| (1) | Subject to subregulations (4) and (5), the immediate container of every medicine in which a medicine intended for administration to or use by humans is sold shall have a label attached to it on which the following particulars shall appear in clearly legible indelible letters in English and at least one other official language— |
| (a) | in the case of a medicine containing any substance listed in any Schedule made in terms of the Act, the letter "S" followed by the number of the relevant Schedule, in a prominent typeface and size and surrounded by a square border, immediately preceding the proprietary name of such medicine; |
| (b) | the proprietary name of the medicine; |
| (i) | registration number of the medicine allocated in terms of section 15(5) of the Act; or |
| (ii) | application number allocated by the Authority followed by the expression "Act 101/1965 "; |
| (d) | the dosage form of the medicine; |
| (e) | the approved name of each active ingredient of the medicine and the quantity thereof contained in a dosage unit, or per suitable mass or volume or unit, ranked according to the active ingredients with the highest schedule, in lettering which has minimum legibility: Provided that labelling of medicines in solutions for injections must identify the active ingredient in terms of the active component per unit volume of solution; |
| (f) | the name and percentage of any bacteriostatic or bactericidal agent which has been added to the medicine as a preservative; |
| (g) | the approved name of any anti-oxidant contained in the medicine; |
| (h) | in the case of a medicine— |
| (i) | for oral or parenteral administration which contains sugar, the statement: "contains sugar" and the name and quantity of the sugar must be stated or which does not contain sugar, the statement: "sugar free"; |
| (ii) | for oral or parenteral administration the quantity of ethyl alcohol contained in the medicine, expressed as a percentage of the total volume of the medicine, if such quantity exceeds two per cent by volume; and |
| (iii) | for oral administration the name and quantity of sweetener other than sugar contained in the medicine and the statement: "contains sweetener ". |
| (i) | the content of the medicine package expressed in the appropriate unit or volume of the medicine; |
| (j) | approved indications where practical, for use of the medicine; |
| (k) | the recommended dosage of the medicine, where practical; |
| (I) | where applicable, the instruction "Shake the bottle before use "; |
| (m) | in the case of a medicine intended for injection by a particular route of administration only, that route of administration by means of suitable words or abbreviations; |
| (n) | the tot number of the medicine; |
| (o) | the expiry date of the medicine in a font size that makes it clearly visible; |
| (p) | a barcode suitable for the identification and tracking of medication: Provided that where such barcode appears on the outer label it may be excluded on the immediate container label; |
| (q) | the name of the holder of certificate of registration of the said medicine; |
| (r) | the requirements regarding the manner in which the medicine shall be stored with specific reference to the applicable storage temperature, humidity and light exposure and other precautions required for the preservation of the medicine; |
| (s) | where applicable, the statement: "For external use only "; |
| (t) | the warning: "Keep out of reach of children "; |
| (u) | in the case of a medicine which contains aspirin or paracetamol, the warning: "Do not use continuously for more than 10 days without consulting your doctor"; |
| (v) | in the case of a medicine for oral administration which contains fluorides, the warning: "Contains fluoride "; |
| (w) | in the case of a medicine for oral administration which contains an antihistamine, the warning: "This medicine may lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol or other central nervous system depressants"; |
| (x) | in the case of eye drops or artificial tear solutions in respect of which evidence concerning the self-sterilising ability of the medicine has not been approved by the Authority, the warning: "Do not use more than 30 days after opening"; |
| (y) | any specified warning to be given on the label of the medicine as a condition of registration thereof as may have been determined in terms of section 15(6) of the Act; |
| (z) | in the case of a medicine that contains tartrazine, the warning: "Contains TARTRAZINE"; |
| (aa) | the category of medicine immediately preceding the registration or application number; |
| (bb) | the class of the medicine in terms of Annexure 1; and |
| (cc) | in the case of complementary medicine— |
| (i) | the words "Complementary Medicine"; |
