Renewals, Transfers & Withdrawals

Renewal application

Marketing authorisations are valid for five years from the date of first issue. For the authorisation to remain valid, it must be renewed at the end of this five-year period. Following this renewal, the authorisation remains valid for an indefinite period (unless a further renewal is deemed necessary by the HPRA on grounds of public or animal safety).

Renewal applications must be submitted to the HPRA at least six months before the expiry of the authorisation. An earlier renewal application may be accepted to facilitate a common renewal date for:

  • A range of products; or
  • products which have been authorised following a mutual recognition procedure where the date of the marketing authorisation differs between the Member States (the common renewal date should be agreed with the Reference Member State);
  • products that have been harmonised, aligned or joint labelled with the UK;
  • products that are awaiting transfer to a new marketing authorisation holder.

 

For applications for Renewal of Marketing Authorisation please complete the following:

Application for Renewal of Marketing Authorisation Word

For more information on preparing renewal applications, please consult the:


For products authorised by the European Commission through the centralised procedure, renewal applications must be submitted to the European Medicines Agency (EMA). For more information please consult the EMA website.

Transfer

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.

Withdrawal

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.