The European Medicines Agency is providing pharmaceutical companies with
information on the next steps for the maintenance of information
provided on human medicines in accordance with Article 57(2) of the 2010
pharmacovigilance legislation.
Article 57(2), second subparagraph, point c of Regulation (EC) 726/2004 requires marketing-authorisation holders to inform the Agency of any new or varied marketing authorisations granted in the European Union as of 2 July 2012 using the updated electronic format provided by the Agency on 5 March 2012.
On 28 June 2012, the Agency hosted a third workshop with European pharmaceutical industry associations on the implementation of this Article, focusing on a proposal for maintenance of information on human medicines. During the workshop, attendees were supportive of the Agency’s proposals
Article 57(2), second subparagraph, point c of Regulation (EC) 726/2004 requires marketing-authorisation holders to inform the Agency of any new or varied marketing authorisations granted in the European Union as of 2 July 2012 using the updated electronic format provided by the Agency on 5 March 2012.
On 28 June 2012, the Agency hosted a third workshop with European pharmaceutical industry associations on the implementation of this Article, focusing on a proposal for maintenance of information on human medicines. During the workshop, attendees were supportive of the Agency’s proposals
To find more information please use the below mentioned weblink
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