Common guidelines from the Commission to prevent problems in the supply of medicines
On 25 February 2019, the Commission issued common guidelines to prevent problems in the supply of medicines as a result of Brexit. The guidelines provide the national authorities with an opportunity to take extraordinary measures to safeguard the uninterrupted treatment of patients.
Unless otherwise decided in the UK’s Withdrawal Agreement, pharmaceutical companies must ensure that the marketing authorisation holder of the medicine concerned, the person responsible for pharmacovigilance and the manufacturer responsible for batch release are based in the EU area. The batch control/testing of the final product must also take place within the EU territory.
However, according to the Commission guidelines, national authorities have the option of making an exemption to the transition rule as long as the transfer of the marketing authorisation holder and the manufacturer responsible batch release have been done and the transfer processes of batch control/testing site have been duly initiated. If no exemption has been granted and the analytics of the final product has not been transferred, a temporary marketing and distribution ban can be imposed on the product, in which case it can no longer be imported from the UK to the EU territory.
Fimea is considering taking extraordinary measures in line with the Commission guidelines with regard to critical products in particular. Marketing authorisation holders are required to file their applications with Fimea no later than 29 March 2019, and the transfer of the marketing authorisation holder and of the manufacturer responsible for contract analytics to the territory of the rest of the EU must be described in the application.
In other potential disruptions in supply, recourse may be taken to interchangeable products or other medicinal treatments.
- Esa Heinonen, Director, Assessment of Medicinal Products, tel. +358 295223310