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19.—(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—
anything that is a medicinal product within the meaning given by Article 1 of Directive 2001/83/EC, and
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;”.
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