On 30th March 2019, according to the European Commission and the European Medicines Agency, The United Kingdom will become a “third country”. This has several important legal implications.
It is still uncertain what will happen in the post-Brexit era, however, here are the consequences of the current state:
- EU law requires that for centrally authorised medicinal products, the marketing authorisation holders are established in the EU (or EEA). That means a pharmaceutical company will need a registered and licenced office or facility with licence in the EU/EEA.
- Some activities like, for example, batch release and pharmacovigilance activities must be performed in the EU (or EEA). Therefore, QP and QPPV must be located in the EU/EEA.
- Possible changes to the terms of the marketing authorisation “in order to ensure its continuous validity and exploitation” should be considered.
Of course, the details depend on the on-going negotiations between UK and EU-27, and the resulting Withdrawal Agreement and Mutual Recognition Agreement. Until now, both parties have agreed on a Transition Period, which will go on until 31st December 2020. However, the medicines regulation is out of scope, meaning that the UK falls out of EU Regulatory Framework on 30th March 2019.
The EMA and EU-27 National Competent Authorities agree on the fact that there is not much time left. The advise for the life sciences industry is to not take the risk and prepare for the worst case scenario.
Asphalion has established a Brexit Task Force who is closely monitoring the situation and can support you finding solutions. We endorse the Regulatory Network’s position and urge you to start preparing Brexit transition now. To make your Brexit transition smoother we can:
- Assess your regulatory impact and develop your Brexit transition strategy
- Manage MAH transfers and other necessary variations
- RMS Transfers
- Act as your QPPV
- Batch update all your records with the new QPPV and PSFM information in the Article 57 database
- Hold your pharmacovigilance system master file at our location
- Re-establish your SME status
Do not wait until it is too late – necessary transfers or variation requests need to be submitted well in advance to ensure they are processed in time.
Contact us at info@asphalion.com
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You can have all this information with this summary leaflet!
