11.05.2022

Classification of Packaging Changes

Recommendation

17/18 October 2023
Heidelberg, Germany

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").

Classification of unforeseen packaging variations

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:

The material of the primer is not changed,
Stability studies have been started under ICH conditions in at least two pilot scale or industrial scale batches. These studies must be finalized and data will be provided immediately to the competent authorities if out of specifications (OOS) results or potentially OOS results occur.

For more information please see the CMDh Recommendation for classification of unforeseen variations according to Article 5 of Commission Regulation (EC) 1234/2008.