Paragraph 2
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)
Where, at the specific written request of the licensing authority, an application is made for the variation of a marketing authorization so as to—
(a)
restrict any one or more of the indications, dosage or target population, or
(b)
add a contraindication or a warning or both of these,
as a consequence of new information having a bearing on the safe use of the product, the fee payable under regulation 7(1) shall be refunded or, if it has not yet been paid, shall be waived.