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








News title
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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Notification for marketing authorisation holders
2020-10-29

Dear marketing authorisation holders,

Thank you for your comments and active participation in the harmonisation process. Baltic agencies greatly appreciate it. Most of the comments were related to Type IA variations as well as general activities to indicate the RMS approval date for Type IB and Type II variations.

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Information for marketing authorisation holders
2020-10-21

Please be informed template of Registration certificate of the medicinal product has been changed on 15th of October, 2020. More information you can find here

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Notification for marketing authorisation holders (hereinafter - MAH)
2020-10-01

In order to harmonize the approval of variations of medicinal products authorised via mutual recognition or decentralised procedures and to ensure the smooth supply of medicinal products, experts from the Baltic agencies agreed on a single date of approval of IA, IB, II type variations.  

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Information for the Applicants
2020-07-22

From 14 July 2020 a short procedure, the so called “zero-day procedure” has been approved in Lithuania.

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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 vvkt@vvkt.lt 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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Information for the applicants/Marketing authorisation holders
2019-12-23

The State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania informs that form the 1st of January 2020 names of the medicinal products in MR / DC authorisation procedures will be evaluated during the validation, the whole procedure and in the national phase only. When applying for name change variation - during variation procedures.

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Supply to the market of certain medicinal products containing the active substance ranitidine is prohibited
2019-09-26

The State Medicines Control Agency (SMCA) made a decision to prohibit the supply to the market medicinal products containing the active substance ranitidine hydrochloride. This decision was made because of the presence of impurity N-nitrosodimethylamine (NDMA) in several batches of this active substance.

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First twinning project in regard to the medicines and medicinal products in North Macedonia with the Republic of Lithuania
2019-09-17

On 13th September 2019, the opening ceremony of the EU-funded Twinning Light Project “Harmonisation of the legislation for medicinal products with the EU legislation and building capacities for its implementation” took place in Skopje, the Republic of North Macedonia.

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Attention for Marketing authorization holders
2019-05-23

Please be informed that from 1st of June, 2019 all certificates for marketing authorization of medicinal products will be issued only by requests from marketing authorization holders. Requests should be sent by email sertifikatai@vvkt.lt

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