http://www.legislation.gov.uk/uksi/2004/1031/schedule/6/paragraph/3A
The Medicines for Human Use (Clinical Trials) Regulations 2004
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MEDICINES
Statute Law Database
2024-06-19
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 6PARTICULARS THAT MUST ACCOMPANY AN APPLICATION FOR A MANUFACTURING AUTHORISATION
F13A
Where the application relates to the inactivation of viral or non-conventional agents, a statement of the manufacturing process to which the authorisation is to relate.