Marketing authorisations (MAs) issued after 28th January 2022 in accordance with the regulation on veterinary medicinal products (VMP Regulation (EU) 2019/06), will have unlimited validity with the exceptions of MAs granted under the legal basis “limited markets” or “exceptional circumstances”. This is applicable even though the marketing authorisation application was submitted in accordance with Directive 2001/82/EC.
Existing marketing authorisations which are issued in accordance with Directive 2001/82/EC and which have 5 years validity, must be replaced by an amended MA letter with unlimited validity in order to comply with Regulation (EU) 2019/6.
For VMPs approved in central procedure, the Norwegian Medicines Agency refers to EMA's website:
Q&A: Renewals | European Medicines Agency (europa.eu)
For VMPs approved in national procedure/MRP/DCP and where the submission date for the renewal application falls before 28 January 2022, renewal should be applied for even though the validity period of the MA ends after 28 January 2022. These renewal applications will be handled in accordance with Directive 2001/82/EC. For more information, see the
CMDv web site about transitional arrangements.
MA holders for VMPs approved in national procedure/MRP/DCP where the submission date for the renewal application falls after 28 January 2022, will eventually automatically receive an amended MA letter of unlimited validity. This will be done when Regulation (EU) 2019/6 is implemented in Norwegian law. No action is required from these MA holders.