http://www.legislation.gov.uk/id/uksi/2004/1031/schedule/7

http://www.legislation.gov.uk/uksi/2004/1031/schedule/7/part/3/paragraph/9/2012-08-14

The Medicines for Human Use (Clinical Trials) Regulations 2004

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MEDICINES

Statute Law Database

2024-06-19

Expert Participation

2012-08-14

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 7STANDARD PROVISIONS FOR MANUFACTURING AUTHORISATIONS

PART 3PROVISIONS WHICH MAY BE INCORPORATED IN AN AUTHORISATION RELATING TO THE IMPORTATION OF INVESTIGATIONAL MEDICINAL PRODUCTS

9

The holder of the authorisation shall at all times provide and maintain such staff, premises, equipment and facilities as will enable the qualified person who is at his disposal pursuant to regulation 43(1) to carry out the duties referred to in regulation 43(2).