Pharmacovigilance in Lithuania
How is it with the drug safety system in this Baltic state? Read our guide to get a clear picture.
And of course, if you feel you need a local consultant, we’re here for you.
Current status of our Lithuanian pharmacovigilance services:
LCPPV / EU QPPV in Lithuania
AVAILABLE
Easily managed through Tepsivo Platform >
Local Literature Screening
AVAILABLE
Automated monitoring with Tepsivo Literature >
Who is the main PV authority in Lithuania?
RESPONSIBILITY FOR NATIONAL PV SYSTEM
The main authority on pharmacovigilance in Lithuania is the State Medicines Control Agency (VVKT), which operates under the Ministry of Health of the Republic of Lithuania, it is located in Vilnius.
The agency is responsible for monitoring the safety of medicines and collecting reports on adverse drug reactions (ADRs).
Useful insights about the authority website
CONTENT IN ENGLISH
The website does offer an English version, but some important content seems to be accessible only when using the website originally in Lithuanian.
If you’re having trouble finding what you need, we recommend checking out the Lithuanian version of the website and using online translation tools like Google Translate, this approach might help you discover the information you’re looking for.
Interesting website sections related to pharmacovigilance
PHARMACOVIGILANCE INFORMATION
Information for drug registrants can be found here, regarding EudraVigilance network, important e-mail adresses and notifications about NRV, whole section only in Lithuanian.
MARKETING AUTHORIZATION
This is vast section with many subcategories giving you many important information. The first thing you’ll see are Application forms and when you scroll down below them you’ll find information regarding Marketing authorization fees, E-submission, Summary product characteristic, labelling, package leaflet.
GENERAL INFORMATION FOR APPLICANTS
This section, Lithuanian only, contains the most basic information on many areas such as Registration of the medicinal product, Authorizations and more. Also forms of applications and requests can be found here as well.
LEGISLATION
Here you’ll find a list of some laws and regulations, both from Lithuanian government and EU, some documents are not in English, but don’t worry next to the title of each document it says if it is only in Lithuanian or not.
This a link specifically for the legislation section regarding pharmacovigilance (vissible only while using Lithuanian version), and here is for the full legislation section (again accessible only in Lithuanian version).
REGISTERED MEDICINAL PRODUCTS
In this section, Lithuanian only, you’ll find many links regarding what exactly you’re looking for. Probably the two most important links are this: 1) whether you want to know if a medicinal product is registered in Lithuania visit this site, 2) Medicinal products approved by the European Commission, accessible across all EU member states, can be viewed here.
Other important institutions & industry groups
MINISTRY OF HEALTH OF THE LITHUANIAN REPUBLIC
A governmental body responsible for overseeing the country’s healthcare system. Its mission focuses on promoting public health, ensuring access to quality healthcare services, and addressing health risk factors to foster a healthy and safe society for all citizens.
On Ministry’s website you can find publication section, where are linked articles from Medical Library of Lithuania, medical journals (some are linked on our page below in section “What local literature to screen?”) and others, you can also subscribe their newsletter, so you would not miss out on any news.
Ministry’s website: https://sam.lrv.lt/en/
LITHUANIAN GCP & RA ASSOCIATION
This association represents the pharmaceutical industry by promoting good clinical practices and regulatory affairs in Lithuania. It aims to create favorable conditions for clinical trials and the registration of medical products, fostering innovation within the healthcare environment.
Their website does not seem to provide much of interesting contenct, but you can check out their library of articles, though they are only in Lithuanian.
GKRP’s website: https://gkrp.lt/
LITHUANIAN BIOTECHNOLOGY ASSOCIATION (LithuaniaBIO)
It unites businesses involved in biotechnology and life sciences. Its mission is to promote the application of biotechnology in addressing global challenges, focusing on health technologies and fostering international partnerships.
As it is with the website of Lithuanian Good Clinical Practice (GCP) and Regulatory Affairs (RA) Association, this website also does not seem to provide much of interesting contenct, but you can check out their newsroom, articles presented here are in English.
LithuaniaBIO’s website: https://lithuaniabio.com/en/lithuanianbio/
Some of the most important laws
Basic legislation
This law regulates pharmaceutical activities, including the management and control of medicinal products in Lithuania.
This act outlines the requirements for marketing authorization and the obligations related to pharmacovigilance.
Guidelines
Good Pharmacovigilance Practice (GVP) Modules
The GVP modules, developed by the European Medicines Agency (EMA), provide guidelines on the implementation of pharmacovigilance activities.
Essential EU Legislation and EMA Guidlines
Since Lithuania is a member of the EU, every Marketing Authorization Holder with a product on the Lithuanian market needs to follow the European pharmacovigilance legislation and guidelines by EMA (European Medicine Agency).
