The Human Medicines Regulations 2012

Application for manufacturer's or wholesale dealer's licenceU.K.

This section has no associated Explanatory Memorandum

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.