Medicines Act 1975 · 2020 Revised Edition · Part 2 · Licences and Certificates Relating to Medicinal Products
18. Clinical trials and medicinal tests on animals
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The Minister may by regulations provide for —
Minister
“Minister” means —(a)except as provided in paragraph (b), the Minister for Health; and(b)for the purpose of performing any function under this Act (whether by the making of any regulations or order or otherwise) where the function is performed exclusively in relation to veterinary medicinal products and animals, the Minister for National Development;
the conduct of clinical trials, the issue of clinical trial certificates, the exemption of clinical trials from sections 5 and 6, and matters relating to any consent for a subject to participate in a clinical trial, including —
clinical trial
“clinical trial” means an investigation or series of investigations consisting of the administration of one or more medicinal products of a particular description by, or under the direction of —(a)a doctor or dentist to one or more of his or her patients; or(b)two or more doctors or dentists, each product being administered by or under the direction of one or other of those doctors or dentists to one or more of his or her patients,where (in any such case) there is evidence that medicinal products of that description have effects which may be beneficial to the patient or patients in question and the administration of the product or products is for the purpose of ascertaining whether, or to what extent the product has, or the products have, those or any other effects, whether beneficial or harmful;
the persons who may so consent;
the considerations which any such person must take into account before so consenting;
the circumstances in which the consent of such person may be relied upon; and
the circumstances in which no consent of any person is required for the subject’s participation in the trial,and whether any matter so prescribed has effect in addition to or despite any other written law or rule of law;
the conduct of medicinal tests on animals, the issue of animal test certificates, the exemption of medicinal tests on animals from sections 5 and 6; and
the control, housing and other restrictions in the sale, supply, manufacture, import and export of animal feeding stuffs in which medicinal products are incorporated,and for any matter ancillary or incidental thereto.