OpenLegislation

Division 3.2.2.8 Stability of the finished medicinal productF1

United Kingdom

Original text. Later amendments are not shown.

  1. a))

    The types of studies conducted, protocols used, and the results of the studies shall be summarised;

  2. 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;

  3. c))

    The post authorisation stability protocol and stability commitment shall be provided.

Annotations

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).