S.L. 458.37 Art. 3Distribution of medicinal products.

(1) (a) Only products in respect of which a marketing authorisation has been granted by the Licensing

Authority, hereinafter referred to as "the Authority", or the Agency shall be distributed or brokered in Malta.

(b) In the case of brokering, wholesale distribution and storage, medicinal products shall be covered by a marketing authorisation granted by the Agency or by the competent authority of a Member State:

Provided that in the case where medicinal products are stored but not distributed in Malta and in the case of wholesale distribution of medicinal products to third countries, only the licence laid down in regulation 4 shall be required.

(2) Any distributor, not being the marketing authorisation holder, who brings into Malta a product from another Member State, shall notify the marketing authorisation holder and the Authority of each product he intends to bring into Malta. In the case of products which have not been granted an authorisation pursuant to Regulation (EC) No 726/2004, the notification to the Authority shall be without prejudice to additional procedures provided for in the law at the time and to fees payable to the Authority for examining the notification:

Provided that where the distributor intends to place the product on the market in Malta, he shall notify the Authority of each batch he brings into Malta.

(3) In the case of medicinal products which have been granted an authorisation pursuant to Regulation (EC) No. 726/2004, the distributor shall submit the notification in accordance with sub-regulation (2) to the marketing authorisation holder and the Agency. A fee shall be payable to the Agency for checking that the conditions laid down in European Union legislation on medicinal products and in the marketing authorisations are observed.

(4) Persons brokering medicinal products established in Malta shall have a permanent address and contact details, so as to ensure accurate identification, location, communication and supervision of their activities by the Licensing Authority.