Marketing authorisations are valid for five years from the date of first issue. For the authorisation to remain valid, it should be renewed at the end of this five year period. Following this renewal, the authorisation remains valid for an indefinite period (unless further renewals are deemed necessary by the IMB on drug safety grounds). However, authorisation holders should note that under the ‘Sunset Clause’ of the Medicinal Products (Control of Placing on the Market) Regulations 2007, marketing authorisations will cease to be valid if the product is not placed on the market within three years from date of authorisation or three years from 23 July 2007 (whichever is the later date).
Renewal applications should be submitted to the IMB at least six months before the expiry of the authorisation, although earlier renewals are acceptable in order to facilitate a common renewal date for a range of products or for products within the Mutual Recognition procedure which may have been authorised at different times in different Member States (the common renewal date should be agreed with the Reference Member State).
Renewal applications should be accompanied by the EU Renewal Application form.
For more information on preparing renewal applications, please see the IMB Guide to Renewal of Marketing Authorisations - Human Medicines and the Mutual Recognition Facilitation Group (MRFG) Guideline on the Processing of Renewals in the Mutual Recognition and Decentralised Procedures
The above guides, as well as the application forms, are available on the publications page of the IMB website.
For products authorised by the European Commission (centralised procedure), renewal applications must be submitted to the European Medicines Agency (EMA). For more information, please consult the EMA website.
For more information please contact the Customer Service Unit of the IMB at:
Customer Service Unit
Irish Medicines Board
Kevin O'Malley House