Statistics Act, 1999
R 385
Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)RegulationsGeneral RegulationsRegistration of Medicines14. Professional information for veterinary medicines |
| (1) | Subject to subregulation (2), professional information shall be made available for each veterinary medicine, in at least English or one official language and in type having a minimum legibility, under the headings and in the format specified in this regulation, and which shall contain the following particulars: |
| (a) | The proprietary name; |
| (b) | scheduling status; |
| (c) | dosage form; |
| (d) | composition, using generic or approved names; |
| (e) | class of the medicine in terms of Annexure 2; |
| (f) | pharmacological action; |
| (g) | pharmacokinetic properties and pharmacodynamic properties; |
| (h) | contra-indications; |
| (i) | warnings or withdrawal period in the case of food producing animals; |
| (j) | side effects and special precautions; |
| (k) | known signs of overdose and particulars of its treatment; |
| (I) | quantity and strength of active ingredients per dosage unit; |
| (m) | storage instructions; |
| (n) | registration number; |
| (o) | name and business address of holder of certificate of registration; |
| (p) | any other information as the Authority may from time to time determine; and |
| (q) | in the case of a complementary medicine— |
| (i) | a statement identifying the discipline of the medicine where relevant; and |
| (ii) | if the medicine has not received registration with the Authority the disclaimer "This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use." |
| (2) | The Authority may, upon application, authorise a deviation from subregulation (1). |
