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

http://www.legislation.gov.uk/uksi/2004/1031/schedule/7/part/1/2010-08-19

The Medicines for Human Use (Clinical Trials) Regulations 2004

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MEDICINES

Statute Law Database

2024-06-19

Expert Participation

2010-08-19

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

The Medicines for Human Use (Clinical Trials) Regulations 2004

Sch. 7

Pt. 1

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

reg. 25

reg. 1

SCHEDULE 7STANDARD PROVISIONS FOR MANUFACTURING AUTHORISATIONS

PART 1INTERPRETATION

In this Schedule, “product specification” means—

a

in the case of an investigational medicinal product manufactured before a request for authorisation to conduct the clinical trial involving those products has been made in accordance with regulation 17 or any equivalent provisions in any EEA State other than the United Kingdom, the specification for that product provided by the person who is to act as the sponsor of the proposed clinical trial,

b

in the case of an investigational medicinal product manufactured for the purpose of export, the specification for that product provided by the person to whose order the products are manufactured, or

c

in any other case, the specification for an investigational medicinal product contained in the investigational medicinal product dossier for that product.