politicians, one businessman and one journalist. These measures will be extended for a period of 12 months.
Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was...24 January 2017
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published guidance for companies submitting a Manufacturing Authorisation application or variation on...06 January 2017