Brexit significantly affects the marketing authorisations of medicines
Great Britain’s exit from the EU gives pharmaceutical companies a lot of work, and significantly affects a large number of the marketing authorisations for medicines sold in the Nordic countries.
Great Britain has held an important role in the tasks associated with the evaluation and supervision of medicines in the EU, and when Brexit is enforced on the 30th of March 2019, there will be significant changes to this role.
"After Brexit is enforced, it is unlikely that Great Britain will participate in activities related to the duties within the evaluation and supervision of medicines, such as functioning as a rapporteur or reference member state, or releasing medicine batches for sale. Thus, pharmaceutical companies need to transfer these tasks to another EU country", says Laura Riihimäki-Lampén, Regulatory Affairs Team Lead.
According to EU legislation, the marketing authorisation holders are also required to reside within the EU region. This will lead to numerous applications for transfers of marketing authorisation holders.
The experienced regulatory affairs experts at Oriola help pharmaceutical companies with activities in the Nordic countries to prepare for the changes brought by Brexit. We offer our expertise and energetic approach to handle all matters related to marketing authorisations, and can help you in any specific areas where you need support.
We would be happy to answer any of your questions!
Read more about our Regulatory Affairs Services here.