| (1) |
Subject to subregulation (4), professional information shall be made available— |
| (i) |
in hard copy either separately or as an integral part of the package; or |
| (ii) |
electronically: Provided that the manner in which the professional information may be accessed is stated on the patient information leaflet as contemplated in regulation 12(2)(p); |
| (b) |
in the English language; |
| (c) |
in type having a minimum legibility; and |
| (d) |
shall contain the particulars specified in sub-regulation (2) under the headings as determined by the Authority. |
[Regulation 11(1)(d) substituted by section 3 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) |
Subject to subregulations (3) and (4), the professional information referred to in subregulation (1) shall contain the following particulars: |
| (a) |
Scheduling status of the medicine assigned by the Authority; |
| (b) |
proprietary name and dosage form; |
| (c) |
composition, including— |
| (i) |
the approved name of each active ingredient and the quantity thereof contained in a dosage unit or per suitable mass or volume or unit of the medicine; |
| (ii) |
the approved name of all excipients included in the formulation; |
| (iii) |
the approved name and quantity of any bactericidal or bacteriostatic agent included in the medicine as a preservative, expressed as a percentage; |
| (iv) |
the quantity of ethyl alcohol included in a preparation for oral or parenteral administration, if such quantity exceeds two per cent by volume; |
| (v) |
the words "contains TARTRAZINE" should the medicine contain such ingredient; |
| (vi) |
in the case of a medicine, 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 warning: "sugar free"; and |
| (vii) |
in the case of a medicine, for oral administration, which contains sweetener, the name and quantity of sweetener and the statement: "contains sweetener"; |
| (d) |
the category and class, including the number and the description as stated in regulation 9; |
| (e) |
pharmacological action and, where applicable, under a sub-heading: Pharmacokinetic properties, pharmacodynamic properties; summary of pre-clinical or clinical studies; |
| (h) |
warnings and special precautions; |
| (k) |
dosage and directions for use; |
| (m) |
known symptoms of over -dosage and particulars of its treatments; |
| (p) |
storage instructions that are practically formulated and which indicate storage temperatures, humidity and exposure to light; |
| (q) |
registration number which corresponds to— |
| (i) |
the number allocated in terms of section 15(5) of the Act; or |
| (ii) |
in the case of a medicine the registration of which has been applied for, the reference number allocated to such application, followed by the expression "Act 101/1965 "; |
| (r) |
name and business address of the holder of the certificate of registration, or in case of a parallel imported medicine, the name and business address of the holder of the parallel importation permit; |
| (s) |
date of publication of the professional information which is the date of the most recent amendment to the professional information as approved by the Authority, as well as the date of registration: Provided that– |
| (i) |
if the Authority decides that there is no applicable information to be furnished under a particular heading, such heading may be omitted with the approval of the Authority; |
| (ii) |
the Authority may on application authorise the deviation from the format and content of the professional information prescribed as a condition of registration of a medicine; |
| (iii) |
the Authority may on application authorise the inclusion of any specified information not required by this regulation to be so included; and |
| (iv) |
the Authority may on application determine under a particular heading the information to be furnished in respect of an interchangeable multisource medicine; and |
| (t) |
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 following warning: "contains genetically modified organisms". |
| (3) |
The Authority may determine additional professional information to be provided. |
| (4) |
The requirements of subregulations (1) and (2) shall not apply to— |
| (a) |
any medicine sold in accordance with the provisions of section 14(4) of the Act; |
| (b) |
any medicine compounded or sold by a pharmacist or any other person who is licensed to compound and dispense medicines in the course of his or her professional activities for the treatment of a particular patient; and |
| (c) |
any medicine sold by a pharmacist in accordance with a prescription issued by a medical practitioner, dentist or practitioner for the treatment of a particular patient. |
| (5) |
Nothing contained in subregulations (4) shall be construed as prohibiting the inclusion of professional information with any medicine. |
| (6) |
The Authority may withdraw any indication for a medicine if it is of the opinion that the risk benefit profile for such indication is not in the public interest. |
| (7) |
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 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. |
Statistics Act, 1999
