Pharmacovigilance in Croatia
How is it with the drug safety system in this Mediterranean 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 Croatian pharmacovigilance services:
LCPPV / EU QPPV in Croatia
AVAILABLE
Easily managed through Tepsivo Platform >
Local Literature Screening
AVAILABLE
Automated monitoring with Tepsivo Literature >
Who is the main PV authority in Croatia?
RESPONSIBILITY FOR NATIONAL PV SYSTEM
The main authority on pharmacovigilance in Croatia is the Agency for Medicinal Products and Medical Devices (HALMED).
This agency, based in Zagreb, is responsible for monitoring the safety of medicinal products and medical devices, including the collection and analysis of data on adverse drug reactions.
Useful insights about the authority website
CONTENT IN ENGLISH
It seems that all important content regarding pharmacovigilance is translated into English.
If you’re struggling to find the information you need, we recommend looking at the Croatian version of the website and using translation tools like Google Translate to help you uncover the details. This method can make it much easier for you to access the information you’re after.
Interesting website sections related to pharmacovigilance
PHARMACOVIGILANCE
A vast signpost that can direct you in many ways, whter you’re looking for some general information about pharamcovigilance or information for Marketing Authorisation Holders (MAHs), such as PSUR, Risk management plan, Instructions.
Information for Industry representatives regarding instructions on both Medicinal Products Area and Pharmacovigilance can be found here (left column about in the middle).
FORMS TO DOWNLOAD
Here you can find all the important forms individually, for each form is stated whether it is in both English and Croatian or only Croatian. Also if you cannot find some form in the English section, try the Croatian one.
NEWS & EDUCATION
Though it seems it does not offer much content, it offers monthly published report on Newly approved medicinal products, each report can be downloaded as PDF, more detailed information can be found in Medicinal Products Database.
MEDICINAL PRODUCTS DATABASE
On this page, when you scroll a bit down, you’ll find a table, where you can search for any medicinal product that is eligible to be placed on the market can be found, keep in mind that the loading process takes a while.
MEDICINAL PRODUCTS
Once again another vast signpost that can direct you in many ways, here you can find information regarding Instructions for Applicants Procedure (such as Granting Marketing Authorisation or Renewal of Marketing Authorisation) or Drug utilisation (FAQ, Drug utilisation report).
LEGISLATION
This page contains all the imporant Acts and Ordinances, some are in English and some of them can be downloaded as PDF, others have only link, that will redirect to another page.
Other important institutions & industry groups
MINISTRY OF HEALTH
Central government body responsible for health policy, regulation, and oversight in the country. It manages healthcare legislation, public health programs, and the training of healthcare professionals.
There is not much interesting content on Ministry’s website, and basically no regarding pahramcovigilance. You can visit their News section, though it seems it includes only very general news or visit their Projects section, where you can find information about National recovery and resilience plan 2021-2026 or National plan for specialist training of healthcare workers for example.
Ministry’s website: https://zdravlje.gov.hr/
INSTITUTE OF PUBLIC HEALTH (HZJZ)
Focuses on public health issues, disease prevention, and health promotion across Croatia. It conducts research and provides data on public health trends while implementing national health programs aimed at improving population health.
The most interesting section here, is probably Publications, which is sorted into individual categories, such as international, national and periodical publications. For example, you could be interested in Croatian health and statistical yearbook, covering areas like population, primary healthcare and much more. Each category has its own Excel file. Bear in mind, that the section is visible only when using Croation version of the website.
HZJZ’s website: https://www.hzjz.hr/en/
INNOVATIVE PHARMACEUTICAL INITIATIVE (iF!)
An association that unites innovative pharmaceutical manufacturers operating in Croatia, advocating for innovation and health preservation through its activities.
Their webpage is fully translated to English, so there is no need to switching to Croation version at all. There is a interesting project mentioned on their website called “HeMED”, which is a multimodal e-platform, that should offer free access to continuously updated medical textbooks in the local language, if you want to know more, there are introducting videos on the linked website. There are also many useful links for other important institutions.
iF’s website: https://ifi.hr/en/
CROATIAN PHARMACEUTICAL SOCIETY (HFD)
Focuses on advancing pharmaceutical sciences and education in Croatia. It serves as a professional organization for pharmacists, promoting best practices and continuous professional development within the field.
The HFD website seems a bit empty when looking for interesting information, the Society publishes a monthly newsletter called “Farmaceutski Glasnik”, but it seems it is only in paper form (subscriptions are mentioned on the linked website), since when you scroll down a bit, you’ll find a part of the newsletter, but that contains only the notices, not regular articles. It also publishes Acta Pharmaceutica, a quarterly journal, but you can read more about that in our section regarding local literature as always.
HFD’s website: https://farmaceut.org/
Some of the most important laws
Basic legislation
This foundational law regulates the testing, marketing, manufacture, and distribution of medicinal products in Croatia.