To navigate through the European regulations, its is useful to know following:
– EMA Pharmacovigilance System Manual
– Directive 2001/83/EC
– Regulation (EC) 726/2004
– Commission Implementing Regulation (EU) 520/2012
Local pharmacovigilance specifics
Useful abbreviations to know
If you want to study local materials about pharmacovigilance in Lithuania, following terms will be helpful for you to get familiar with:
EMEA (Europos vaistų agentūra)
→ EMA (European Medicine Organization) / Key part of the EU, dedicated to ensuring the safety and effectiveness of medicines.
EVPM (EudraVigilance post-authorization module)
→ Dedicated to the collection of ICSRs related to all medicinal products authorised in the EEA.
PRAC (Pharmacovigilance Risk Assessment Committee)
→ Committee responsible for assessing and monitoring the safety of human medicines
VVKT (Valstybinė vaistų kontrolės tarnyba)
→ State Medicines Control Agency / Main authority on pharmacovigilance.
NRV (nepageidaujamas reakcijas)
→ ADR / adverse drug reaction
NR (nepageidaujamus reiškinius)
→ AE / adverse events
Is LCPPV needed or is EU QPPV enough?
In Lithuania, having a Local Contact Person for Pharmacovigilance (LCPPV) isn’t required, as the country’s Law of pharmacy does not include any provisions for it. While the European Medicines Agency (EMA) suggests that a contact person may be needed, Lithuanian regulations currently do not mandate this.
If you need a translation of those instructions or more information about LCPPV requirements in Europe in general, just check our free comprehensive guide available here.
How can be adverse events reported in Lithuania?
To submit a report, you can use the electronic reporting form available on VVKT’s website, there are different forms for public and healthcare professionals & pharmaceutical specialists.
This form allows you to report suspected ADRs related to medicines used in humans. It is also possible to report via email or phone, more information here.
Local medical journals to screen
Here are few examples of Lithuanian local literature sources that medical authorization holders should monitor:
ACTA MEDICA LITUANICA
This peer-reviewed journal, published by Vilnius University, focuses on original research, reviews, and case studies primarily from Central and Eastern Europe.
It aims to disseminate multidisciplinary knowledge in medicine and biomedical sciences, making it a valuable resource for researchers and clinicians alike.
ISSN: 1392-0138
SVEIKATOS MOKSLAI
Established in 1990, this journal covers a broad spectrum of topics including public health, clinical research, nursing, and health economics.
With articles published in multiple languages, it serves as an essential platform for sharing knowledge among health professionals and researchers in Lithuania.
ISSN: 2335-867X
MEDICINA
A monthly journal published since 1920, Medicina focuses on clinical and experimental investigations relevant to both developed and developing countries.
It serves as a forum for discussing health-related issues globally, providing insights that are crucial for medical practitioners and researchers.
ISSN: 1648-9144
Rather then spending your budget for hours of repetitive manual work to monitor those sources, we recommend to simply automate this task using our Tepsivo Literature solution.
Other interesting resources
Country Public Health / Health System Assessments
Lithuania: Country Health Profile 2023
The 2023 edition of “State of Health in the EU: Lithuania” provides a comprehensive look at the health landscape in the country, exploring key topics such as overall health status, important health determinants and risk factors, and how the health system is organized and funded.
Publications by VVKT
PDF report with many infographics regarding agency activities, only in Lithuanian.
Annual report on suspected adverse reactions
Annual reports from 2010 to nowadays, PDF docuemnt conatining infograrphics, only in Lithuanian.
Medicine Surveillance
This document contains statistics of the medicial consumption in Lithuania, it is a PDF document with infographics and table of all medicine registered in the country regarding consumption of medicines by ATC group (2018-2023).
Medicine consumption statistics of the three Baltic countries
With the collaboration of the drug agencies from Lithuania, Latvia, and Estonia, a thorough analysis of drug consumption in these Baltic countries was conducted, revealing that their medicine usage patterns are quite similar. This new publication not only highlights these findings but also offers a concise overview of the drug market, legal requirements, and reimbursement systems in all three nations.
Studies related to pharmacovigilance in Lithuania
A recent study reveals that while Lithuanian consumers generally lack a deep understanding of pharmacovigilance, they hold a positive attitude towards the importance of reporting adverse drug reactions (ADRs). This groundbreaking research not only uncovers the reasons behind why consumers choose to report—or not report—ADRs but also provides valuable insights that can inform future educational campaigns aimed at improving awareness and engagement in pharmacovigilance efforts.
A recent study highlights that while community pharmacists (CPs) and general practitioners (GPs) in Lithuania possess a basic understanding of medication safety, their knowledge of the adverse drug reaction (ADR) reporting system is often lacking. The research identifies key barriers to reporting, such as insufficient information and education, heavy workloads, and complicated procedures, while also revealing new challenges like organizational culture and distrust in authorities.
Do you need some help with putting the Lithuanian PV System together? We’re here for you.
And while you’re here…
…consider also our global end-to-end PV solution!
Thanks to the Tepsivo platform, you can get a full pharmacovigilance system in all countries you need – for a fraction of the usual budget.
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