Veterinary Product Labelling in South Africa: What Act 36 of 1947 Actually Requires

Veterinary product labelling in South Africa is governed by the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act (Act 36 of 1947) and its associated regulations. Despite the Act's age, its labelling requirements remain the enforceable standard, administered by the Registrar of Act 36 within the Department of Agriculture, Land Reform and Rural Development (DALRRD). Getting labelling wrong doesn't just risk a regulatory query — it can delay registration, trigger post-market corrective actions, or, in the case of food-producing animals, create genuine public health consequences through incorrect or missing withdrawal period information.

Mandatory Label Elements Under Act 36

The regulations under Act 36 prescribe a specific set of information that must appear on every stock remedy label. At a minimum, this includes the product name, the registration number assigned by the Registrar (prefixed with a "G" number), the name and address of the registration holder, the active ingredient(s) and their concentration, the net contents, batch number, manufacturing date, and expiry date.

Directions for use must be explicit: target species, dose rates, route of administration, frequency, and duration of treatment. Vague instructions such as "use as directed by a veterinarian" are not acceptable as a substitute for complete dosing information on the label itself. The label must also include warnings and contraindications, precautionary statements relevant to the handler and the environment, and storage conditions.

One point that trips up applicants is the language requirement. Labels must be presented in at least two of the three official languages historically required under the Act's regulations — typically English and Afrikaans. Submitting a label in English alone is a common reason for a query from the Registrar's office.

Withdrawal Period Requirements for Food-Producing Animals

For any stock remedy intended for use in food-producing animals — cattle, sheep, goats, pigs, poultry, fish in aquaculture — the label must state a withdrawal period for each relevant animal tissue and, where applicable, for milk and eggs. The withdrawal period is the minimum time that must elapse between the last administration of the product and slaughter for human consumption or the collection of milk or eggs for the human food chain.

These periods must be supported by residue depletion data submitted as part of the registration dossier. The Registrar will not accept a generic statement such as "observe an appropriate withdrawal period." The label must specify the period in days, clearly differentiated by tissue type (meat, offal, milk, eggs) and species if the product is registered for use across multiple food-producing species.

Failure to include correct withdrawal periods is not merely an administrative deficiency. It directly affects food safety and can result in violative residues in animal-derived foodstuffs, which has downstream consequences under the Meat Safety Act (Act 40 of 2000) and Foodstuffs, Cosmetics and Disinfectants Act (Act 54 of 1972).

Scheduling Declarations

Stock remedies containing scheduled substances must carry the appropriate scheduling declaration as prescribed under the Medicines and Related Substances Act (Act 101 of 1965), read together with the Schedules published by SAHPRA. Even though Act 36 products are not registered by SAHPRA, the scheduling status of their active ingredients still applies and must be reflected on the label.

This means products containing Schedule 2 through Schedule 6 substances must display the correct schedule number and the prescribed warning statement associated with that schedule. A Schedule 5 product, for example, must include the statement that it is to be kept out of reach of children and used under supervision. Omitting or incorrectly stating the schedule is a regulatory non-conformance that the Registrar will flag during label review.

Species Restrictions and Off-Label Warnings

Where a product is registered for specific species only, the label must make this explicit. Using broad language such as "for use in livestock" when the product is approved only for cattle and sheep creates an ambiguity with real consequences — particularly if the product is contraindicated in other species. Certain anthelmintics, for instance, are toxic to specific breeds or species, and the label must carry a clear species restriction and, where applicable, a breed-specific warning.

Common Non-Conformances in Practice

In practice, the most frequent labelling deficiencies identified during registration review and post-market surveillance include: missing or incorrect registration numbers, absent Afrikaans text, withdrawal periods that do not match the data in the dossier, incomplete dosing directions, missing scheduling declarations, and labels that reference indications or species not covered by the approved registration. Another recurring issue is the failure to update labels after a variation has been approved, leading to marketed products carrying outdated information.

Each of these creates regulatory exposure — and in a market where Act 36 enforcement is tightening, registration holders cannot afford to treat labelling as an afterthought.

Getting It Right Before Submission

Avidara's Document Review service provides a detailed, regulation-referenced assessment of your veterinary product labels and dossier documents before they reach the Registrar's desk, identifying non-conformances against Act 36 requirements so you can resolve them proactively rather than reactively. If you want to reduce queries and avoid costly label rework, book a review.