http://www.legislation.gov.uk/uksi/2012/1916/schedule/8/paragraph/18/2014-03-31
The Human Medicines Regulations 2012
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text/xml
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Statute Law Database
MEDICINES
2024-07-10
Expert Participation
2014-03-31
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. 8
para. 18(a)
The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024
reg. 137(a)(i)
reg. 1(1)
The Human Medicines Regulations 2012
Sch. 8
para. 18(b)
The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024
reg. 137(a)(ii)
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
SCHEDULES
SCHEDULE 8Material to accompany an application for a UK marketing authorisation
PART 1General requirements
18
Where an application for authorisation for the medicinal product to be placed on the market is under consideration in a member State or States—
a
a list of the member State or States concerned; and
b
in relation to each application, a copy of—
i
the summary of the product characteristics proposed by the applicant, and
ii
the package leaflet proposed by the applicant.