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The integrity of a primary packaging system (container closure system) is essential to prevent product loss by leakage or evaporation and at the same time protect the product from contamination. The task of a primary packaging system (container closure system) is essentially to prevent the product from being lost (e.g. leakage, evaporation, etc.) and to prevent the product from being contaminated from the outside.

With Commission Decision (EU) 2025/2371, the European Commission has formally declared that the first four EUDAMED modules meet the required functional specifications. Publication in the OJEU on 27 November 2025 activates the six-month transition period foreseen in Regulation (EU) 2024/1860.

From 1 December 2025, medicines intended solely for use by healthcare professionals no longer require a printed package leaflet. Instead, a QR code on the outer packaging must provide direct access to the professional information.

Appendix 1 of EMA’s Questions and Answers on nitrosamine impurities has been updated. This appendix contains acceptable intakes (AIs) established for N-nitrosamines.