Paragraph 4 Marketing authorizations

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, para.1 (defn. of Type II Application) rev.in pt. by Medicines (Products for Human Use—Fees) 1996 reg.5(3)(a)
Sch.1, Pt.III, para.1 (defn. of Type II complex variation11) defn.of ( sub-para. (a) (b) amended by Medicines (Products for Human Use—Fees) 1996 reg.5(3)(b)(i) (ii)
Sch. 1, Pt.III, para.1 defn.of ( sub-para. (Ccl) substituted by Medicines (Products for Human Use—Fees) 1996 reg.5(3)(b) (iii)
Sch.1, Pt.III, para.6(a) (vi) added by Medicines (Products for Human Use—Fees) 1996 reg.5(4)
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, Pt.III, para.1 (defn. of Type II Application) amended by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 1998 reg.4(2)(a)
Sch.1, Pt.III, para.1 amended by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 1998 reg.4(2)(b)
Sch.1, Pt.III, para.1(b) substituted by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 1998 reg.4(2)(c)
Sch.1, Pt.III, para.2(a)-(c) amended by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 1998 reg.5, Sch.
Sch.1, Pt.III, paras.2(c), 3(c) amended by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 1998 reg.4(3)
Sch.1, Pt.III, paras.3(c), 6(b),11 amended by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 1998 reg.5, Sch.
Sch.1, Pt.III, para.14 amended by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 1998 reg.4(4)
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 IIIA added by Medicines for Human Use and Medical Devices(Fees Amendments) 2003 reg 4(1), (6)
Sch. 1 Pt. 3 para. 7 words inserted by Medicines for Human Use (Clinical Trials Fees Amendments) 2004 reg. 9(4)(a)(i)
Sch. 1 Pt. 3 para. 7 words inserted by Medicines for Human Use (Clinical Trials Fees Amendments) 2004 reg. 9(4)(a)(ii)
Sch. 1 Pt. 3 para. 8 words inserted by Medicines for Human Use (Clinical Trials Fees Amendments) 2004 reg. 9(4)(b)(i)
Sch. 1 Pt. 3 para. 8 words inserted by Medicines for Human Use (Clinical Trials Fees Amendments) 2004 reg. 9(4)(b)(ii)
Sch. 1 Pt. 3 para. 8 words substituted by Medicines for Human Use (Clinical Trials Fees Amendments) 2004 reg. 9(4)(b)(iii)
Sch. 1 Pt. 3 para. 11 substituted by Medicines for Human Use (Clinical Trials Fees Amendments) 2004 reg. 9(4)(c)
Sch. 1 Pt. 3 para. 12 omitted by Medicines for Human Use (Clinical Trials Fees Amendments) 2004 reg. 9(4)(d)
Sch. 1 Pt. 3 para. 2(a) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 1 Pt. 3 para. 2(aa) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 1 Pt. 3 para. 2(b) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 1 Pt. 3 para. 2(c) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 1 Pt. 3 para. 2(cc) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 1 Pt. 3 para. 2(d) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 1 Pt. 3 para. 3(a) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 1 Pt. 3 para. 3(aa) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 1 Pt. 3 para. 3(b) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 1 Pt. 3 para. 3(c) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 1 Pt. 3 para. 3(d) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 1 Pt. 3 para. 5A(1) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 1 Pt. 3 para. 6(a) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 1 Pt. 3 para. 6(b) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 1 Pt. 3 para. 6(c) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 1 Pt. 3 para. 7(a) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 1 Pt. 3 para. 7(b) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 1 Pt. 3 para. 8 sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 1 Pt. 3 para. 9 sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 1 Pt. 3 para. 10 sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 1 Pt. 3 para. 11 sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 1 Pt. 3 para. 15(a)(ii) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 1 Pt. 3 para. 15(a)(iii) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 1 Pt. 3 para. 15(b)(ii) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
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. 3 para. 2 substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 7(4)(a)
Sch. 1 Pt. 3 para. 3 omitted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 7(4)(b)
Sch 1 Pt. 3 para. 5A(1) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch 1 Pt. 3 para. 5B(a) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch 1 Pt. 3 para. 5B(b) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch 1 Pt. 3 para. 5B(c) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch 1 Pt. 3 para. 6(a) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch 1 Pt. 3 para. 6(b) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch 1 Pt. 3 para. 6(c) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch 1 Pt. 3 para. 11(1)(a) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch 1 Pt. 3 para. 11(1)(b) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch 1 Pt. 3 para. 11(1)(c) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch 1 Pt. 3 para. 11A(a) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch 1 Pt. 3 para. 11A(b) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch 1 Pt. 3 para. 11A(c) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch 1 Pt. 3 para. 11A(d) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch 1 Pt. 3 para. 15(a)(iii) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch 1 Pt. 3 para. 15(b)(ii) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 1 Pt. 3 para. 2 substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 7(4)(a)
Sch. 1 Pt. 3 para. 3 omitted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 7(4)(b)
Sch. 1 Pt. 3 para. 5A(1) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 1 Pt. 3 para. 5B(a) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 1 Pt. 3 para. 5B(b) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 1 Pt. 3 para. 5B(c) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 1 Pt. 3 para. 6(a) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 1 Pt. 3 para. 6(b) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 1 Pt. 3 para. 6(c) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 1 Pt. 3 para. 11(1)(a) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 1 Pt. 3 para. 11(1)(b) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 1 Pt. 3 para. 11(1)(c) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 1 Pt. 3 para. 11A(a) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 1 Pt. 3 para. 11A(b) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 1 Pt. 3 para. 11A(c) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 1 Pt. 3 para. 11A(d) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 1 Pt. 3 para. 15(a)(ii) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 1 Pt. 3 para. 15(a)(iii) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 1 Pt. 3 para. 15(b)(ii) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
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)

Subject to paragraph 5, where a marketing authorization has been granted in accordance with an application to which Section G of Part 4 of the Annex to Council Directive 75/318/EEC^f1 applies, the fee in connection with the first application for variation of that marketing authorization made within 5 years of the date of the grant of that marketing authorization, so as to authorise use of the medicinal product in a new therapeutic area, shall, in addition to the fee payable under regulation 7(1), be the difference between the fee paid in connection with that application and the fee which would have been payable had the application been a major application.

Annotations

Footnotes

f1: OJ No. L147, 9.6.75, p. 1. The Directive was amended by Directives 89/341/EEC (OJ No. L142, 25.5.89, p. 11), 91/507/EEC (OJ No. L270, 26.9.91, p. 32) and 93/39/EEC (OJ No. L214, 24.8.93, p. 22).