http://www.legislation.gov.uk/uksi/2012/1916/regulation/99/2018-02-06
The Human Medicines Regulations 2012
text
text/xml
en
Statute Law Database
MEDICINES
2024-07-10
Expert Participation
2018-02-06
These Regulations consolidate the law of the United Kingdom concerning medicinal products for human use (“products”) in respect of the topics described below.
The Human Medicines Regulations 2012
reg. 51(9)
The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019
Sch. 1
para. 5
reg. 1
The Human Medicines Regulations 2012
reg. 53(2)(a)
The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019
Sch. 1
para. 6(2)
reg. 1
The Human Medicines Regulations 2012
Sch. 33A
para. 57(2)
The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019
Sch. 1
para. 10(3)(a)
reg. 1
The Human Medicines Regulations 2012
Sch. 33A
para. 57(3)
The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019
Sch. 1
para. 10(3)(b)
reg. 1
The Human Medicines Regulations 2012
Sch. 33A
para. 57A
The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019
Sch. 1
para. 10(4)
reg. 1
The Human Medicines Regulations 2012
reg. 52(1)(a)(i)(ii) and words
The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019
reg. 57(2)
reg. 1
The Human Medicines Regulations 2012
reg. 53(2)-(2C)
The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019
reg. 58(3)
reg. 1
The Human Medicines Regulations 2012
Sch. 11
para. 1(1)(d)-(f)
The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019
reg. 63(2)(a)(ii)
reg. 1
The Human Medicines Regulations 2012
reg. 99(1)
The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019
reg. 96(2)
reg. 1
The Human Medicines Regulations 2012
reg. 99(2)
The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019
reg. 96(3)
reg. 1
The Human Medicines Regulations 2012
reg. 3(12)(d)
(ia)
The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024
reg. 4(a)
reg. 1(1)
The Human Medicines Regulations 2012
reg. 4(4)(d)
(ia)
The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024
reg. 5
reg. 1(1)
The Human Medicines Regulations 2012
reg. 43(7)(b)(ii)(bb)
The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024
reg. 18(b)
reg. 1(1)
The Human Medicines Regulations 2012
reg. 49(1ZA)-(1ZD)
The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024
reg. 26(a)
reg. 1(1)
The Human Medicines Regulations 2012
reg. 49(3ZA)
The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024
reg. 26(d)
reg. 1(1)
The Human Medicines Regulations 2012
reg. 55(1)(b)(iii)(bb)
The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024
reg. 43(a)(ii)
reg. 1(1)
The Human Medicines Regulations 2012
reg. 60A(10A)
The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024
reg. 49(e)
reg. 1(1)
The Human Medicines Regulations 2012
reg. 68(11H)-(A12)
The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024
reg. 56(b)
reg. 1(1)
The Human Medicines Regulations 2012
reg. 257(9)
The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024
reg. 110(c)
reg. 1(2)
reg. 1(1)
The Human Medicines Regulations 2012
reg. 257AA
257AB
The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024
reg. 111
reg. 1(2)
reg. 1(1)
The Human Medicines Regulations 2012
reg. 327(1)(c)
(va)
The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024
reg. 128(a)
reg. 1(1)
The Human Medicines Regulations 2012
reg. 346(2)(c)
(iia)
The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024
reg. 132(b)
reg. 1(1)
The Human Medicines Regulations 2012
reg. 346(2)(c)
(iiia)
The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024
reg. 132(b)
reg. 1(1)
The Human Medicines Regulations 2012
reg. 346(2)(c)
(iva)
The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024
reg. 132(b)
reg. 1(1)
The Human Medicines Regulations 2012
reg. 346(2)(c)
(xviia)
The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024
reg. 132(b)
reg. 1(1)
The Human Medicines Regulations 2012
reg. 346(2)(c)
(xxviiij)
The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024
reg. 132(b)
reg. 1(1)
The Human Medicines Regulations 2012
reg. 347B
The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024
reg. 133
reg. 1(1)
The Human Medicines Regulations 2012
Sch. 24
para. 18B
The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024
reg. 142(e)
reg. 1(1)
The Human Medicines Regulations 2012
Sch. 24 Pt. 1
para. 23
The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024
reg. 142(f)
reg. 1(1)
The Human Medicines Regulations 2012
Sch. 33B
The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024
reg. 146
reg. 1(1)
The Human Medicines Regulations 2012
reg. 173(e)
The Ionising Radiation (Medical Exposure) Regulations 2017
Sch. 4
para. 2(2)(b)
reg. 1
The Human Medicines Regulations 2012
reg. 240(2A)
The Ionising Radiation (Medical Exposure) Regulations 2017
Sch. 4
para. 2(3)(c)
reg. 1
The Human Medicines Regulations 2012
reg. 240(6A)
The Ionising Radiation (Medical Exposure) Regulations 2017
Sch. 4
para. 2(3)(g)
reg. 1
PART 5Marketing authorisations
General provisions relating to offences
Penalties99
1
A person guilty of an offence under this Part, other than a breach of regulation 79 (failure to provide information on marketing authorisations to EMA), is liable—
a
on summary conviction, to a fine not exceeding the statutory maximum; or
b
on conviction on indictment, to a fine, to imprisonment for a term not exceeding two years or to both.
2
A person guilty of a breach of regulation 79 is liable—
a
on summary conviction, to a fine not exceeding the statutory maximum; or
b
on conviction on indictment, to a fine.