The following must be in place in order to maintain a valid MA:
- MAH should be established in the EEA
- Qualified person (QP) for pharmacovigilance (PhV) should be established in the EEA
- PhV system master file (PSMF) should be located in the EEA
- Batch release site should be located in the EEA
- Batch control site should be located in the EEA
Transfer of MAH
Transfer of the Marketing Authorization Holder (MAH) from one company to another (other legal entity)
Brexit related switch of RMS
United Kingdom (UK) cannot be Reference Member State (RMS) for medicinal products approved in MRP/DCP after Brexit. MAHs of medicinal products with UK as the current RMS, are welcome to apply for Norway to act as the new RMS.
If a situation with a large amount of applications occurs, the Norwegian Medicines Agency (NoMA) will prioritise biologicals, antibiotics and veterinary medicines for fish.
The European medicinal collaboration are in agreement that the following criteria must be fulfilled:
- Norway is currently a Concerned Member State in the relevant procedure.
- All current regulatory procedures with UK as RMS (e.g. variations applications, renewals) must be completed before a switch of RMS can take place. The MAH may however approach NoMA in advance with an informal request, thus allowing an immediate switch of RMS when ongoing procedures are completed.
Requests for switch of RMS to NoMA should be addressed to MT@noma.no using the "Template for RMS change".
There are no fee charges for switching RMS to NoMA.
For more information on matters MAHs should be aware of in relation to Brexit, please refer to information published by CMDh and CMDv.
Change of batch control site
Marketing authorisation holders (MAH) may until the 12th of April 2019 request a time-limited exemption to continue batch control testing in the United Kingdom (UK) after UK's withdrawal from the European Union.
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:
Veterinary medicinal products:
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 case of MRP/DCP product or <national MA number> in 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.
Change of batch release site
Change of QP