Harmonisation of pharmaceutical law must also include requirements of the introduction of variations to the terms of marketing authorisations for medicinal products. In this aim the first of January 2010 it was introduced a new Commission Regulation (EC) No 1234/2008 of 24 November 2008. This directive concern only medicinal products which were introduced to the pharmaceutical market on base of the European regulation (mutual recognition procedure and centralised marketing authorization). Nevertheless that the new directive make easier for the marketing authorization holder to submit variations but it cannot be used for medicinal products which have an marketing authorisations on base of the national regulation. Those medicinal products are regulated on base on the regulation of Ministry of Health of 18 December 2002 concerning the examination of variations to the terms of marketing authorizations and documentation concerning introduction on the market of medicinal products. Topicality and rationalization of this regulation are the subject of discussion in this article.