Specifications and control tests on the finished product

  • Email
  • Help

This guideline applies to human and veterinary medicines.

Current effective version

Adopted guideline

Reference number3AQ11A
Published01/12/1991
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.


Related content for human medicines



Related content for veterinary medicines


How helpful is this page?

Average rating:

 Based on 4 ratings

Add your rating:

See all ratings
0 ratings
0 ratings
0 ratings
0 ratings
4 ratings
    

Tell us more