LT RMS

For Marketing authorisation applicants 

Lithuania acts as Reference Member State in DC- procedures.  SMCA is ambitious to actively participate in assessment of marketing authorisation applications. 

How to apply? The applicants are invited to submit requests with Common request form, which is presented in CMD(h) website: http://www.hma.eu/219.html

Please send requests via e-mail to [email protected]. If you have any questions regarding LT RMS procedures (koordination isuues) please contact. [email protected]

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 [email protected]. 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 [email protected] 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 [email protected] .
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 [email protected]. Requirements are available at /index.php?2287345064.

Availability of SLOTS for 2025 will be announced at the end of 2024 (or at the beginning of 2025). Priority, as previous, will be given to applications for authorization of medicinal products intended for children, as well as antibiotics, as there is a lack of medicinal products of the aforementioned groups on the Lithuanian market.