Withdrawal

Withdrawal of an authorisation or 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 IMB should be notified of the withdrawal.

This applies to the withdrawal by the holder of an authorisation for a medicinal product, a certificate of registration for a homeopathic medicinal product or a certificate of traditional-use registration for a herbal medicinal product.

Notification of the withdrawal of an authorisation or certificate should be made using the form Notification of Withdrawal of Authorisations or Certificates for Medicinal Products for Human Use

Further information may be found in the Guide to Withdrawal of Authorisations or Certificates for Medicinal Products for Human Use.

The Irish Medicines Board - www.imb.ie

Withdrawal