S.L. 458.43 Art. 16Verification of compliance of investigational medicinal products with good clinical and manufacturing practice.

(1)(a) To verify compliance with the provisions on good clinical and manufacturing practice, the Licensing

Authority shall appoint inspectors who shall on behalf of the Community carry out inspections and inspect the sites concerned by any clinical trial conducted, particularly the trial site or sites, the manufacturing site of the investigational medicinal product, any laboratory used for analyses in the clinical trial and, or the sponsor’s premises.

(b) The Licensing Authority shall inform the Agency of the inspections carried out and the results shall be recognised by all the other Member States.

(c) These inspections shall be coordinated by the Agency, within the framework of its powers as provided for in Regulation (EEC) No 2309/93. A Member State may request assistance from another Member State in this matter.

(2) After an inspection is performed an inspection report shall be drawn up. The report shall be made available to the sponsor while safeguarding confidential aspects. It may be made available to the other Member States, to the Ethics Committee and to the Agency, at their reasoned request.