Paragraph 8 Manufacturer’s 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 am by Medicines for Human Use (Fees and Miscellaneous Amendments) 2003 reg 10
Sch 1, Pt III, para 1 defn(s) added by Medicines for Human Use (Fees and Miscellaneous Amendments) 2003 reg 11(1), (2)(a)
Sch 1, Pt III, para 1 defn(s) subst by Medicines for Human Use (Fees and Miscellaneous Amendments) 2003 reg 11(1), (2)(b)
Sch 1, Pt III, para 1 defn(s) am by Medicines for Human Use (Fees and Miscellaneous Amendments) 2003 reg 11(1), (2)(c)
Sch 1, Pt III, para 2 am by Medicines for Human Use (Fees and Miscellaneous Amendments) 2003 reg 11(1), (3)
Sch 1, Pt III, para 3 am by Medicines for Human Use (Fees and Miscellaneous Amendments) 2003 reg 11(1), (4)
Sch 1, Pt III, paras 4, 5 am by Medicines for Human Use (Fees and Miscellaneous Amendments) 2003 reg 11(1), (5)
Sch 1, Pt III, para 14 am by Medicines for Human Use (Fees and Miscellaneous Amendments) 2003 reg 11(1), (6)
Sch 1, Pt II, para 1 am by Medicines for Human Use (Fees Amendments) 2005 reg 3(1), (2)
Sch 1, Pt II, para 7 rev in pt by Medicines for Human Use (Fees Amendments) 2005 reg 3(1), (3)
Sch 1, Pt IIIA, para 2 am by Medicines for Human Use (Fees Amendments) 2005 reg 4
Sch.1, Pt.llA added by Medicines (Products for Human Use—Fees) 2000 reg.5
Sch. 1 Pt. 2 para. 1 Table words substituted by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2000 reg. 4(2)
Sch. 1 Pt. 3 para. 4 5 words inserted by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2000 reg. 4(3)(a)
Sch. 1 Pt. 2 para. 1(1) Table sums substituted by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2000 reg. 4(5) Sch.
Sch. 1 Pt. 2 para. 5(1)(a)-(c) sums substituted by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2000 reg. 4(5) Sch.
Sch. 1 Pt. 2 para. 6(1)(2) sums substituted by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2000 reg. 4(5) Sch.
Sch. 1 Pt. 2 para. 6(4) sum substituted by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2000 reg. 4(5) Sch.
Sch. 1 Pt. 2 para. 7 sum substituted by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2000 reg. 4(5) Sch.
Sch. 1 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. 1 Pt. 3 para. 6-12 sums substituted by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2000 reg. 4(5) Sch.
Sch.1, Pt.II amended by Medicines (Products for Human Use—Fees) 1996 reg.3, Sch.
Sch.1, Pt.III, paras.11. 12, Sch.2 amended by Medicines (Products for Human Use—Fees) 1996 reg.3, Sch.
Sch 1, Pt I, para 1 defn(s) am by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2001 reg 5(5)
Sch 1, Pt II, para 1, Table am by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2001 reg 5(6), (14), Schedule
Sch 1, Pt II, paras 5–7 am by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2001 reg 5(14), Schedule
Sch 1, Pt IIA, para 2 am by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2001 reg 5(7)
Sch 1, Pt III, para 1 defn(s) am by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2001 reg 5(8)
Sch 1, Pt III, paras 2, 3 am by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2001 reg 5(14), Schedule
Sch 1, Pt III, paras 6–12 am by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2001 reg 5(9), (14), Schedule
Sch 1, Pt III, para 7 am by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2001 reg 5(14), Schedule
sch 1 am by Medicines for Human Use (Fees Amendments) 2006 reg 3
regs.6,10,11, Sch.1, Pt.II, paras.1, Table, 5,6, Pt.III, paras.2,3. 6-12 amended by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 1999 reg.4(2), Sch.
