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Legality · Pregabalin

Is Pregabalin legal in South Africa?

Confirmed against a primary sourceVerified October 4, 2026
Legal status
Controlled as a Schedule 5 substance under the Medicines and Related Substances Act 101 of 1965, as at the SAHPRA consolidation of 1 August 2025; it is not printed in the Drugs and Drug Trafficking Act 140 of 1992.
Consequences if caught
Schedule 5 prints it under its own name as "Pregabalin." on page 175, with no specified marker. Its neighbour in chemistry, gabapentin, sits two schedules lower, as "Gabapentin." in Schedule 3 on page 68. Section 22A (1) of the Medicines Act says no person shall "sell, have in his or her possession or manufacture any medicine, Scheduled substance, medical device or IVD, except in accordance with the prescribed conditions." Section 22A (16) (b) lets any person possess a Schedule 3, Schedule 4, Schedule 5 or Schedule 6 substance "if he or she is in possession of a prescription issued by an authorised prescriber", and section 22A (5) confines the sale of a Schedule 5 substance to a pharmacist acting on a prescription or on the verbal instructions of an authorised prescriber, to a manufacturer or wholesale dealer, and to the prescribing professions it lists. Section 22A (10) adds that no person shall sell or administer any Scheduled substance or medicine "for other than medicinal purposes". Section 29 (k) makes it an offence to contravene "any provision of section 22A", and section 30 (1) makes a person convicted of an offence referred to in section 29 "liable to a fine, or to imprisonment for a period not exceeding 10 years." Section 30 (2) lets the court declare the substance forfeited to the State, and section 30 (4) makes a magistrate's court competent to impose the penalty. Section 22A (11) (a) requires an import permit for "any specified Schedule 5, Schedule 6, Schedule 7 or Schedule 8 substance or other substance or medicine prescribed for that purpose", and section 22A (12) (a) extends import control to substances the Minister prescribes and to substances under international control. This entry carries no specified marker and sits in Schedule 5, and no instrument prescribing it for that purpose was found, which does not rule one out; on what was read, that subsection does not itself require a permit to bring it in, and possession on arrival still turns on section 22A (16). Under the Drugs Act the position is different. The chemistry of this substance is closer to gabapentin than to anything in the Act. Neither schedule carries a substituted amino acid of this kind. The nearest entry by effect is the Part III "Gamma-hydroxybutyrate (GHB)." and the comparison is thin: a short chain with a functional group at each end, and nothing else in common. The Act contains no sedative amino acid and no other calcium channel ligand, so the first half of the homologue definition has nothing to attach to and the second half is left to run alone. The limb in question is Part III paragraph 2 (e), which reads "(e) all homologues of the listed substances (being any chemically related substances that incorporate a structural fragment into their structures that is similar to the structure of a listed substance or exhibit pharmacodynamic properties similar to the listed substances in this Part of the Schedule), unless listed separately in any Part of Schedule 2." The equivalent limb in Part I is paragraph 2 (c) and is worded identically for that Part. If the limb does reach this substance the consequences are the ordinary ones for the Part the listed relative sits in: section 4 (b) with section 17 (d) at up to 15 years for use or possession, and section 5 (b) with section 17 (e) at up to 25 years for dealing. If it does not, the Act does not reach the substance at all. This cell does not choose between those two outcomes under the Drugs Act. The Act supplies no test for deciding a homologue case. Capital exposure: none, and life exposure: none. Section 30 (1) of the Medicines Act fixes the penalty for an offence under section 29 at a fine or imprisonment for a period not exceeding 10 years, and section 17 sets out the whole penalty scale of the Drugs Act, whose highest figure is 25 years for dealing; neither Act carries a death sentence or a sentence of life imprisonment.
If prescribed or medical
