S.L. 458.36 ст. 3Manufacturing licence.

(1)(a) No medicinal product, biological active substance, or active substance to be used directly as an investigational medicinal product, may be manufactured in Malta unless there is, in respect of such product or substance, a manufacturing licence, hereinafter referred to as "licence", to that effect. This manufacturing licence shall also be required for the processes of sterilisation of active substances.

(b) This manufacturing licence shall be required notwithstanding that the medicinal products manufactured are intended for export.

(2) (a) A licence, which shall remain in force for a period to be determined by the Licensing Authority, hereinafter referred to as "the Authority", shall be required for both total and partial manufacture, and for the various processes of dividing up, packaging or presentation.

(b) A licence shall not be required for preparation, dividing up, changes in packaging or presentation where such processes are carried out solely for retail supply by pharmacists in pharmacies, or by persons legally authorised to carry out such processes.

(3) An importer’s licence, hereinafter also referred to as "licence", shall be required for the importation of medicinal products.

(4) A licence shall include a licence to distribute by wholesale the medicinal products in respect of which the licence has been issued.

(5) The Authority shall forward to the Agency a copy of the licence referred to in subregulation (1).

(6) The Authority shall enter the information relating to the licence referred to in sub-regulation (1) in the European Union database referred to in Article 111(6) of Directive 2001/83/EC as amended.