Plastic primary packaging materials

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This guidelines applies to human and veterinary medicines.

Current effective guideline

Adopted guideline

Reference number

CPMP/QWP/4359/03

EMEA/CVMP/205/04

Published19/05/2005
Effective from01/12/2005
KeywordsPlastic, immediate packaging, active substance, finished product
DescriptionThis document 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. Elastomeres and natural and synthetic rubber are not within the scope of this guideline.


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