Government amends Swedish ordinance on trade in medicinal products

The Swedish Government has amended the ordinance on trade in medicinal products. The amending ordinance, SFS 2026:1796, was published in Svensk författningssamling on 13 October 2026 and signed in Stockholm on 9 October 2026. It changes the ordinance (2009:659) om handel med läkemedel, the rulebook that governs pharmacies, pharmaceutical wholesalers and the Läkemedelsverket.

The document is formally a “förordning om ändring i förordningen (2009:659) om handel med läkemedel” — the standard Swedish instrument by which the Regeringen rewrites individual provisions of an existing ordinance instead of replacing it. It is carried in section I of the statute book, the section reserved for laws and ordinances issued by the Government through Regeringskansliet. The amended ordinance belongs to the medicinal-products trade regime whose statutory basis is lagen (2009:366) om handel med läkemedel.

Under that framework the Läkemedelsverket is the authority that decides on permits for trade in medicinal products. Other ordinances published in the same statute book this autumn confirm that role: SFS 2026:1758 and SFS 2026:1759 both authorise the release of register data to the Läkemedelsverket for the vetting of applicants for permits under 2 kap. 1 § lagen (2009:366) om handel med läkemedel or lagen (1992:860) om kontroll av narkotika.

What the gazette records

• Amending act: SFS 2026:1796, “Förordning om ändring i förordningen (2009:659) om handel med läkemedel”.
• Issuing body: Regeringen, through Regeringskansliet.
• Publication: Svensk författningssamling, 13 October 2026, section I.
• Signature: Stockholm, 9 October 2026.
• Ordinance amended: 2009:659 om handel med läkemedel.

Who is affected

• Pharmacies and other operators in retail trade with medicinal products, licensed under lagen (2009:366) om handel med läkemedel.
• Pharmaceutical wholesalers, whose activity is regulated by the same trade regime.
• The Läkemedelsverket, as the licensing and supervisory authority.
• Public bodies that provide electronic identification infrastructure for retail trade with medicinal products, a task assigned to the Digitaliseringsmyndigheten by SFS 2026:1769.

Why it matters

An amending ordinance of this kind changes the operative text that pharmacies and wholesalers must follow, so operators need to check the new wording against their own procedures and permits. The change also matters for the Läkemedelsverket, whose permit decisions and supervision rest on the ordinance.

Because the instrument is published as an amendment, the change takes effect as a revision of the existing text of 2009:659 rather than as a new, self-contained regulation. The amendment is dated 13 October 2026 in the statute book, the same day it was made public.

For readers — patients, pharmacy operators and wholesalers — the practical effect is that the legal basis for trade in medicinal products has been updated, with the Läkemedelsverket continuing to act as the deciding and supervising authority.

Source: Svensk författningssamling, SFS 2026:1796, 13 October 2026, section I (official reference: SFS 2026:1796).