Chiara Ottavianelli -

It is now well-known that, following the Withdrawal Agreement between the United Kingdom and the European Union, the United Kingdom (UK) formally left the European Union on 31st January 2020 and became a third country.

Following the formal exit of UK from EU, a transitional period started on 1st February 2020 and ended on 31st December 2020. The question now is: how does Brexit affects national, MRP and DCP medicinal products in Italy?

Some Marketing Authorizations still involve UK in a few aspects like:

  • Marketing authorization holder
  • Pharmacovigilance system master file
  • Qualified Person for Pharmacovigilance
  • Batch control site(s) for finished product
  • Batch release site(s) for finished product

Recently AIFA asked companies to give an update regarding any actions that will be performed by MAHs for non-compliant medicinal products in order to avoid any legal actions such as the suspension or revocation of non-compliant marketing authorizations.

In the same press-release, AIFA specified the corrective actions to be performed and the relevant timelines.

Regulatory Pharma Net team is available to fully support companies to make any Marketing Authorization compliant to the above-mentioned requirements.

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