CRED Getting the CMC Dossier Right 2024

28/08/2024

3.2.P.7 Container Closure System

• Description of all components of the packaging system.

• Specification, description of test methods, CoAs.

• Compliance with relevant Ph. Eur. monographs 03 Materials for containers and containers.

• For plastic components in contact with the drug product:

- Commission Regulation (EU) No 10/2011 on plastic materials and articles;

- CPMP/QWP/4359/03 Guideline on plastic immediate packaging materials.

• For child resistant packaging: ISO 8317 (vial with screwcap), EN 14375 (blister); US 16 CFR§1700.20.

Alejandro Montón Silva

The Organisation for Professionals in Regulatory Affairs

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3.2.P.7 Container Closure System

Medical device

● CE marking or data – medical device components should be shown to comply with the Essential Requirements as outlined in Annex I of the Medical Devices Directive (93/42/EEC) ● Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 (MDR). ● Article 117 of the MDR introduced a new requirement for medicines with an integral device . From 26 May 2021, the marketing authorisation application should include a CE certificate for the device or, if it is not CE marked but would need to be certified if marketed separately, the applicant must include an opinion from a notified body on the conformity of the device.

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EMA Q&A implementation MDR

Alejandro Montón Silva

The Organisation for Professionals in Regulatory Affairs

32