läkemedelssubstansens

Läkemedelssubstans is a term used in pharmaceutical regulation to refer to the active ingredient in a medicinal product. It is the component of a drug that is responsible for its pharmacological effect. The term is commonly used in the context of patent law, where the patentability of a medicinal product is often assessed based on the novelty and non-obviousness of its active substance.

The concept of läkemedelssubstans is important in the pharmaceutical industry for several reasons. Firstly, it helps in the classification and comparison of different drugs. Two drugs with the same active substance are considered to be generics of each other, regardless of their dosage form, route of administration, or other differences. Secondly, it is crucial for patent protection. A new active substance can be patented, but a new formulation or a new route of administration of an existing active substance generally cannot.

In the European Union, the term "active substance" is used instead of "läkemedelssubstans." The European Medicines Agency (EMA) and the European Patent Office (EPO) use this terminology in their respective regulations. The EMA defines an active substance as "any substance (other than a living organism, biological material or a virus) that is not normally found in the human body and that is administered to or used by humans with the intention of preventing, diagnosing, treating or curing a disease or to restore, correct or modify physiological functions in man."

Understanding the concept of läkemedelssubstans is essential for healthcare professionals, researchers, and policymakers. It ensures that drugs are developed and regulated in a way that promotes public health while also encouraging innovation in the pharmaceutical industry.