Commission Directive 2005/28/ECDangos y teitl llawn

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 27U.K.

Member States shall establish the relevant procedures for the following:

(a)

appointing experts for accompanying inspectors in case of need;

(b)

requesting inspections/assistance from other Member States, in line with Article 15(1) of Directive 2001/20/EC and for cooperating in inspections in another Member State;

(c)

arranging inspections in third countries.