S.L. 417.3 ст. 5Conditions for granting a certificate.

A certificate shall be granted if on the date of the application:

(a) the product is protected by a patent;

(b) an authorisation to place the product on the market as a medicinal product has been granted and is in force;

(c) the said authorisation is the first authorisation to place the product on the market as a medicinal product; and

(d) the product has not already been granted a certificate.