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Part 6 · Miscellaneous

23. Enforcement requirements

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(1)

An enforcement officer may conduct routine inspections of —

(a)

any premises that are being used for the manufacture, supply or storage of any clinical research material; and

(b)

any conveyances that are being used for the transport of any clinical research material.

(2)

An enforcement officer conducting a routine inspection under paragraph (1) may —

(a)

require any person having possession or control of any clinical research material that is found during the inspection to furnish, without charge, a sample of such material for the Authority’s examination; and the person must comply with the requirement; and

(b)

take or cause to be taken any photograph of —

(i)

the premises or conveyances referred to in paragraph (1); or

(ii)

any property or material found on the premises or in the conveyances.

Subregulation 1

An enforcement officer may conduct routine inspections of —

(a)

any premises that are being used for the manufacture, supply or storage of any clinical research material; and

(b)

any conveyances that are being used for the transport of any clinical research material.

Subregulation 2

An enforcement officer conducting a routine inspection under paragraph (1) may —

(a)

require any person having possession or control of any clinical research material that is found during the inspection to furnish, without charge, a sample of such material for the Authority’s examination; and the person must comply with the requirement; and

(b)

take or cause to be taken any photograph of —

(i)

the premises or conveyances referred to in paragraph (1); or

(ii)

any property or material found on the premises or in the conveyances.

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