Council of Ministers approved amendments to the Law on Medicinal Products for Human Use (LMPHM). The document reflects the changes in European regulation of medicinal products, the entry into force of Regulation (EC) 1234/2008 and it clarifies the existing provisions of LMPHM.

Regulation (EC) 1234/2008 has a direct effect on the process of changing authorizations of medicinal products, issued under the Mutual Recognition Procedure and Decentralised procedure between the Member States. It introduces entirely new principles of classification and grouping of changes, new deadlines for their completion and implementation.