http://www.legislation.gov.uk/id/uksi/2004/1031/schedule/1

http://www.legislation.gov.uk/uksi/2004/1031/schedule/1/part/5/paragraph/12/2004-05-01

The Medicines for Human Use (Clinical Trials) Regulations 2004

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MEDICINES

Statute Law Database

2024-05-16

2004-05-01

These Regulations implement Directive 2001/20/EC on the approximation of laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (“the Directive”).

The Medicines for Human Use (Clinical Trials) Regulations 2004

Sch. 3 Pt. 2

para. 7

The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019

reg. 24(3)(c)(i)

reg. 1

The Medicines for Human Use (Clinical Trials) Regulations 2004

Sch. 3 Pt. 2

para. 7

The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019

reg. 24(3)(c)(ii)

reg. 1

The Medicines for Human Use (Clinical Trials) Regulations 2004

Sch. 3 Pt. 2

para. 8(1)

The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019

reg. 24(3)(d)(i)

reg. 1

The Medicines for Human Use (Clinical Trials) Regulations 2004

Sch. 3 Pt. 2

para. 8(2)

The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019

reg. 24(3)(d)(ii)(aa)

reg. 1

The Medicines for Human Use (Clinical Trials) Regulations 2004

Sch. 3 Pt. 2

para. 8(2)

The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019

reg. 24(3)(d)(ii)(bb)

reg. 1

The Medicines for Human Use (Clinical Trials) Regulations 2004

Sch. 3 Pt. 2

para. 8(2)

The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019

reg. 24(3)(d)(ii)(cc)

reg. 1

The Medicines for Human Use (Clinical Trials) Regulations 2004

Sch. 3 Pt. 2

para. 8(2)(a)

The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019

reg. 24(3)(d)(ii)(dd)

reg. 1

SCHEDULE 1CONDITIONS AND PRINCIPLES OF GOOD CLINICAL PRACTICE AND FOR THE PROTECTION OF CLINICAL TRIAL SUBJECTS

PART 5CONDITIONS AND PRINCIPLES WHICH APPLY IN RELATION TO AN INCAPACITATED ADULT

Principles12

Informed consent given by a legal representative to an incapacitated adult in a clinical trial shall represent that adult’s presumed will.