Paragraph 4 Marketing authorisations and product 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

Where–

(a)

a major or a complex application is made by a person who is already the holder of an animal test certificate, in respect of a product containing the same active ingredient as the product in respect of which the marketing authorisation or product licence is applied for, or

(b)

a major or a complex application is made by a person who is already the holder of a product licence (covering export only), relating to the same product as the marketing authorisation or product licence applied for,

the fee shall be reduced by the amount of the fee paid in connection with the application for that certificate or licence.