We are pleased to announce that as of today, Purple Vigilance is able to offer a new service; we can now assist Marketing Authorisation Holders (MAHs) and Sponsors with data entry and maintenance of products details in the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD).
Background on the XEVMPD
One of the key deliverables of the 2010 Pharmacovigilance legislation relates to the submission by MAHs of information about medicines to the European Medicines Agency (EMA). The requirement is described in Article 57(2) of Regulation (EC) No 1235/2010.
It requires:
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MAHs to submit information to the EMA electronically on all medicinal products for human use authorised in the European Union by 2 July 2012, using this format;
- MAHs to inform the EMA of any new or varied marketing authorisations granted in the EU as of 2 July 2012, using this format.
Purple Vigilance can enter the details of your products onto XEVMPD and provide on-going maintenance to ensure continued compliance.
Contact us now to discuss your requirements!