54. Repeal of regulations Annexure I Pharmacological classification of categorised medicines Annexure II [Annexure II deleted by GN 28/2015] Annexure III Medicines register for medicines are not veterinary medicines or complementary medicines Annexure IV Veterinary medicines register Annexure V Complementary medicines register Annexure VI Application for amendment of entry in register Annexure VII Certificate of registration Annexure VIII Application for approval of transfer of certificate of registration Annexure IX Report of adverse drug reaction Annexure X Certificate by inspector Annexure XI Certificate by analyst Annexure XII Schedule 4 substances register and prescription book Annexure XIII Application for permit to import a Schedule 4 substance or a specified Schedule 3 substance Annexure XIV Import/Export* permit for a Schedule 4 substance or a specified Schedule 3 substance Annexure XV Application for permit to export a Schedule 4 substance or a specified Schedule 3 substance Annexure XVI Application for permit to manufacture a Schedule 4 substance or a specified Schedule 3 substance Annexure XVII Permit to manufacture a Schedule 4 substance or a specified Schedule 3 substance Annexure XVIII Application for permit to cultivate or collect plants or a portion of a plant from which a Schedule 4 substance or a specified Schedule 3 substance can be extracted, derived, produced, or manufactured Annexure XIX Permit to cultivate or collect plants or a portion of a from which a Schedule 4 substance or a specified Schedule 3 substance can be extracted, derived, produced, or manufactured
(b) the international non-proprietary or approved name and quantity of each active ingredient of the medicine; (c) the dosage form of the medicine; and (d) the name of the applicant who lodged the application for registration. Compounding of medicines by pharmacist for sale in the retail 19. (1) A pharmacist compounding a medicine for sale in the retail trade as contemplated in section 18(5)(b) of the Act may only compound a medicine that is - (a) related to a treatment regimen of a particular patient; and (b) sufficient to be used by the patient for not more than 30 consecutive days from the date of dispensing. (2) Any medicine referred to in subregulation (1) must be compounded extemporaneously. Method of taking samples by inspector and form of certificate where inspector has taken samples 20. (1) Any inspector who takes a sample in terms of section 36(1)(d) of the Act - (a) must take a sample that is representative of the whole medicine or scheduled substance concerned; (b) must, if taking samples from bulk medicines or large containers of scheduled substances, take care to reduce the risk of contamination by dust or other substances of the sample and the remaining bulk medicine or scheduled substance; (c) may, if taking samples in the premises of a manufacturer, cause the personnel of the manufacturer to collect the sample under his or her observation if the taking of the samples by him or her may increase the risk of contaminating the remaining medicine or scheduled substance; (d) must in every case take enough quantities of the sample concerned for - (i) two runs of the intended analysis; (ii) two runs of parallel testing; and (iii) a retention sample that is enough for two runs of the intended analysis, and if the of the sample concerned wants to carry out a parallel analysis the sample must include the extra quantity required therefore; (e) must take care that the container in which the sample of a bulk medicine or scheduled substance is packed does not interact with the medicine or scheduled substance concerned and may not allow contaminants to affect the medicine or scheduled substance in any way that would have a negative effect on the analytical results;