Paragraph 6 Manufacturer’s licences

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

Sch 1, Pt I defn(s) rev in pt by Medicines (Products for Animal Use—Fees) 2001 reg 2(1), (5)
Sch 1, Pt II, Table A rev in pt by Medicines (Products for Animal Use—Fees) 2001 reg 2(1), (6)
Sch 1, Pt IV, Table E rev in pt by Medicines (Products for Animal Use—Fees) 2001 reg 2(1), (7)
Sch 1, Pt II, para 1 am by Medicines (Products for Animal Use—Fees) 2001 regs 2(1), 3, Schedule, Pt I
Sch 1, Pt II, paras 2, 3 am by Medicines (Products for Animal Use—Fees) 2001 regs 2(1), 3, Schedule, Pt I
Sch 1, Pt II, paras 6–9 am by Medicines (Products for Animal Use—Fees) 2001 regs 2(1), 3, Schedule, Pt I
Sch 1, Pt III, paras 4, 5 am by Medicines (Products for Animal Use—Fees) 2001 regs 2(1), 3, Schedule, Pt I
Sch 1, Pt IV, paras 1, 2 replaced (by paras 1, 2, 2A) by Medicines (Products for Animal Use—Fees) 2001 regs 2(2), 3, Schedule, Pt II
Sch 1, Pt IV, paras 3–7 am by Medicines (Products for Animal Use—Fees) 2001 regs 2(1), 3, Schedule, Pt I
Sch 1, Pt V, paras 1–3 am by Medicines (Products for Animal Use—Fees) 2001 regs 2(1), 3, Schedule, Pt I
regs.12 14, Sch.1, Pts.l-V, Sch.2 amended by Medicines (Products for Animal Use—Fees) 1999 reg.2, Sch.
regs 12,13.14. Sch 1. Pt.II, paras.1 -3,6-9, Pt.III. paras 4,5, Pt.IV, paras.1- 3,5-7, Pt.V, paras.1 -3. Sch.2. paras.2.3 amended by Medicines (Products for Animal Use—Fees) 2000 reg.2. Sch.
Sch 1, Pt I defn(s) added by Medicines (Products for Animal Use—Fees) 2003 regs 3(1), (2)(a), 4, Sch 2, para 2
Sch 1, Pt I defn(s) rev by Medicines (Products for Animal Use—Fees) 2003 regs 3(1), (2)(a), 4, Sch 2, para 6
Sch 1, Pt I defn(s) subst by Medicines (Products for Animal Use—Fees) 2003 regs 3(1), (2)(a), 4, Sch 2, para 8
Sch 1, Pt I defn(s) am by Medicines (Products for Animal Use—Fees) 2003 regs 3(1), (2)(a), 4, Sch 2, paras 1, 3–5, 7
Sch 1, Pt II am (heading am) by Medicines (Products for Animal Use—Fees) 2003 regs 3(1), (2)(b)(i), 4
Sch 1, Pt II, para 1, Table A am by Medicines (Products for Animal Use—Fees) 2003 regs 3(1), (7), 4, Sch 4
Sch 1, Pt II, paras 2, 3 am by Medicines (Products for Animal Use—Fees) 2003 regs 3(1), (2)(b)(ii), 4
Sch 1, Pt II, para 2, Table B am by Medicines (Products for Animal Use—Fees) 2003 regs 3(1), (7), 4, Sch 4
Sch 1, Pt II, para 3 am by Medicines (Products for Animal Use—Fees) 2003 regs 3(1), (7), 4, Sch 4
Sch 1, Pt II, paras 6, 7 am by Medicines (Products for Animal Use—Fees) 2003 regs 3(1), (7), 4, Sch 4
Sch 1, Pt II, para 8 am by Medicines (Products for Animal Use—Fees) 2003 regs 3(1), (2)(b)(iii), 4
Sch 1, Pt II, para 9 am by Medicines (Products for Animal Use—Fees) 2003 regs 3(1), (7), 4, Sch 4
Sch 1, Pt II, para 10 added by Medicines (Products for Animal Use—Fees) 2003 regs 3(1), (2)(b)(iv), 4
Sch 1, Pt III, para 4, Table C am by Medicines (Products for Animal Use—Fees) 2003 regs 3(1), (7), 4, Sch 4
Sch 1, Pt III, para 5, Table D am by Medicines (Products for Animal Use—Fees) 2003 regs 3(1), (7), 4, Sch 4
Sch 1, Pt IV, paras 1, 2 am by Medicines (Products for Animal Use—Fees) 2003 regs 3(1), (7), 4, Sch 4
Sch 1, Pt IV, para 3, Table F am by Medicines (Products for Animal Use—Fees) 2003 regs 3(1), (2)(c)(i), 4, Sch 3
Sch 1, Pt IV, para 4 subst by Medicines (Products for Animal Use—Fees) 2003 regs 3(1), (2)(c)(ii), 4
Sch 1, Pt IV, paras 5–7 am by Medicines (Products for Animal Use—Fees) 2003 regs 3(1), (7), 4, Sch 4
Sch 1, Pt V, paras 1–3 am by Medicines (Products for Animal Use—Fees) 2003 regs 3(1), (7), 4, Sch 4
Sch 1, Pt V, para 4 subst by Medicines (Products for Animal Use—Fees) 2003 regs 3(1), (2)(d), 4
Sch 1, Pt II, paras 1–3 am by Medicines (Products for Animal Use—Fees) 2002 regs 2(1), 3, Schedule
Sch 1, Pt II, paras 6–9 am by Medicines (Products for Animal Use—Fees) 2002 regs 2(1), 3, Schedule
Sch 1, Pt III, paras 4, 5 am by Medicines (Products for Animal Use—Fees) 2002 regs 2(1), 3, Schedule
Sch 1, Pt IV, paras 1–3 am by Medicines (Products for Animal Use—Fees) 2002 regs 2(1), 3, Schedule
Sch 1, Pt IV, paras 5–7 am by Medicines (Products for Animal Use—Fees) 2002 regs 2(1), 3, Schedule
Sch 1, Pt V, para 1–3 am by Medicines (Products for Animal Use—Fees) 2002 regs 2(1), 3, Schedule

(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 £2,040; 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 manufacture or assembly of–

(a)

products the sale 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 1971^f1 applies; or

(b)

emergency vaccines.

Annotations

Footnotes

f1: S.I. 1971/1450; the relevant amending instrument is S.I. 1972/1200.