Pharmacovigilance in Slovakia
How is it with drug safety system in European country? Follow our guide and you will be in the picture.
And of course, if you feel you need a local consultant, we’re here for you.
Current status of our Slovak pharmacovigilance services:
LCPPV / EU QPPV in Slovakia
AVAILABLE
Easily managed through Tepsivo Platform >
Local Literature Screening
AVAILABLE
Automated monitoring with Tepsivo Literature >
Who is the main PV authority in Slovakia?
RESPONSIBILITY FOR NATIONAL PV SYSTEM
The main authority on pharmacovigilance in Slovakia is the State Institute for Drug Control (ŠÚKL), located in Bratislava.
The institute is responsible for monitoring the safety of medicinal products, collecting and analyzing reports of adverse drug reactions.
Useful insights about the authority website
LIMITED CONTENT IN ENGLISH
The website has an English version, though it’s trully simplified and we strongly recommend to use the original version and use translator.
By using the Slovak version and the translator, you have potentially much bigger chance to find what you’re looking for.
Interesting website sections related to pharmacovigilance
PHARMACOVIGILANCE
Virtually the only main activities of the Pharmacovigilance Department are translated into English on this page, under subsection “Instruction” you won’t currently find anything at all, thus we strongly recommend to use original version.
You won’t find much information there either but, at least some Methodological guidelines or Definitions of basic pharmacovigilance terms can be found here. As the most useful page dedicated to pharmacovigilance seems to be this one, where you find the most important links.
REGISTRATION OF MEDICINAL PRODUCT
The English version does not provide much information just like the pharmacovigilance section, only instructions are translated. For more information about registration of medicine use this link, here you can follow updates on the registration of medicinal products for human use.
FORMS TO DOWNLOAD
Important forms can be found in this section in a table, next to each form you can see if both English and Slovak version are available.
NEWS & NEWS SUBSCRIPTION
Stay up to date on what’s happening in the phamracovigilance field in Slovakia, though you will need to use translator as the page is accessible only Slovak.
ŠÚKL seems to be missing an official newsletter but, they’re offering the possibility to recieve special notices and news into your e-mail via RSS information channel, instructions can be found on the linked page.
INFORMATION FROM PRAC
Here you will find summary on the Conclusions of the Committee on the Risk Assessment of Medicinal Products, each meeting has its own link.
LEGISLATION
This page provides a comprehensive overview of the legislation, other relevant laws, and implementing regulations that govern the activities of the State Institute for Drug Control (SÚKL).
Other important institutions & industry groups
MINISTRY OF HEALTH
This ministry is the central administrative body responsible for national health policy, nursing education, quality assurance in healthcare, and managing health programs.
Slovakia’s ministry of health seems entirely not to cover area of pharmacovigilance on their webstite, nor there are any insteresting sections we could recommend, though still it’s an important institution.
Ministry’s website: https://www.health.gov.sk/Titulka
NATIONAL HEALTH INFORMATION CENTRE (NHIC)
The NHIC manages national health data and statistics, providing essential information for health policy-making and public health initiatives.
The most complex document regarding data and statistics is The Health Statistics year book (last one is from 2022), focusing on demography, healht population status etc., published completely in English. Other statistical documents that are published quarterly or monthly can be found here, though they are only in Slovak.
NHIC website: https://www.nczisk.sk/Pages/default.aspx
THE ASSOCIATION OF CHEMICAL AND PHARMACEUTICAL INDUSTRY (ZCHFP)
This association includes various pharmaceutical manufacturers and aims to promote cooperation among members, address industry challenges, and enhance the overall pharmaceutical environment.
There is not much content on their website but, what is worth mentioning is the Selected PDF document called “Indicators of the development of the chemical and pharmaceutical industry (CHPI)” where you can find some statistics.
ZCHFP website: https://zchfp.sk/index_en.php?
SLOVAK ASSOCIATION OF INNOVATIVE PHARMACEUTICAL INDUSTRY (AIFP)
Represents innovative pharmaceutical companies operating in Slovakia, advocating for policies that support research, development, and market access for new medicines.
