http://www.legislation.gov.uk/id/uksi/2004/1031/schedule/9

http://www.legislation.gov.uk/uksi/2004/1031/schedule/9/paragraph/10/2008-05-01

The Medicines for Human Use (Clinical Trials) Regulations 2004

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MEDICINES

Statute Law Database

2024-06-19

Expert Participation

2008-05-01

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 9MODIFICATIONS OF THE ENFORCEMENT PROVISIONS OF THE ACT SUBJECT TO WHICH THOSE PROVISIONS ARE APPLIED FOR THE PURPOSES OF THESE REGULATIONS

10

In section 118(1)(b) (restrictions on disclosing of information obtained in pursuance of the Act), for “this Act” substitute “ the Clinical Trials Regulations or any provision of this Act applied by regulation 47 of those Regulations ”.