Marketing authorisation holders (MAHs) are reminded that it is their responsibility to make the necessary changes to their dossiers and to submit the necessary variations before 31 December 2020.
On 29 March 2017, the United Kingdom submitted the notification of its intention to withdraw from the European Union pursuant to Article 50 of the Treaty on European Union.
Following the ratification of the withdrawal agreement by the UK and the EU, the UK formally left the EU on 31 January 2020 and became a third country to the EU.
The transition period started on 1 February 2020 and will end on 31 December 2020.
As the law provides for certain activities relating to medicinal products to be carried out only in a Member State of the European Union, the FAMHP reminds MAHs that it is their responsibility to make the necessary changes to their marketing authorisation dossiers and to submit the necessary variations.
These measures must ensure continuity of the supply of medicinal products to the EU Member States.
As of 1 January 2021, the following activities may no longer be located in the UK and will have to be located in the EU:
- the marketing authorisation holder;
- the batch control site for the finished product;
- the batch release site for the finished product;
- the Qualified Person for Pharmacovigilance (QPPV) at European level;
- the Pharmacovigilance System Master File (PSMF).
According to information from the FAMHP, not all the MAHs concerned the necessary actions to comply with regulations. The FAMHP therefore asks the companies concerned to submit the necessary variations as soon as possible. As a reminder, the deadline for submitting variations to the FAMHP during the end-of-year period is 15 December 2020.