medicines and related substances control act 101 of 1965

8(3) In the case of a medicine which was available for sale in the Republic immediately prior to the date ofpublication in the Gazette of the resolution by virtue of which it is subject to registration in terms of thisAct, the provisions of subsection (1) shall come into operation-(a)(b)if no application for the registration of such medicine is made within the period of six monthsimmediately succeeding that date, on the expiration of that period; orif application for the registration of such medicine is made within the said period, on the date onemonth after the date on which a notice in respect of such medicine is published in the Gazette interms of section 15 (10) or section 17 (a).(4) The provisions of subsection (1) shall not apply in respect of the sale of any medicine-(a)(b)compounded in the course of carrying on his or her professional activities by a pharmacist,veterinarian or person who is the holder of a license contemplated in section 22C (1) (a), for aparticular patient in a quantity not greater than the quantity required for treatment as determined bythe medical practitioner, pharmacist, practitioner or veterinarian; orcompounded by a pharmacist in a quantity not greater than that prescribed by regulation for sale inthe retail trade, subject to the conditions likewise prescribed or in a quantity for a particular personor animal as prescribed by a medical practitioner or a dentist or a veterinarian or a practitioner or anurse or other person registered under the Health Professions Act, 1974, and referred to in section22A, as the case may be,if such medicine does not contain any component the sale of which is prohibited by this Act or anycomponent in respect of which an application for registration has been rejected, and is not or has not beenadvertised: Provided that the active components of such medicine appear in another medicine which hasbeen registered under this Act.15. Registration of medicines(1) Every application for the registration of a medicine shall be submitted to the registrar in the prescribedform and shall be accompanied by the prescribed particulars and samples of the relevant medicine and bythe prescribed registration fee.(2) The registrar(a)(b)as soon as possible after receipt by him or her of any such application submit the applicationtogether with any particulars and samples which accompanied the application to the council forconsideration and shall simultaneously inform the applicant in writing that the application has beenso submitted;ensure that such an application in respect of medicine which appears on the latest Essential DrugList or medicine which does not appear thereon but which, in the opinion of the Minister, isessential for national health is subject to such procedures as may be prescribed in order to expeditethe registration.(3) (a) If after consideration of any such application and after any investigation or enquiry which it mayconsider necessary the council is satisfied that the medicine in question is suitable for the purposefor which it is intended and complies with the prescribed requirements and that registration of thatmedicine is in the public interest, it shall approve of the registration thereof.