Commission Directive 2005/28/ECShow full title

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 30U.K.

1.Member States shall lay down all necessary rules to ensure that confidentiality is respected by inspectors and other experts. With regard to personal data, the requirements of Directive 95/46/EC of the European Parliament and of the Council(1) shall be respected.

2.Inspection reports shall be made available by the Member States only to the recipients referred to in Article 15(2) of Directive 2001/20/EC, in accordance with national regulations of the Member States and subject to any arrangements concluded between the Community and third countries.