http://www.legislation.gov.uk/id/uksi/2012/1916

http://www.legislation.gov.uk/uksi/2012/1916/regulation/40/made

The Human Medicines Regulations 2012

Medicines

Management information systems

Motor industry

King's Printer of Acts of Parliament

2016-09-14

MEDICINES

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

PART 3Manufacturing and wholesale dealing

Conditions for holding a manufacturer’s licence

Obligation to provide information relating to control methods40

1

This regulation applies in relation to any manufacturer’s licence.

2

The licensing authority may require the licence holder to provide the authority with proof of the control methods employed by the holder in relation to a medicinal product.