Marketing authorisation of pharmaceuticals
Any proprietary medicinal product is subject to marketing authorisation prior to its placement on the market in the Czech Republic. The marketing authorisation procedure includes an assessment of a dossier, in which the future marketing authorisation holder (MAH) evidences the safety, efficacy, and quality of the product. Furthermore, the indications, contraindications, dosage of the product, general classification for supply, as well as the package leaflet for the patient and proposed texts on the labelling of the medicinal products are assessed. The Summary of Product Characteristics (SPC) forms part of the marketing Authorisation. It serves as the key source of information about the medicinal product for doctors and healthcare professionals.