The present Act regulates the distribution and sale of medicines across the entire supply chain, including retail pharmacies, wholesale distribution, hospital supply, and certain intermediary activities. It establishes a licensing system under the supervision of the Swedish Medical Products Agency, requiring authorisation for retail and wholesale activities and setting detailed operational requirements (e.g. staffing with qualified pharmacists, appropriate premises, traceability, and quality control). The law aims to ensure that medicines are handled safely and effectively, without harm to people, property, or the environment, while maintaining product quality throughout distribution. It also defines key concepts such as retail trade, wholesale trade, pharmacies, and pharmaceutical professionals, and clarifies its relationship with other national and EU legislation. The Act further imposes obligations on pharmacy operators and wholesalers, including ensuring access to prescribed medicines, providing independent advice to consumers, maintaining stock based on demand, and reporting data to national authorities. It includes rules on distance sales, age restrictions (e.g. for nicotine medicines), and the use of pharmacy agents to improve access in underserved areas. Enforcement mechanisms include inspections, orders, fines, and the possibility of revoking licences, as well as criminal penalties for unlawful trade. The law also covers hospital medicine supply, return of medicines, supervision, fees, and appeals.
Sweden · 2009-05-07