http://www.legislation.gov.uk/uksi/2016/190/schedule/3/paragraph/10
The Medicines (Products for Human Use) (Fees) Regulations 2016
text
text/xml
en
Statute Law Database
MEDICINES
FEES AND CHARGES
2024-02-02
Expert Participation
2021-08-11
These Regulations revoke and re-enact, with some amendments, the Medicines (Products for Human Use) (Fees) Regulations 2013 (“the 2013 Regulations”). They make amendments to the Medical Devices (Consultation Requirements) (Fees) Regulations 1995 (“the 1995 Regulations”).
The Medicines (Products for Human Use) (Fees) Regulations 2016
reg. 19A(1)
The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023
reg. 13(a)
reg. 1(2)
The Medicines (Products for Human Use) (Fees) Regulations 2016
reg. 19A(2)(a)
The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023
reg. 13(b)
reg. 1(2)
The Medicines (Products for Human Use) (Fees) Regulations 2016
reg. 19A(2)(b)
The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023
reg. 13(c)
reg. 1(2)
The Medicines (Products for Human Use) (Fees) Regulations 2016
reg. 19B
The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023
reg. 14
reg. 1(2)
The Medicines (Products for Human Use) (Fees) Regulations 2016
reg. 19C(2)(a)
The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023
reg. 15(a)(i)
reg. 1(2)
The Medicines (Products for Human Use) (Fees) Regulations 2016
reg. 19C(2)(b)
The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023
reg. 15(a)(ii)
reg. 1(2)
The Medicines (Products for Human Use) (Fees) Regulations 2016
reg. 19C(2)(c)
The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023
reg. 15(a)(iii)
reg. 1(2)
The Medicines (Products for Human Use) (Fees) Regulations 2016
reg. 19C(3)(a)
The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023
reg. 15(b)(i)
reg. 1(2)
The Medicines (Products for Human Use) (Fees) Regulations 2016
reg. 19C(3)(b)
The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023
reg. 15(b)(ii)
reg. 1(2)
The Medicines (Products for Human Use) (Fees) Regulations 2016
reg. 19C(3)(c)
The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023
reg. 15(b)(iii)
reg. 1(2)
The Medicines (Products for Human Use) (Fees) Regulations 2016
reg. 19E(2)(a)
The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023
reg. 16(a)
reg. 1(2)
The Medicines (Products for Human Use) (Fees) Regulations 2016
reg. 19E(2)(b)
The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023
reg. 16(b)
reg. 1(2)
The Medicines (Products for Human Use) (Fees) Regulations 2016
reg. 19EA
The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023
reg. 17
reg. 1(2)
The Medicines (Products for Human Use) (Fees) Regulations 2016
Sch. 2
para. 27(2)(a)(i)
The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023
reg. 24(5)(a)(i)
reg. 1(2)
The Medicines (Products for Human Use) (Fees) Regulations 2016
Sch. 2
para. 27(2)(b)(i)
The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023
reg. 24(5)(a)(ii)
reg. 1(2)
The Medicines (Products for Human Use) (Fees) Regulations 2016
Sch. 2
para. 27(2)(c)(i)
The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023
reg. 24(5)(a)(iii)
reg. 1(2)
The Medicines (Products for Human Use) (Fees) Regulations 2016
Sch. 2
para. 27(2)(d)(i)
The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023
reg. 24(5)(a)(iv)
reg. 1(2)
The Medicines (Products for Human Use) (Fees) Regulations 2016
Sch. 2
para. 27(3)(a)(i)
The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023
reg. 24(5)(b)
reg. 1(2)
The Medicines (Products for Human Use) (Fees) Regulations 2016
Sch. 2
para. 28(2)(a)(i)
The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023
reg. 24(6)(a)(i)
reg. 1(2)
The Medicines (Products for Human Use) (Fees) Regulations 2016
Sch. 2
para. 28(2)(b)(i)
The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023
reg. 24(6)(a)(ii)
reg. 1(2)
The Medicines (Products for Human Use) (Fees) Regulations 2016
Sch. 2
para. 28(2)(c)(i)
The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023
reg. 24(6)(a)(ii)
reg. 1(2)
The Medicines (Products for Human Use) (Fees) Regulations 2016
Sch. 2
para. 28(3)(b)(i)
The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023
reg. 24(6)(b)
reg. 1(2)
The Medicines (Products for Human Use) (Fees) Regulations 2016
Sch. 2
para. 28(3)(c)(i)
The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023
reg. 24(6)(b)
reg. 1(2)
The Medicines (Products for Human Use) (Fees) Regulations 2016
Sch. 2
