Act No. 13, 2003 MEDICINES AND RELATED SUBSTANCES CONTROL ACT, 2003 (dd) declaring chemicals or equipment to be controlled chemicals or controlled equipment for the purpose of controlling the use of those chemicals or the equipment in the manufacture of Schedule 3, Schedule 4 and Schedule 5 substances; (ee) regulating or prohibiting the manufacture, importation, transshipment or exportation of controlled chemicals or controlled equipment; (ff) prescribing methods of identifying an importer of controlled chemicals or controlled equipment, the purpose for which those chemicals are, or the equipment is, used and the quantities of the chemicals or equipment, which the importer handles annually; (gg) prescribing the minimum standards for good manufacturing practices to be followed in the manufacture of medicines; (hh) prescribing the quantities of unregistered medicine, which may be compounded and sold in the pharmaceutical trade and the conditions under which that medicine may be sold; (ii) (jj) prescribing the form and manner of, and the fee for, an application for the registration of premises and things used, and persons engaged, in the pharmaceutical business; and relating to anything that may be registered under this Act. (2) Not less than three months before a regulation is made under subsection (1), the Minister must cause the text of that regulation to be published in the Gazette together with a notice declaring his or her intention to make that regulation and inviting interested persons to furnish the Minister with any comments on it or with any representations they may wish to make in regard to that regulation. (3) Subsection (2) does not apply in respect of ­ (a) a regulation to which, after the provisions of that subsection have been complied with, the Minister has made changes in consequence of comments or representations received by him or her in pursuance of the notice issued under the said subsection (2); or (b) a regulation in respect of which the Minister, after consultation with the Council, is of the opinion that the public interest requires that regulation to be made without delay. (4) Regulations may be made under this section in respect of ­ (a) particular medicines or scheduled substances; or (b) particular categories of medicines or scheduled substances; or (c) medicines or scheduled substances other than particular categories of medicines or scheduled substances, and different provisions may be made in respect of different medicines or scheduled substances or different categories of medicines or scheduled substances. (5) A regulation made under this section may prescribe penalties for a contravention of that regulation or failure to comply with it, not exceeding a fine of N$4 000 or imprisonment for a period not exceeding one year or both the fine and imprisonment.