Pharmacovigilance in Estonia
How is it with the drug safety system in this Baltic country? 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 Estonian pharmacovigilance services:
LCPPV / EU QPPV in Estonia
AVAILABLE
Easily managed through Tepsivo Platform >
Local Literature Screening
AVAILABLE
Automated monitoring with Tepsivo Literature >
Who is the main PV authority in Estonia?
RESPONSIBILITY FOR NATIONAL PV SYSTEM
The main authority on pharmacovigilance in Estonia is the State Agency of Medicines (Ravimiamet).
Ravimiamet operates under the Ministry of Social Affairs and is responsible for overseeing the safety and efficacy of medicinal products in the country, it is headquartered in Tartu.
Useful insights about the authority website
CONTENT IN ENGLISH
The webpage does provide English version, but only some pages have been translated, most of pages are accessible only originally in Estonian.
If you’re having trouble finding the information you need, we suggest checking the Estonian version of the website and using translation tools like Google Translate to help uncover the details you’re looking for. This approach could make it easier for you to access the information you seek.
Interesting website sections related to pharmacovigilance
SAFETY INFORMATION LETTERS
These letters are designed to quickly share important updates about a drug’s safety with healthcare professionals, here on this page you’ll find PDF versions in user-friendly tables sorted by years.
MARKETING AUTHORISATION (MA) & APPLICATION
General information (only in Estonian) regarding this topic can be found here, this page also serves as a signpost that can direct you furhter, for that use the menu on the left side, there you can find other links, such as Amendments to the marketing authorization or Start of marketing, delivery difficulties, termination of marketing authorization and much more.
FORMS & LEGISLATION FOR MA
Here you can find a list of legislation regarding MA and also some important forms bellow, all in English.
More forms and instruction can be found here, though all contenct is accessible only in Estonian.
STATISTICS OF MEDICINAL PRODUCTS
The medicine statistics compiled by the Medicines Board are based on quarterly reports from licensed wholesalers in Estonia. This page contains various infographics and important summaries.
More statistics can be found in these yearbooks by Medicines Board.
HANDLING OF MEDICINE
This is basically a vast library, wher you can find all the important legislation, newsletters related to pharmacies, guidelines, forms of use of medicine without MA and more. All these areas are sorted below each other in drop-down lists.
FREQUENTLY ASKED QUESTIONS (KKK)
Another vast library, but this time filled with Q&A, it does not matter wheter you have questions regarding Sales licenses, Packaging and delivery difficulties, Drug Advertising or Safety features of medicines, answers to all these areas and to much more can be found here.
Other important institutions & industry groups
MINISTRY OF SOCIAL AFFAIRS
It manages health services, including public health initiatives and social care policies. It was established in 1993 by merging three previous ministries, including the former Ministry of Health.
The website does not offer much content when using the English website whatsoever, so we reccomend to use the Estonian verison. There you can find Estonia’s drug policy white paper, which outlines the country’s key objectives in the drug sector until 2030, focusinhttps://www.sm.ee/eng on five main priorities: prevention, support and treatment, harm reduction, market regulation, and penalties. This strategic document aims to address these priorities effectively to improve public health and safety in relation to drug use. There is also a Medicine policy 2030, where you can read for example more about Estonia’s key priorities in European pharmaceutical policy or Developing high quality and patient-centred pharmacy services.
Ministry’s website: https://www.sm.ee/en
HEALTH BOARD (Terviseamet)
It oversees health promotion, disease prevention, and ensures compliance with health regulations across the country. The board plays a crucial role in implementing public health policies as outlined in the National Health Plan
Again, this page doesn’t offer much, but from what we can mention, these are brochure Healthcare in Estonia (2021), which a short introducting document with useful information on how does healthcare work in Estonia, fully in English. When you switch to the Estonian version o the website, you can also visit news archive.
Board’s website: https://www.terviseamet.ee/en/health-board
ASSOCIATION OF PHARMACEUTICAL MANUFACTURERS (RTL)
APME is a non-profit organization representing research-based and generic pharmaceutical manufacturers operating in Estonia. It covers approximately 90% of the turnover in the Estonian pharmaceutical market.
