Pharmacovigilance in Cyprus
How is it with the drug safety system in “The Island of Aphrodite”? 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 Cypriot pharmacovigilance services:
LCPPV / EU QPPV in Cyprus
AVAILABLE
Easily managed through Tepsivo Platform >
Local Literature Screening
AVAILABLE
Automated monitoring with Tepsivo Literature >
Who is the main PV authority in Cyprus?
RESPONSIBILITY FOR NATIONAL PV SYSTEM
The main authority on pharmacovigilance in Cyprus is the Pharmaceutical Services, which operates under the Ministry of Health, headed in Nicosia.
This body is responsible for ensuring the safety, quality, and efficacy of pharmaceutical products marketed in Cyprus.
Useful insights about the authority website
CONTENT IN ENGLISH
The website offers an English version with many translated pages, but occasionally you’ll come across a page that hasn’t been translated, so you might need to refer to the original version.
If you’re struggling to find what you need, we recommend checking the Cypriot version of the site and using translation tools like Google Translate to help you navigate and discover the information you’re looking for.
Interesting website sections related to pharmacovigilance
APPLICATION
Individual applications can be found in this section, where you can download them, they are held in a user-friendly table, so no problem finding the right application here. More information about Submissions & Validation can be found here.
CIRCULARS
Similar table as used with applications, only this time it includes manuals from various areas, such as Pharamcovigilance, Clinical Trials or Marketing Authorisations for Medicinal Products for Human Use, you can sort it by sectors.
PUBLIC SERVICES
This page contains many moduls, such as search for pharmaceutical products for human use, price request, periodic sales report or Yellow Card (report issues related to the use or quality of pharmaceutical products immediately). Sadly, this section is not accesible in English, but Yellow Card is.
Other important institutions & industry groups
MINISTRY OF HEALTH
The Ministry is responsible for public health policy, regulation, and oversight of health services in Cyprus. It manages health promotion, disease prevention, and the overall healthcare system.
In section called “Informational Materials” you can find some interesting documents regarding health system, health professionals etc. as well as some studies or annual reports, it’s a bit mess there. Other than this, there is nothing much to see, you can read some statements from the Ministry on the home page, but that is pretty much it.
Ministry’s website: https://www.gov.cy/moh/
STATISTICAL SERVICE OF CYPRUS (CYSTAT)
CYSTAT is responsible for collecting, analyzing, and disseminating statistical data in various fields, including health. It provides comprehensive health and hospital statistics, which help inform public health policies and decisions.
There is section regarding health, where you can see many statistics, as well as infographics or predifend tables. Many subareas withing health are coverd, such as Health care indicators, Hospital Statistics and more.
CYSTAT’s website: https://www.cystat.gov.cy/en/default
CYPRUS ASSOCIATION OF RESEARCH & DEVELOPMENT PHARMACEUTICAL COMPANIES (KEFEA)
Established in 2006, KEFEA represents multinational pharmaceutical companies engaged in research and development in Cyprus. It is a member of the European Federation of Pharmaceutical Industries and Associations (EFPIA) and advocates for improved access to medicines and healthcare standards.
This website does not offer much interesting content, perhaps only the “articles” section, where they inform about the events in the sector, what is happening in the association, etc. There are not many articles in the English version and they are mainly old, there are more in the original version, but in the last few years it seems that there is only one a year.
KEFEA’s website: http://kefea.org.cy/
CYPRUS DRUG VERIFICATION ORGANIZATION (KOEΦ)
KOEΦ is responsible for implementing the national medicines verification system in compliance with EU regulations. It ensures the safety and authenticity of medicines distributed within Cyprus, contributing to public health protection.
If you’d like to know more about the legislation regarding Falsified Medicines, head into this section, where an introduction awaits you as well as PDF with the regulations and Directive.
KOEΦ ‘s website: https://koef.org.cy/
Some of the most important laws
Basic legislation
This law establishes the framework for the regulation of pharmaceuticals in Cyprus.
Pharmacy and Poisons Law (Cap. 254)
Governs the operation of pharmacies, the sale of medicinal products, and the responsibilities of pharmacists in Cyprus.
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 Cyprus is a member of the EU, every Marketing Authorization Holder with a product on the Cypriot 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
Is LCPPV needed or is EU QPPV enough?
The Pharmaceutical Services of Cyprus mandates that a Local Contact Person for Pharmacovigilance (LCPPV) must be appointed. This local person must be a healthcare professional, biologist, or chemist with appropriate training in pharmacovigilance.
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 Cyprus?
The Yellow Card system allows for easy submission of reports to the Pharmaceutical Services, which will assess and take necessary actions to ensure patient safety. You can submit a Yellow Card either online or offline.
Local medical journals to screen
Here are few examples of Cypriot local literature sources that medical authorization holders should monitor:
CYPRUS JOURNAL OF MEDICAL SCIENCES
This is an open-access, peer-reviewed journal that covers a wide range of topics in general medicine, including pharmacovigilance.
It is notable for its commitment to publishing high-quality research that contributes to the medical community in Cyprus and beyond.
ISSN: 2536-507X
TURKISH JOURNAL OF PHARMACEUTICAL SCIENCES
It publishes research articles related to pharmaceutical sciences, including pharmacovigilance studies.
It focuses on both theoretical and practical aspects of pharmacy, providing insights that can be applied in clinical settings. It serves as a key resource for researchers in Turkey and neighboring regions.
ISSN: 2148-6247
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
pharmaceutical services' annual report
The reports provide a comprehensive overview of the agency’s activities and achievements over the year, altough they’re accessible only in English and only two (2018, 2023) are available.
Cyprus: Country Health Profile 2023
SoHEU Cyprus – 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 Cypriot-specific version.
Scientific publications regarding pharmacovigilance
Defining the awareness and attitude of the clinicians through pharmacovigilance in Turkey
Curious about how well clinicians in Turkey and Northern Cyprus understand pharmacovigilance and adverse drug reactions? This study reveals surprising gaps in knowledge and awareness among healthcare professionals, highlighting that while many doctors encounter adverse drug reactions, a significant number are not filling out the necessary reports or staying updated on best practices.
Budget impact analysis of daratumumab for light-chain amyloidosis in Cyprus
Ever wondered how the introduction of D-VCd affects healthcare budgets over time? This study uncovers the financial implications of daratumumab for AL amyloidosis, revealing a significant budget impact that grows each year and suggesting innovative strategies to manage costs—insights that could be crucial for healthcare decision-makers.
interesting resources
This page contains basic staticsits about Cyprus in various fields such as Population, Life expectancy or Health statistics.
Do you need some help with putting the Cypriot PV System together? We’re here for you.
And while you’re here…
…consider also our global end-to-end PV solution!
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