Ravimi müügiloa taotluse liigid ja vorminõuded, täiendava dokumentatsiooni loetelu, täiendavale dokumentatsioonile esitatavad nõuded, taotluse erialase hindamise tasu suurus taotluse eri liikide kaupa ning tasu arvestamise ja tasumise kord

This regulation sets out the types and formal requirements for applications for marketing authorisation for medicinal products. It details the list of supplementary documentation needed, the requirements for this documentation, and the fees for the scientific assessment of applications. This affects pharmaceutical companies seeking to market medicines in Estonia. It clarifies the administrative and financial procedures involved in the authorisation process.