European Commission scraps some pharmacovigilance red tape

Published: 24-Feb-2016
Regulatory

No special filings needed to alert regulator to changes to qualified persons contact details


From 1 February, pharmaceutical firms no longer have to make special filings alerting regulators to changes to contact details of company qualified persons responsible for their pharmacovigilance and pharmacovigilance system master files.

The European Commission said this information is already logged on the so-called European Union ‘Article 57’ database, established under the EU pharmacovigilance regulation No 726/2004.

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