EU MAHs Will See Relief on Some Pharmacovigilance Updates

Regulatory NewsRegulatory News | 22 January 2016 |  By 

Beginning 1 February, drug companies operating in the EU will only have to update a database for some pharmacovigilance changes and will no longer have to submit a particular IA variation to the European Medicines Agency (EMA).

According to the update from the European Commission on Friday, marketing authorization holders (MAH) have to inform competent authorities about changes to the Qualified Person responsible for Pharmacovigilance (QPPV) including contact details and changes in the location of the Pharmacovigilance System Master File (PSMF).

Currently, those changes are subject to a type IA variation, but once the Article 57 database is fully up to speed, changes in QPPV, including contact details (telephone and fax numbers, postal address and email address) and changes to the location of the PSMF (street, city, postcode, country) may be updated through the Article 57 database only, meaning a variation will not be necessary.

The changes came about after EMA’s Management Board confirmed at its December 2015 meeting that the Article 57 database of medicines authorized in the EU can now be relied on.

EMA also clarifies that the information on the deputy QPPV is not within the required information to be included in the summary of the applicant’s pharmacovigilance system.

“The information relating to the QPPV provided in the pharmacovigilance system master file (PSMF) shall include details of back-up arrangements to apply in the absence of the QPPV,” EMA says.

What’s Going Public?

As far as what pharmacovigilance information will be made public, an article from a regulation from 2004 said that EMA and member states are required to make public, “at least, a list of the locations in the Union where pharmacovigilance system master files are kept and contact information for pharmacovigilance enquiries, for all medicinal products for human use authorised in the Union.”

On this basis, EMA says it will publish the email address and phone number for pharmacovigilance enquiries from the data submitted under the 2014 regulation.

EMA will also publish the locations in the EU where PSMFs are kept, from the data submitted under the 2004 regulation, as follows:

  • Code assigned to the PSMF;
  • Company name; and
  • PSMF location country code.

Regulatory Information 01/2016 - Variations - Article 57 database


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