F1ANNEX IANALYTICAL, PHARMACOTOXICOLOGICAL AND CLINICAL STANDARDS AND PROTOCOLS IN RESPECT OF THE TESTING OF MEDICINAL PRODUCTS
Annotations:
Amendments (Textual)
PART ISTANDARDISED MARKETING AUTHORISATION DOSSIER REQUIREMENTS
3.MODULE 3: CHEMICAL, PHARMACEUTICAL AND BIOLOGICAL INFORMATION FOR MEDICINAL PRODUCTS CONTAINING CHEMICAL AND/OR BIOLOGICAL ACTIVE SUBSTANCES
3.2.Content: basic principles and requirements
3.2.2.Finished medicinal product
3.2.2.8.Stability of the finished medicinal product
- a)
The types of studies conducted, protocols used, and the results of the studies shall be summarised;
- b)
Detailed results of the stability studies, including information on the analytical procedures used to generate the data and validation of these procedures shall be presented in an appropriate format; in case of vaccines, information on cumulative stability shall be provided where appropriate;
- c)
The post authorisation stability protocol and stability commitment shall be provided.
Substituted by Commission directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use (Text with EEA relevance).