Marketing Authorisation Variation for the Removal of a Pharmaceutical Form or Strength from Shared Texts Following the Cancellation of a Medicinal Product Registration

In accordance with the update of the document “Q/A-LIST FOR THE SUBMISSION OF VARIATIONS ACCORDING TO COMMISSION REGULATION (EC) No 1234/2008” published on the CMDh website – Question 3.10 – the State Institute for Drug Control (SÚKL) informs that, in cases where an MRP/DCP registration of a pharmaceutical form or strength of a medicinal product that shares common texts with other strengths or pharmaceutical forms is cancelled, an MRP Type IB variation classified as C.z must be submitted in order to remove that strength or pharmaceutical form from the shared texts.

In situations where the shared texts within MRP/DCP registrations of medicinal products exist only in the Czech language version or the pharmaceutical form or strength was cancelled only in the Czech republic, SÚKL recommends removing the strength or pharmaceutical form of the cancelled medicinal product registration within another concurrently ongoing text variation of Type IB or Type II, classification “C”. If no such variation is ongoing, it is necessary, following the cancellation of the MRP/DCP registration, to submit a national Type IB variation classified as C.z for the purpose of removing that strength or pharmaceutical form from the shared Czech texts.

In the case of cancellation of a national registration of a pharmaceutical form or strength of a medicinal product that shares common texts with other strengths or pharmaceutical forms, SÚKL recommends removing the strength or pharmaceutical form of the cancelled medicinal product registration within another concurrently ongoing text variation of Type IB or Type II, classification “C”. If no such variation is ongoing, it is necessary, following the cancellation of the national registration, to submit a Type IB variation classified as C.z for the purpose of removing that strength or pharmaceutical form from the shared texts.