17/18 October 2023
Prior to submission of a variation whose classification is not provided for in Commission Regulation (EC) 1234/2008, a Marketing Authorization Holder (MAH) or a competent authority of a Member State may request the CMDh (Co-ordination group for Mutual recognition and Decentralized procedures – human) or the EMA (for centralized procedures) to provide a recommendation on the classification of the proposed change ("Article 5 Recommendations").
Recommendations regarding packaging changes are listed for APIs (e.g. for deletion of one of the authorized bulk or final containers, change of a secondary packaging component of the drug substance) and for finished products (e.g. change in the name of a supplier of a packaging component). Details on testing frequency for packaging material are seen as a GMP issue; therefore all the detailed information on testing frequency for packaging material in the dossier (Module 3) should be deleted via a Type IB variation.
Recently, the CMDh added a recommendation for the classification of the proposed change “total thickness” for the blister foil of the primary packaging material for a solid dosage form (specification widened due to a difference in grammage of the primer material). According to the CMDh this change should be submitted as a type IA variation under B.II.e.2.z. However, the following conditions apply:
For more information please see the CMDh Recommendation for classification of unforeseen variations according to Article 5 of Commission Regulation (EC) 1234/2008.