Article 18U.K.Safety and efficacy of medicinal products
1.Where the application for a compulsory licence concerns a medicinal product, the applicant may avail himself of:
(a)the scientific opinion procedure as provided for under Article 58 of Regulation (EC) No 726/2004, or
(b)any similar procedures under national law, such as scientific opinions or export certificates intended exclusively for markets outside the Community.
2.If a request for any of the above procedures concerns a product which is a generic of a reference medicinal product which is or has been authorised under Article 6 of Directive 2001/83/EC, the protection periods set out in Article 14(11) of Regulation (EC) No 726/2004 and in Articles 10(1) and 10(5) of Directive 2001/83/EC shall not apply.