Release date: 16 November 2011
Date of updating: 5 December 2011
The list of categorised medicinal products to be published by the Ministry of Health of the Slovak Republic (hereinafter referred to as "the Ministry') on its website from 1 January 2012 will include the designation of original and generic medicinal products.
Definition of the original and generic medicinal product pursuant to Article 8 (2) of Law No 363/2011 Coll.:
- Original product for the purposes of this Act, "drug' means a drug which has been at the time of granting the marketing authorisation for a medicinal product protected by patent protection./
- Generics for the purposes of this Act, the term "medicinal product' means a medicinal product which is the same qualitative and quantitative composition of the medicinal products and the same pharmaceutical form as the original medicinal product and whose biological equivalence with the original medicinal product has been demonstrated by appropriate bioavailability tests; different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of the active substance shall be considered to be the same medicinal product if their properties do not differ significantly in terms of safety or efficacy from the original medicinal product.
The Ministry shall submit, for comments, preliminary material in which information is assigned to each medicinal product on whether it is an original medicinal product or a generic medicinal product.
Comments on the material submitted, together with the justification, can be sent to kategorizacia@health.gov.sk .
Comments shall be sent in the form of: The product is subject to the following conditions:.
The subject matter of the e-mail shall indicate: A reminder of the original / generic: code of the medicinal product or medicinal products.