Medicines and Allied Substances [No. of 2013 23 33. (1) A person shall not manufacture, distribute or deal in any medicine or allied substance without a pharmaceutical licence. (2) A person who contravenes subsection (1) commits an offence and is liable, upon conviction, to a fine not exceeding two million penalty units or to imprisonment for a period not exceeding four years, or to both. 34. (1) A person who intends to manufacture, distribute or deal in any medicine or allied substance shall apply to the Authority for a pharmaceutical licence in the prescribed manner and form upon payment of the prescribed fee. (2) The Authority shall, within ninety days of the receipt of an application under subsection (1), issue a pharmaceutical licence to the applicant if the applicant meets the requirements of this Act. (3) The Authority shall reject an application which does not meet the requirements of this Act and inform the applicant of the reasons for the rejection. Prohibition of manufacture, distribution, etc. of medicine or allied substance without pharmaceutical licence Pharmaceutical licence (4) The Minister may, on the recommendation of the Authority, by statutory instrument, provide for— (a) the criteria for the licensing of persons under subsection (1); (b) the procedure for applying for a pharmaceutical licence and the grant, amendment, renewal, transfer and revocation of a pharmaceutical licence; (c) the terms and conditions attaching to an application, grant, amendment, refusal, renewal, transfer or revocation of a pharmaceutical licence; and (d) such other matters as are necessary or incidental to the effective regulation of licences under this Part. (5) The Minister may, on the recommendation of the Authority, and for the purposes of facilitating the effective implementation and enforcement of this Act— (a) exempt certain categories of persons from the application of some or all of the provisions of this section; and (b) provide that some or all of the provisions of this section shall not apply in certain circumstances. 35. (1) A person shall not import any medicine or allied substance without an import permit. (2) This section does not apply to any medicine or allied substance imported by a traveller entering Zambia for the traveller’s use as Import permit