This website is only in English and so are the materials that includes but, if there’s anything you should visit on their website it’s the section called “Médiá a verejnosť” (Media and Public), where you find articles. For example you can read how come that modern medicines are still lacking in Slovakia or whether the expected change in the availability of modern medicines has finally started.
AIFP website: https://aifp.sk/sk/
Some of the most important laws
Basic legislation
Act No. 362/2011 Coll. on Health Care
Important law that regulates Medicinal Products and Medical Devices.
Act No. 363/2011 Coll. on Health Care
This law regulates various aspects of healthcare provision, including the use of medicinal products in clinical settings.
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 Slovakia is a member of the EU, every MAH with a product on the Slovak market needs to follow the European pharmacovigilance legislation and guidelines by EMA (European Medicine Organization).
To navigate through the European regulations, its is useful to know following:
EMA Pharmacovigilance System Manual
Directive 2001/83/EC and Regulation (EC) 726/2004
Commission Implementing Regulation (EU) 520/2012
Local pharmacovigilance specifics
Is LCPPV needed or is EU QPPV enough?
Yes, the Local Contact Person for Pharmacovigilance (LCPPV) is required in Slovakia according to national legislation, specifically Act No. 362/2011 on Medicines and Medical Devices.
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 Slovakia?
ADRs can be reported directly through online form here, you can also use paper form or report by phone, more information here (only in Slovak). It is also possible to report via mail or e-mail.
Local medical journals to screen
Here are few examples of Slovak local literature that medical authorization holders should monitor:
BRATISLAVA MEDICAL JOURNAL
This peer-reviewed journal publishes articles on all aspects of biomedical sciences and clinical medicine, making it a vital resource for healthcare professionals.
Its commitment to high-quality research and clinical practice ensures that readers stay informed about the latest developments in medicine.
ISSN: 0006-9248
CZECH AND SLOVAK PHARMACY
This journal serves as an official publication for the Czech Pharmaceutical Society and the Slovak Pharmaceutical Society.
It focuses on a wide range of topics related to pharmacy, including pharmacotherapy, drug profiles, and pharmaceutical practice.
ISSN: 1805-4439
JOURNAL OF CZECH PHYSICIANS
While not a local Slovakia journal, it’s still a prominent and well respected journal in both Czech Republic and Slovakia.
It publishes articles related to various medical fields and is a key resource for healthcare professionals in the country.
ISSN: 1805-4420
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
Slovakia: Country Health Profile
The 2023 editions provide 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.
ŠÚKL's annual report
ŠÚKL’s annual reports can be found in Výročné správy, reports are sorted by year into two columns and each report can be downloaded as PDF document.
opportunities in slovakia
Pharmaceutical & Life Sciences Sector in SLOVAKIA
This publication highlights the exciting opportunities Slovakia presents for investors in the pharmaceutical and life sciences sectors, showcasing compelling facts and figures across all major subcategories.
Scientific publications regarding pharmacovigilance
An expert review of clozapine in Eastern European countries: Use, regulations and pharmacovigilance
This study compares the prevalence, regulations, and pharmacovigilance practices surrounding clozapine, revealing surprising insights, you’ll discover how clozapine prescription rates vary wildly and why improving monitoring practices is crucial for enhancing patient safety.
The COVID-19 pandemic has tragically claimed over 6.5 million lives globally, and in Slovakia, the vaccination rate against the virus stands at only 58%, partly due to concerns about adverse reactions. This article delves into a critical analysis of reported adverse reactions to registered COVID-19 vaccines.
Slovak law has established clear guidelines for drug pricing and reimbursement, but recent cost-containment measures have led to some unintended consequences, including a decrease in the availability of medications. This article explores how these regulations, particularly the ban on re-exporting medicines, have shifted the landscape of drug reimbursement in Slovakia.
Do you need some help with putting the Slovak PV System together? We’re here for you.
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…consider also our global end-to-end PV solution!
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