Pharmaceutical and medical companies have been advised to make themselves aware of the potential impact Brexit could have on the approval status of their products.
The European Commission and the European Medicines Agency have called upon marketing authorisation holders of centrally approved medicinal products for human and veterinary use to make sure they are up to date on all the possible legal repercussions of the UK's expected departure from the EU bloc in March 2019.
“The European Commission has warned drug companies that the UK's exit from the EU could affect the approval status of their medicines.“
Current EU law requires that marketing authorisation holders are established in the EU or the European Economic Area, while it is also mandated that certain activities - related for example to pharmacovigilance and batch release - also take place in Europe.
As such, companies may be required to adapt processes and to consider changes to the terms of the marketing authorisation in order to ensure continued validity post-Brexit, and to ensure that any necessary action is taken in a timely manner.
The regulators said: "Marketing authorisation holders will need to act sufficiently in advance to avoid any impact on the continuous supply of medicines for human and veterinary use within the European Union."
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