Specifications and control tests on the finished product

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This guideline applies to human and veterinary medicines.

Current effective version

Adopted guideline

Reference number3AQ11A
Effective from01/06/1992
KeywordsSpecification, finished product, chemical, control, test, acceptance criteria, limit, release
DescriptionThis document aims to facilitate the application of Part 2, section E of the Annex to Directive 75/318/EEC, as amended. It provides guidance on the information to be included in the marketing authorisation application on specifications and control test on the finished product.

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