The Danish Medicines Agency participates actively in the Brexit-related considerations and preparations that have been going on in the pharmaceutical area for quite some time. We still maintain a strong focus to ensure that the common European regulatory network in the pharmaceutical area and the pharmaceutical companies in the EU achieve a successful Brexit transition in order to ensure the continued supply of medicines for the benefit of patients. The Danish Medicines Agency is therefore ready to take its share of tasks when the UK leaves the EU, e.g. by taking over the leading role for medicinal products, which the UK has currently played.
The negotiations on the exact details of the agreement between the EU and the UK are still ongoing, and there are still uncertainties in a number of areas. A draft transition agreement exists between the EU and the UK which serves as a basis for the framework being negotiated, but a political agreement has yet to be concluded. Nonetheless, there is a need for mutual and ongoing information between the Danish Medicines Agency and the pharmaceutical companies for the best possible arrangements to be made in the transition period.
In this connection, the Danish Medicines Agency needs information from the companies about how they plan the transition so that we can target our resources and plan our work procedures in the best possible way. We require information even though the companies’ plans may not be final. So, the Danish Medicines Agency would very much like to receive further details from individual companies about their transitional plans.
It is necessary for the companies that they can easily engage in dialogue with us as an agency and obtain information about how the individual company will be affected by Brexit.
To make things easier, we have gathered information about the consequences of Brexit, and we will regularly update and expand the tabs on the left-hand side under “Brexit” as more and more elements fall into place in the pharmaceutical area.
The Danish Medicines Agency follows the central guidelines and interpretations that have currently been issued by the CMDh/v, the EU Commission, the EMA, etc. We do not know the answer to what will apply in the UK in the pharmaceutical area after Brexit, but we can refer to the website of the English medicines agencies: MHRA for human medicines and VMD for veterinary medicines.
We advise companies to consider very carefully and in good time which adjustments and changes they need to make for those of their medicinal products that are linked to the UK in order to deal with any needed changes before the UK leaves the EU and in order to minimise overstretching of our resources close to the cut-off date.
We encourage the companies to contact us as required to discuss possible considerations and questions in case our website does not seem to provide the answer.
You will find contact details under the individual menu items on the left-hand side, and you can also send an email to firstname.lastname@example.org.
EMA (European Medicines Agency)