Brexit means Brexit.
The role of EUQPPV and EU Regulatory Submissions

 

BREXIT PICTURE

It was announced last week by the EMA that there would be significant and tangible changes and impact from the UK decision to leave the European Union by March 2019.  They can be summarized as follows:

Changes to be done by 30 March 2019:

Regulatory Affairs - Centralized Procedures

  • Centralised Procedure (CP) Marketing Authorisation Holders (MAHs) - For centrally authorised medicinal products, the marketing authorisation holder will therefore normally need to transfer its marketing authorisation to a holder established in the Union (EEA).

Pharmacovigilance

  • All QPPVs based in the UK should change their place of residence and carry out their tasks in the Union (EEA). Alternatively, a new QPPV residing and carrying out their tasks in the Union (EEA) would need to be appointed (no variation is required)
  • The PSMF must be located within the Union (EEA) – so in case it is based with a UK-based PHV provider, it should be relocated to the EEA

Our Opinion:

We take no pleasure from the fact that we believe it was and is inevitable that either being based in the UK, holding an MA in the UK, or having your EUQPPV in the UK will be affected by the UK’s decision to leave the European Union.  We have already been contacted by many concerned companies looking to either move or adapt to this situation, including providers of Pharmacovigilance services based in the UK.  We also believe that MAs will need to be adapted to work with this situation.

As a full-service provider of ConsultancyRegulatory Affairs and Pharmacovigilance with offices in both the Republic of Ireland and Central Europe, we are not affected in any way by Brexit, except for the fact that we are in a unique positon to support companies from a strategic, regulatory AND Pharmacovigilance perspective in terms of working around the Brexit deadline that is now only 21 months away.

To summarise - How we could help you:

  • We have an EEA based system and EU QPPV based outside the UK
  • We could be the MAH in EU

If you wish to discuss your current situation as well as receiving a free consultation on how to navigate the impact of Brexit, please contact your Arriello account manager or [email protected]

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