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Legality · Pregabalin

Is Pregabalin legal in Belgium?

Also known as: lyrica

Confirmed against a primary sourceVerified October 8, 2026
Legal status
Pregabalin is a controlled substance in Belgium because it is listed. The Royal Decree of 6 September 2017 prints it at Annex IV limb B, where the entry is pregabaline with a stated start date of 19 July 2026, and, for preparations composed with one or more other substances that stay at or below 330 mg per dosage unit or 5 percent in undivided form, also at Annex IV limb C with the same start date. The entry is what proves listing. The operative provisions come from the instrument named for this row, the Royal Decree of 6 September 2017, where article 2 defines the controlled substances through Annexes I to V and article 61 routes a breach back to the Law of 24 February 1921. Belgium works a delegated model: article 2bis §1 of the Law of 24 February 1921 punishes breaches concerning substances whose list is settled by the King, and the Royal Decree of 6 September 2017 supplies that list. The named lists are closed, so pharmacological resemblance, a similar spelling or a substring match cannot enlarge them. Like the related anticonvulsant in this table, the entry carries its own commencement date, and the date is part of what the entry says.
Consequences if caught
Capital exposure: none. Belgium's drug law carries no death penalty and no life sentence. What does attach to pregabalin is the article 2bis ladder in the Law of 24 February 1921, which article 61 of the decree routes a breach to once the substance is listed, and here the control commenced on a stated date printed in the annex itself. Article 2bis §1 sets the ordinary band at three months to five years of imprisonment with a fine of EUR 1,000 to 100,000. Article 2bis §3 raises that to ten to fifteen years for its stated aggravations, including where use following the offence causes death. Article 2bis §4 carries the ceiling, fifteen to twenty years, where the offence concerns a child under twelve or participation as a leader in an association, so twenty years is the maximum imprisonment this statute exposes. Article 2bis §5 allows a further fine of EUR 1,000 to 100,000 in the §2 to §4 cases, which makes that fine available rather than automatic. Annex IV limb B is the national limb, where Belgium adds entries of its own rather than importing an international schedule, and the limb bears on the traveller document rule rather than on the band.
If prescribed or medical
The rule that applies to a traveller carrying the medicine in international traffic is article 3, paragraph 4, point 4 of the Royal Decree of 6 September 2017, which provides that the decree does not apply to that carriage. It is a document exception rather than a schedule, and it is not a prescribing right. It covers a medicine carried by a traveller in international traffic, in a quantity that does not exceed three months of treatment, for that traveller's own personal use, and lawfully obtained, and it expressly excludes the substances listed in Annex II limb A. Pregabalin is printed at Annex IV limb B and, for preparations composed with one or more other substances that stay at or below 330 mg per dosage unit or 5 percent in undivided form, also at Annex IV limb C, both with effect from 19 July 2026. Article 3, paragraph 4, point 4 excludes only Annex II limb A, so neither limb removes the exception, and the exception can apply on its own terms where the medicine was lawfully obtained and the international travel, personal use, three month and certificate conditions are all met. To rely on it, the traveller must be able to present a certificate from their own authority or from a health professional, to the competent officials referred to in article 7 of the Law of 24 February 1921. Pregabalin's control commenced on the printed date of 19 July 2026, and the article 3 exception stated above is the only traveller route this entry states.
Documentation
Carry a certificate from your own authority or from a health professional, to present to the competent officials referred to in article 7 of the Law of 24 February 1921. Article 3, paragraph 4, point 4 of the Royal Decree of 6 September 2017 is the only document exception this entry states. The exception covers the carriage by travellers in international traffic of medicines, for their personal use, lawfully obtained, in a quantity not exceeding three months of treatment. Note the commencement date of 19 July 2026 printed on this entry. The placement at Annex IV limb B was read on 18 September 2026 in the non official consolidated version published by the AFMPS; it is informative and the Moniteur belge controls. The same consolidated version prints a pregabaline entry in Annex IV limb C, for preparations, with the same start date. That annex consolidation is valid from 29 March 2026, following the amending Royal Decree published 19 March 2026, and carries a correction dated 16 July 2026.
Primary sources
  • Belgium, Royal Decree of 6 September 2017, Annex IV limb B, with articles 2, 8 and 61 of that decree and article 2bis of the Law of 24 February 1921 carrying the offence and the penalties
  • the printed entry relied on is pregabaline with a stated start date of 19 July 2026
  • read at https://www.afmps.be/sites/default/files/content/INSP/NARC/annex%20IV_non%20official%20consolidated%20version.pdf on 18 September 2026
  • the printed limb C entry for preparations is pregabaline with a stated start date of 19 July 2026 and the 330 mg per dosage unit or 5 percent condition
  • the decree is at https://www.ejustice.just.fgov.be/eli/arrete/2017/09/06/2017031231/justel and the 1921 Law bilingual consolidation at https://afmps.be/sites/default/files/downloads/LOI-WET-1921-02-24.pdf
  • the annex text is the AFMPS non official consolidated version, valid from 29 March 2026 with a correction dated 16 July 2026, and the Moniteur belge controls
  • article 3, paragraph 4, point 4 of the same decree and article 7 of the Law of 24 February 1921 for the traveller's document exception, Dutch Justel consolidation read at https://www.ejustice.just.fgov.be/cgi_loi/change_lg.pl?cn=2017090603&la=N&language=nl&table_name=wet on 7 October 2026

Court records

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

Other substances confirmed in Belgium

Same substance, other countries