Pharmaceuticals Act (2015: 315).

The Pharmaceuticals Act is Sweden’s primary legal framework for the regulation of medicinal products. Its overarching aim is to safeguard human and animal health, public health, and the environment, while enabling the development and trade of pharmaceuticals within Sweden and the European Economic Area (EEA). The Act defines the scope of its application, including definitions of pharmaceutical terms, and sets legal requirements for the approval, registration, and sale of both human and veterinary medicines. It establishes strict criteria for manufacturing, clinical trials, safety monitoring, and marketing, and lays out processes for recognizing approvals from other EEA states. It also provides special rules for homeopathic and traditional herbal medicines, as well as drugs made under hospital exemptions.
The Act consists of 18 chapters and includes provisions on everything from the handling of active substances and safety obligations to the responsibilities of manufacturers and marketers. Regulatory oversight is assigned mainly to the Swedish Medical Products Agency (Läkemedelsverket), which is empowered to approve or withdraw licenses, enforce compliance, and manage classification and interchangeability of medicines. The Act also outlines administrative processes, such as appeal procedures, fee structures, and penalties for violations. Overall, it aligns Swedish pharmaceutical regulation with EU directives and ensures a structured and controlled pharmaceutical market that prioritizes safety and efficacy.