Since July 2012, marketing-authorisation holders (MAHs) are required to submit to the Agency information on new marketing authorisations granted in the EEA within 15 calendar days from the date of notification of the granting of the marketing authorisation by the competent authority, keep the medicinal product information up to date and notify the European Medicines Agency of any variation to the terms of marketing authorisation within 30 calendar days of the date of approval of the changes. In July 2014 the Agency began a systematic review of the quality and integrity of product entities submitted by MAHs. The Agency published the outlines of the quality control (QC) process in the “Quality Control of medicinal product data submitted as per the legal requirement introduced by Article 57(2) of Regulation (EC) No 726/2004” document available on the Agency’s “Guidance Documents” webpage.
The outcome of the QC process is currently communicated to the QPPV of the MAH organisation via email. Following discussions with Industry Associations at the Article 57 Implementation Working Group (IWG), as of November 2015, the Agency will communicate the outcome of the quality control process via an additional XEVPRM XML Acknowledgement message (so called “3rd Acknowledgement”) to the MAH sender’s organisation ID. The Agency will offer Gateway user organisations the possibility to test the receipt of the 3rd acknowledgment in the External Compliance Testing environment (XCOMP) as of 1 July 2015. For related information and further guidance on how to participate in the testing of the receipt of the 3rd Acknowledgement please refer to the updated version of the “Quality Control of medicinal product data submitted as per the legal requirement introduced by Article 57(2) of Regulation (EC) No 726/2004” document (http://www.ema.europa.eu/docs/en_GB/document_library/Other/2014/11/WC500177533.pdf).
Note that the specifications for the medicines database and the electronic update messages can be found here: Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the European Medicines Agency inaccordance with Article 57(2) of Regulation (EC) No. 726/2004Chapter 3.II: XEVPRM User Guidance
More info at:
European Medicines Agency
30 Churchill Place | Canary Wharf | London E14 5EU | United Kingdom
Tel. +44 (0)20 3660 7523 | Fax +44 (0)20 3660 5560
Eudraservice@ema.europa.eu | www.ema.europa.eu