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

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1

Amendments in section 132(1) (interpretation) as follows.

2

At the beginning, for “In this Act,” substitute “In the provisions of this Act applied by regulation 47 of the Clinical Trials Regulations,”.

3

In the definition of “enforcement authority”, for the words from “power” to “or under” substitute “to enforce the provisions of the Clinical Trials Regulations is imposed by”.

4

After the definition of “manufacture” insert—

  • “medicinal product” means—

    1. a

      anything that is a medicinal product within the meaning given by Article 1 of Directive 2001/83/EC, and

    2. b

      anything that is an investigational medical product for the purposes of the Clinical Trials Regulations;

5

Omit the definition of “offence under this Act”.

6

For the definition of “prescribed” substitute—

  • “prescribed” means prescribed by regulations made by the Secretary of State and the Department for Health, Social Services and Public Safety, acting jointly;