Paragraph 6 Manufacturers' licences

Changes not yet applied. Later legislation changes this provision in ways not yet written into the text below:

Sch.1, Pt II, para 1, Table, entry l(a)(b), 2-6 amended by Medicines (Products for Human Use—Fees) 1994 reg.2, Sch
Sch.1, Pt II, para 1, Table, entry l(a)(i) amended by Medicines (Products for Human Use—Fees) 1994 reg.7(3)(a)
Sch.1, Pt II, para 2 amended by Medicines (Products for Human Use—Fees) 1994 reg.2, Sch
Sch.1, Pt II, para 4(1) (defn of primary applicant) amended by Medicines (Products for Human Use—Fees) 1994 reg.7(3)(b)(i)
Sch.1, Pt II, para 4(2) amended by Medicines (Products for Human Use—Fees) 1994 reg.7(3)(b)(ii)
Sch.1, Pt II, para 4(3) added by Medicines (Products for Human Use—Fees) 1994 reg.7(3)(b)(iii)
Sch.1, Pt II, paras 6(1)(a)(b), 7(1) amended by Medicines (Products for Human Use—Fees) 1994 reg.2, Sch
Sch.1, Pt II, para 7(2) substituted by Medicines (Products for Human Use—Fees) 1994 reg.7(3)(c)
Sch.1, Pt II, para 8, Pt III, para 1(a) amended by Medicines (Products for Human Use—Fees) 1994 reg.2, Sch
Sch.1 substituted by Medicines (Products for Human Use– Fees) 1992 reg.8(2)(c)
Sch.1, Pt I. para l(n), head (defn of complex application) substituted by Medicines (Products for Human Use– Fees) 1992 reg.8(2)(a)
Sch.1, Pt l(n). head (v) added by Medicines (Products for Human Use– Fees) 1992 reg.8(2)(b)

(1)

The fee payable under regulation 4(a) in connection with an application for a manufacturer’s licence shall be—

(a)

in a case to which sub-paragraph (2) applies, £80;

(b)

in any other case, £1,400.

(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.