Changes with the report to the art 57 database

Changes with the report to the art 57 database

The EMA management board has released a communication that from 1
February 2016, any changes to the location of the Pharmacovigilance System
Master File (PSMF) and details of the Qualified Person Responsible for
Pharmacovigilance (QPPV) can be reported to the art 57 database and separate
type IA variations do not have to be submitted.

The full announcement can be found by following below link:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/12/news_detail_002451.jsp&mid=WC0b01ac058004d5c1

If you have any question about the art 57 database, or are interested in
the services that Asphalion provides for maintenance, installation and training
of IT tools, or preparation for ISO IDMP, please contact us at xevmpd@asphalion.com

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