Renewal applications
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 HPRA on drug safety grounds).
Renewal applications should be submitted to the HPRA at least nine 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 Application form for renewal of a marketing authorisation.
For more information on preparing renewal applications, please see the HPRA Guide to Renewal of Marketing Authorisations - Human Medicines and the CMDh Best Practice Guide on the processing of renewals in the Mutual Recognition and Decentralised Procedures.
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.
Shortened Renewal Procedure
Applicants are reminded that products authorised under Directive 2001/83/EC may follow a shortened renewal procedure i.e. a 30-day timetable under certain circumstances. Changes to MA particulars will not be accepted during the shortened renewal procedure. Please see relevant sections of the CMDh Best Practice Guide on the processing of renewals in the Mutual Recognition and Decentralised Procedures.
Transfer applications
A marketing authorisation or parallel import licence may be transferred from the existing authorisation/licence holder to another holder using a transfer procedure. A transfer may occur before a product is authorised or after authorisation, to a company related to the existing holder or to an unrelated company. The transfer procedure must be used where the legal entity of an authorisation/licence holder is changed as (P)PA [(Parallel)Product Authorisation] product authorisations are transferred to a new company number.
Using the administrative procedure described in the Guide to Transfers of Marketing Authorisations, Parallel Import Licences and Dual Pack Import Registrations for Human Medicines
Products can be transferred either before authorisation of once authorised. Link to applications forms below:
Transfer of Medicinal Product Application before authorisation - Application Form B
Transfer of an authorised medicinal product - Application Form A
Transfer applications are subject to the national procedure, even if the product has been authorised via the mutual recognition procedure.
Withdrawal applications
Withdrawal of an authorisation / certificate may occur during the period of validity of the authorisation or certificate or on renewal when the holder may decide not to renew it.
In each case, the HPRA should be notified of the intention to withdraw.
Notification of withdrawal of authorisations or certificates for human medicines should be made using this form.
Further information can be found in the Guide to Withdrawal of Authorisations or Certificates for Medicinal Products for Human Use.