Quality control of Article 57 data: electronic notifications

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 “3^rd Acknowledgement”) to the MAH sender’s organisation ID. The Agency will offer Gateway user organisations the possibility to test the receipt of the 3^rdacknowledgment 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 3^rd 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. 

If you have any doubts regarding the matter, please do not hesitate to contact us at [email protected]