The Regulations of the Swedish Medicines Agency on Trade in Certain Over-the-counter Medicines (HSLF-FS 2024:27)

Sweden Introduces New Regulations for Over-the-Counter Medicine Distribution
This document outlines new regulations for the retail trade, distribution, and handling of certain over-the-counter (OTC) medicines in Sweden, emphasizing:

• Self-Control Programs: Businesses must implement self-control measures, including risk assessments, process mapping, and systematic follow-ups to ensure compliance with safety and quality standards.
• Documentation & Traceability: Records must be maintained for procurement, distribution, and the handling of complaints and product withdrawals to ensure traceability.
• Distribution Requirements: Medicines must be stored and distributed under approved conditions to prevent quality deterioration, theft, or unauthorized access. Any deviations must be addressed immediately.
• Enforcement & Exceptions: The Swedish Medicines Agency will enforce these regulations, with exceptions granted under special circumstances.

The regulations will take effect on 01-Nov-2025, with specific deadlines set for compliance.

Region: Sweden
Source: https://www.lakemedelsverket.se/4aaf25/globalassets/dokument/lagar-och-regler/hslf-fs/hslf-fs-2024-27.pdf