http://www.legislation.gov.uk/uksi/2012/1916/regulation/63/2019-02-09
The Human Medicines Regulations 2012
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text/xml
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Statute Law Database
MEDICINES
2024-07-10
Expert Participation
2019-02-09
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. 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
Consideration of application
Frequency of periodic safety update reports63
1
The licensing authority must, if paragraph (2) applies, include in a UK marketing authorisation a term that specifies the frequency, calculated from the date on which the authorisation is granted, with which the holder of the authorisation must submit periodic safety update reports in accordance with regulation 191(8) (obligation on holder to submit periodic safety update reports: general requirements).
2
This paragraph applies in the case of a medicinal product in relation to which regulation 191(8) applies by virtue of regulation 191(1).