S.L. 458.47 Art. 21Duties of the Authority.

(1) The Authority shall:

(a) make publicly available in Malta the documents relating to the adoption of good clinical practice principles;

(b) establish the legal and administrative framework within which good clinical inspections operate, with definitions of the powers of inspectors for entry into clinical trial sites and access to data; and

(c) ensure that, on request and where appropriate, inspectors of the competent authority of other Member States also have access to the clinical trial sites and data.

(2) The Authority shall provide for sufficient resources and shall in particular appoint an adequate number of inspectors to ensure effective verification of compliance with good clinical practice.

(3) The Authority shall establish the relevant procedures for verification of good clinical practice compliance. The procedures shall include the modalities for examining both the study management procedures and the conditions under which clinical trials are planned, performed, monitored and recorded, as well as follow-up measures.

(4) The Authority 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; and

(c) arranging inspections in third countries.

(5) The Authority shall maintain records of national and, if applicable, international inspections including the good clinical practice compliance status, and of their follow-up.

(6) The Authority shall ensure that national inspection procedures are in compliance with the guidance documents published by the Commission.

(7) The Authority 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 shall be respected.

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