F1SCHEDULE 9MODIFICATIONS OF THE ENFORCEMENT PROVISIONS OF THE 2012 REGULATIONS SUBJECT TO WHICH THOSE PROVISIONS ARE APPLIED FOR THE PURPOSES OF THESE REGULATIONS

Regulation 47(1)

Annotations:
Amendments (Textual)

1

The modifications of the 2012 Regulations mentioned in regulation 47 are as follows.

2

In regulation 2 (medicinal products)—

a

at the beginning of paragraph (1) insert “ Subject to paragraph (3), ”; and

b

after paragraph (2) insert the following paragraph—

3

“Medicinal product” includes any investigational medicinal product.

2

In regulation 8(1) (interpretation)—

a

the definition “assemble” is substituted by the definition of that expression in regulation 2(1) of these Regulations; and

b

there is inserted in the appropriate position in alphabetical order a definition “container” in the same terms as the definition of that expression in regulation 2(1) of these Regulations; and

c

the definition “qualified person” is substituted by the definition of that expression in regulation 2(1) of these Regulations.

3

In regulation 322(1) (validity of decisions and proceedings) omit “or” and insert a comma before “ 8 (Article 126a authorisations) ”, and after those words insert “ or the Clinical Trials Regulations ”.

4

In regulation 325(1) (rights of entry) insert after sub-paragraph (b) the following sub-paragraph—

ba

in order to verify any statement contained in an application or request for an authorisation under the Clinical Trials Regulations;

5

1

Regulation 327 (powers of inspection, sampling and seizure) is amended as follows.

2

In paragraph (1)—

a

after sub-paragraph (b) omit “; or”;

b

after sub-paragraph (c) insert “ ; or ” and the following sub-paragraph—

d

in order to verify any statement contained in an application or request for an authorisation under the Clinical Trials Regulations.

3

After paragraph (2)(g) insert the following sub-paragraph—

h

information and documents relating to clinical trials

4

In paragraph (3)—

a

omit “or” following sub-paragraph (a); and

b

following paragraph (b) insert “ ; or ” and the following sub-paragraph—

c

a medicinal product used, or intended to be used, in a clinical trial

5

In paragraph (4)—

a

after “require” insert “ — (a) ”; and

b

after “control” insert “ ; or ” and the following sub-paragraph—

b

a person associated with a clinical trial to produce information or documents relating to the clinical trial which are in the person's possession or under the person's control

6

In paragraph (5)(a) for “(2)(f) or (g)” substitute “ (2)(f), (g) or (h) ”.

7

After paragraph (9) insert the following paragraph—

10

In this regulation, “a person associated with a clinical trial means any of the following—

a

the sponsor of a clinical trial (within the meaning of regulation 3 of the Clinical Trials Regulations);

b

any person who, under arrangements made with the sponsor of a clinical trial, carries out functions of the sponsor of the trial;

c

in investigator for a clinical trial (within the meaning of regulation 2(1) of the Clinical Trials Regulations);

d

any person, other than an investigator, who conducts a clinical trial;

e

any person occupying premises at which a clinical trial is being conducted; or

f

any person who, in the course of employment with a person listed in any of sub-paragraphs (a) to (e), undertakes activities in connection with a clinical trial.

8

In regulation 335(6) (contravention due to fault of another person) omit “and” after sub-paragraph (e) and after sub-paragraph (f) insert “ ; and ” and the following sub-paragraph—

g

any obligation or prohibition under the Clinical Trials Regulations

9

In regulation 336(3) (warranty as defence) omit “and” after sub-paragraph (c) and after sub-paragraph (d) insert “ ; and ” and the following sub-paragraph—

e

regulation 46 of the Clinical Trials Regulations (labelling)