Here you can view a short brochure Pharmaceutical Industry in Figures 2023, which contains interesting infographics and is fully in English, also if you want to find out more about a pilot project for medicine packaging without a paper leaflet, head to this text, which talks about the e-newsletter (the replacement of the paper leaflet) and its advantages.
RTL’s website: https://rtl.ee/en/
ASSOCIATION OF PHARMACEUTICAL WHOLESALERS (RHL)
This association represents pharmaceutical wholesalers in Estonia, focusing on the distribution side of the pharmaceutical supply chain.
Sadly, there is trully nothing on their website, doesn’t matter whether you’re using English or Estonian version. In either way you’ll just see a quick description of RHL and its members.
RHL’s website: https://rhl.ee/
Some of the most important laws
Basic legislation
This act lays the foundation for the regulation of medicinal products in Estonia.
Regulation of the Minister of Social Affairs No. 59
Here you’ll find conditions and procedure for defining a substance or product as a medicine.
Regulation of the Minister of Social Affairs No. 26
Procedure for providing safety information about medicinal products, for calculating the fees charged for the safety, etc.
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 Estonia is a member of the EU, every Marketing Authorization Holder with a product on the Estonian 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 Estonia, following terms will be helpful for you to get familiar with:
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
RAVIMIAMET
→ State Agency of Medicines / Main authority on pharmacovigilance.
REKS (Esti Ravimite Ehtsuse Kontrolli Sihtasutus)
→ EtMVS / The Estonian Medicines Verification System
Is LCPPV needed or is EU QPPV enough?
While having a Local Contact Person for Pharmacovigilance (LCPPV) isn’t typically required, an Estonian-speaking contact may be necessary if healthcare providers need to be informed about safety risks related to a medicine’s use, this is based on Regulation of the Minister of Social Affairs No. 26 (§ 4 section 4).
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 Estonia?
Local medical journals to screen
Here are few examples of Estonian local literature sources that medical authorization holders should monitor:
ESTI ARST (Estonian Medical Journal)
The Estonian Medical Journal is a leading publication that covers a wide range of medical topics. Published 11 times a year, it features articles primarily in Estonian, with English summaries for broader accessibility.
This journal is essential for healthcare professionals who want to stay updated on local medical research and practices.
ISSN: 2228-1665
PEREARST (General Practitioner Journal)
This journal focuses specifically on the needs and interests of general practitioners in Estonia, providing practical insights into family medicine, case studies, and updates on best practices.
It is essential for those, who want to learn about the latest developments in primary healthcare.
LEGE ARTIS
A peer-reviewed journal aimed at medical specialists, covering various fields including surgery, internal medicine, and pediatrics. It publishes original research articles, reviews, and clinical guidelines.
This journal is perfect for specialists seeking in-depth analyses and updates on advanced medical practices, ensuring they remain at the forefront of their fields.
ISSN: 1406-9156
APTEEKER (Pharmacist Journal)
Dedicated to pharmacists and focuses on pharmaceutical sciences, practice issues, and regulatory updates. It aims to support pharmacists in their professional development and enhance their role in patient care.
This journal is crucial for pharmacists who want to expand their knowledge about drug management.
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
Estonia: Country Health Profile 2023
The 2023 edition of “State of Health in the EU: Estonia” 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.
Studies related to pharmacovigilance in Estonia
This study reveals significant trends in fluoroquinolone prescriptions, highlighting a notable decline in usage following EMA recommendations, yet it also uncovers a concerning number of patients still at risk for serious side effects. Dive into the findings to understand how these changes impact patient safety and what they mean for future prescribing practices.
Drug utilization research in Europe (chapter about Estonia)
This chapter delves into the diverse drug utilization research communities across the WHO Europe Region, featuring insightful case studies on both the Estonian and Danish healthcare systems. Readers can expect to discover how Estonia’s State Agency of Medicines oversees pharmaceutical practices and promotes rational drug use.
Do you need some help with putting the Estonian 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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