S.L. 458.63 Art. 3Permission. 2 [S.L.

(1) When the Central Procurement and Supplies Unit does not have access to any medicinal product, intended to be used in the National Health Service, which is registered or may be registered under the Act or any other legislation within the applicable time frame, and subsequent to a request made under the first proviso of article 20 of the Act, it may request permission to the Licensing Authority to procure and place an unauthorised medicinal product on the market within the National Health Services in accordance with these regulations.

(2) Permission to place an unauthorised medicinal product on the market within the National Health Services may also be requested by an importer.

(3) The Licensing Authority may grant permission to place such unauthorised medicinal product on the market within the National IN THE NATIONAL HEALTH SERVICES IN EXCEPTIONAL 458.63 CIRCUMSTANCES

Health Services after an evaluation is carried out by the said Licensing Authority, under exceptional circumstances of inherent public health need.