Nationally authorised medicinal products

10 September 2018
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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 godkendelse@dkma.dk

Links

CMDh Brexit information including Q&A

CMDv Brexit information including Q&A

 

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