Pregabalin is a medicine on prescription in South Africa. Outside the practitioners and pharmacies that section 22A (16) (c) and (d) cover, section 22A (16) (b) makes possession lawful only with a prescription issued by an authorised prescriber. For a visitor, SAHPRA's guideline SAHPGL-INSP-RC11, version 2 of June 2022, which restates the General Regulations, says "Any person entering the Republic may be in possession, for personal medicinal use, of- 3.2.1. a quantity of a Schedule 3, 4 or 5 substances, which shall not exceed for use for a period of six months; oral quantity of a Schedule 6 substance, which shall not exceed use for a period of 30 days;" and requires the original prescription, a certified copy of it, or a certificate or letter from the person who prescribed or dispensed it certifying the substance and quantity, with that person's name, physical and email address. The regulation the guideline restates sits behind the same SAHPRA sign in as the July 2026 schedules and was not itself read, so the allowance is stated here from the guideline. Section 22A (17) (a) defines an authorised prescriber as "a medical practitioner, dentist, veterinarian, practitioner, nurse or other person registered under the Health Professions Act, 1974". Section 22A (6) (g) lets a Schedule 5 sale be repeated for no longer than six months, and then only if the prescriber has stated the number of times and the intervals, and section 22A (6) (h) (i) stops a Schedule 5 substance used for its anxiolytic, antidepressant or tranquillising properties being prescribed for longer than six months unless the prescriber has consulted a registered psychiatrist. The Drugs Act's own exceptions in section 4, paragraphs (i) to (vi), run through a practitioner acting in accordance with the Medicines Act, and section 2 of the Drugs Act says it applies "in addition to, and not in substitution for" the Medicines Act.
Documentation
Medicines Act search record, 3 October 2026. Terms searched: pregabalin, Lyrica and gabapentin. Pregabalin returns one Schedule 5 entry on page 175; gabapentin returns one Schedule 3 entry on page 68. The consolidation is a text PDF of 199 pages and was searched as extracted text, every schedule from 0 to 8. The Medicines Act schedules are stated as at the SAHPRA Consolidated Schedules of 1 August 2025, which on a comparison of two of its changes, the inserted fluconazole entry in Schedule 2 and the reworded nicotine metered spray line, both read on pages 4 and 6 of the scanned notice, already carry Government Notice R6466 of 1 August 2025; the rest of that notice was not read. That consolidation is read with Government Notice 7446 in Government Gazette 54627 of 8 May 2026, whose only change is to insert a veterinary yohimbine entry in Schedule 4; both were read on 3 October 2026. SAHPRA now labels the 1 August 2025 file an archived version and offers its July 2026 consolidation only through a Microsoft sign in that refused an anonymous request, so that file was not read, and this does not rule out a later amendment. The text of the Medicines Act read is the consolidation published in Government Gazette 40869 of 26 May 2017, whose list of amending Acts ends at Act 14 of 2015; a search on 3 October 2026 found no later amending Act, which does not rule one out. Drugs Act search record carried from the earlier cell. Search record. The terms searched were pregabalin, Lyrica, gabapentinoid, isobutyl and aminomethyl. All return zero occurrences. The text read for this cell is the Juta consolidation of the Act downloaded on 29 May 2025, taken from the Department of Justice copy at justice.gov.za whose sha256 begins bc1216a3. It carries the substitution of Schedules 1 and 2 by section 2 of Act 14 of 2022 with effect from 14 December 2022, and it marks section 7 of the Cannabis for Private Purposes Act 7 of 2024, the provision that would amend Schedule 2 again, as not yet put into operation by proclamation. The schedules are stated as at that consolidation and this does not rule out a later amendment made or commenced since.
Primary sources
  • Medicines and Related Substances Act 101 of 1965, Schedules made under section 22A (2), Schedule 5, page 175
  • SAHPRA Consolidated Schedules of 1 August 2025, read on 3 October 2026
  • sahpra.org.za
  • Government Notice 7446, Government Gazette 54627 of 8 May 2026, read on 3 October 2026
  • gov.za
  • Medicines and Related Substances Act 101 of 1965, ss 1, 22A, 29 and 30, consolidation in Government Gazette 40869 of 26 May 2017, read on 3 October 2026
  • sahpra.org.za
  • Drugs and Drug Trafficking Act 140 of 1992 fetched again on 3 October 2026, sha256 beginning bc1216a3 and byte identical to the cached copy
  • SAHPRA guideline SAHPGL-INSP-RC11, Guidelines for Release of Imported Health Products at Ports of Entry, version 2, June 2022, paragraphs 3.1.3 and 3.2, read on 3 October 2026
  • sahpra.org.za
  • Drugs and Drug Trafficking Act 140 of 1992, Schedule 2 open homologue limb, nearest entry by effect read and rejected
  • Drugs and Drug Trafficking Act 140 of 1992, ss 1, 2, 3, 4, 5, 13, 17 and 19, with Schedules 1 and 2
  • justice.gov.za
  • read from the cached text at research/instruments/south-africa/za-drugs-act-140-1992.txt, 84,091 bytes, against the.pdf beside it at 127,460 bytes
  • the consolidation is dated 29 May 2025 and carries the Act 14 of 2022 substitution of both schedules with effect from 14 December 2022

Court records

We have not yet assessed whether court records are publicly available for this jurisdiction.

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