http://www.legislation.gov.uk/uksi/2004/1031/schedule/1/part/4/paragraph/10/2020-12-31
The Medicines for Human Use (Clinical Trials) Regulations 2004
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MEDICINES
Statute Law Database
2024-06-19
Expert Participation
2020-12-31
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 4CONDITIONS AND PRINCIPLES WHICH APPLY IN RELATION TO A MINOR
10
Some direct benefit for the group of patients involved in the clinical trial is to be obtained from that trial.