http://www.legislation.gov.uk/uksi/2012/1916/regulation/77/2012-08-14
The Human Medicines Regulations 2012
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text/xml
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Statute Law Database
MEDICINES
2024-07-10
Expert Participation
2012-08-14
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. 77
The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019
reg. 85
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
Obligations of holder of marketing authorisation
Record-keeping obligations77
The holder of a marketing authorisation must keep any documents or information that will facilitate the withdrawal or recall from sale or supply of any product to which the authorisation relates.