Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)RegulationsGeneral RegulationsSupply of Medicines1. Definitions |
In these Regulations any word or expression to which a meaning has been assigned in the Act shall have the meaning so assigned and, unless the context otherwise indicates—
"adverse drug reaction"
means a noxious and unintended response to a medicine;
"adverse event"
is any untoward medical occurrence that may present during treatment with a medicine but which does not necessarily have a causal relationship with this treatment;
"as determined by the Authority"
means as determined by the South African Health Products Regulatory Authority (SAHPRA in guidelines as published from time to time;
"authorised prescriber"
means any person authorised by the Act to prescribe any medicine;
"batch" or "lot"
in relation to a medicine means a defined quantity of a medicine manufactured in a single manufacturing cycle and which has homogeneous properties;
"batch number" or "lot number"
means a unique number or combination of numbers or ciphers allocated to a lot or a batch by the manufacturer;
"bioequivalence"
means the absence of a statistically significant difference in bioavailability between two pharmaceutically equivalent products under similar conditions in an appropriately designed study;
"bonded warehouse"
means a customs and excise warehouse licensed in terms of section 19 of the Customs and Excise Act, 1964 (Act No. 91 of 1964);
"Chief Executive Officer"
means the Chief Executive Officer of the Authority as appointed in terms of section 3 of the Act;
"clinical trial"
means an investigation in respect of a medicine for use in humans or animals that involves human participants or animals and that is intended to—
| (a) | discover or verify the clinical, pharmacological or pharmacodynamic effects of the medicine; |
| (b) | identify any adverse events; |
| (c) | study the absorption, distribution, metabolism and excretion of the medicine; or |
| (d) | ascertain its safety or efficacy; |
"complementary medicine"
means any substance or mixture of substances that—
| (a) | originates from plants, fungi, algae, seaweeds, lichens, minerals, animals or other substance as determined by the Authority; |
| (b) | is used or purporting to be suitable for use or manufactured or sold for use— |
| (i) | in maintaining, complementing or assisting the physical or mental state; or |
| (ii) | to diagnose, treat, mitigate, modify, alleviate or prevent disease or illness or the symptoms or signs thereof or abnormal physical or mental state of a human being or animal; and |
| (c) | is used— |
| (i) | as a health supplement; or |
| (ii) | in accordance with those disciplines as determined by the Authority; |
means to prepare, mix, combine, package and labelling of a medicine—
| (a) | by a pharmacist practising in accordance with the Pharmacy Act, 1974; |
| (b) | by a veterinarian practising in accordance with the Veterinary and Para-Veterinary Professions Act, 1982 (Act 19 of 1982); or |
| (b) | by a person licensed in terms of section 22C(1)(a) of the Act and practising in accordance with their scope of practice; |
[Definition substituted by section 2 of Notice No. 2853, GG47673, dated 8 December 2022]
"counterfeit medicine"
means a medicine in respect of which a false representation has been made about its contents, identity or source by any means including its labelling and packaging;
"dispense"
| (a) | in the case of a pharmacist, means dispense as defined in the Regulations Relating to the Practice of Pharmacy made in terms of the Pharmacy Act; or |
| (b) | in the case of a medical practitioner, dentist, practitioner, veterinarian, nurse or any authorised prescriber to dispense medicines, means— |
| (i) | the interpretation and evaluation of a prescription; |
| (ii) | the selection, reconstitution, dilution, labelling, recording and supply of the medicine in an appropriate container; or |
| (iii) | the provision of information and instructions to ensure safe and effective use of a medicine by a patient; |
"dosage form"
means the pharmaceutical form in which the active ingredients and excipients, and physical formulation of a medicine is presented;
"expiry date"
means the date up to which a medicine will retain the strength and other properties stated on the label which strength and other properties can change after the lapse of time and after which date the medicine shall not be sold to the public or used;
"health care provider"
means a health care provider as defined in section 1 of the National Health Act, 2003 (Act No. 61 of 2003);
"health supplement"
means any substance, extract or mixture of substances as determined by the Authority, sold in dosage forms used or purported for use in restoring, correcting or modifying any physical or mental state by—
| (a) | complementing health; |
| (b) | supplementing the diet; or |
| (c) | a nutritional effect, |
and excludes injectable preparations, medicines or substances listed as Schedule 1 or higher in the Act;
"holder of a certificate of registration"
means a person in whose name a registration certificate has been granted and who is responsible for all aspects of the medicine, including quality and safety and compliance with conditions of registration;
"identification number"
means the number drawn from a—
| (a) | birth certificate, passport, valid driver's licence; |
| (b) | South African identification document; or |
| (c) | any other relevant document issued by the Department of Home Affairs; |
"manufacture"
means all operations including purchasing of material, processing, production, packaging, releasing, storage and shipment of medicines and related substances in accordance with quality assurance and related controls;
"manufacturer"
means a person manufacturing a medicine and includes a manufacturing pharmacy;
"minimum legibility"
means a printing in 6 -point Helvetica, typeface in black ink on white cartridge paper or the equivalent thereof;
means labelling which is false, misleading, inaccurate or fails to provide information as required;
"parallel importation"
means the importation into the Republic of a medicine protected under patent or registered in the Republic that has been put onto the market outside the Republic by or with the consent of such patent holder;
"patient information leaflet"
means the information pertaining to a medicine as provided for in regulation 12, written in a manner which is easily understandable by the patient;
"person"
means a natural or a juristic person;
"Pharmacy Act"
means the Pharmacy Act, 1974 (Act No. 53 of 1974);
"professional information"
means the information about a medicine as provided for in regulation 11;
"proprietary name", "brand name" or "trade name"
means the name which is unique to a particular medicine and by which the medicine is generally identified and which in the case of a registered medicine is the name approved in terms of section 15(5) of the Act;
"responsible pharmacist"
means a responsible pharmacist as defined in section 1 of the Pharmacy Act;
"Site Master File"
means a document prepared by the manufacturer containing specific and factual good manufacturing practice information about the production or control of pharmaceutical manufacturing operations carried out at a named site and any closely integrated operations at adjacent and nearby buildings;
"sugar"
means arty of a class of natural, water -soluble crystalline carbohydrates, of relatively low molecular weight, and typically having a sweet taste depending on the polymeric composition, and includes related alcohols such as sorbitol, mannitol, and xylitol;
means any additive or excipient other than sugar which is used or intended to be used to impart a sweet taste to medicines;
"the Act"
means the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965), as amended; and
"wholesaler"
including a wholesale pharmacy means a person who holds, stores, delivers or purchases medicines or Scheduled substances from a manufacturer and sells them in terms of section 22H of the Act.