Paragraph 4 Fees

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

Sch. 2 para. 2(c)(ii) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 2 para. 2(a)(i) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 2 para. 2(a)(ii) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 2 para. 5A(a) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 2 para. 5A(b) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 2 para. 5A(c) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 2 para. 2(a)-(d) sums substituted by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2000 reg. 4(5) Sch.
Sch. 2 para. 5(1) sum substituted by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2000 reg. 4(5) Sch.
Sch.1, Pt.III, paras.11. 12, Sch.2 amended by Medicines (Products for Human Use—Fees) 1996 reg.3, Sch.
Sch 2, para 2 am by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2001 reg 5(14), Schedule
Sch 2, para 5 am by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2001 reg 5(14), Schedule
Sch.2, para.2(a)(ii)(iii) (iv)(b)(i)(ii)(iii)(iv) amended by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 1998 reg.5, Sch.
Sch.2, para.5(2)(c) amended by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 1998 reg.4(1)(b)
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 2, para 5 am by Medicines for Human Use (Fees Amendments) 2005 reg 16(1), (4)
Sch 2, para 1 defn(s) added by Medicines for Human Use and Medical Devices(Fees Amendments) 2003 reg 4(1), (7)(a)
Sch 2, para 2 am by Medicines for Human Use and Medical Devices(Fees Amendments) 2003 reg 4(1), (7)(b)
Sch 2, para 2 am by Medicines for Human Use and Medical Devices(Fees Amendments) 2003 reg 4(1), (9), Schedule
Sch 2, para 3 am by Medicines for Human Use and Medical Devices(Fees Amendments) 2003 reg 4(1), (7)(c)
Sch 2, para 4 am by Medicines for Human Use and Medical Devices(Fees Amendments) 2003 reg 4(1), (7)(d)
Sch 2, para 5 am by Medicines for Human Use and Medical Devices(Fees Amendments) 2003 reg 4(1), (7)(e)
Sch 2, para 5 am by Medicines for Human Use and Medical Devices(Fees Amendments) 2003 reg 4(1), (9), Schedule
Sch 2, para 5A added by Medicines for Human Use and Medical Devices(Fees Amendments) 2003 reg 4(1), (7)(f)
Sch. 2 para. 7 8 inserted by Medicines for Human Use (Clinical Trials Fees Amendments) 2004 reg. 10
Sch. 2 para. 1(1) words inserted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 13(2)(a)
Sch. 2 para. 1(1) words substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 13(2)(b)
Sch. 2 para. 4A inserted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 13(3)
Sch. 2 para. 2(a)(iii) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 2 para. 2(a)(iv) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 2 para. 2(b)(i) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 2 para. 2(b)(ii) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 2 para. 2(b)(iii) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 2 para. 2(b)(iv) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 2 para. 2(c)(i) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 2 para. 2(c)(ii) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 2 para. 2(c)(iii) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 2 para. 2(c)(iv) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 2 para. 2(cc)(i) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 2 para. 2(cc)(ii) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 2 para. 2(cc)(iii) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 2 para. 2(d) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 2 para. 5(1) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch. 2 para. 5(3) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 15 Sch.
Sch 2, para 2 am by Medicines for Human Use (Fees Amendments) 2005 reg 16(1), (2)
Sch 2, para 2A added by Medicines for Human Use (Fees Amendments) 2005 reg 16(1), (3)
Sch 2, paras 5B–5D added by Medicines for Human Use (Fees Amendments) 2005 reg 16(1), (5)
Sch. 2 para. 1(1) words omitted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 8(a)
Sch. 2 para. 2(f) omitted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 8(b)
Sch. 2 para. 5(1) words omitted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 8(c)(i)
Sch. 2 para. 5(3) omitted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 8(c)(ii)
Sch. 2 para. 2(a)(i) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 2 para. 2(a)(ii) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 2 para. 2(a)(iii) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 2 para. 2(a)(iv) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 2 para. 2(b)(i) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 2 para. 2(b)(ii) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 2 para. 2(b)(iii) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 2 para. 2(b)(iv) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 2 para. 2(c)(i) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 2 para. 2(c)(iii) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 2 para. 2(c)(iv) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 2 para. 2(cc)(i) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 2 para. 2(cc)(ii) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 2 para. 2(cc)(iii) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 2 para. 2(d) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 2 para. 2A(a) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 2 para. 2A(b) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 2 para. 2A(c) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 2 para. 2A(d) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 2 para. 4A(1)(a) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 2 para. 4A(1)(b) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 2 para. 