The Human Medicines Regulations 2012

36.—(1) The Medicines Act 1971(1) shall have effect as follows.

(2) In section 1 (fees)—

(a) in subsection (1), the reference to any application in pursuance of the Medicines Act 1968 for a licence or certificate under Part II of that Act, or for the variation or renewal of such a licence or certificate, shall have effect as a reference to any application under Parts 3 to 8 of these Regulations for the grant, variation or renewal of—

(i) a manufacturer’s licence,

(ii) a wholesale dealer’s licence,

(iii) a marketing authorisation,

(iv) a certificate of registration,

(v) a traditional herbal registration, or

(vi) an Article 126a authorisation; and

(b) in subsection (2)(b), the reference to any licence or certificate under the Medicines Act 1968 shall have effect as a reference to a manufacturer’s licence, a wholesale dealer’s licence, a marketing authorisation, a certificate of registration, a traditional herbal registration, or an Article 126a authorisation under these Regulations.

(3) Paragraph (2) has effect in relation to references of the kind mentioned in that paragraph in regulations made under section 1.

(1)

1971 c.69.