In Panacea News

On 31st January, the EMA published the Legal Notice and updated the accompanying guidance regarding the submission of information on medicinal products by MAH to the EMA.  The Legal Notice can be found here:

Click here to see the EMA announcement

MAH are required to review the minimum mandatory fields and update in accordance with the requirements laid down in the Legal Notice.  The timelines for completion is from 16 June 2014 to 31 December 2014.  Changes to the name and contact details of the QPPV can be made via EVMPD from 16 June.

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