Pharmacovigilance in Hungary
How is it with the drug safety system in the “Land of Thermal Baths”? 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 Hungarian pharmacovigilance services:
LCPPV / EU QPPV in Hungary
AVAILABLE
Easily managed through Tepsivo Platform >
Local Literature Screening
AVAILABLE
Automated monitoring with Tepsivo Literature >
Who is the main PV authority in Hungary?
RESPONSIBILITY FOR NATIONAL PV SYSTEM
The main authority on pharmacovigilance in Hungary is the National Center for Public Health and Pharmacy (NNGYK). This authority was established on August 1, 2023, following the merger of the National Institute of Pharmacy and Nutrition (OGYÉI) into the National Public Health Center.
The NNGYK is responsible for overseeing pharmacovigilance activities, including inspections related to medicinal products and ensuring compliance with safety regulations in the pharmaceutical sector.
Useful insights about the authority website
LIMITED CONTENT IN ENGLISH
At this moment it seems that not every part of the website does have English version, perhaps due to the fact that it’s relatively recently established. Let’s hope it gets better soon.
Until then, if you encounter a section without official translation, you can use Google Translator or other extensions for your browser to translate the original website.
THE TWO WEBSITES
At this moment the OGYÉI website is still functional and the information regarding pharmacovgilance can be found on both sites, NNYGK and OGYÉI. So, if you encounter a problem finding some information on one website, try the other one.
Luckily, the OGYÉI website has English version, though still not all pages are translated, but it’s better than nothing.
Interesting website sections related to pharmacovigilance
PHARMACOVIGILANCE
This page includes general information, that we are sure you already know, but when you scroll down it gets a bit more interesting. There, you’ll find additional information regarding EU-QPPV, Periodic safety update reports (PSUR) and more.
MARKETING AUTHORISATION
A huge singpost that will direct you into more concrete subsections and subthemes of the marketing authorisation, this page includes information regarding procedures, renewals, withdrawals etc.
LEGISLATION
This site has two subsections, one is strictly for Hungarian laws and the other for EU ones. Both are quite cluttered, the EU one is better, but you will find the important stuff there. Only the EU section includes links to the laws, the Hungarian section is just a list.
FORMS TO DOWNLOAD
This webpage presents the most important forms, some can be downloaded right away, some links will not start the download, but they will redirect you to the EMA website section regarding the form, where you have find the document again and download it.
DRUG DATABSE
Classical database that you might know from other countries, simply fill in some of the search criteria and it’s done, you’ll see a table with with general information about the product.
PUBLICATIONS
Usually, in this section you can find articles or studies etc., but in NNGYK case, there are their magazines and journal (currently not accessible, the link does not work), though sadly everything is only in Hungarian.
Other important institutions & industry groups
MINISTRY OF HUMAN RESOURCES
Responsible for the overall functioning of the national healthcare system, welfare policies, education, and cultural heritage. It oversees health policy development and the regulation of health services.
The ministry’s website does not offer much content, basically you will only find news related to the health sector. If you don’t want to go to the Ministry’s stands just for the news, there is an option to subscribe to the news (you can choose from which ministries).
Ministry’s website: https://2010-2014.kormany.hu/hu/emberi-eroforrasok-miniszteriuma
HUNGARIAN IN VITRO DIAGNOSTIC INDUSTRY ASSOCIATION (HIVDA)
Established in 1999, HIVDA represents the interests of in vitro diagnostic companies in Hungary. It aims to support the diagnostic profession and collaborates with healthcare authorities and similar associations.
If you want to get clearer picture of the goals they want to achieve, simply just head to the link bellow. Also on their website there is quick introductory brochure, that’s practically evertyhing their website offers.
HIVDA’s website: https://hivda.hu/
ASSOCIATION OF MEDICAL DEVICES MANUFACTURERS (AMDM)
The AMDM is a recognized lobbying organization that represents the interests of medical device manufacturers in Hungary. It works to protect its members’ interests in relation to healthcare authorities and other associations, both domestically and internationally.
When you get to their home page, the most important part there is latest news from the sector, that is something you can browse from time to time. If you’d like to get to know Code of Ethics, you can do so here. There is also section called “Information materials”, but sadly the content seems to be missing, though maybe one day something will show up.
AMDM’s website: https://osz.hu/hu/
Some of the most important laws
Basic legislation
Decree 15/2012 (VIII. 22.) of the Ministry of Human Resources
This decree outlines the requirements for pharmacovigilance of human medicinal products.
Act XCV of 2005 on the Medicinal Products
This act regulates the marketing authorization, production, and distribution of medicinal products in Hungary.
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 Hungary, 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
NNGYK (Nemzeti Népegészségügyi és Gyógyszerészeti Központ)
→ National Center for Public Health and Pharmacy / Main authority on pharmacovigilance.
OGYÉI (Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet)
→ National Institute of Pharmacy and Nutrition
Is LCPPV needed or is EU QPPV enough?
In Hungary, the appointment of a Local Pharmacovigilance Contact Person (LCPPV) is mandatory if the EU Qualified Person for Pharmacovigilance (EU QPPV) is located outside of Hungary. The legal basis for these requirements is outlined in Decree 15/2012 (VIII. 22.).
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 Hungary?
Reports can be submitted by healthcare professionals, patients, or anyone who observes an adverse drug reaction. Adverse drug reactions should be reported to the NNGYK, you can do so via this site.
The reports can be also submitted electronically using the EudraVigilance system.
Local medical journals to screen
Here are few examples of Hungarian local literature sources that medical authorization holders should monitor:
ORVOSI HETILAP
One of Hungary’s oldest medical journals, publishing peer-reviewed articles on various medical topics, including pharmacovigilance.
It offers a comprehensive view of current medical practices and research, making it essential for healthcare professionals.
ISSN: 1788-6120
MAGYAR BELORVOSI ARCHÍVUM
This journal publishes original research articles, case studies, and reviews in the field of internal medicine, offering a platform for sharing clinical findings and advancements.
It is particularly valuable for healthcare professionals interested in the latest developments in pharmacovigilance and patient safety within internal medicine.
ISSN: 0025-0066
ACTA PHARMACEUTICA HUNGARICA
It focuses on pharmaceutical sciences, including drug development, pharmacology, and pharmacovigilance.
It is essential for researchers and professionals interested in the latest advancements in pharmaceuticals and drug safety.
ISSN: 1587-1495
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
Hungary: 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.
Scientific publications regarding pharmacovigilance
Overview of the causes and management of drug shortages in the United States and in Hungary
You’ll discover how the alarming rise in drug shortages is not just a local issue in Hungary but a global health crisis affecting patients everywhere. The authors delve into the root causes of these shortages and propose actionable solutions.
Dive into the complex world of the pharmaceutical supply chain, revealing how globalization and trade practices have made it easier for counterfeit medicines. Readers will uncover the financial implications of anti-falsification measures, the challenges faced by hospital pharmacies in implementing new regulations, and more.
Interesting resources
This page contains basic staticsits about Hungary in various fields such as Population, Life expectancy or Health statistics.
Do you need some help with putting the Hungarian PV System together? We’re here for you.
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