Company code 191351864
Žirmūnų str. 139A, Vilnius, Lithuania
E-mail: vvkt@vvkt.lt,
Phone: +370 5 263 92 64
Fax: +370 5 263 92 65






National requirements in MRP/DCP
  1. National translations of the final SPC, package leaflet and labelling should be send in Microsoft Word within 5 working days after the end of the procedure to registracija@vvkt.lt. The templates are available here. The translations should be made by the qualified medical professional and reviewed by qualified linguistic professional. Translations of poor quality such as made by Google translator will never be accepted.
  2. To transfer Marketing Authorisation during the procedure, the original of the transfer agreement signed by both sides should be submitted to registracija@vvkt.lt and a hard copy to State Medicine Control Agency of Lithuania, Žirmūnų str. 139A, Vilnius, Lithuania.
  3. The name of the medicinal product should be agreed during validation phase or, as an alternative, during national phase i.e. after Day 90/210. For issues regarding names of the medicinal products please contact Dovilė Zacharkienė dovilezacharkiene@vvkt.lt or pavadinimai@vvkt.lt .
  4. Electronic response documents regarding marketing authorisation, renewal and variations should be sent to State Medicine Control Agency of Lithuania, Žirmūnų str. 139A, Vilnius, Lithuania. A copy may also be send to response@vvkt.lt. Requirements are available at /index.php?2287345064.




Last Update: 2015-07-31 15:25:35