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