Paragraph 6

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

Sch. 5 para. 1A(1A) inserted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 14
Sch 5, para 1A added by Medicines for Human Use (Fees and Miscellaneous Amendments) 2003 reg 13(1), (2)
Sch 5, para 2 am by Medicines for Human Use (Fees and Miscellaneous Amendments) 2003 reg 13(1), (3)
Sch 5, para 2C added by Medicines for Human Use (Fees Amendments) 2005 reg 5
Sch.5, para.3(1)(c) amended by Medicines (Products for Human Use—Fees) 1996 reg.7(1)
Sch.5, para.4A added by Medicines (Products for Human Use—Fees) 1996 reg.7(2)
Sch.5, para,6(3) revoked by Medicines (Products for Human Use—Fees) 1996 reg.7(3)
Sch.5, para.7 added by Medicines (Products for Human Use—Fees) 1996 reg.7(4)
Sch 5, para 2A added by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2001 reg 5(12)
Sch 5, para 6 am by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2001 reg 5(13)
Sch 5, para 2 am by Medicines for Human Use and Medical Devices(Fees Amendments) 2003 reg 4(1), (8)(a)
Sch 5, para 5A added by Medicines for Human Use and Medical Devices(Fees Amendments) 2003 reg 4(1), (8)(b)
Sch. 5 para. 3(1) words substituted by Medicines for Human Use (Clinical Trials Fees Amendments) 2004 reg. 13(2)(a)(i)
Sch. 5 para. 3(1) words substituted by Medicines for Human Use (Clinical Trials Fees Amendments) 2004 reg. 13(2)(a)(ii)
Sch. 5 para. 3(1) words substituted by Medicines for Human Use (Clinical Trials Fees Amendments) 2004 reg. 13(2)(a)(iii)
Sch. 5 para. 3(1)(a) words inserted by Medicines for Human Use (Clinical Trials Fees Amendments) 2004 reg. 13(2)(a)(iv)
Sch. 5 para. 3(3) words substituted by Medicines for Human Use (Clinical Trials Fees Amendments) 2004 reg. 13(2)(b)(i)
Sch. 5 para. 3(3) words substituted by Medicines for Human Use (Clinical Trials Fees Amendments) 2004 reg. 13(2)(b)(ii)
Sch. 5 para. 3(3) words inserted by Medicines for Human Use (Clinical Trials Fees Amendments) 2004 reg. 13(2)(b)(iii)
Sch. 5 para. 4 words inserted by Medicines for Human Use (Clinical Trials Fees Amendments) 2004 reg. 13(3)
Sch. 5 para. 4A words substituted by Medicines for Human Use (Clinical Trials Fees Amendments) 2004 reg. 13(4)
Sch. 5 para. 5(1) Sch. 5 para. 5(5) renumbered as Sch 5. para. 5(1) by Medicines for Human Use (Clinical Trials Fees Amendments) 2004 reg. 13(5)
Sch. 5 para. 5(1) words inserted by Medicines for Human Use (Clinical Trials Fees Amendments) 2004 reg. 13(5)(a)(i)
Sch. 5 para. 5(1) words inserted by Medicines for Human Use (Clinical Trials Fees Amendments) 2004 reg. 13(5)(a)(ii)
Sch. 5 para. 5(2) inserted by Medicines for Human Use (Clinical Trials Fees Amendments) 2004 reg. 13(5)(b)
Sch. 5 para. 8 inserted by Medicines for Human Use (Clinical Trials Fees Amendments) 2004 reg. 13(6)
Sch 5, para 2B rev in pt by Medicines for Human Use (Fees Amendments) 2005 reg 19(1), (2)
Sch 5, para 2D added by Medicines for Human Use (Fees Amendments) 2005 reg 19(1), (3)
Sch 5, para 3 am by Medicines for Human Use (Fees Amendments) 2005 reg 19(1), (4)(a), (b)(i)
Sch 5, para 3 rev in pt by Medicines for Human Use (Fees Amendments) 2005 reg 19(1), (4)(b)(ii)
Sch 5, para 4A am by Medicines for Human Use (Fees Amendments) 2005 reg 19(1), (5)
Sch. 5 para. 6 words substituted by Medicines (Codification Amendments Etc.) 2002 reg. 16(l)
Sch 5, para 2B added by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2002 reg 5(1), (8)

In relation to a marketing authorization (parallel import), the fee payable in respect of each such application shall be waived—

(a)

where the authorization relates to a medicinal product in respect of which a separate marketing authorization has been granted pursuant to the provisions of Council Directive 65/65/EEC in more than one member State, those marketing authorizations are indicated on the marketing authorization (parallel import) as having been validly granted in those member States and the holder of that authorization applies for the grant of a separate marketing authorization (parallel import) in respect of each marketing authorization which has been granted and so indicated; or

(b)

the holder of the authorization applies for a variation to the authorization solely relating to a change in the number of a marketing authorization referred to in sub-paragraph (a).

(3)

Where a marketing authorization is varied so as to include the provisions of another marketing authorization in the circumstances set out in paragraph 4(4) of Part III of Schedule 3, the fee payable in respect of that variation under regulation 7(1) shall be refunded or, if it has not yet been paid, shall be waived.