Is it necessary to report terminated marketing in cases where the marketing authorisation has been revoked?

Yes, in cases of revocation of marketing authorisation upon request of the MA holder, as well as ex officio, the MA holder has to report terminated marketing of the medicinal product in compliance with Section 33, paragraph 2 of the Act on Pharmaceuticals. Where an ex-officio revocation of marketing authorisation of a medicinal product is concerned, it is possible to avail of the option of exceptional circumstances and to report on the terminated marketing upon the expiry of the timeline for filing appeals, or upon waiving the right to file an appeal from the decision concerned.
Furthermore, SÚKL hereby draws attention the obligation set forth by Section 34, paragraph 8 of the Act on Pharmaceuticals for a person who was a holder of marketing authorisation of a medicinal product. Once the revocation of marketing authorisation becomes final, or in case the marketing authorisation ceased to exist by the expiry of its effective period, such person is obliged to withdraw the medicinal product from the market without any delay.