PART 3 U.K.[F1 Manufacture and distribution of medicinal products and active substances]

Textual Amendments

F1 Pt. 3 heading and Pt. 3 Ch. 1 inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 4

[F2 CHAPTER 2] U.K.Manufacturing and wholesale dealing

Textual Amendments

F2 Pt. 3 Ch. 2 heading inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 4

Grant etc of licences U.K.

Application for manufacturer's or wholesale dealer's licence U.K.

21.—(1) An application for a grant of a licence under this Part must—

(a) be made to the licensing authority;

(b) be made in the way and form specified in Schedule 3; and

(c) contain or be accompanied by the information, documents, samples and other material specified in that Schedule.

(2) An application must indicate the descriptions of medicinal products in respect of which the licence is required, either by specifying the descriptions of medicinal products in question or by way of an appropriate general classification.