Updated set of mandatory Article 57(2) requirements for marketing authorisation holders

pharmafile | March 15, 2012 | News story | Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Wainwright Associates; EMA; Pharmacovigilance; PV 

An updated set of mandatory requirements for Marketing Authorisation Holders (MAH) to comply with Article 57(2) of the forthcoming new Pharmacovigilance legislation has been published by the European Medicines Agency. The Agency has considerably reduced the number of data fields initially required in the format published on 2 July 2011. The legal deadline for submitting data is the 2nd July 2012. 

Article 57(2) requires the EMA to establish lists of all human medicines authorised in the European Union (EU), based on data submitted by the MAH.  The lists will help coordinate pharmacovigilance activities and the protection of public health by aiding a clear identification of medicines reported for adverse reactions and of medicines affected by a safety review.

If you are going to be affected by the forthcoming pharmacovigilance changes and would like to know more or you are a Marketing Authorisation Holder and need assistance with the data submission process, please contact us on +44 (0)1628 530554 or email enquiries@wainwrightassociates.co.uk.

Visit www.wainwrightassociates.co.uk

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