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Biological medicines

Group of substances

Schedule 4, conditions apply

No structure available

Biological medicines is a group of substances, so there is no single molecule to show.

Background

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Listing

Schedules
Schedule 4, conditions apply
Source
Consolidated Schedules 06 July 2026

Registered medicines

The ingredient index links no registered medicine to Biological medicines (register of 13 September 2026).

Counted through the register's ingredient index, which does not reach every record.

Regulatory status

Where S4 sits on the scale

Prescription-only medicine.

Schedule 4 covers most ordinary prescription medicines. You need a prescription from an authorised prescriber, such as a doctor or dentist, and a pharmacist dispenses it. Its price, name, pack size and strength can still be told to the public, as long as nothing links it to what it treats.

Schedule S4, as the Consolidated Schedules list it.

Who may supply: A pharmacist dispensing against a written or verbal prescription from an authorised prescriber; a veterinarian, who may also prescribe, compound or dispense it directly; a medical practitioner or dentist, who may prescribe it and may compound or dispense it directly only if licensed under section 22C(1)(a); manufacturers and wholesalers may supply people who may lawfully possess it; and, for animal treatment, a person practising a para-veterinary profession, on a veterinarian's written or verbal instruction.

Consolidated Schedules listings for Biological medicines

  • S4: Biological medicines

    • injectable preparations thereof, when intended for human use and unless listed elsewhere in the Schedules,
    • except vaccines, when listed elsewhere in the Schedules and vaccines registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).
    • but specifically including the following - (i) Equine anti-human thymocyte globulin; (ii) Equine gamma globulin; (iii) Human anti-D immunoglobulin; (iv) Human anti-thymocyte rabbit immunoglobulin; (v) Hepatitis A vaccine; (vi) Hepatitis B immunoglobulin; (vii) Human normal immunoglobulin, possibly polyvalent or possibly including IgG, IgA, or IgM; (viii) Human plasmaalbumin; (ix) Neiserria meningitides vaccine; (x) Pneumococcal vaccine, polysaccharide; (xi) Rabies immunoglobulin; (xii) Rabies vaccine; (xiii) Recombinant cholera toxin B subunit; (xiv) rhDNase-dornase alfa; (xv) Snake antivenom; (xvi) Tetanus immunoglobulin; (xvii) Varicella immunoglobulin; (xviii) Varicella-zoster virus vaccine; (xix) Yellow Fever virus, attenuated.

    Consolidated Schedules 06 July 2026, lines 5503 to 5553

This is an informational summary of the Medicines and Related Substances Act 101 of 1965 and its 2017 General Regulations. It is not medical advice and not legal advice. Always check the medicine's label, which carries the schedule number inside a square border, or ask a pharmacist if you are unsure.

Research articles

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