Sch.1, Pt.III, para.6 amended by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 1999 reg.4(1)
Sch 1, Pt II, para 1 am by Medicines for Human Use and Medical Devices(Fees Amendments) 2003 reg 4(1), (9), Schedule
Sch 1, Pt II, para 1A am by Medicines for Human Use and Medical Devices(Fees Amendments) 2003 reg 4(1), (9), Schedule
Sch 1, Pt II, paras 4–7 am by Medicines for Human Use and Medical Devices(Fees Amendments) 2003 reg 4(1), (9), Schedule
Sch 1, Pt IIA, para 2 am by Medicines for Human Use and Medical Devices(Fees Amendments) 2003 reg 4(1), (9), Schedule
Sch 1, Pt III, paras 2, 3 am by Medicines for Human Use and Medical Devices(Fees Amendments) 2003 reg 4(1), (9), Schedule
Sch 1, Pt III, para 5A am by Medicines for Human Use and Medical Devices(Fees Amendments) 2003 reg 4(1), (9), Schedule
Sch 1, Pt III, paras 6–12 am by Medicines for Human Use and Medical Devices(Fees Amendments) 2003 reg 4(1), (9), Schedule
Sch 1, Pt III, para 15 am by Medicines for Human Use and Medical Devices(Fees Amendments) 2003 reg 4(1), (9), Schedule
Sch 1, Pt IV, paras 1, 2 am by Medicines for Human Use and Medical Devices(Fees Amendments) 2003 reg 4(1), (9), Schedule
Sch 1, Pt I, para 1 defn(s) added by Medicines for Human Use (Fees Amendments) 2005 reg 12(a), (c), (e), (g), (i), (k)
Sch 1, Pt I, para 1 defn(s) am by Medicines for Human Use (Fees Amendments) 2005 reg 12(b), (f), (j)
Sch 1, Pt I, para 1 defn(s) rev by Medicines for Human Use (Fees Amendments) 2005 reg 12(d)
Sch 1, Pt I, para 1 defn(s) subst by Medicines for Human Use (Fees Amendments) 2005 reg 12(h)
Sch 1, Pt II, para 1, Table subst by Medicines for Human Use (Fees Amendments) 2005 reg 13(1), (2)
Sch 1, Pt II, para 3 defn(s) rev in pt by Medicines for Human Use (Fees Amendments) 2005 reg 13(1), (3)
Sch 1, Pt II, para 5 am by Medicines for Human Use (Fees Amendments) 2005 reg 13(1), (4)
Sch 1, Pt II, para 8 added by Medicines for Human Use (Fees Amendments) 2005 reg 13(1), (5)
Sch 1, Pt III, para 1 defn(s) added by Medicines for Human Use (Fees Amendments) 2005 reg 14(1), (2)
Sch 1, Pt III, para 7 rev in pt by Medicines for Human Use (Fees Amendments) 2005 reg 14(1), (3)(a)
Sch 1, Pt III, para 7 am by Medicines for Human Use (Fees Amendments) 2005 reg 14(1), (3)(b)
Sch 1, Pt III, para 11A added by Medicines for Human Use (Fees Amendments) 2005 reg 14(1), (4)
Sch 1, Pt III, para 13 am by Medicines for Human Use (Fees Amendments) 2005 reg 14(1), (5)
Sch 1, Pt IIIA, para 1 am by Medicines for Human Use (Fees Amendments) 2005 reg 15
schs 1 - 3 am by Medicines for Human Use and Medical Devices (Fees Amendments) 2006 reg 2, schedule
Sch. 1 Pt. 1 para. 1 words substituted by Medicines (Codification Amendments Etc.) 2002 reg. 16(e)(i)
Sch. 1 Pt. 1 para. 1 words substituted by Medicines (Codification Amendments Etc.) 2002 reg. 16(e)(ii)
Sch. 1 Pt. 2 para. 1(1) Table words substituted by Medicines (Codification Amendments Etc.) 2002 reg. 16(f)
Sch. 1 Pt. 2A para. 2 words substituted by Medicines (Codification Amendments Etc.) 2002 reg. 16(g)
Sch. 1 Pt. 3 para. 1 words substituted by Medicines (Codification Amendments Etc.) 2002 reg. 16(h)(i)
Sch. 1 Pt. 3 para. 4 words substituted by Medicines (Codification Amendments Etc.) 2002 reg. 16(h)(ii)
Sch. 1 Pt. 3 para. 5 words substituted by Medicines (Codification Amendments Etc.) 2002 reg. 16(h)(ii)
Sch 1, Pt I, para 1 defn(s) am by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2002 reg 5(1), (4)
Sch 1, Pt II, para 1, Table am by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2002 reg 5(1), (9), Schedule
Sch 1, Pt II, para 1 am by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2002 reg 5(1), (5)(a)
Sch 1, Pt II, para 1A added by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2002 reg 5(1), (5)(b)
Sch 1, Pt II, para 4 am by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2002 reg 5(1), (5)(c)
Sch 1, Pt II, para 5 am by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2002 reg 5(1), (9), Schedule
Sch 1, Pt II, para 6 am by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2002 reg 5(1), (9), Schedule
Sch 1, Pt II, para 7 am by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2002 reg 5(1), (9), Schedule
Sch 1, Pt IIA, para 2 am by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2002 reg 5(1), (9), Schedule
Sch 1, Pt III, para 1 defn(s) added by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2002 reg 5(1), (6)(a)(i)
Sch 1, Pt III, para 1 defn(s) am by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2002 reg 5(1), (6)(a)(ii)
Sch 1, Pt III, para 2 am by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2002 reg 5(1), (6)(b), (9), Schedule
Sch 1, Pt III, para 3 am by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2002 reg 5(1), (9), Schedule
Sch 1, Pt III, para 5A added by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2002 reg 5(1), (6)(c)
Sch 1, Pt III, para 6 am by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2002 reg 5(1), (6)(d), (9), Schedule
Sch 1, Pt III, paras 7–11 am by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2002 reg 5(1), (9), Schedule
Sch 1, Pt III, para 12 am by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2002 reg 5(1), (6)(e)
Sch 1, Pt III, para 12 am by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2002 reg 5(1), (9), Schedule
Sch 1, Pt III, para 15 added by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2002 reg 5(1), (6)(f)
Sch 1, Pt IV added by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2002 reg 5(1), (7)

The fee payable under regulation 7(1)(b) in connection with an application for variation of a manufacturer’s licence shall be £90 in respect of each variation applied for which constitutes a change to the licence not requiring an inspection or medical, scientific or pharmaceutical assessment.