Paragraph 3 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)

Where any inspection at a site would be a supersite inspection and that site consists of two or more separate manufacturing operations on different parts of the site, an inspection may, pursuant to a request in writing from the applicant or, as the case may be, the marketing authorization or licence holder, relate to one or more manufacturing operations at that site.

(2)

An inspection referred to in sub-paragraph (1) shall be categorised in accordance with the number of relevant persons employed in each manufacturing operation which is inspected as if that operation constituted the entire site, and the fee payable for that inspection shall be the appropriate fee specified for that category in paragraph 2, or if more than one manufacturing operation is inspected, the aggregate of the appropriate fees shall be payable.