para. 28A(1)(a)-(c)
The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023
reg. 24(7)(a)
reg. 1(2)
The Medicines (Products for Human Use) (Fees) Regulations 2016
Sch. 2
para. 28A(2)(a)-(c)
The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023
reg. 24(7)(b)
reg. 1(2)
The Medicines (Products for Human Use) (Fees) Regulations 2016
Sch. 2
para. 35A
The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023
reg. 24(14)
reg. 1(2)
The Medicines (Products for Human Use) (Fees) Regulations 2016
Sch. 2
para. 56(c)
The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023
reg. 24(27)(b)
reg. 1(2)
The Medicines (Products for Human Use) (Fees) Regulations 2016
Sch. 2
para. 57A(a)
The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023
reg. 24(29)(a)
reg. 1(2)
The Medicines (Products for Human Use) (Fees) Regulations 2016
Sch. 2
para. 57A(b)
The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023
reg. 24(29)(b)
reg. 1(2)
The Medicines (Products for Human Use) (Fees) Regulations 2016
Sch. 2
para. 57A(c)
The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023
reg. 24(29)(c)
reg. 1(2)
The Medicines (Products for Human Use) (Fees) Regulations 2016
Sch. 2
para. 57A(d)
The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023
reg. 24(29)(d)
reg. 1(2)
The Medicines (Products for Human Use) (Fees) Regulations 2016
Sch. 2
para. 57B(4)
The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023
reg. 24(30)(a)(i)
reg. 1(2)
The Medicines (Products for Human Use) (Fees) Regulations 2016
Sch. 2
para. 57B(4)
The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023
reg. 24(30)(a)(ii)
reg. 1(2)
The Medicines (Products for Human Use) (Fees) Regulations 2016
Sch. 2
para. 57B(4)
The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023
reg. 24(30)(a)(iii)
reg. 1(2)
The Medicines (Products for Human Use) (Fees) Regulations 2016
Sch. 2
para. 57B(4)
The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023
reg. 24(30)(a)(iv)
reg. 1(2)
The Medicines (Products for Human Use) (Fees) Regulations 2016
Sch. 2
para. 57B(4)
The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023
reg. 24(30)(a)(v)
reg. 1(2)
The Medicines (Products for Human Use) (Fees) Regulations 2016
Sch. 2
para. 57B(4)
The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023
reg. 24(30)(a)(vii)
reg. 1(2)
The Medicines (Products for Human Use) (Fees) Regulations 2016
Sch. 2
para. 57B(4)
The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023
reg. 24(30)(a)(viii)
reg. 1(2)
The Medicines (Products for Human Use) (Fees) Regulations 2016
Sch. 2
para. 57B(4)
The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023
reg. 24(30)(a)(ix)
reg. 1(2)
The Medicines (Products for Human Use) (Fees) Regulations 2016
Sch. 2
para. 57B(4)
The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023
reg. 24(30)(b)(i)
reg. 1(2)
The Medicines (Products for Human Use) (Fees) Regulations 2016
Sch. 2
para. 57B(4)
The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023
reg. 24(30)(b)(ii)
reg. 1(2)
The Medicines (Products for Human Use) (Fees) Regulations 2016
Sch. 2
para. 57B(4)
The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023
reg. 24(30)(b)(iii)
reg. 1(2)
The Medicines (Products for Human Use) (Fees) Regulations 2016
Sch. 2
para. 57B(4)
The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023
reg. 24(30)(b)(iv)
reg. 1(2)
The Medicines (Products for Human Use) (Fees) Regulations 2016
Sch. 2
para. 57B(4)
The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023
reg. 24(30)(b)(v)
reg. 1(2)
The Medicines (Products for Human Use) (Fees) Regulations 2016
Sch. 3
para. 10(a)
The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023
reg. 25(8)(a)
reg. 1(2)
The Medicines (Products for Human Use) (Fees) Regulations 2016
Sch. 3
para. 10(b)
The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023
reg. 25(8)(b)
reg. 1(2)
The Medicines (Products for Human Use) (Fees) Regulations 2016
Sch. 4
para. 15(3)
The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023
reg. 26(8)
reg. 1(2)
SCHEDULES
SCHEDULE 3Fees for inspections
Office-based inspections10
The fee for an inspection comprising an office-based evaluation and risk assessment of documentation but not involving inspection of a site, in connection with the monitoring of—
a
good manufacturing practice, good clinical practice or good pharmacovigilance practice, is £1,863 per day;
b
good distribution practice, is £1,354 per day.