Pharmacovigilance in Romania
How is it with the drug safety system in “The Land of Dracula”? 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 Romanian pharmacovigilance services:
LCPPV / EU QPPV in Romania
AVAILABLE
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Local Literature Screening
AVAILABLE
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Who is the main PV authority in Romania?
RESPONSIBILITY FOR NATIONAL PV SYSTEM
The main authority on pharmacovigilance in Romania is the National Agency for Medicines and Medical Devices (ANMDMR). This agency is responsible for overseeing the safety of medicines and medical devices in the country, including the management of pharmacovigilance activities.
The agency is located in Bucharest and in terms of regional centers, the ANMDMR does not specifically mention having distinct regional centers for pharmacovigilance.
Useful insights about the authority website
LIMITED CONTENT IN ENGLISH
The website has an English version, some pages containing information regarding pharmacovigilance seem to be translated, though some pages are accessible only in Romanian.
If you’re having difficulty locating the information you need, we recommend checking the Romanian version of the website and utilizing translation tools like Google Translate to help uncover the details you’re after. This method could simplify your access to the information you seek.
Interesting website sections related to pharmacovigilance
IMPORTANT NOTIFICATIONS
All important notices on medicines for human use in one place, under the name of each notification and the date, you can see for who it’s meant, for example there are few “to the attention of all Marketing Authorisation Holders”.
LAW SECTION
A library containing all the most important laws, regulations, directives and ordinances regarding the field of medicines for human use. All of these can be downloaded of course, but keep in mind that they’re only in Romanian.
LEGISLATION ON PV
This section is specially desinged for the laws on pharamcovigilance, though, it is accessible only in Romanian. So, if you want to download any of these documents, just clik on the “descarca documentul …”.
FORMS TO DOWNLOAD
Here you’ll find many important forms (in English) from various areas, for instance at the bottow you’ll find Application for marketing authorisation of medicinal products for human use or renewal.
Q&A ON MEDICINAL PRODUCT SAFETY
The content here is categorized into individual sections, where each has its own document with Q&A. Sadly, this section is accessible only in Romanian.
INFORMATION FOR MAH
Few documents providing more information on some areas, such as nomination of a contact person for pharmacovigilance or Electronic Reporting of Spontaneous Individual Case Safety Reports (ICSRs).
Other important institutions & industry groups
MINISTRY OF HEALTH
The primary governmental body responsible for public health policy, regulation, and the management of healthcare services in Romania. It oversees the National Health Program and addresses various health concerns, including nutrition, drugs, and vaccinations.
There are basically only two pages, that are worth visiting, though neither of them is breathtaking in some way. The first one is Legislation, you can find there documents regarding health reform, national health strategy etc, the second one is simply the News. Also the ministry’s website has English version, but it mainly translates only the menu, the content in these mentioned sections is still in Romanian.
Ministry’s website: https://www.ms.ro/ro/
NATIONAL INSTITUTE OF PUBLIC HEALTH (INSP)
The INSP acts as an informal national node for health information in Romania. It is responsible for monitoring the health of the population, conducting analyses on communicable and non-communicable diseases, and developing methodologies for public health statistics. The institute also collects and disseminates data relevant to public health.
As you’d be expecting, there are statistics regarding public health, these datasets are sorted into individual categories, such as Causes of death, Infant mortality etc., but it is accessible only in Romanian. If you’d like more statistics, perhaps also on different areas, visit the National Institute of Statistics.
INSP’s website: https://insp.gov.ro/
ROMANIAN ASSOCIATION OF INTERNATIONAL MEDICINES MANUFACTURERS (ARPIM)
ARPIM represents the innovative pharmaceutical industry in Romania, comprising 29 member companies that account for over 75% of the Romanian pharmaceutical market’s value. The association advocates for access to innovative treatments and a stable business environment.
They have section with factsheets full of infographics on many topics, for instance there is one on Access to flu vaccination 2023. Also there is part of the website designated for news/articles on what’s going on in the sector, what does the Association do etc.
ARPIM’s website: https://arpim.ro/
ROMANIAN ASSOCIATION OF MEDICAL DEVICE MANUFACTURERS (AFPM)
AFPM serves as a representative voice for the medical device industry in Romania, advocating for a competitive market and ensuring that members have access to information and resources necessary for effective operation within the healthcare system.
When you come to their homepage, you can read about their objectives, their vision & mission. Then there is the “Blog”, which seems to be including news, their articles, notifications about what’s going on in the sector, what does the Association.
AFPM’s website: https://afpm.ro/
Some of the most important laws
Basic legislation
This law serves as the foundational legal framework for healthcare in Romania, including provisions for the regulation of medicines and medical devices.
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 Romania is a member of the EU, every Marketing Authorization Holder with a product on the Romanian 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 Romania, 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
ANMDMR (Agenția Națională a Medicamentului și a Dispozitivelor Medicale din România)
→ National Agency for Medicines and Medical Devices (NAMMDR) / main authority on pharmacovigilance
Is LCPPV needed or is EU QPPV enough?
The Local Contact Person for Pharmacovigilance (LCPPV) is not required in Romania (based on Law No. 95/2006) , the ANMDM may request the appointment of a LCPPV, although this is rarely implemented in practice, so EU QPPV level is usually sufficient.
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 Romania?
The ANMDM provides online forms for reporting side effects, there is also a posiibility to contact them via fax, phone or mail. Sadly, the page containing information about reporting as well as the form itself is accessible on in Romania.
Local medical journals to screen
Here are few examples of Romanian local literature sources that medical authorization holders should monitor:
ROMANIAN JOURNAL OF PHARMACEUTICAL PRACTICE (RJPhP)
An open-access journal that focuses on clinical pharmacy and pharmaceutical practice, providing a platform for research related to pharmacovigilance and medication safety.
It is unique for its annual awards recognizing outstanding scientific contributions, making it a valuable resource for those interested in the latest developments in the field.
ISSN: 2069-6671
FARMACIA JOURNAL
It publishes articles on various aspects of pharmacy, including pharmacovigilance, drug safety, and legislation affecting pharmaceutical practices in Romania.
Its unique focus on legal frameworks and practical implications makes it essential reading for professionals involved in pharmacy and healthcare policy.
ISSN: 2065-0019
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
ANMDMR's activity report
The annual reports from the National Agency for Medicines and Medical Devices (ANMDMR) in Romania provide a comprehensive overview of the agency’s activities and achievements over the year.
Romania: Country Health Profile 2023
SoHEU Romania – 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 Romania-specific version.
Scientific publications regarding pharmacovigilance
Involving Pharamcies in Pharmacovigilance – A Comparison between France and Romania
This reveals how each country engages pharmacies in monitoring drug safety. Readers can expect to uncover best practices from France’s decentralized approach and learn about the necessary steps Romania can take to enhance its own system, ultimately improving medication safety for patients.
This article reveals surprising insights into how well pharmacy students in Romania understand and feel about reporting adverse drug reactions (ADRs). With over 90% expressing a willingness to report ADRs, yet less than half feeling prepared to do so, you will discover the gaps in education and training that need to be addressed to enhance patient safety in the future.
This analysis dives into the safety profile of a popular hepatitis C treatment regimen in Romania, revealing important insights about adverse drug reactions and potential drug interactions. Be prepared to uncover key findings, such as the most common side effects experienced by patients and the serious risks associated with this therapy, highlighting the critical need for careful monitoring in clinical practice.
interesting resources
This page contains basic staticsits about Romania in various fields such as Population, Life expectancy or Health statistics.
Do you need some help with putting the Romanian PV System together? We’re here for you.
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