# Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products (Text with EEA relevance), Article 19

Extent: E+W+S+N.I.

The sponsor shall appoint individuals within its organisation who are responsible for archives.
Access to archives shall be restricted to the named individuals responsible for the archives.

---
Source: https://www.legislation.gov.uk/eudr/2005/28/article/19 (the official version)
Page: https://openlegislation.uk/eu-directive-2005-28/article-19
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.