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Paragraph 8 Manufacturer’s licences and authorisations

Original text. Later amendments are not shown.

(1)

The fee payable under regulation 12(1)(a) in connection with an application for a manufacturer’s licence or a manufacturing authorisation is—

(a)

£169, in a case to which sub-paragraph (2) applies;

(b)

£319, in the case of a change of ownership application; and

(c)

£2,911, in any other case.

(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 which are to be sold or supplied in circumstances to which article 2(2)(i)(e) (exemptions for certain special manufactured products) of the Medicines (Exemption from Licences) (Special and Transitional Cases) Order 1971 applies.