S.L. 458.43 Art. 14Manufacture and import of investigational medicinal products. S.L. 458.36 S.L. 458.36

(1) The holder of the authorisation referred to in regulation 13 shall have at his continuous and permanent disposal the services of at least one qualified person having the qualifications and experience defined under the Manufacture of Medicinal Products for Human Use Regulations, and he shall be responsible for carrying out the duties specified in subregulation (2).

(2) In addition to his duties defined under the Manufacture of

Medicinal Products for Human Use Regulations, the qualified person shall also, for the purposes of these regulations, be responsible for ensuring that:

(a) in the case of investigational medicinal products manufactured in Malta, each batch of medicinal products has been manufactured and checked in compliance with the principles and guidelines of good manufacturing practice laid down by the law in force, the product specification file and the information notified pursuant to regulation 9(2);

(b) in the case of investigational medicinal products manufactured in a third country, each production batch has been manufactured and checked in accordance with standards of good manufacturing practice at least equivalent to those laid down by the law in force, in accordance with the product specification file, and that each production batch has been checked in accordance with the information notified pursuant to regulation 9(2);

(c) in the case of an investigational medicinal product which is a comparator product from a third country, and which has a marketing authorisation, where the documentation certifying that each production batch has been manufactured in conditions at least equivalent to the standards of good manufacturing practice referred to above cannot be obtained, each production batch has undergone all relevant analyses, tests or checks necessary to confirm its quality in accordance with the information notified pursuant to regulation 9(2).

(3) Insofar as the provisions laid down in subregulation (2)(a), (b), or (c) are complied with, investigational medicinal products shall not have to undergo any further checks if they are imported into another Member State together with batch release certification signed by the qualified person.

(4) In all cases, the qualified person shall certify in a register or equivalent document that each production batch satisfies the provisions of this regulation. The said register or equivalent document shall be kept up to date as operations are carried out and shall remain at the disposal of the Licensing Authority for a period of five years.