Nationally authorised medicinal products

We advise holders of marketing authorisations for purely nationally authorised medicines that even though they are nationally authorised medicines, it may be necessary to make changes as a result of Brexit before the cut-off date.

As with MRP/DCP authorised medicines, it is important to determine if it is necessary to change, for example, the marketing authorisation holder, batch control as well as the batch-release site, etc. because the UK will generally be considered a third country after the cut-off date.

For more information about this, please see the Q&As published by the coordination groups for human and veterinary medicinal products in the EU (CMDh/v).

We encourage everyone to implement any needed changes well before the cut-off date.

Changes and questions to nationally authorised products (NAPs) can be sent to Send an email

Links

CMDh Brexit information including Q&A

CMDv Brexit information including Q&A