| (1) |
Subject to subregulations (2), (3) and (4), the immediate container of every package in which a veterinary medicine is sold shall have a label attached to it on which the following particulars pertaining to the contents of such package shall appear in clearly legible, indelible lettering in at least English or one official language: |
| (a) |
The words "Veterinary Medicine "; |
| (b) |
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; |
| (c) |
the proprietary name of such medicine; |
| (d) |
the registration number allocated to such medicine under section 15(5) of the Act or, in the case of a medicine in respect of which an application for registration has been submitted in accordance with section 14(3), the reference number allocated to such application by the Authority, followed by the words "(Act 101/1965)"; |
| (e) |
the dosage form of the medicine; |
| (f) |
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 in lettering which shall not be less than— |
| (i) |
in the case of a medicine containing only one active ingredient, one half the size of the largest lettering which is used for the said proprietary name; |
| (ii) |
in the case of a medicine which contains more than one but less than six active ingredients, one-quarter the size of the largest lettering which is used for the said proprietary name; and |
| (iii) |
in the case of a medicine containing six and more active ingredients, the minimum type size permitted by this regulation: Provided that such lettering shall have a minimum legibility; |
| (g) |
the name and percentage of any bacteriostatic or bactericidal agent which has been added to the medicine as a preservative; |
| (h) |
the content of the medicine package expressed in the appropriate unit or volume of the medicine; |
| (i) |
where practicable, the indications for use of the medicine; |
| (j) |
where practicable, the recommended dosage of the medicine; |
| (k) |
where applicable, the instruction "Shake the bottle before use "; |
| (I) |
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; |
| (m) |
in the case of a medicine listed in any Schedule to 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; |
| (n) |
the lot number of the medicine; |
| (o) |
the expiry date of the medicine; |
| (p) |
the name of the holder of certificate of registration of the said medicine; |
| (q) |
the requirements regarding the manner in which the medicine shall be stored with specific reference to the applicable storage temperature and other precautions required for the preservation of the medicine; |
| (r) |
where applicable, the statement: "For external use only"; |
| (s) |
the warning: "Keep out of reach of children and uninformed persons"; |
| (t) |
in the case of any medicine intended to be used in food producing animals and involving the possibility of the ingredients of such medicine or metabolites thereof being present in the eggs, milk or tissue of such animals, a warning regarding the withdrawal period of such medicine; |
| (u) |
any specified warning which has to be included on the label of a particular medicine as a condition of registration of that medicine in terms of the provisions of section 15(6) of the Act; |
| (v) |
the category of medicine; |
| (w) |
the class of the medicine in terms of Annexure 2; and |
| (x) |
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 following disclaimer: This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use." |
| (2) |
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 medicines intended for administration by injection and having a total volume not exceeding 5 ml, the particulars referred to in subregulation (1)(a), (b), (e), (k), (I) (m), (n) and (w); |
| (b) |
in the case of an ointment, cream, gel or powder having a net mass not exceeding 10 grams, the particulars referred to in subregulation (1)(a), (b), (c), (e), (m), (n), (o) and (w); |
| (c) |
in the case of a liquid, solution or suspension having a total volume more than 1 ml but not exceeding 15 ml, the particulars referred to in subregulation (1)(a), (b), (c), (d), (e), (I), (m), (n), (o) and (w); |
| (d) |
in the case of a liquid, solution or suspension having a total volume not exceeding 1 nil, the particulars referred to in subregulation (1)(a), (b), (o) and (w); and |
| (e) |
in the case of a medicine packed in blister or similar packaging, the particulars referred to in subregulation (1)(a), (b), (m), (n), (o) and (w), repeated as frequently as is practicable. |
| (3) |
The Authority may, on application to it by an applicant, authorise the inclusion on the label of a medicine of any specified information, which is not required by this regulation to be so included. |
| (4) |
The requirements of subregulation (1) shall not apply to a medicine excluded there from by the Minister in terms of section 36 of the Act or to— |
| (a) |
any medicine sold in accordance with the provisions of section 14(4) of the Act for the treatment of a specific animal; |
| (b) |
any medicine sold by a veterinarian or pharmacist in the course of his or her professional activities for the treatment of a particular animal; or |
| (c) |
any medicine sold by a pharmacist in accordance with a prescription issued by a veterinarian for treatment of a particular animal: |
Provided that such medicine shall be sold in a package to which is attached a label containing the following information:
| (i) |
The name of the medicine or the name of each active ingredient or constituent medicine; |
| (ii) |
the name of the person to whom such medicine has been sold and a description, as accurate as possible, of the animals for which the treatment is intended; |
| (iii) |
the directions for the use of such medicine; |
| (iv) |
the name and address of the veterinarian or pharmacist who has sold such medicine; |
| (v) |
the reference number allocated to the sale of the medicine as referred to in regulation 11(1)0; and where applicable, the warning, referred to in subregulation (1)(s), regarding the withdrawal period of such medicine; |
| (vi) |
date of dispensing; and |
| (vii) |
a statement identifying the discipline of the medicine, if falling in Category D. |
Housing Development Agency Act, 2008
