| (1) |
Each medicine shall be accompanied by a patient information leaflet— |
| (a) |
attached to the immediate container; |
| (b) |
included as part of the immediate container or outer package; or |
| (c) |
inserted into the outer package. |
| (2) |
The patient information leaflet shall contain the following information with regard to the medicine in at least English and one other official language— |
| (b) |
proprietary name and dosage form; |
| (c) |
the composition of the medicine in terms of information contemplated in regulation 11(2)(c); |
| (d) |
the approved indications and use; |
| (e) |
instructions before taking the medicine, which shall include— |
| (v) |
the following general statement: |
"Always tell your health care provider if you are taking any other medicine.
If you are pregnant or breast feeding your baby please consult your health
care provider for advice before taking this medicine.";
| (f) |
instructions on how to take the medicine, including the following statements: |
"Do not share medicines prescribed for you with any other person."
"In the event of over -dosage, consult your doctor or pharmacist. If neither is
available, contact the nearest hospital or poison control centre ";
| (g) |
side effects, including the following general statement: |
"Not all side effects reported for this medicine are included in this leaflet.
Should your general health worsen or if you experience any untoward effects while taking this medicine, please consult your health care provider for advice";
| (h) |
storage and disposal information, including the following general statement: |
"store all medicines out of reach of children.";
| (i) |
presentation, which includes the number, volume or mass per package unit and a description of the packaging material; |
| (j) |
identification and description 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"; |
| (l) |
the name, business address and telephone number of— |
| (i) |
the holder of the certificate of registration; or |
| (m) |
date of publication of the patient information leaflet which is the date of the most recent amendment to the patient information leaflet as approved by the Authority, as well as the date of registration of the medicine; |
| (n) |
in the case of a 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 genetically modified organisms, the identification of the affected ingredient(s) and the following warning "contains genetically modified organisms"; |
| (o) |
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 "; |
| (p) |
and the manner in which the corresponding professional information as per regulation 11 may be obtained. |
| (3) |
Information contemplated in subregulation (2) may also be provided in electronic format accessible in any of the other official languages and in any other format to enable its accessibility for persons living with disabilities. |
| (4) |
The Authority may determine additional requirements for inclusion in any patient information leaflet. |
| (5) |
The Authority may authorise a deviation from subregulation (1). |
| (6) |
The Authority may, on application, in respect of an interchangeable multisource medicine determine additional information to be furnished under a particular heading. |
| (7) |
The requirements of subregulation (1) shall not apply to any medicine sold in accordance with section 14(4) of the Act. |
| (8) |
In addition to the requirement of subregulation (2), the following information may be included: |
| (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 regulator 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. |
Statistics Act, 1999
