Pharmacovigilance in Slovenia
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 Slovenian pharmacovigilance services:
LCPPV/EU QPPV in Slovenia
AVAILABLE
Easily managed through Tepsivo Platform >
Local Literature Screening
AVAILABLE
Automated monitoring with Tepsivo Literature >
Who is the main PV authority in Slovenia?
RESPONSIBILITY FOR NATIONAL PV SYSTEM
The main authority on pharmacovigilance in Slovenia is the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP), located Ljubljana.
JAZMP responsibilities include overseeing the safety of medicinal products, including the collection and assessment of data related to adverse drug reactions.
Useful insights about the authority website
LIMITED CONTENT IN ENGLISH
The website has an English version, however it is quite simplified and not all pages are accesible in English, in adition to that some pages in English are also under construction.
By using the Slovenian version and the translator, you have potentially much bigger chance to find what you’re looking for.
Interesting website sections related to pharmacovigilance
PHARMACOVIGILANCE
Here you’ll find general information about pharmacovigilance, by what lagislation is this field managed in Slovenia, about PRAC and important contact information. You can also see received Reports of adverse drug reactions throughout the years, only in Slovenian.
MEDICINAL PRODUCT DATABASE
On this page you’ll find a link that will redirect you to “Central drug database”, where all medicinal products that are eligible to be placed on the market can be found but, the database is not visually very user friendly and it is not accessible in English.
PRICING OF MEDICINAL PRODUCTS
If you’re interesting in the field of pricing, visit this page and you can learn more about maximum allowed prices of medicinal products, list of regulated prices and more. To get to these mentioned sections, use the sidebar on the right side.
LEGISLATION
List of every important legislation of the Republic of Slovenia regarding health, for you the most important one will probably be the very first, which Medicinal Products Act. As always, you will find an overview of the most important legislation on our website below.
PHARMACOVIGILANCE BULLETIN
JAZMP has launched a free electronic newsletter aimed at healthcare professionals, providing them with essential updates on new drug safety notifications and important changes to drug information, that you can have delivered directly to your e-mail, only in Slovenian.
EDUCATIONAL MATERIALS
This page contains list of medicinal products on Slovenia market in alphabetcaly ordered list, under every product you’ll find Checklist for healthcare professionals & Patient guide. This is one of the pages its English version is under construction so, you will probably need to use translator.
Other important institutions & industry groups
MINISTRY OF HEALTH
This is the primary governmental body responsible for public health policy, healthcare legislation, and the overall management of health services in Slovenia.
Information about ministry of health can be found on this linked governmental website, which is a joint platform for a variety of governmental bodies. Sadly, you won’t much there, basically the only section that is worth mentioning is legislation section (accessible only in English) and overall health policies. The English version of the website is truly simplified.
Ministry’s website: https://www.gov.si/en/state-authorities/ministries/ministry-of-health/
NATIONAL INSTITUTE OF OUBLIC HEALTH (NIJZ)
This institution operates under the Ministry of Health and is tasked with public health surveillance, epidemiology, hygiene, and health promotion. It plays a crucial role in monitoring public health trends and implementing health programs.
You can visit page dedicated to eHealth Slovenia, where you can read how do they keep up with digitalization and there is also Report on the drug situation in the country (2023). There is also a data portal, where you can find statistics. The controls of the portal are not entirely user-friendly, since under every category there is quite a lot subcategories and then you have to set individual parameters such as year etc. and only then you will see the resulting statistics as a table.
NIJZ website: https://nijz.si/en/
FORUM OF INTERNATIONAL RESEARCH & DEVELOPMENT PHARMACEUTICAL COMPANIES (FARMAFORUM)
This organization represents the innovative pharmaceutical industry in Slovenia, it focuses on promoting innovative medicines, vaccines, and therapies while advocating for ethical cooperation among stakeholders in healthcare.
The website doesn’t seem to provide much interesting content, you can check out the members, where you can find all the big names in the medical field, or check out the news section, although there are only two publications from 2024, and judging by the amount from previous years, there doesn’t seem to be much more this year.
Farmaforum website: https://www.farmaforum.si/en
SLOVENIAN PHARMACEUTICAL SOCIETY (SFD)
Established in 1945, this society serves as a professional link between various segments of the pharmacy sector, including industry experts, pharmacies, and educational institutions.
Read more about SFD on their website, visit their page dedicated to publications or to Farmacevtski vestnik (Journal of Pharmacy), which is divided into sections, where the first one is covering years from 1950 to 2004 and the second one from 2005 to 2024, though only the second one has actual PDFs of the journal. It is published five times a year and it’s in Slovenian.
SFD website: https://www.sfd.si/
Some of the most important laws
Basic legislation
Medicinal Products Act (ZZdr-2)
This is the primary legal framework for medicinal products in Slovenia, it outlines the conditions for the quality, safety, and efficacy of medicinal products.
Rules on Pharmacovigilance of Medicinal Products for Human Use
These rules provide detailed guidelines on the implementation of pharmacovigilance practices.
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 Slovenia is a member of the EU, every MAH with a product on the Slovenian 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?
In Slovenia, the requirement for a Local Contact Person for Pharmacovigilance (LCPPV) is not mandatory, the LCPPV is only required if specifically mandated by authorities for individual cases.
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 Slovenia?
ADRs can be reported directly through online form here, you can also use application DNUZ, which can be installed on your smart device (QR here), or use paper form, more information here.
Local medical journals to screen
Here are few examples of Slovenian local literature that medical authorization holders should monitor:
FARMACEVTSKI VESTNIK
As mentioned above, it is published by Slovenian Pharmaceutical Society (SFD) and it primarily publishes in Slovenian with English summaries.
It is a professional journal that publishes scientific and professional articles related to pharmacy, innovations in the field, and news relevant to pharmaceutical professionals.
ISSN: 2536-4316
SLOVENIAN JOURNAL OF PUBLIC HEALTH
Established in 1962, published by National Institute of Public Health Slovenia and since 2014 using English language.
This journal focuses on public health issues, including primary care, disease prevention, health promotion, and environmental health. It has shown a steady increase in its impact factor over the years.
ISSN: 1854-2476
BRATISLAVA MEDICAL JOURNAL
While not a local journal, some articles on all aspects of biomedical sciences and clinical medicine can be found here. It is a reliable resource for healthcare professionals not only in Slovakia.
Its commitment to high-quality research and clinical practice ensures that readers stay informed about the latest developments in medicine.
ISSN: 0006-9248
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
Slovenia: 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.
JAZMP's annual report
JAZMP’s annual reports can be found in Letna poročila, reports are sorted by year and each report can be downloaded as PDF document.
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.
Slovenia has been falling short of international standards when it comes to reporting and learning from patient safety incidents in healthcare. To tackle this issue, the country has launched the SenSys project, supported by the European Commission and the Danish Patient Safety Authority, which aims to adapt and implement the World Health Organization’s International Classification for Patient Safety.
Do you need some help with putting the Slovenian 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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