This Act regulates the development, authorisation, manufacture, distribution, supervision, and monitoring of medicinal products intended for human and veterinary use in Slovenia. It defines the legal framework governing medicinal products and establishes rules concerning their quality, safety, and therapeutic effectiveness. It sets out the definitions of key concepts related to medicinal products, including active substances, biological medicines, pharmacovigilance, clinical trials, and marketing authorisation. These definitions provide the basis for regulating the lifecycle of medicinal products, from their development and evaluation to their distribution and use within the healthcare system.
It describes the documentation and scientific evidence necessary to demonstrate the quality, safety, and efficacy of medicinal products and outlines different regulatory pathways for authorisation. The Act also contains provisions relating to specific categories of medicinal products, including generic medicines, traditional herbal medicinal products, homeopathic medicines, and medicines with well-established medical use. In addition, it includes provisions governing special situations such as compassionate use programmes that allow access to certain medicinal products before full authorisation in cases involving serious or life-threatening conditions.
The Act regulates the manufacturing, import, and wholesale distribution of medicinal products. These provisions establish requirements for licensing, quality control, and record-keeping throughout the pharmaceutical supply chain. The Act also provides rules for product labelling, packaging, and patient information, ensuring that medicines are accompanied by clear instructions and safety information. Conditions for the dispensing of medicines are also defined. By regulating these activities, the Act seeks to maintain the integrity and traceability of medicinal products from production to patient use.
The Act further contains provisions governing the advertising and promotion of medicinal products. Advertising is defined broadly and includes any form of communication intended to promote the prescription, supply, sale, or consumption of medicines. In that regard, the Act distinguishes between advertising directed at the general public and that directed at healthcare professionals and sets conditions designed to ensure that promotional information is accurate and consistent with approved product characteristics.