http://www.legislation.gov.uk/uksi/2012/1916/schedule/8/paragraph/17
The Human Medicines Regulations 2012
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text/xml
en
Statute Law Database
MEDICINES
2024-05-20
Expert Participation
2024-03-31
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. 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
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. 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
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. 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
The Human Medicines Regulations 2012
reg. 217BA
The Human Medicines (Amendment Relating to Original Pack Dispensing) Regulations (Northern Ireland) 2024
reg. 2(2)
reg. 1(2)
The Human Medicines Regulations 2012
reg. 217CA
The Human Medicines (Amendment Relating to Original Pack Dispensing) Regulations (Northern Ireland) 2024
reg. 2(3)
reg. 1(2)
SCHEDULES
SCHEDULE 8Material to accompany an application for a UK marketing authorisation
PART 1General requirements
17
A document showing that the manufacturer of the medicinal product is authorised to produce medicinal products in the manufacturer's own country.