Module 3 Presentations

07/05/2024

In this presentation we covered

What does “packaging” mean? / Definitions What are requirements for pharmaceutical packaging? Proof of Quality Proof of Suitability

Specifications and other documentation Specifics on Drug-Device combinations

The Organisation for Professionals in Regulatory Affairs

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Recommended references

Reference

Comment

Guidance for Industry "Container Closure Systems for Packaging Human Drugs and Biologics”

[US] Guidance is intended to provide guidance on general principles for submitting information on packaging materials used for human drugs and biologics.

Guideline on plastic immediate packaging (CPMP/QWP/4359/03)

[EU] Covers the specific requirements for plastic immediate packaging materials for active substances or medicinal products. It is not intended to outline general requirements also applicable to other types of packaging materials or to properties of the container closure system, e.g. performance. [EU] Guidance is provided on dossier requirements for drug-device combinations (DDCs) in the context of a regulatory submission (marketing authorisation application and post authorisation application). The types of DDCs within the scope of this guideline are medical devices that are integral to the medicinal product, co-packaged with the medicinal product or referenced in the medicinal product information and obtained separately. [EU] Regulation lays down provisions concerning the examination of variations to the terms of all marketing authorisations for medicinal products for human use and veterinary medicinal products granted in accordance with Regulation (EC) No 726/2004, Directive 2001/83/EC, Directive 2001/82/EC, and Council Directive 87/22/EEC. [EU] Notice on presentation and content of the dossier

Notice to Applicants - Volume 2B

Guideline on quality documentation for medicinal products when used with a medical device

Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices

[EU] Medical Device Regulation (MDR)

The Organisation for Professionals in Regulatory Affairs

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