Paragraph 3 Marketing authorizations

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

Sch. 3 Pt. 3 para. 7(b) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 3 Pt. 3 para. 8(1) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 3 Pt. 3 para. 8(2) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 3 Pt. 3 para. 10 word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 3 Pt. 3 para. 11 word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 3 Pt. 3 para. 7(a) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 3 Pt. 3 para. 7(b) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 3 Pt. 3 para. 8(1) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 3 Pt. 3 para. 8(2) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 3 Pt. 3 para. 10 word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 3 Pt. 3 para. 11 word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 3 Pt. 3 para. 1 Table sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch 3, Pt I, para 1 defn(s) am by Medicines for Human Use (Fees and Miscellaneous Amendments) 2003 reg 12
Sch. 3 Pt. 1 para. 1 words inserted by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2000 reg. 4(3)(b)
Sch. 3 Pt. 3 para. 4(2A) inserted by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2000 reg. 4(4)(a)
Sch. 3 Pt. 3 para. 4(4)(a) words substituted by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2000 reg. 4(4)(b)
Sch. 3 Pt. 3 para. 4(5) words substituted by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2000 reg. 4(4)(c)
Sch. 3 Pt. 3 para. 4(6) substituted by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2000 reg. 4(4)(d)
Sch. 3 Pt. 3 para. 1 Table sums substituted by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2000 reg. 4(5) Sch.
Sch. 3 Pt. 3 para. 2-3 sums substituted by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2000 reg. 4(5) Sch.
Sch. 3 Pt. 3 para. 7-8 sums substituted by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2000 reg. 4(5) Sch.
Sch.3, Pt.III, para.1 amended by Medicines (Products for Human Use—Fees) 1996 reg.3, Sch.
Sch.3, Pt.III, para.3 substituted by Medicines (Products for Human Use—Fees) 1996 reg.6(2)
Sch.3, Pt.III, para.4(1) (2) revoked by Medicines (Products for Human Use—Fees) 1996 reg.6(3)
Sch 3, Pt III, para 1, Table am by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2001 reg 5(14), Schedule
Sch 3, Pt III, paras 2, 3 am by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2001 reg 5(14), Schedule
Sch 3, Pt III, paras 7, 8 am by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2001 reg 5(14), Schedule
Sch 3, Pt IV, para 1 am by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2001 reg 5(10)
Sch.3, Pt.III, para.1, Table rev. in pt. by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 1998 reg.4(6)
Sch.3, Pt.III, paras.1, Table, Column 2, Entry 1-2(e),2(a)(b)(c),3(a) (b),7,8(1)(2) amended by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 1998 reg.5, Sch.
Sch.3, Pt.III, para.8(2) (a) amended by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 1998 reg.4(1)(d)
sch 3 am by Medicines for Human Use (Fees Amendments) 2006 reg 4
Sch.2, paras.2.5, Sch.3, Pt.III, paras. 1, Table, 2,3,7,8 amended by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 1999 reg.4(2), Sch.
Sch 3, Pt III, paras 1–3 am by Medicines for Human Use and Medical Devices(Fees Amendments) 2003 reg 4(1), (9), Schedule
Sch 3, Pt III, paras 7, 8 am by Medicines for Human Use and Medical Devices(Fees Amendments) 2003 reg 4(1), (9), Schedule
Sch. 3 Pt. 3 words inserted by Medicines for Human Use (Clinical Trials Fees Amendments) 2004 reg. 11(a)
Sch. 3 Pt. 3 para. 10 inserted by Medicines for Human Use (Clinical Trials Fees Amendments) 2004 reg. 11(b)
Sch. 3 Pt. 3 para. 2(a) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 3 Pt. 3 para. 2(b) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 3 Pt. 3 para. 2(c) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 3 Pt. 3 para. 3(a) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 3 Pt. 3 para. 3(b) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 3 Pt. 3 para. 7 sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 3 Pt. 3 para. 8(1) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 3 Pt. 3 para. 8(2) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch 3, Pt I, para 1 defn(s) rev in pt by Medicines for Human Use (Fees Amendments) 2005 reg 17(1), (2)
Sch 3, Pt III, para 7 subst by Medicines for Human Use (Fees Amendments) 2005 reg 17(1), (3)(a)
Sch 3, Pt III, para 11 added by Medicines for Human Use (Fees Amendments) 2005 reg 17(1), (3)(b)
Sch. 3 Pt. 3 para. 1 Table words inserted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 9(2)(a)
Sch. 3 Pt. 3 para. 1 Table words inserted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 9(2)(b)
Sch. 3 Pt. 3 para. 7(3) inserted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 9(3)
Sch. 3 Pt. 3 para. 8(1) words substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 9(4)
Sch. 3 Pt. 3 para. 9A 9B inserted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 9(5)
Sch. 3 Pt. 3 para. 1 Table words substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 3 Pt. 3 para. 2(a) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 3 Pt. 3 para. 2(b) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 3 Pt. 3 para. 2(c) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 3 Pt. 3 para. 3(a) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 3 Pt. 3 para. 3(b) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 3 Pt. 3 para. 1 Table words inserted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 9(2)(a)
Sch. 3 Pt. 3 para. 1 Table words inserted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 9(2)(b)
Sch. 3 Pt. 3 para. 7(3) inserted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 9(3)
Sch. 3 Pt. 3 para. 8(1) words substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 9(4)
Sch. 3 Pt. 3 para. 9A 9B inserted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 9(5)
Sch. 3 Pt. 3 para. 1 Table words substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 3 Pt. 3 para. 2(a) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 3 Pt. 3 para. 2(b) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 3 Pt. 3 para. 2(c) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 3 Pt. 3 para. 3(a) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 3 Pt. 3 para. 3(b) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 3 Pt. 3 para. 7(a) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 3 Pt. 1 para. 1 words substituted by Medicines (Codification Amendments Etc.) 2002 reg. 16(i)
Sch. 3 Pt. 4 para. 1 words substituted by Medicines (Codification Amendments Etc.) 2002 reg. 16(j)
Sch 3, Pt III, para 1, Table am by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2002 reg 5(1), (9), Schedule
Sch 3, Pt III, paras 2, 3 am by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2002 reg 5(1), (9), Schedule
Sch 3, Pt III, paras 7, 8 am by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2002 reg 5(1), (9), Schedule

Subject to paragraph 4, where a marketing authorization is held in respect of a derivative of a new active substance, the fee payable under regulation 14(3) shall be—

(a)

where it is of the same dosage form as, but of a different strength of active ingredient or different combination of active ingredients from, that relating to the new active substance, £3,575;

(b)

where it is of a different dosage form from that relating to the new active substance, £5,950.