S.L. 458.40 Art. 4Application for granting of a licence.

(1) Any application for the granting of a parallel import licence shall be made to the Licensing Authority and shall contain such information, documents and any other material in accordance with the provisions of this regulation.

(2) Such application as is mentioned in subregulation (1) shall indicate the following:

(a) name, address and contact person of the proposed parallel import licence holder;

(b) name and address of the applicant, if different from that of the licence holder;

(c) parallel import licence holder’s trading style on labels and leaflets;

(d) name, pharmaceutical form, any active ingredient, strength, pack size details, marketing authorisation holder, marketing authorisation number of the medicinal product for which a parallel import licence is being applied for;

(e) name, pharmaceutical form, strength, name and address of the marketing authorisation holder and marketing authorisation number of the Maltese-market product;

(f) copy of the wholesale dealer’s licence and, if the parallel imported product is to be repackaged, of the manufacturer’s licence; provided that if the holder of the manufacturer’s licence is responsible for both repackaging and distribution of the parallel imported product, then only a copy of the manufacturer’s licence shall be required; and

(g) basis on which the applicant makes a presumption of essential similarity between the local and imported product.

(3) The Authority shall process an application for a parallel import license within forty-five working days of validation of the application. Such period shall be suspended in those cases where the applicant is requested to furnish additional data.