S.L. 458.63 Art. 4Request for permission.

(1) The Central Procurement and Supplies Unit and, or an importer may, upon confirming that no medicinal product from alternative sources is available, present to the Licensing Authority an application in writing, requesting that the unauthorised medicinal product is permitted to be procured and placed on the market within the National Health Services.

(2) Each application shall be accompanied by the prescribed fee in the Schedule and shall include:

(a) the full name of the medicinal product, its active ingredients, strength, dosage form and country of origin;

(b) the full name, address and contact details of the supplier and the manufacturer;

(c) the detailed reasons for the request;

(d) information, documentation, or evidence proving that no offers were received for a registered medicinal product or a medicinal product which may be registered within the applicable time frame; and

(e) any other information, documentation, or evidence as may be requested by the Licensing Authority:

Provided that seventy-five percent (75%) of the prescribed fee shall be refunded if the application is rejected.