Pharmacovigilance in Czech Republic
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And of course, if you feel you need a local consultant, we’re here for you.
Current status of our Czech pharmacovigilance services:
LCPPV / EU QPPV in Czech Republic
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Local Literature Screening
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Who is the main PV authority in Czech Republic?
RESPONSIBILITY FOR NATIONAL PV SYSTEM
The main authority on pharmacovigilance in the Czech Republic is the State Institute for Drug Control (SÚKL – Státní ústav pro kontrolu léčiv), headquatered in Prague.
This agency is responsible for ensuring that all pharmaceuticals available in the Czech market meet safety, quality, and efficacy standards. It oversees the pharmacovigilance system, which includes monitoring the safety of medicinal products post-authorization and ensuring compliance with relevant legislation.
Useful insights about the authority website
LIMITED CONTENT IN ENGLISH
The website has English version but, the content in English is quite limited, you may not find all the important pages on pharmacovigilance, or on other topics, translated.
Therefore if you cannot find what you’re looking for, we suggest you to use the website originally in Czech and use translator, this way you have potentially much bigger chance to find what you’re looking for.
NOTICE
The website is currently under construction, it is being improved and modified, both in the Czech and English versions.
Be aware that not all content may not be available or may move to other sections.
Interesting website sections related to pharmacovigilance
PHARMACOVIGILANCE SECTION
In this section you will find general infromation on pharmacovigilance. Furhtermore all legislative requirements, as well as instructions, forms and how to report ADRs.
Guidelines on Pharmacovigilance are accessible form this link.
OVERVIEW OF MEDICINES
This is a clasical medicine databse with every drug placed on Czech Republic’s market. As usually you can search by name, register number etc. When choose some medicine, you can see particular information about it, including package leaflet, summary and more.
IMPORTANT NEWS
The most important information in one place, at least when using Czech version, then you can find here information letters, changing the registration of medicines, important messages from SÚKL overall and more. When using English version there is considerably less content.
NEWSLETTER
The bulletin is designed to share important updates from the SÚKL, though the section through which you can subscribe is accessible only via Czech version. You can choose which categories of articles you want to receive or whether you want information related to pharmacology or glitches.
BULLETIN ON ADVERSE DRUG REACTIONS
It provides essential updates from the pharmacovigilance system, emphasizing key information on drug safety while also acting as a feedback mechanism. Drawing on insights from international collaboration, it keeps you updated on developments throughout the European Union and around the world. Published quarterly and sadly it is only in Czech.
GUIDELINES & FORMS
All important documents in one place, it is a big signpost that can direct you into more specefic areas, such as Clinical Trials, Pharmacovigilance, etc., and concrete guidelines & forms.
Other important institutions & industry groups
MINISTRY OF HEALTH (Ministerstvo zdravotnictví České republiky)
This governmental body oversees public health policies, including the regulation of pharmaceuticals and medical devices. It plays a crucial role in the legislative framework governing pharmacovigilance.
We recommend to visit their legislation section, where you can find new legislation under the Ministry for example. You can also access a database of medicines through the Ministry’s website. The website has an English version but, most of the content is missing thus we strongly recommend to use it originally in Czech and use translator.
Ministry website: https://mzd.gov.cz/
CZECH MEDICAL CHAMBER
This professional organization represents physicians in the Czech Republic and is involved in promoting medical ethics and standards, including the reporting of adverse drug reactions.
There is not much of interest to be found on their website, and nothing at all on pharmacology. However, despite the not very interesting content on their website, it is still a distinguished institution in the Czech Republic and it is worth mentioning.
Chamber’s website: https://www.lkcr.cz/
ASSOCIATION OF INNOVATIVE PHARMACEUTICAL INDUSTRY (AIFP)
AIFP represents innovative pharmaceutical companies operating in the Czech Republic. It focuses on promoting innovation, research, and development in the pharmaceutical sector.
If you’re more interesting in their activities, you can view annual reports. Also what might be interesting for some is the “Code of Practice”, which is a set of ethical guidelines created by AFIP members.
AIFP website: https://aifp.cz/en/
CZECH ASSOCIATION OF PHARMACEUTICAL COMPANIES (ČAFF)
ČAFF represents generic and biosimilar pharmaceutical companies. It advocates for the interests of its members, focusing on ensuring the availability of affordable medicines, promoting competition, and supporting the sustainable development of the pharmaceutical market.
