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 sent 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. 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].
3. Electronic response documents regarding marketing authorisation, renewal and variations should be sent to State Medicine Control Agency of Lithuania, Studentų g. 45A, Vilnius, Lithuania. A copy may also be sent to [email protected]. Requirements are available at /index.php?2287345064.

The State Medicines Control Agency will accept 10 applications for registration procedures in 2025, in which Lithuania will act as reference member state. 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. 

Currently SMCA-LT can accept 2 applications for the decentralised procedure for 2025, when Lithuania acts as a reference member state. The applicants are invited to submit requests by carefully filling out the Common request form, it can be found on the CMD(h) website: http://www.hma.eu/219.html. Requests must be submitted by e-mail to vvkt@vvkt. A properly fill out Common request form is very important in assessing the Authority capabilities and deciding on the compliance of the proposed medicinal product with the applicable priority criteria.

IMPORTANT: Applicants are requested to inform us at least 2 months before the agreed application submission date whether they intend to submit their application on time. If the applicant is unable to submit the application(s) on time or does not intend to submit the application(s) or wishes to switch the medicinal product for which the Authority has already agreed to act as a RMS, the Authority reserves the right to remove such applications from the list and offer their time slot to the other applicants.