Company code 191351864
Studentų str. 45A, Vilnius, Lithuania
E-mail: [email protected],
Phone: +370 5 263 92 64
Fax: +370 5 263 92 65









News title
Available Slots for RMS procedures in 2023
2022-12-01

For the last few years, the Agency has been actively involved in the registration procedures of medicinal products as a reference state (RMS), responsible for preparing a medicinal product evaluation protocol that is recognized/not recognized by other parties participating in the procedure.

In 2023, it is already planned to accept 18 RMS procedures, but in the III-IV quarter of that year, the Agency is ready additionally to accept 5 more procedures. Since a very small number of procedures will be additionally accepted in 2023, priority will be given to applications for registration of medicinal products intended for children, as well as antibiotics, as there is a lack of medicinal products of the aforementioned groups in the Lithuanian market.

We would like to point out that the participation of the Office in medicines registration procedures as a reference state is very important for the whole country, as it primarily ensures the conditions for new medicines to enter the Lithuanian market. At the same time, competition between marketing authorization holders is encouraged, which means that conditions are created for drug prices to decrease and the availability of drugs to patients is increased. Meanwhile, Lithuanian manufacturers have more favorable conditions to present their developed and produced medicines to the markets of other EEA countries.

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Legislation of the "grace period"
2022-11-10

In order to create conditions for the uninterrupted supply of medicinal products to the market of the Republic of Lithuania, the postponement of the implementation of changes to the conditions of the registration certificate (hereinafter - Changes) is legalized in Lithuania (except for cases related to the safety of medicinal products).

For that purpose, the order of State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania no. 1A-233 “On the sale of packages of medicinal products” (24th of March, 2011) had been changed. After legalizing the proposed changes, marketing authorisation holders will have the opportunity to smoothly and continuously supply medicinal products to the Lithuanian market in packages labelled in the Lithuanian language with Lithuanian package leaflets.

The practice of postponing the implementation of changes will significantly reduce the administrative burden of marketing authorisation holders - after each change approval, they will not be asked to submit a report on the quantities of batches and packages of the medicinal product on the market of the Republic of Lithuania and/or produced and released on the market of the Republic of Lithuania before the conditions of the registration certificate of the medicinal product were changed. The practice of delaying the implementation of changes is also applied in other EU countries.

You can find the current version of the order by clicking here.

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For the attention of customers! The address of the State Medicines Control Agency is changing!
2022-04-12

We would like to inform you that from the 9th of May 2022, the State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania will move to new premises. The new address is Studentų str. 45A Vilnius. 

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How to clarify the information about the medicines on which the Ukrainians were treated?
2022-03-22

Dear friends

The situation in Ukraine is resulting in a million refugees wave into many countries. One issue is naturally the continuation of existing medical treatment. IQVIA, the leading provider of market information about pharmaceuticals, using IQVIA and Ukraine data from Proxima, has set up a “Script Translator”.

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Requests for Lithuania acting as Reference Member State
2022-03-01

Lithuania acts as Reference Member State (RMS) in Decentralised procedures (DCP) and Mutual recognition procedures (MRP).

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Regarding medicinal products for which „sunset clause“ may already
2022-02-21

The State Medicines Control Agency on the ground of market monitoring data has compiled the list of medicinal products authorized in the Republic of Lithuania which more than for three years had not been supplied to the Lithuanian market.

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Regarding medicinal products for which „sunset clause“ may already be applied
2021-03-05

The State Medicines Control Agency on the ground of market monitoring data has compiled the list of medicinal products authorized in the Republic of Lithuania which more than for three years had not been supplied to the Lithuanian market.

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Notification for marketing authorisation holders
2021-03-03

We remind you that ATC codes have been changed by World Health Organization in 1st of January, 2021. Marketing authorisation holders should submit variation application in order to implement changes in summary product characteristic. Marketing authorisation holder can do this by submitting a separate application (A.6/ IA type), or by merging with the next related variation application. The changed list of ATC codes can be found here (clause 6.6): /index.php?2872196176

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Information for marketing authorisation holders
2021-01-04

Please be informed that a Report of batches and quantities of the medicinal product manufactured for the market of the Republic of Lithuania and/or changing the conditions of the marketing authorization of the medicinal product manufactured and released from 4th of January ((https://www.e-tar.lt/portal/lt/legalAct/80df48514b4711eb8d9fe110e148c770), 2021 should be submitted to SMCA via online report form. The form is placed on the SMCA website section /index.php?1148175238

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Collaboration with Visegrad group
2020-05-11

The State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania (SMCA) is continuing its collaboration with the Visegrad group. 

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For the attention of legal entities providing information on supply shortages
2020-05-07

The Agency has developed a tool, based on the format developed by the EEA and taking into account the practice of other countries, to enable legal entities to provide the Agency with unified data on shortages in the supply of medicinal products. The data you provide will be easier to organize and process. Marketing authorisation holders and holders of parallel import authorizations are requested to provide information on supply disruptions of medicinal products only by completing this special electronic form. You can find it by clicking on the following link: https://bit.ly/VPtiekimoSutrikimai  

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Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic
2020-03-24

The impact of the COVID-19 pandemic on European health systems will make it necessary for sponsors to adjust how they manage clinical trials and the people who participate in these trials.

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Twinning project in North Macedonia laid a new basis for future cooperation
2020-03-19

Central Project Management Agency (CPMA) in cooperation with the State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania (VVKT) completed the EU funded Twinning project „Harmonisation of the legislation for medicinal products with EU legislation and building capacities for its implementation“ in North Macedonia.

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For Marketing authorisation applicants
2020-02-21

Lithuania intends to act as Reference Member State (RMS) in 10 Decentralised procedures (DCP) in 2020. Currently there are free slots.

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Regarding medicinal products for which „sunset clause“ may already be applied
2020-02-18

The State Medicines Control Agency on the ground of market monitoring data has compiled the list of medicinal products authorized in the Republic of Lithuania which more than for three years had not been supplied to the Lithuanian market.

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Information for Marketing authorisation holders
2020-02-10

To assess the likelihood of a potential drug supply disruption related to coronavirus infection, the Agency is asking all marketing authorisation holders whose active substances are manufactured in China inform the Agency of any unexpected disruption of the active substances due to the named reason. Information should be send by e-mail [email protected] until 17th of February 2020.

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Cardiovascular drugs – the most used in all three Baltic countries from 2016-2018
2020-01-23

The most widely used in all three Baltic countries is the group of cardiovascular drugs consumption of which exceeds more than threefold the consumption of second most widely used ATC* groups in each country – shows the data in the new book “Baltic Statistics on Medicines 2016–2018”. The second most widely used group of medicines was an alimentary tract and metabolism drugs in Latvia and Estonia and the nervous system drugs in Lithuania.

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New possibilities for submission of Clinical Trials applications
2020-01-06

In order to simplify the submission process of applications for clinical trials on medicinal products and to waive the submission of paper documents, The State Medicines Control Agency (SMCA) will now accept all documentation related to clinical trial applications in an electronic file format.

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