Paragraph 1

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

Sch 3, Pt I, para 1 defn(s) am by Medicines for Human Use (Fees and Miscellaneous Amendments) 2003 reg 12
Sch. 3 Pt. 1 para. 1 words inserted by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2000 reg. 4(3)(b)
Sch. 3 Pt. 3 para. 4(2A) inserted by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2000 reg. 4(4)(a)
Sch. 3 Pt. 3 para. 4(4)(a) words substituted by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2000 reg. 4(4)(b)
Sch. 3 Pt. 3 para. 4(5) words substituted by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2000 reg. 4(4)(c)
Sch. 3 Pt. 3 para. 4(6) substituted by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2000 reg. 4(4)(d)
Sch. 3 Pt. 3 para. 1 Table sums substituted by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2000 reg. 4(5) Sch.
Sch. 3 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. 3 Pt. 3 para. 7-8 sums substituted by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2000 reg. 4(5) Sch.
Sch.3, Pt.IV, para.2 revoked by Medicines (Products for Human Use—Fees) 1996 reg.6(4)
Sch 3, Pt III, para 1, Table am by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2001 reg 5(14), Schedule
Sch 3, Pt III, paras 2, 3 am by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2001 reg 5(14), Schedule
Sch 3, Pt III, paras 7, 8 am by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2001 reg 5(14), Schedule
Sch 3, Pt IV, para 1 am by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2001 reg 5(10)
sch 3 am by Medicines for Human Use (Fees Amendments) 2006 reg 4
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 3, Pt III, paras 1–3 am by Medicines for Human Use and Medical Devices(Fees Amendments) 2003 reg 4(1), (9), Schedule
Sch 3, Pt III, paras 7, 8 am by Medicines for Human Use and Medical Devices(Fees Amendments) 2003 reg 4(1), (9), Schedule
Sch. 3 Pt. 3 words inserted by Medicines for Human Use (Clinical Trials Fees Amendments) 2004 reg. 11(a)
Sch 3, Pt I, para 1 defn(s) rev in pt by Medicines for Human Use (Fees Amendments) 2005 reg 17(1), (2)
Sch 3, Pt III, para 7 subst by Medicines for Human Use (Fees Amendments) 2005 reg 17(1), (3)(a)
Sch 3, Pt III, para 11 added by Medicines for Human Use (Fees Amendments) 2005 reg 17(1), (3)(b)
Sch. 3 Pt. 1 para. 1 words substituted by Medicines (Codification Amendments Etc.) 2002 reg. 16(i)
Sch. 3 Pt. 4 para. 1 words substituted by Medicines (Codification Amendments Etc.) 2002 reg. 16(j)
Sch 3, Pt III, para 1, Table am by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2002 reg 5(1), (9), Schedule
Sch 3, Pt III, paras 2, 3 am by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2002 reg 5(1), (9), Schedule
Sch 3, Pt III, paras 7, 8 am by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2002 reg 5(1), (9), Schedule

Marketing authorizations (parallel import) in respect of which separate marketing authorizations have been granted pursuant to the provisions of Council Directive 65/65/EEC^f1 in two or more member States of the European Community, which have no differences having therapeutic effect, from a medicinal product in respect of which a single marketing authorization has previously been granted in the United Kingdom.

Annotations

Footnotes

f1: OJ No. L22, 9.2.65, p. 369/65. The Directive was amended by Directives 75/319/EEC (OJ No. L147, 9.6.75, p.13); 83/570/EEC (OJ No. L332, 28.11.83, p. 1); 87/21/EEC (OJ No. L15, 17.1.87, p. 36); 89/341/EEC (OJ No. L142, 25.5.89, p.11); 89/343/EEC (OJ No. L142, 25.5.89, p. 16) and 93/39/EEC (OJ No. L214, 24.8.93, p. 22).