S.L. 458.47 Art. 20Inspection procedures.

(1) Good clinical practice inspections may take place on any of the following occasions:

(a) before, during or after the conduct of clinical trials; INVESTIGATIONAL MEDICINAL PRODUCTS (HUMAN USE)

(b) as part of the verification of applications for marketing authorisation; and

(c) as a follow-up to the granting of authorisation.

(2) In accordance with Article 15(1) and (2) of Directive 2001/ 20/EC, inspections may be requested and coordinated by the European Medicines Agency (hereinafter referred to as "the Agency") within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council, especially in connection with clinical trials relating to applications through the procedure established by Regulation 726/2004.

(3) Inspections shall be conducted in accordance with the inspection guidance documents developed to support the mutual recognition of inspection findings within the Community.

(4) Improvement and harmonisation of inspection guidance shall be achieved by the Authority, in collaboration with the Commission and the Agency, through joint inspections, agreed processes and procedures and sharing of experience and training.