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PART 5Marketing authorisations

Application of this Part

48.—(1) This Part applies to relevant medicinal products.

(2) In this Part—

“generic medicinal product” has the meaning given in Article 10(2)(b) of the 2001 Directive;

“relevant medicinal product” means a medicinal product that is not—

(a)

a registrable homoeopathic medicinal product; or

(b)

a traditional herbal medicinal product; and

“reference medicinal product” has the meaning given in Article 10(2)(a) of the 2001 Directive.