The State Medicines Control Agency informs that from 1st January 2010 applications for variations to the terms of purely national marketing authorisations should be submitted according to the Regulation (EC) 1234/2008 or Regulation (EC) 1084/2003.

Presumably, in spring 2010 the Parliament of the Republic of Lithuania shall amend the Law on Pharmacy of the Republic of Lithuania requiring variations to the terms of purely national marketing authorisations to be examined according to the Regulation (EC) 1234/2008. Afterwards, all variations to the terms of marketing authorisations of medicinal products shall be submitted and examined according the Regulation (EC) 1234/2008 only.

Regulation (EC) 1234/2008 shall apply from 1 January 2010. It  will be directly applicable to authorisations granted through decentralised or mutual recognition procedure as well as to ones granted in accordance with Council Directive 87/22/EEC („ex-concertation“) or following Community referral.

Regulation (EC) 1234/2008 repeals Regulations (EC) No 1084/2003 and No 1085/2003. It  requires all References to the repealed Regulation to be construed as references to the new Regulation.