4A(1)(c) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 2 para. 4A(2)(a) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 2 para. 4A(2)(b) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 2 para. 4A(2)(c) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 2 para. 5(1) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 2 para. 5A(a) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 2 para. 5A(b) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 2 para. 5A(c) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 2 para. 5B(1)(a) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 2 para. 5B(1)(b) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 2 para. 5B(1)(c) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 2 para. 5C(1)(a) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 2 para. 5C(1)(b) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 2 para. 5C(1)(c) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 2 para. 5D(1)(a) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 2 para. 5D(1)(b) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 2 para. 5D(1)(c) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 2 para. 7(4)(a) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 2 para. 7(4)(b) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 2 para. 7(4)(c) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 2 para. 7(4)(d) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 2 para. 7(4) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch. Table
Sch. 2 para. 1(1) words omitted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 8(a)
Sch. 2 para. 2(f) omitted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 8(b)
Sch. 2 para. 5(1) words omitted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 8(c)(i)
Sch. 2 para. 5(3) omitted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 8(c)(ii)
Sch. 2 para. 2(a)(i) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 2 para. 2(a)(ii) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 2 para. 2(a)(iii) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 2 para. 2(a)(iv) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 2 para. 2(b)(i) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 2 para. 2(b)(ii) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 2 para. 2(b)(iii) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 2 para. 2(b)(iv) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 2 para. 2(c)(i) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 2 para. 2(c)(ii) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 2 para. 2(c)(iii) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 2 para. 2(c)(iv) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 2 para. 2(cc)(i) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 2 para. 2(cc)(ii) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 2 para. 2(cc)(iii) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 2 para. 2(d) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 2 para. 2A(a) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 2 para. 2A(b) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 2 para. 2A(c) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 2 para. 2A(d) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 2 para. 4A(1)(a) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 2 para. 4A(1)(b) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 2 para. 4A(1)(c) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 2 para. 4A(2)(a) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 2 para. 4A(2)(b) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 2 para. 4A(2)(c) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 2 para. 5(1) words substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 2 para. 5A(a) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 2 para. 5A(b) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 2 para. 5A(c) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 2 para. 5B(1)(a) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 2 para. 5B(1)(b) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 2 para. 5B(1)(c) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 2 para. 5C(1)(a) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 2 para. 5C(1)(b) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 2 para. 5C(1)(c) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 2 para. 5D(1)(a) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 2 para. 5D(1)(b) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 2 para. 5D(1)(c) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 2 para. 7(4)(a) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 2 para. 7(4)(b) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 2 para. 7(4)(c) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 2 para. 7(4)(d) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch. 2 para. 7(4) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 11 Sch.
Sch 2, para 2 am by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2002 reg 5(1), (9), Schedule
Sch 2, para 5 am by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2002 reg 5(1), (9), Schedule

(1)

Subject to sub-paragraph (2), unless the applicant or, as the case may be, the holder of the marketing authorization or licence establishes that an inspection is a minor inspection, standard inspection or major inspection, the fee payable shall be the appropriate fee specified in paragraph 2 for a supersite inspection.

(2)

If, following an inspection, it becomes apparent that the inspection fell into a different category from that established by the applicant or the holder of the marketing authorization or licence, the fee payable in respect of that inspection shall be the fee payable in respect of an inspection falling within the category into which the inspection should have fallen.