On their website, you can find an article explaining prices and reimbursement of medications or you can visit their infographics section with simple pictures.
ČAFF website: https://www.caff.eu/en
Some of the most important laws
Basic legislation
Act No. 378/2007 Coll. on Pharmaceuticals
This is the primary legal framework for the regulation of pharmaceuticals in the Czech Republic.
This act amends the Act on Pharmaceuticals and further refines the regulations related to pharmacovigilance.
Decree No. 228/2008 Coll. of the Ministry of Health
This decree provides detailed regulations regarding the marketing authorization of medicinal products.
Decree on Pharmacovigilance (Decree No. 226/2008 Coll.)
This decree provides specific regulations on pharmacovigilance activities.
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 Czech Republic is a member of the EU, every MAH with a product on the Czech 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?
SÚKL requires MAH to appoint a QPPV, who must reside in the EU and have the necessary expertise in pharmacovigilance activities. Additionally, if the QPPV does not speak Czech or Slovak, a LCPPV must be appointed in the Czech Republic to facilitate communication.
The obligations of MAH are enshrined in Act No.378/2007 Coll, further information can be also find here.
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 Czech Republic?
Reporting can be done via SÚKL’s friendly online form specifically designed for reporting suspected adverse reactions. You can access this form on their official website. It is also possible to report via email or phone.
Local medical journals to screen
Here are few examples of Czech local literature that medical authorization holders should monitor:
JOURNAL OF CZECH PHYSICIANS
A prominent, and one of the is the oldest and most prestigious, Czech medical journal that is a key resource for healthcare professionals in the country.
it publishes original research across all medical fields, along with articles on current topics, conference news, medical histories, society reports, and book reviews to support postgraduate education.
ISSN: 1805-4420
PRAGUE MEDICAL REPORT
This English-language biomedical journal, published quarterly by the First Faculty of Medicine at Charles University, covers a diverse range of medical topics and is recognized in major databases like MEDLINE and Scopus.
ISSN: 2336-2936
KONTAKT
Officially associated with the Faculty of Health and Social Sciences of the University of South Bohemia, this journal publishes research related to nursing and social sciences in health, accepting articles in Czech, Slovak, and English
ISSN: 1212-4117
INTERNAL MEDICINE
Another important journal in internal medicine, covering research, case reports, and reviews across various internal medicine specialties.
ISSN: 1801-7592
PHARMACOTHERAPEUTIC INFORMATION
An independent drug bulletin for physicians and pharmacists, has been published since 1996. Its aim is to present high quality, up-to-date and independent professional information, published monthly.
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
CZECH REPUBLIC: 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.
publications by sÚKL
SÚKL’s annual reports have its own section under “Publishing activities”, all annual reports from 1998 to nowadays can be found there. Here is Annual report 2023, only in Czech.
Here you will find a quick booklet of the target for the period, including a report on the past year’s performance.
Published monthly, providing updates on the activities of the State Institute for Drug Control and the latest developments in regulations concerning medicines and medical devices. It’s a great resource for staying informed about important changes and initiatives in the field, only in Czech.
Scientific publications regarding pharmacovigilance
The position and importance of pharmacovigilance in the Czech Republic and in the world
An article from journal Internal Medicine discussing how does the Czech PV system stands in comparison with abroad PV systems.
Spontaneous reports of adverse drug reactions related to oral anticoagulants in the Czech Republic
Oral anticoagulants are vital for preventing blood clots, but monitoring their safety is crucial. A recent study in the Czech Republic analyzed reports of adverse reactions, revealing that while the overall number of reports was low, a significant portion were serious, highlighting the need for ongoing vigilance in their use.
How Covid-19 Pandemic Affected the National Pharmacovigilance System in the Czech Republic
Discover how the pandemic changed Czech PV system, how and why in response to a surge in reported adverse drug reactions (ADRs), the national pharmacovigilance system in the Czech Republic adapted by implementing a triage system and hiring more trained staff.
Diverse pharmacovigilance jurisdiction—The right way for global drug safety?
Dives into the world of pharmacovigilance, comparing how different countries tackle drug safety and the unique laws that shape their approaches. Discover how these varying strategies influence the reporting of adverse drug reactions (ADRs) and what it means for patient safety worldwide.
Do you need some help with putting the Czech PV System together? We’re here for you.
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