What does the term 'expiration date' mean in the authorisation decision?
Regular prolongation/renewal
A product is authorised for a limited period. This period expires on the final date referred to in the decision: the expiration date. After this date, the authorisation is no longer valid. Consequently, after the expiration date the product can no longer be sold, kept in inventory or used, unless the Ctgb has explicitly ruled otherwise.
If the authorisation holder wants to retain a valid authorisation following the expiration date, he or she must submit an application for renewal of the authorisation in at least 1.5 years (78 weeks) before the expiry date. In that case, the Ctgb will again assess whether the product can be authorised based on current criteria and requirements. If the Ctgb is unable to issue the extension before the expiration date, and this delay is not the fault of the applicant, the Ctgb can in principle suspend the expiration of the authorisation for a limited period in expectation of the completion of the assessment and a decision on the renewal.. In that case, the authorisation will remain valid for some time following the expiration date.