Pharmacovigilance in Greece
How is it with the drug safety system in “The Cradle of Western Civilization”? 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 Greek pharmacovigilance services:
LCPPV / EU QPPV in Greece
AVAILABLE
Easily managed through Tepsivo Platform >
Local Literature Screening
AVAILABLE
Automated monitoring with Tepsivo Literature >
Who is the main PV authority in Greece?
RESPONSIBILITY FOR NATIONAL PV SYSTEM
The main authority on pharmacovigilance in Greece is the National Organization for Medicines (EOF), which is responsible for the regulation and oversight of pharmacovigilance activities within the country, ensuring that the safety of medicinal products is monitored effectively
The EOF is headquartered in Athens, it operates under the Ministry of Health and in terms of regional centers there seems to be no explicitit mention.
Useful insights about the authority website
CONTENT IN ENGLISH
The website does offer an English version, but in reality you won’t find much content trasnlated, sometimes it also gets quite tough to distinguish which version you’re browsing.
We strongly suggest exploring the Greek version of the website and utilizing translation tools like Google Translate to help you find the information you need. This approach can make it easier for you to uncover the details you’re looking for.
Interesting website sections related to pharmacovigilance
PHARMACOVIGILANCE
This section does not include, as usually does, the general information regarding PV, but rather some documents and news, mostly from PRAC or EMA, or important information about some medications.
DOCUMENTS
Sorted into individual categories, such as Fees, Application, Procedures and instructions, List of Inspectors, etc.
DRUG SALES DATA
If you’d like to get more information about the sales, then visit this section, where you find individual documents representing each year.
PRODUCT SEARCH
Feel free to use this library to find any and every officially listed medicines in Greece, it’s much more user-friendly and clear than EOF’s website.
Other important institutions & industry groups
MINISTRY OF HEALTH
It’s the primary government body responsible for managing the health system in Greece. It oversees health policies, public health initiatives, and the regulation of healthcare services.
Ministry’s webpage is full of articles on various areas, such as Primary Health Care Actions or Medicine, specifially on Drugs there is only one article though. Also if you’re interested in Health Actions, e.g. what current projects are, what’s being prepared etc., visit this section.
Ministry’s website: https://www.moh.gov.gr/
NATIONAL HEALTH PUBLIC ORGANIZATION (EODY)
The EODY focuses on public health promotion, disease prevention, and response to health emergencies. It plays a crucial role in epidemiological surveillance and public health education.
There can be found many pages dedicated to the epidemiological data, so if you’d like more infromation on this topic, definitely head to EODY’s website, there are for example weekly reports or Annual epidemiological reports of individual diseases. They aslo got their own newsletter if you’d like to stay in touch with EODY a bit more.
EODY’s website: https://eody.gov.gr/
HELLENIC ASSOCIATION OF PHARMACEUTICAL COMPANIES (SFEE)
SFEE represents over 95% of the pharmaceutical industry in Greece, including both Greek and multinational companies. It advocates for the interests of patients and the pharmaceutical workforce.
For one thing, you can read about their way of contributing to prevention, research, etc. here. You can also visit this section, which includes some interesting materials, such as The Pharmaceutical Market in Greece: Facts & Figures 2023 or IFPMA Facts & Figures regarding pharmaceutical innovation.
SFEE’s website: https://www.sfee.gr/
Some of the most important laws
Basic legislation
Ministerial Decision Δ.ΥΓ3α/Γ.Π. 32221/2013
It harmonizes Greek legislation with EU regulations concerning the manufacturing and circulation of medicinal products for human use, in compliance with Directive 2001/83/EC.
Ministerial Decision Δ.ΥΓ3α/Γ.Π. 90023/2013
This transposes Directive 2012/26/EU into Greek law, amending Directive 2001/83/EC regarding pharmacovigilance. It outlines specific obligations for marketing authorization holders.
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 Greece is a member of the EU, every Marketing Authorization Holder with a product on the Greek 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 Greece, 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
EΟΦ (Εθνικός Οργανισμός Φαρμάκων)
→ EOF / National Organization for Medicines / nain authority on pharmacovigilance
Is LCPPV needed or is EU QPPV enough?
The Greek national authority, EOF, has indicated in an EMA document that the local qualified person for pharmacovigilance in Greece is appointed by the EU QPPV for human medicinal products. 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 Greece?
To report Adverse Drug Reaction (ADR) use the Yellow Card through EOF’s website, you can submit your report either online or offline. Though the webpage seems a bit out of date, once you actually enter the Yellow Card’s web, it’s much more user-friendly.
Local medical journals to screen
Here are few examples of Greek local literature sources that medical authorization holders should monitor:
PHARMAKEFTIKI
This journal focuses on pharmaceutical sciences, including pharmacovigilance, drug safety, and therapeutic advancements.
It serves as a platform for sharing research and developments that impact public health in Greece.
ISSN: 2241-3081
EPITHEORESE KLINIKES FARMAKOLOGIAS KAI FARMAKOKINETIKES
Publishes articles related to clinical pharmacology and pharmacokinetics, emphasizing the importance of drug safety monitoring and pharmacovigilance practices in clinical settings.
It is valuable for professionals seeking insights into the latest research and methodologies in these fields.
ISSN: 2945-1914
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
Greece: Country Health Profile 2023
SoHEU Greece – 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 Greek-specific version.
Scientific publications regarding pharmacovigilance
This article dives into the challenges healthcare professionals face in detecting and reporting adverse drug reactions (ADRs) related to antibiotics in the Peloponnese region of Greece. With a surprising 75.8% response rate from physicians, it reveals that many rarely observe or report ADRs, highlighting the need for better training and awareness to improve pharmacovigilance practices.
Explore the critical challenges mothers face when taking medications during breastfeeding and highlights the essential role of healthcare professionals, especially midwives, in ensuring medication safety. This research aims to empower healthcare providers to support and extend breastfeeding through informed, evidence-based guidance.
Impact of Adverse Drug Reactions in Patients with End Stage Renal Disease in Greece
This study sheds light on the challenges faced by patients with end-stage renal disease (ESRD) undergoing hemodialysis, particularly the risks of adverse drug events and interactions due to complex medication regimens. With insights from 60 patients, it reveals how common comorbidities like cardiovascular disease and diabetes contribute to these risks.
interesting resources
This page contains basic staticsits about Greece in various fields such as Population, Life expectancy or Health statistics.
Do you need some help with putting the Greek PV System together? We’re here for you.
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