Marketing authorisation of medicines

Every mass-produced medicinal product is subject to registration before being placed on the market in the Czech Republic. As part of the registration process, the dossier in which the prospective marketing authorisation holder demonstrates the safety, efficacy and quality of the product is assessed. The indications, contraindications, dosage of the product, classification for dispensing, as well as the patient package leaflet and draft texts on the packaging of the medicinal product are also assessed. The Summary of Product Characteristics (SmPC), which is sent with the marketing authorisation decision, serves as a key source of information on the medicinal product for doctors and healthcare professionals.