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 IMB on public safety grounds).
Renewal applications must be submitted to the IMB 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 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 PdF
Application for Renewal of Marketing Authorisation Word
For more information on preparing renewal applications, please consult the:
The relevant application forms and IMB guide are available from the Publications section of the IMB website.
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.