EC Consultation on PV Regulations Closes Soon

You may not be aware but the EC Commission opened a consultation on the 31st August on Pharmacovigilance activities (Amendment Regulation (EU) 520/2012. This consultation closes on the 15th October at 12.00CET so there is not long to go to get your thoughts submitted back to them.

The proposal covers, but is not limited to:

  • Requiring marketing authorisation holders that subcontract pharmacovigilance activities to include “a description of the process in place to ensure third parties are in compliance”
  • Requiring MAHs to monitor EudraVigilance “in a manner proportionate to the risk, together with other available data sources”
  • Deletion of the term ‘expedited’ is proposed to ensure applicability of the minimum reporting requirements  to  all  individual  case  safety  reports  (ICSRs).
  • Requesting MAHs register post-authorisation study in the electronic post-authorisation study register maintained by the Agency. The marketing authorisation holder shall submit electronically to the register the study protocol before the start of the data collection and the abstract of results submitted within one month after the finalisation of the final study report.

Responses should preferably be sent to referring in the subject line to “TSC/2021/24 – Targeted stakeholder consultation on the amendments to the Commission Implementing Regulation No (EU) 520/2012”. Full details in the consultation document.

James Hall
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