Pharmacovigilance in Bulgaria
How is it with the drug safety system in one of the “Oldest European Countries”? 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 Bulgarian pharmacovigilance services:
LCPPV / EU QPPV in Bulgaria
AVAILABLE
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Local Literature Screening
AVAILABLE
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Who is the main PV authority in Bulgaria?
RESPONSIBILITY FOR NATIONAL PV SYSTEM
The main authority on pharmacovigilance in Bulgaria is the Bulgarian Drug Agency (BDA), located in Sofia. This agency operates under the Ministry of Health and is responsible for supervising the quality, safety, and efficacy of drugs and medical devices.
While the BDA itself does not explicitly mention regional centers for pharmacovigilance, it collaborates with Regional Health Inspectorates that implement health policies at the district level.
Useful insights about the authority website
CONTENT IN ENGLISH
The BDA’s website does offer an English version, but the content it’s quite limited, many sections are translated only partially.
If you’re having difficulty finding the information you need, we suggest looking at the Bulgarian version of the website and utilizing translation tools like Google Translate to help you navigate and uncover the details you’re searching for. This method can make it easier for you to access the information you want.
Interesting website sections related to pharmacovigilance
HOMEPAGE LIBRARY
There is this special “library”, right in the middle of the page, that contains notifications, news, etc. from many areas, thankfully you cal filter this by choosing the area and also, wheter you’re interested in information fro public, companies or medical professionals. You migh encounter this kind of “library” also in other sections.
LEGISLATION
List of the most important laws and guidelines (in the Bulgarian version there are also some by-laws and regulations), all can be viewed and downloaded as PDF.
ADMINISTRATIVE SERVICES
Issue of Marketing Authorization, Registration of medical devices and more can be sorted out here. When using the English version, you usually end up on different page that is only in Bulagarian a has a downloadable document at the bottom. When using the Bulgarian one, you’ll be redirected to another governmental website, where you need to click on the “Изпълнителна агенция по лекарствата” (Executive Agency for Medicines) and then there are instructions.
DATABASE OF MEDICINE
As it seems it’s impossible to search by typing something, you need to choose a letter and then see the list of medicines and then choose the specific one to see the information.
IMPORTANT INFORMATION
Includes notices, EMA’s warnigns, drug shortages etc., there are truly many things you can find here, it’s kinda vast, so it’s good thing that you can filter here the same ways as in the case of homepage “library”.
Other important institutions & industry groups
MINISTRY OF HEALTH
Primary governmental body responsible for public health, medical standards, and patient rights in Bulgaria. It oversees the healthcare system, drafts health legislation, and implements national health policies.
Ministry’s website is really user-friendly, it’s easy to navigate through. If you’d like to know more about national strategies or plans regarding health, you can download some materials in the linked sections. There is also a Annual report on the state of health of citizens available which is very comprehensive indeed, offering a lot of data not only in the form of graphs. If you’d like to get a complete list with all the most important laws and regulations regarding public health, the ministry’s got you covered.
Ministry’s website: https://www.mh.government.bg/
NATIONAL CENTER FOR PUBLIC HEALTH AND ANALYSES (NCPHA)
Focuses on public health research, analysis, and monitoring. It plays a crucial role in epidemiological surveillance, health promotion, and disease prevention initiatives across the country.
There is a vast section containing all sorts of reports and analysis (including Annual report on the state of health of citizens), such as those regarding public health, noise or air polution etc. The part of their website called “Annual data” offers you a more detailed look on some areas, for example Status and movement of the population, Morbidity of the population, Medical establishments and more, usually in form of tables. They also publish a “Public health statistics”, which is a guide that mostly includes the sections that can be found in “Annual data” individually.
NCPHA’s website: https://ncpha.government.bg/?lang=en
ASSOCIATION OF RESEARCH-BASED PHARMACEUTICAL MANUFACTURERS IN BULGARIA (ARPharM)
Established in 1996, ARPharM represents research-oriented pharmaceutical manufacturers in Bulgaria. It focuses on promoting innovation and ethical practices within the pharmaceutical industry.
The “Onco Panel” page provides statistics in form of graphs regarding cancer and it’s treatment, drug therapies etc., but even if you switch the page into English version, the statistics are still in Bulgarian. Then there are news & press releases, which you can see from time to time to stay in the picture and to know what’s going on in the industry, lastly, there published many campaigns, so if you’d like to know more about them, head there from the menu on homepage see the one you’re most interesting in.
