http://www.legislation.gov.uk/id/uksi/2004/1031/schedule/3

http://www.legislation.gov.uk/uksi/2004/1031/schedule/3/part/4/paragraph/1

The Medicines for Human Use (Clinical Trials) Regulations 2004

text

text/xml

MEDICINES

Statute Law Database

2024-05-16

Expert Participation

2023-11-06

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 3PARTICULARS AND DOCUMENTS THAT MUST ACCOMPANY AN APPLICATION FOR AN ETHICS COMMITTEE OPINION, A REQUEST FOR AUTHORISATION, A NOTICE OF AMENDMENT AND A NOTIFICATION OF THE CONCLUSION OF A TRIAL

PART 4NOTIFICATION OF CONCLUSION OF A CLINICAL TRIAL

1

The name and address of—

a

the sponsor, and

b

if the sponsor is not established in F1the United Kingdom or a country that is included in the list referred to in regulation 3(11A) , his legal representative.

Annotations:

Amendments (Textual)

Words in Sch. 3 Pt. 4 para. 1(b) substituted (31.12.2020) by The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/744), regs. 1, 24(5); 2020 c. 1, Sch. 5 para. 1(1)