http://www.legislation.gov.uk/uksi/2004/1031/schedule/8/paragraph/3/2008-05-01
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 8PROCEDURAL PROVISIONS RELATING TO PROPOSALS TO GRANT, REFUSE TO GRANT, VARY, SUSPEND OR REVOKE MANUFACTURING AUTHORISATIONS
3
Any notification given under paragraph 2 shall include a statement of the proposals of the licensing authority and of the reasons for them.