S.L. 458.47 Art. 7Manufacturing or import authorisation.

(1) Authorisation, as provided for in Article 13(1) of Directive 2001/20/EC, shall be required for both total and partial manufacture of investigational medicinal products, and for the various processes of dividing up, packaging or presentation:

Provided that by way of derogation from sub-regulation (1), the Licensing Authority shall allow investigational medicinal products to be imported from parts of the United Kingdom other than Northern Ireland without such an authorisation provided that all of the following conditions are fulfilled:

(a) the imported investigational medicinal products have undergone certification of batch release either in the Union, as provided for in paragraph 3, point (a) of Article 13 (1) of Directive 2001/20/EC, or in parts of the United Kingdom other than Northern Ireland in compliance with the requirements set out in paragraph INVESTIGATIONAL MEDICINAL PRODUCTS (HUMAN USE)

3, point (b) of the same Directive;

(b) the imported investigational medicinal products are only made available in Malta.

(2) Such authorisation shall be required even if the products manufactured are intended for export.

(3) Authorisation shall also be required for imports from non-EU Member States into Malta.

(4) Authorisation, as provided for in Article 13(1) of Directive 2001/20/EC, shall not be required for reconstitution prior to use or packaging, where those processes are carried out in hospitals, health centres or clinics, by pharmacists or other persons legally authorised in Malta to carry out such processes and if the investigational medicinal products are intended to be used exclusively in those institutions.