Pharmacovigilance in Poland
How is it with the drug safety system in this European 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 Polish pharmacovigilance services:
LCPPV / EU QPPV in Poland
AVAILABLE
Easily managed through Tepsivo Platform >
Local Literature Screening
AVAILABLE
Automated monitoring with Tepsivo Literature >
Who is the main PV authority in Poland?
RESPONSIBILITY FOR NATIONAL PV SYSTEM
The main authority on pharmacovigilance in Poland is The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, URPL). It is located in Warsaw, Poland.
The URPL is responsible for carrying out procedures and activities involving medicinal products for human use and veterinary medicinal products.
Useful insights about the authority website
NO CONTENT IN ENGLISH
There used to be English version, but the website seems currently not to have English version, probably due to its ongoing modifications.
If you can’t locate the information you’re seeking, we advise visiting the website in its original Polish and utilizing a translation tool. This approach may greatly enhance your likelihood of finding the desired content.
Interesting website sections related to pharmacovigilance
REGISTRATION ISSUES
A signpost where you can find everything important regarding registration issues such as New registration, Information forms (the names are in English), Extension of permit validity and more.
Obligations of the responsible entity can also be found in the menu on the left side.
DRUG SAFETY
Everything you need to know about drug safety, can be found here and once again it is a signpost, that redirects you further. This page contains information regarding Medicinal Product Safety Bulletin (monthly lists of medicinal products that have been granted MA for the first time), Guidelines, Safety studies and much more.
QUESTIONS & ANSWERS
Here you’ll find quick and basic Q&A, containing 6 examples and among them questions that focus on how to effectively present a summary of the pharmacovigilance system and the duration of the marketing authorization process for medicinal products under national procedures.
REGISTER OF MEDICINAL PRODUCTS
The Register includes medicinal products approved by the President of the Office through national, mutual recognition, and decentralized procedures, as well as those authorized by the European Commission, feel free to use basich or advanced search, more information here.
NEWS SECTION
This section seems to provide some useful information from time to time (such as article about types of ADRs or reminders like this one), you’ll find here notices, product withdrawls, news and more.
Other important institutions & industry groups
MINISTRY OF HEALTH
This is the primary policymaker and regulatory body responsible for national health policy, overseeing the healthcare system’s organization, financing, and implementation of health programs.
As the whole governmental website seems to be lacking English version, so does the Ministry’s website. There is also basically no information to pharmacovigilance, but we can recommend their legislation section, where you can find both Legal and Draft legal acts, List of legislative works, Official Journal (with notices, ordinances, announcements, etc.). For full text of laws we recommend the linked site in our next section. Also you can their various programs and projects, such as National Health Programme 2021-2025.
Ministry’s website: https://www.gov.pl/web/zdrowie
NATIONAL INSTITUTE OF PUBLIC HEALTH
This is the main public health research institute in Poland, focusing on public health research, monitoring health status, and providing guidance on health policies.
Dive into their vast publication section, where many interesting articles, studies, reports and even journals (such as Experimental Medicine and Microbiology) are awaiting you, that can be done either by entering their scientific library or publication section. We can recommend report on the health situation of the Polish population, report on the estimated financial gap in healthcare system or publication Health 3.0.
Institute’s website: https://www.pzh.gov.pl/
POLISH CHAMBER OF COMMERCE “POLISH PHARMACY”
As the largest industry organization in the pharmacy sector, it has been active for over 30 years, supporting the interests of pharmacy professionals and businesses in Poland.
Their website does not seem to offer much content, basically the only thing that is worth mentioning is the “Pisma” section (“writings”), where it seems you can see such a jumble of their comments to various topics, such as Pharmaceutical law and overall on legislation.
Chamber’s website: https://farmacja-polska.org.pl/
POLISH UNION OF INNOVATIVE MEDICAL BIOTECH COMPANIES (BioInMed)
This group focuses on building an ecosystem for innovative biotech companies, promoting collaboration and development within the biotechnology sector in Poland.
Their website doesn’t have a lot of content to explore; the main highlight is the News section, which features various articles. However, it’s worth noting that the articles differ between the English and Polish versions, and even in that section, there isn’t much that stands out as particularly interesting.
BioInMed’s website: https://bioinmed.pl/en/home
Some of the most important laws
Basic legislation
Pharmaceutical Law (Act of 6 September 2001)
This foundational law outlines the regulatory framework for medicinal products, including the obligations for reporting ADRs.
Regulation on Pharmacovigilance (2012)
This regulation specifies the procedures for monitoring the safety of medicinal products.
Guidelines
Good Pharmacovigilance Practice (GVP) Modules
The GVP modules, developed by the European Medicines Agency (EMA), provide guidelines on the implementation of pharmacovigilance activities.
