Renewal application following the implementation of Regulation (EU) 2019/6
Under Article 5(2) of Regulation (EU) 2019/6 the validity of a marketing authorisation (MA) of a veterinary medicinal product (VMP) is unlimited. The requirement for a renewal procedure will become obsolete. A provision for a renewal under exceptional cases will be retained; however, it is expected that this will occur very infrequently.
Where the validity of a MA falls on or after the 28 July 2022 the HPRA will provide the marketing authorisation holder (MAH) with an updated document with unlimited validity of the MA.
The process will be performed by the HPRA.
There will be no documentation required to be submitted by the MAH.
The process involves the removal of the date of expiry of the validity of the MA from the licence, and replacing it with an unlimited MA.
The HPRA will provide the MAH with an updated document that reflects the change. No other change will be made to the MA.
To note: Renewals are handled nationally. The HPRA has no role as RMS in relation to pending renewals and EU procedures.
Please send related questions to email@example.com.
For applications for Renewal of Marketing Authorisation under exceptional cases please complete the following:
Application for Renewal of Marketing Authorisation
For more information on preparing renewal applications, please consult the:
For information regarding renewals following the implementation of Regulation (EU) 2019/6 for products authorised by the European Commission through the centralised procedure, please consult the EMA website.
A marketing authorisation for a veterinary medicine may be transferred from the existing marketing authorisation holder to another using a transfer procedure.
A transfer may occur before a product is authorised or following authorisation, to a company related to the marketing authorisation holder, to an unrelated company or to a company which does not already hold an MA.
Further information on the procedure may be found in the HPRA Guide to transfer of veterinary marketing authorisations and applications.
The following application forms are available for transfer before or after authorisation of a medicinal product: Application form A for transfer of a veterinary marketing authorisation
Application form B for transfer of a veterinary marketing authorisation application
Transfer applications are the subject of national procedures, even if the product has been authorised under the mutual recognition or decentralised procedures.
A marketing authorisation holder may decide to withdraw a marketing authorisation during the period of validity of the authorisation.
The HPRA must be notified of the withdrawal of a marketing authorisation. Notification of the withdrawal of an authorisation should be made using the form: Notification of withdrawal of authorisations or certificates for veterinary medicines.
Further information on the procedure can be found in the Guide to withdrawal of authorisations or certificates for veterinary medicines