S.L. 458.43 ст. 9Commencement of a clinical trial. Cap. 458.

(1) It shall be an offence for the sponsor to start a clinical trial in Malta unless the Ethics Committee has issued a favourable opinion and the Licensing Authority has not informed the sponsor of any grounds for non-acceptance. The procedures to reach these decisions can be run in parallel or not, depending on the sponsor.

(2) Before commencing any clinical trial in Malta, the sponsor shall submit a valid request for authorisation to conduct the clinical trial to the Licensing Authority.

(3) If the Licensing Authority notifies the sponsor of grounds for non-acceptance, the sponsor may, on one occasion only, amend the content of the request referred to in subregulation (2) in order to take due account of the grounds given. If the sponsor fails to amend the request accordingly, the request shall be considered rejected and the clinical trial may not commence.

(4) (a) Consideration of a valid request for authorisation by the Licensing Authority shall be carried out as rapidly as possible and may not exceed sixty days.

(b) No further extensions to the period referred to in paragraph (a) shall be permissible except in the case of trials involving the medicinal products listed in subregulation (6), for which 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 of the Ethics Committee. In the case of xenogenic cell therapy there shall be no time limit to the authorisation period.

(c) Within the period of examination of the application the Licensing Authority may request information supplementary to that already supplied by the applicant. The period laid down in paragraphs (a) and

(b) shall be suspended until receipt of the supplementary information.

(5) Without prejudice to subregulation (6), written authorisation may be required before the commencement of clinical trials for such trials on medicinal products which do not have a marketing authorisation within the meaning of the Medicines Act, and any regulations thereunder, and are referred to in Part A of the Annex to Regulation (EEC) No 2309/93, and other medicinal products with special characteristics, such as medicinal products the active ingredient or active ingredients of which is or are a biological product or biological products of human or animal origin, or contain biological components of human or animal origin, or the manufacturing of which requires such components.

(6) Written authorisation shall be required before commencing clinical trials involving medicinal products for gene therapy, somatic cell therapy including xenogenic cell therapy and all medicinal products containing genetically modified organisms. No gene therapy trials may be carried out which result in modifications to the subject’s germ line genetic identity.

(7) This authorisation shall be issued without prejudice to the application of Council Directives 90/219/EEC of the 23rd April, 1990 on the contained use of genetically modified micro-organisms and 2001/18/EEC of the 12th March, 2001 on the deliberate release into the environment of genetically modified organisms.