S.L. 458.43 ст. 7Ethics Committee.

(1) The Licensing Authority shall set up an Ethics

Committee which shall give its opinion, before a clinical trial commences, on any issue requested.

(2) In preparing its opinion, the Ethics Committee shall consider, in particular -

(a) the relevance of the clinical trial and the trial design;

(b) whether the evaluation of the anticipated benefits and risks as required under regulation 4(1)(a) is satisfactory and whether the conclusions are justified;

(c) the protocol;

(d) the suitability of the investigator and supporting staff;

(e) the investigator’s brochure;

(f) the quality of the facilities;

(g) the adequacy and completeness of the written information to be given and the procedure to be followed for the purpose of obtaining informed consent and the justification for the research on persons incapable of giving informed consent as regards the specific restrictions laid down in regulation 4;

(h) provision for indemnity or compensation in the event of injury or death attributable to a clinical trial;

(i) any insurance or indemnity to cover the liability of the investigator and sponsor;

(j) the amounts and, where appropriate, the arrangements for justly rewarding investigators and compensating trial subjects and the relevant aspects of any agreement between the sponsor and the site;

(k) the arrangements for the recruitment of subjects.

(3) (a) The Ethics Committee shall within a maximum of sixty days from the date of receipt of a valid application give its reasoned opinion to the applicant and the Licensing Authority.

(b) Within the period of examination of the application for an opinion, the Ethics Committee may send a single request for information supplementary to that already supplied by the applicant. The period mentioned in paragraph (a) shall be suspended until receipt of the supplementary information.

(4) No extension to the sixty-day period referred to in subregulation (3) shall be permissible except in the case of trials involving medicinal products for gene therapy or somatic cell therapy or medicinal products containing genetically modified organisms. In this case, an extension of a maximum of thirty days shall be permitted. For these products, this ninety-day period may be extended by a further ninety days in the event of consultation of a group or committee. In the case of xenogenic cell therapy, there shall be no time limit to the authorisation period.