Basically a Q&A section regarding some common problems questions, such as which medicinal products should be subject to adverse reaction reports, what minimum information you have to include, etc.
Essential EU Legislation and EMA Guidlines
Since Poland is a member of the EU, every Marketing Authorization Holder with a product on the Polish 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
Useful abbreviations to know
If you want to study local materials about pharmacovigilance in Poland, 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
URPL (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych)
→ The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Is LCPPV needed or is EU QPPV enough?
Yes, MAHs are required to designate an LCPPV, the LCPPV should speak Polish according to the Polish legislation, the person shall fulfil the same requirements as the EU QPPV and shall live or have the office in Poland.
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 Poland?
To submit a report, you can use URPL’s patient-friendly online reporting form specifically designed for reporting suspected adverse reactions.
This form allows you to report suspected ADRs related to medicines used in humans. It is also possible to report via email or phone.
Local medical journals to screen
Here are few examples of Polish local sources that medical authorization holders should monitor:
POLISH JOURNAL OF RADIOLOGY
A dynamic, peer-reviewed publication that has been at the forefront of diagnostic imaging since its establishment in 1926.
This journal not only features original research articles on cutting-edge topics in radiology but also offers insights into related fields like public health and medical technology.
ISSN: 1899-0967
POLISH ARCHIVES OF INTERNAL MEDICINE
This monthly, peer-reviewed journal publishes articles in English and covers a wide range of topics in internal medicine.
It aims to disseminate high-quality research and clinical practice information.
ISSN: 1897-9483
ADVANCES IN DERMATOLOGY AND ALLERGOLOGY
This is a vibrant journal that explores the latest research and developments in skin and allergy-related health, making it an essential read for both specialists and general practitioners.
With a focus on innovative treatments and clinical practices this journal offers valuable insights that can deepen your understanding of dermatological and allergic conditions.
ISSN: 2299-0046
VIA MEDICA JOURNALS
It serves as a comprehensive platform for a wide range of medical disciplines, promoting high-quality research and knowledge sharing among healthcare professionals.
By featuring diverse topics and interdisciplinary studies, this journal not only keeps you informed about the latest advancements in medicine but also fosters collaboration across various fields to improve patient outcomes.
POLISH ANNALS OF MEDICINE
Stands out as an interdisciplinary medical platform that publishes peer-reviewed original research on various healthcare issues and medical education.
This journal provides a unique opportunity to dive into a wealth of knowledge from different medical fields, making it an invaluable resource for anyone interested in the evolving landscape of healthcare in Poland and beyond.
ISSN: 2083-5914
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
Poland: 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.
URPL's annual report
URPL’s final accounts and annual report can be found in About the office, ou can also search for it on URPL’s website or Google, we reccomend to use Polish term for annual report “raport roczny”.
INTERESTING RESOURCES
An indispensable resource that addresses key questions about the pharmaceutical landscape in Poland. Whether you’re already operating in the country or considering entering the market, this handbook provides crucial insights to help navigate the legal and regulatory environment effectively.
Find out more about public health in Poland, how healthcare services are divided and which intitutions are responsible for what.
Scientific publications regarding pharmacovigilance
Practical PV Implementation across EU Member States – Poland
This insightful analysis not only explores how pharmacovigilance can enhance public health and safety but also emphasizes the importance of compliance with EU regulations to foster trust and collaboration among member states. With contributions from various experts and discussions held at prominent conferences, this study offers a wealth of knowledge on how effective pharmacovigilance practices can strengthen the European regulatory framework and ultimately improve healthcare for citizens across the continent.
The study reveals a striking contrast in knowledge about adverse reactions among respondents based on their living environment, with city dwellers demonstrating significantly greater awareness than those in rural areas.
In a recent study involving 830 pediatric neurologists, it was found that while many are familiar with pharmacovigilance (PV) and adverse drug reactions (ADRs), a surprisingly low percentage believe that most ADRs are preventable—only 34.1% in Poland and 38.9% in Germany. Despite recognizing the importance of reporting ADRs in children with epilepsy, many neurologists felt that doing so would add unnecessary workload.
Neurologists from both Poland and Egypt demonstrated a solid understanding of pharmacovigilance. However, the findings reveal that Polish neurologists have a more established practice in conducting pharmacovigilance, suggesting that systematic support plays a vital role in translating knowledge into action. This highlights an intriguing opportunity for further research and collaboration, dive into the full study to explore these insights and discover how education and regulatory frameworks can shape the future of pharmacovigilance in neurology!
Do you need some help with putting the Polish PV System together? We’re here for you.
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