Transfers, withdrawals and renewals of marketing authorisations

Transfers

A marketing authorisation for a veterinary medicine may be transferred from one company to another using the transfer procedure. A transfer may occur either before the marketing authorisation is granted, or subsequently. Further information may be found in the HPRA Guide to transfer of veterinary marketing authorisations and applications.

The following application forms should be used, either before or after the authorisation is granted:

Withdrawals

An applicant may withdraw a marketing authorisation at any time and cease marketing the medicine in Ireland. In this case, the company must notify the HPRA using the Notification of withdrawal of authorisations or certificates for veterinary medicines form.

Renewals or re-examination

Marketing authorisations are normally valid indefinitely. However, where the safety or efficacy of the medicine cannot be demonstrated to normal standards (for example, the disease occurs extremely rarely) marketing authorisations can be granted for a limited period.  In these cases, an application for a re-examination of the benefit-risk must be made at least six months before the expiry of the authorisation. The re-examination is limited to reviewing whether the conditions continue to be fulfilled.