26 No. of 2013] Medicines and Allied Substances (e)medicine imported or exported in response to a declared health emergency; (f)medicine imported by an authorised institution for administration to patients under its care; and (g) any medicine or allied substance used for purposes of a clinical trial. (5) The Minister may, on the recommendation of the Authority, by statutory instrument, provide for— (a) the criteria for the regulation of persons under subsection (1); (b) the procedure for applying for a marketing authorisation and the grant, amendment, renewal, transfer and revocation of a marketing authorisation; (c) the terms and conditions attaching to an application, grant, amendment, refusal, renewal, transfer or revocation of a marketing authorisation; and (d) such other matters as are necessary or incidental to the effective regulation of marketing authorisations under this Part. (7) A holder of a marketing authorisation shall pay such annual retention fee as the Minister may prescribe. Categories of medicines Medicines list Prohibition of sale of prescription only medicines without prescription 40. (1) The categories of medicines to which this Part applies are— (a) prescription only medicine; (b) pharmacy medicine; and (c) general sale medicine. (2) Medicines shall be dispensed in accordance with the respective requirements applicable to the categories specified in subsection (1) and as shall be prescribed by statutory instrument. 41. The Minister may, on the recommendation of the Authority, by statutory instrument, provide for a list of substances to be considered as medicines. 42. (1) A person shall not sell or supply medicine which is required to be sold by prescription only to any person without a prescription. (2) For the purposes of this section, an authorised prescriber shall prescribe medicines which under this Act are required to be dispensed only under a prescription by issuing a prescription in the

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