| (ii) | a statement identifying the discipline or the wording "Health Supplement ", as the case may be; |
| (iii) | which is not registered by the Authority, the following disclaimer: "This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use. "; and |
| (iv) | containing at least 5 percent of the genetically modified organisms the following warning "contains genetically modified organisms". |
[Regulation 10(1)(cc)(iv) substituted by section 2 of the General Regulations made in terms of the Medicines and Related Substances Act, 1965, Amendment, 2023, Notice No. R. 3343, GG48475, dated 28 April 2023]
| (2) | In addition to the requirement of subregulation (1), the following information may be included on the label: |
| (a) | The name and address of the manufacturer of the medicine; |
| (b) | the date of manufacture of the medicine; or |
| (c) | the scheduling status and registration number allocated by another national medicines regulatory authority of a country as determined by the Authority: Provided that this information is surrounded by a square border including the name of the reference country. |
| (3) | If the medicine package bears both, an immediate container label and an outer label, the requirements of subregulation (1) shall apply to the outer label: Provided that it shall be sufficient to contain on the immediate container label— |
| (a) | in the case of Category A medicines— |
| (i) | intended for administration by injection and having a total volume not exceeding 5 ml, the particulars referred to in subregulation (1)(b),(e), (m), (n) and (o); |
| (ii) | in the form of an ointment, cream, gel or powder having a net mass not exceeding 10 grams, the particulars referred to in subregulation (1)(b), (c), (e), (f), (n), (o), (q) and (y); |
| (iii) | in the form of liquid, solution or suspension having a total volume of more than 1 ml, but not exceeding 15 ml, the particulars referred to in subregulation (1)(b), (c), (ci), (e), (n), (o), (q), (x) and (y); |
| (iv) | in the form of a liquid, solution or suspension having a total volume not exceeding 1 ml, the particulars referred to in subregulation (1)(b) and (n); and |
| (v) | packed in blister or similar packaging, the particulars referred to in subregulation (1)(b), (n), (o), and (q), repeated as frequently as is practicable; and |
| (b) | in the case of Category D medicines— |
| (i) | intended for administration by injection and having a total volume not exceeding 5 ml, the particulars referred to in subregulation (1)(b), (m), (n), (o) and (cc)(i); |
| (ii) | in the form of an ointment, cream, gel or powder having a net mass not exceeding 10 grams, the particulars referred to in subregulation (1)(b), (c), (f), (n), (o), (q), (y) and (cc)(i); |
| (iii) | in the form of liquid, solution or suspension having a total volume of more than 1 ml, but not exceeding 15 ml, the particulars referred to in subregulation (1 )(b), (o), (d), (n), (o), (q), (x), (y) and (cc)(i); |
| (iv) | in the form of a liquid, solution or suspension having a total volume not exceeding 1 ml, the particulars referred to in subregulation (1)(b), (n) and (cc)(i); and |
| (v) | packed in blister or similar packaging, the particulars referred to in subregulation (1)(b), (n), (o), (q) and (cc)(i), repeated as frequently as is practicable. |
| (4) | The Authority may authorise the inclusion on the label of a medicine of any special information that is not required by this regulation to be so included. |
| (5) | The requirements of subregulation (1) shall not apply to— |
| (a) | any medicine sold in accordance with section 14(4) of the Act; |
| (b) | any medicine sold by a person licensed to dispense in terms of section 22C(1)(a) of the Act or a pharmacist, pharmacist intern or pharmacist's assistant in the course of his or her professional activities for the treatment of a particular patient; or |
| (c) | any medicine sold by a pharmacist, a person authorised to compound and dispense, or in a hospital pharmacy in accordance with a prescription issued by a medical practitioner or dentist for the treatment of a particular patient. |
| (6) | For any medicine sold in terms of subregulation (5), such medicine shall be sold in a package to which is attached a label containing the following information: |
| (a) | the proprietary name, approved name, or the name of each active ingredient of the medicine, where applicable, or constituent medicine; |
| (b) | the name of the person for whose treatment such medicine is sold; |
| (c) | the directions in regard to the manner in which such medicine should be used; |
| (d) | the name and business address of the person authorised to sell such a medicine; |
| (g) | a statement identifying the discipline of the medicine, if falling under Category D. |
