Directive 2001/83/EC of the European Parliament and of the CouncilShow full title

[F1 3.2.2.8. Stability of the finished medicinal product U.K.

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.]

Textual Amendments

F1 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).