lääkeainerekisteri

Lääkeainerekisteri translates to "Drug Substance Register" in English. It is a digital database maintained by the Finnish Medicines Agency (Fimea) that contains comprehensive information about active pharmaceutical ingredients (APIs) authorized for use in medicinal products in Finland. The register serves as a central repository for data related to the quality, safety, and efficacy of these substances.

The primary purpose of the Lääkeainerekisteri is to ensure the consistent availability of high-quality medicinal products for the Finnish population. It plays a crucial role in pharmacovigilance by tracking and monitoring the properties of drug substances. This includes information such as the manufacturer of the API, its origin, its manufacturing process, and its specifications.

Access to the Lääkeainerekisteri is primarily for regulatory authorities like Fimea and other relevant bodies involved in drug authorization and surveillance. Pharmaceutical companies also interact with the register as part of their product authorization and lifecycle management processes. The data within the register is essential for Fimea's oversight activities, including the assessment of new marketing authorizations, variations to existing authorizations, and post-market surveillance. It contributes to the overall safety and reliability of medicines available in Finland.