Ordinance on Pharmacovigilance
This ordinance provides detailed guidelines for the implementation of pharmacovigilance systems in Croatia.
Ordinance on Granting Marketing Authorisations for Medicinal Products
It outlines the specific procedures and requirements for obtaining marketing authorization for 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.
Essential EU Legislation and EMA Guidlines
Since Croatia is a member of the EU, every Marketing Authorization Holder with a product on the Croatian 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 Croatia, 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
HALMED (Agencija za lijekove i medicinske proizvode)
→ Agency for Medicinal Products and Medical Devices / Main authority on pharmacovigilance.
Is LCPPV needed or is EU QPPV enough?
Yes, MAH has to appoint an LCPPV residing in Croatia, this is based on Medicinal Products Act (article 3, point 58) and Ordinance on Pharmacovigilance (article 9).
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 Croatia?
Healthcare professional can use reporting form on this site, via mail, fax or e-mail.
The public can report any suspected adverse reactions directly to the Agency in writing, either through the online application for ADR reporting or by using the form available here. You can also reach out to the marketing authorization holder with your reports.
There is also Rapid alert system, where you can report ADRs by phone.
Local medical journals to screen
Here are few examples of Croatian local literature sources that medical authorization holders should monitor:
CROATIAN MEDICAL JOURNAL (CMJ)
A peer-reviewed diamond open access journal that publishes original research, reviews, and case reports across all fields of medicine.
It is recognized for its commitment to open access, meaning there are no publication fees for authors or charges for readers, making valuable research freely available to the public.
ISSN: 1332-8166
ACTA MEDICA CROATICA
This journal focuses on clinical and experimental medicine, offering a platform for researchers to share their findings with a national and international audience.
It emphasizes the importance of scientific rigor and aims to contribute to the advancement of medical knowledge in Croatia and beyond.
ISSN: 1848-8897
BIOCHEMIA MEDICA
This journal publishes articles related to biochemistry, molecular biology, and clinical chemistry, aiming to bridge the gap between laboratory research and clinical practice.
It provides insights into the biochemical mechanisms underlying various diseases, making it essential reading.
ISSN: 1846-7482
ACTA PHARMACEUTICA
A prominent scientific journal in Croatia that focuses on pharmaceutical sciences, including drug development, pharmacology, and medicinal chemistry.
It publishes original research articles, reviews, and short communications, providing a platform for researchers to share their findings and advancements.
ISSN: 1846-9558
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
Croatia: Country Health Profile 2023
The 2023 edition of “State of Health in the EU: Croatia” 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.
Publications by HALMED
Brochure: Safe use of medicinal products
This brochure serves as a valuable resource for healthcare professionals, offering guidance on how to detect and report adverse reactions while emphasizing their crucial role in the ongoing monitoring of medicinal product safety and efficacy, in Croatian only.
Here you’ll find all of HALMED’s Annual activity reports since 2010, though sadly all documents are only in Croatian.
Annual Report on Drug Utilisation for 2023 – Croatian Document
There is a list of individual annual reports on the right side, there you can choose whichever year you’re interested in, though once again it is only in Croatian.
Annual Report on Spontaneous Reporting of Adverse Drug Reactions for 2023 – Croatian Document
For the page containing these annual reports applies the same as for the above.
Offical newsletter from HALMED, only in Croatian.
Studies related to pharmacovigilance in Croatia
Curious about how well future healthcare professionals understand pharmacovigilance? This study reveals a significant gap in knowledge among pharmacy, dental, and medical students at the University of Split School of Medicine, highlighting the urgent need for better education on this critical topic—especially as new treatments like COVID-19 vaccines emerge.
This study explores the impact of new EU pharmacovigilance legislation on adverse drug reactions in Croatia, revealing a concerning rise in reports linked to off-label use and overdoses. With data from the HALMED pharmacovigilance database, it uncovers critical insights into how these changes are affecting patient safety and highlights the urgent need for improved monitoring and education in the healthcare system.
Future Healthcare Workers and Ecopharmacovigilance: Where Do We Stand?
This study sheds light on the awareness and practices of Croatian students regarding ecopharmacovigilance (EPV), revealing that they possess a solid knowledge foundation but still require further education on the environmental impacts of drug use. With a particular focus on sustainable prescribing and drug disposal practices, the findings emphasize the urgent need to integrate EPV into healthcare curricula to better prepare future prescribers for their roles in promoting environmental safety.
INTERESTING WEBSITES
HOPAL – Croatian Medicines Verification Organisation
HOPAL’s primary role is to secure the legal supply chain of medicines by verifying the authenticity of medicinal products, thereby enhancing patient safety and combating counterfeit drugs in the Croatian market, read more about what falsified medicine actually is.
Do you need some help with putting the Croatian PV System together? We’re here for you.
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