Renewal applications

For a licence to remain valid, it must be renewed after five years.

When to apply for your renewal

Renewal applications should be submitted at least nine months before the five-year expiry date.

Earlier renewals are acceptable to facilitate a common renewal date within the Mutual Recognition procedure.

How to apply for your renewal

You can find information on how to submit your renewal application in our 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

Renewal applications should be accompanied by the application form for renewal of a marketing authorisation.

Further information

Following this renewal, the authorisation remains valid indefinitely (unless further renewals are required on drug safety grounds).

For centrally authorised products, renewal applications must be submitted to the European Medicines Agency website.

Transfer applications

A marketing authorisation or parallel import licence may be transferred to another licence holder using a transfer procedure.

When to apply for your transfer

The transfer procedure must be used where the legal entity of an authorisation/licence holder is changed. Product authorisations will be transferred to a new company number.

Products can be transferred:

• Before, or after authorisation.
• To a company related to the existing holder or to an unrelated company.

How to apply for your transfer

You can find information on how to submit your Transfer application in our AUT-G0019 Guide to Transfers of MAs PPAs and DPRs for Human Medicines v11 changes tracked.

Transfer applications should be accompanied by:

• Application form B for transfer before authorisation before authorisation or,
• Application form A for transfer of an authorised (parallel) or DPR product - Application Form A after authorisation.

Further information:

Transfer applications are subject to the national procedure, even if the product has been authorised via the mutual recognition procedure.

For centrally authorised products, transfer applications must be submitted to the European Medicines Agency website.

Withdrawal application

To withdraw an authorised or certificate, the HPRA should be notified of the intention of withdrawal though a withdrawal application.

How to apply for your withdrawal

You can find information on how to submit a withdrawal application in the HPRA Guide to withdrawal of authorisations or certificates for human medicines. Withdrawal applications should be accompanied by the Notification of withdrawal of authorisations or certificates for human medicines.

Further information:

For centrally authorised products, withdrawal applications must be submitted to the European Medicines Agency website..