LT RMS

In 2026, the Agency issued 15 SLOTs for the decentralized procedure, with Lithuania as the reference member state. Unfortunately, we have no possibility to accept more registration applications for 2026, with Lithuania acting as the reference member state in DC procedure, therefore the applicants are kindly asked not to send the request forms for 2026.
Information about opportunities to submit additional applications for the DC procedure in 2026, when Lithuania is acting as the RMS, will be published on the agency's website.
Applications for DC procedures, where Lithuania is the reference member state and the desired submission date is 2027, are kindly awaited from September 2026.

As before, the requests should be submitted by carefully filling the standard request form (Common request form), which can be found on the CMD(h) website: http://www.hma.eu/219.html. The request form shall be sent by email to vvkt@vvkt. A properly filled out application form is extremely important in assessing the Agency's ability to accept the application and in deciding whether the proposed medicinal product meets the applicable priority criteria.

Priority criteria:
The Agency gives priority to antibiotics, medicinal products intended for children, and medicinal products that are in short supply on the Lithuanian market. Evaluating the applicant’s request, consideration is given to whether the proposed medicinal product will be supplied to the Lithuanian market also availability of experts, and their experience in evaluating the registration dossiers of the relevant medicinal products.
The applicants are kindly asked, if possible, to provide the information about the Mutual Recognition Procedures planned for 2026 to the Agency, when Lithuania would be the Reference Member State. This would help us to properly plan and allocate resources and smoothly organize the work of the experts.

IMPORTANT: Applicants are requested to inform us at least 2 months before the agreed time slot for application submission 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 Agency has already agreed to act as a RMS, the Agency reserves the right to remove such applications from the list and offer their time slot to the other applicants.

Applicants are reminded that, in exceptional cases to alleviate shortages or problems with access to critical medicinal products Zero-day procedure may be initiated.

This is a simplified repeat use procedure, during which Lithuania would unconditionally recognize the registration of a medicinal product authorised in other European Economic Area (EEA) countries under the mutual recognition or decentralized procedure, when submitting a marketing authorisation dossier identical to the approved one in reference member state (hereinafter – RMS). In other words, the Zero-day procedure would apply to those medicinal products whose quality, safety and efficacy have been assessed by experts from the competent authorities of other EEA (at least two individual) countries and an assessment report has been drawn up.

It should be noted that potential applicants should always contact the State Medicines Control Agency (hereinafter – SMCA) and provide request before initiating any procedure, where the goal is a short procedure, and SMCA will decide in advance on a case by case basis, if this approach is acceptable.

Once the SMCA has confirmed that a Zero-day procedure can be initiated, the Applicant should contact the RMS to update an Assessment Report of medicinal product in question, to state the date of submission of application for a Zero-day marketing authorization and to initiate a Zero-day procedure.