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Paragraph 7 Manufacturer’s licences

Original text. Later amendments are not shown.

(1)

The fee for an application for a manufacturer’s licence shall be—

(a)

in a case to which sub-paragraph (2) below applies, £95; or

(b)

in any other case £2,085; and

(c)

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

(2)

This paragraph applies in the case of an application for a manufacturer’s licence which is limited solely to the manufacturer or assembly of—

(a)

products the same or supply of which do not require a marketing authorisation or product licence and to which article 2(2)(i) of the Medicines (Exemption from Licences) (Special and Transitional Cases) Order 1971f1 applies; or

(b)

emergency vaccines.

Annotations

Footnotes

f1

S.I. 1971/1450; the relevant amending instrument is S.I. 1972/1200.