S.L. 458.40 Art. 5Granting of a licence.

(1) A parallel import licence shall only be granted for parallel imported products that fulfill the following criteria:

(a) Maltese-market product shall have a valid marketing authorisation in Malta when the application for a parallel import licence is received;

(b) parallel imported product shall be imported from a Member State or a country of the European Economic Area and it must have a valid marketing authorisation in that country;

(c) parallel imported product shall have the same pharmaceutical form and be identical to, or have no significant therapeutic difference from, the Maltese-market product.

(2) A parallel import licence shall cease to be valid if the marketing authorisation is withdrawn for reasons directly related to the protection of public health.