Paragraph 4 Manufacturers' Licences

(1)

The fee payable under regulation 3(a) of these Regulations in connection with an application for a manufacturer’s licence shall be —

(a)

in a case to which sub-paragraph (2) below applies, £50;

(b)

in any other case, £1,000; and

(c)

in either case, if appropriate, a fee calculated in accordance with Schedule 2 to these Regulations in respect of any inspection made in connection with that application.

(2)

This sub-paragraph applies to the case of an application for a manufacturer’s licence which is limited solely to the manufacture or assembly of medicinal products, the sale or supply of which do not require a product licence and to which Article 2(2)(i)(e) of the Medicines (Exemption from Licences) (Special and Transitional Cases) Order 1971^f1 applies.

Annotations

Footnotes

f1: S.I. 1971/1450; there are no relevant amending instruments.