ARPharM’s website: https://www.arpharm.org/
BULGARIAN ASSOCIATION FOR DRUG INFORMATION (BADI)
BADI is dedicated to improving drug information and education within the pharmaceutical field. It organizes training and congresses for professionals in the industry, aiming to enhance the quality of drug information available to healthcare providers and patients.
The whole website seems to be a quite a big signpost, where you can find many important links, for example there is actually a pharmacovigilance section, that provides you with the links for the most important documents, both on national and EU level. Then there are “Health news”, through which you can get to the National Assembly’s website, more concretely draft laws, meeting of committee or State Gazette or latest news on BDA’s webpage. Also once more there is a list of the most important legislation, all docuemnts are in fulltext.
BADI ‘s website: https://www.badibg.org/
Some of the most important laws
Basic legislation
Medicinal Products in Human Medicine Act
This act governs the authorization, marketing, and monitoring of medicinal products in Bulgaria.
Law on Protection from the Harmful Effects of Chemical Substances and Mixtures
This law establishes the conditions and procedures for the trade, import, export, storage, use, and placement on the market of chemical substances and preparations.
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 Bulgaria is a member of the EU, every Marketing Authorization Holder with a product on the Bulgarian 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 Bulgaria, 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
BDA (Изпълнителната агенция по лекарствата)
→ Bulgarian Drug Agency / main authority on pharmacovigilance
Is LCPPV needed or is EU QPPV enough?
In Bulgaria, the appointment of a Local Contact Person for Pharmacovigilance (LCPPV) is required unless the EU Qualified Person for Pharmacovigilance (QPPV) is located within Bulgaria, more information can be found 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 Bulgaria?
Reports can be made electronically via the BDA’s reporting system (healthcare professionals & public) or directly to the MAH of the drug suspected to have caused the ADR, Marketing Authorisation Holders should report via EudraVigilance.
Local medical journals to screen
Here are few examples of Bulgarian local literature sources that medical authorization holders should monitor:
ACTA MEDICA BULGARICA (AMB)
Leading scientific medical journal published by the Medical University of Sofia since 1973.
It offers a peer-reviewed platform for original research, case reports, and reviews across various medical fields, including pharmacovigilance, making it a vital resource for healthcare professionals and researchers.
ISSN: 2719-5384
JOURNAL OF IMAB
A peer-reviewed scientific publication that covers a wide range of topics in medicine and dentistry.
It is notable for its open-access model, allowing free access to full texts, which promotes the dissemination of research findings.
ISSN: 1312-773X
BULGARIAN JOURNAL OF PUBLIC HEALTH
This journal focuses on public health issues in Bulgaria and publishes research articles that address health policies, epidemiology, and community health initiatives.
It is instrumental in promoting public health awareness and research within the country.
ISSN: 1539-3704
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
bulgaria: Country Health Profile 2023
SoHEU Bulgaria – Country Health Profile 2023
A publication “State of Health in the EU” by European Observatory on Health Systems and Policies and OECD is available here in Bulgarian-specific version.
Scientific publications regarding pharmacovigilance
Reporting of Adverse Drug Reactions by Patients in Bulgaria
This publication examines and analyzes patient participation in the pharmacovigilance system in Bulgaria, providing valuable data on how patients report ADRs. It emphasizes the importance of patient involvement in drug safety monitoring.
Discover how Bulgaria and the Republic of North Macedonia are empowering patients to report adverse drug reactions directly, enhancing the safety of medicinal products in both countries. This article explores the similarities and differences in their pharmacovigilance systems, shedding light on the vital role of patient feedback in drug safety.
Attitude of medical doctors to adverse drug reactions reporting in Bulgaria
This research uncovers a troubling gap in how medical doctors in Bulgaria perceive and report Adverse Drug Reactions (ADRs), despite recognizing their importance for patient safety. With a significant number of doctors feeling overwhelmed and undertrained, the study highlights the urgent need for better education and awareness around pharmacovigilance.
interesting resources
This page contains basic staticsits about Bulgaria in various fields such as Population, Life expectancy or Health statistics.
Do you need some help with putting the Bulgarian PV System together? We’re here for you.
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