Paragraph 1 Interpretation

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)

In this Schedule—

“major inspection” means an inspection at a site at which 60 or more, but fewer than 250, relevant persons are employed;
“minor inspection” means an inspection at a site at which fewer than 10 relevant persons are employed;
“relevant person” means any person directly or indirectly engaged in, or assisting in, the manufacture or assembly of medicinal products and includes any person connected with such production who is involved in management, quality control, site maintenance, packing, storage or distribution;
“standard inspection” means an inspection at a site at which 10 or more, but fewer than 60, relevant persons are employed;
“supersite inspection” means an inspection at a site at which 250 or more relevant persons are employed.

(2)

In calculating the number of relevant persons for the purposes of this Schedule, any person partly engaged in or assisting in the manufacture or assembly of medicinal products (whether as a part-time employee or by virtue of being only partly employed in such work) shall be included in the calculation but only as a fraction calculated by reference to the amount of time spent by that person engaged or assisting in the manufacture or assembly of medicinal products or, where such a calculation is inappropriate, by reference to the percentage of his job which relates to the manufacture or assembly of such products and, in either case, by comparison with the average working week of a relevant person engaged in full-time employment at the same site.

(3)

Any reference in sub-paragraphs (1) and (2) to the manufacture or assembly of medicinal products includes a reference to the preparation of substances which are used in the manufacture of an immunological product or a blood product.