List of text documents of medicinal products with valid marketing authorisation in Slovakia — SPC (Summary of Product Characteristics) and PIL (Payment leaflet)

The list contains DOC or PDF documents. Each authorised medicinal product has its own documents, namely SPC and PIL. These are medicines that have a valid registration in Slovakia. The marketing authorisation shall be issued either by the SCC or by the European Commission. The SUKL issues marketing authorisations for marketing authorisations for marketing authorisations under the national procedure (valid marketing authorisation only in Slovakia) or through the decentralised procedure (medicines registered not only in Slovakia but also in other EU countries at the choice of the registration holder) or by mutual recognition procedure (the same applies conditions as in the case of the decentralised procedure). The European Commission issues decisions for medicinal products authorised on a centralised basis and are valid throughout the EU. The file contains about 25 thousand items. Directory contains files for the current year