Please see communication from the European Commission

Information on how to apply for exemption for nationally authorised medicinal products is available below. For medicinal products authorised through centralised procedure, please see EMAs website.

Human medicinal products:

• CMDhs Practical Guidance – see question 32
• Standard template to use for applying for exemption
• List of national contacts

Veterinary medicinal products:

• CMDvs Practical Guidance – see question 24
• Standard template to use for applying for exemption
• List of national contacts

Request for exemption must be submitted to the Reference Member State (RMS) (include CMSs on cc) for MRP/DCP and to National competent authorities for products authorised through national procedure. Submission should be made via e-mail or Eudralink no later than on the 12th of April 2019.

The subject field of the e-mail should be the following:
"Brexit batch control testing exemption <MRP/DCP number>" in the case of an MRP/DCP product, or with the <national MA number> in the case of products authorised via national procedure.

All requests for exemptions (human/veterinary) to be reviewed by the Norwegian Medicines Agency (NoMA), must be submitted to the following e-mail address: batchcontrolexemption@Noma.no.