National Organization for Medicines in Greece (EOF)

Introduction

The Greek Health Authorities are called the National Organization for Medicines in Greece. The acronym used is EOF, which stands for the first letter of the three words of the name of the organization in Greek, i.e. Εθνικός Οργανισμός Φαρμάκων.

The National Organization for Medicines (EOF) was established in 1983 with Act 1316 and is a public entity of the Ministry of Health Social Solidarity.

Mission

EOF’s mission can be summarized as follows:

“The establishment and promotion of public health through ensuring appropriate safety, quality, and efficacy standards for all products under EOF’s authority that are marketed in Greece. Additionally, the implementation of relevant inspections, auditing and monitoring of the market, and provision of information will contribute to the public’s safe and efficient use of these products.”

Objective

EOF’s objective is to ensure public health and safety for the following products that are marketed in Greece:

– Medicinal products for human and veterinary use

– Biological products for human and veterinary use

– Medicated feed and feed additives

– Special diet foods and food supplements

– Biocides

– Medical devices

– Cosmetics

Tasks

Within the framework of its mission, EOF, in cooperation with the EU, performs the following tasks:

Evaluate and authorize products

Monitors medicines’ quality, safety, and effectiveness throughout their circulation, controls, inspects, and supervises the market for all products under its responsibility.

Controls the observance of the rules of good manufacturing, laboratory, and clinical practice and the correct application of the legislation regarding their handling, distribution, marketing, and advertising.

Develops and promotes medical and pharmaceutical research

Informs Healthcare Professionals, Competent Bodies, and the public of the latest information on the products under its responsibility for their safe and proper use.

Structure & Operation

A 10-member Management Board administers EOF. Presidential Decree (P.D) 142/89 established EOF’s structure today. EOF is comprised of nine divisions, two of which have been accredited and one certified for the services they offer.

To implement its mission, EOF employs 239 employees, of whom 91 are pharmacists, chemists, doctors, veterinarians, and biologists and 26 are lawyers, economists, mathematicians, and computer scientists.

At the same time, EOF cooperates with experts of various specialties (about 400) and participates with its representatives in the Committees of the European Commission, the European Medicines Agency (EMEA), and other Community and International Organizations.

To date, EOF has undertaken the role of co-rapporteur for 8 medicinal products that have been approved or are under evaluation for approval through the centralized procedure.

In addition, EOF actively participates with its representatives in formulating specifications and requirements for marketing authorization applications for medicinal products to be submitted in electronic form and in creating a modern electronic environment for managing and handling issues.

EOF has formed scientific committees and boards, among which the most important are:

The Scientific Board of Approvals provides its opinion on issues related to authorizations, variations, renewals, and suspensions & withdrawals of marketing authorizations for products under the authority of EOF. Various Departments operate (conventional medicines, biologicals, blood products, radiopharmaceuticals, homeopathic and herbal medicines, special diet products, veterinary medicines and vaccines, cosmetics, and medical devices).

The Pharmacovigilance Committee evaluates adverse drug reactions and suggests correcting or amending the Summary of Product’s Characteristics (SmPC) and Patient Information Leaflet (PIL).

The Pharmacopoeia Committee compiles the Greek Pharmacopoeia and is the link to the European Pharmacopoeia.

The National Formulary Committee prepares the National Prescription Book. A similar Committee operates for the Veterinary Prescription Board.

The Second-Degree Scientific Board reviews appeals against initial EOF decisions.

EOF’s headquarters is also where the National Ethics Committee is based. The National Ethics Committee is an independent authority responsible for approving interventional clinical trials involving pharmaceutical products in human subjects as defined by the respective legislation.

Finally, EOF is assisted in its work by its subsidiaries listed below:

Institute of Medicinal Research and Technology (IFET) SA

IFET has undertaken the distribution of products under EOF’s authority (on its behalf or on behalf of third parties) to cover permanent or urgent product shortages in the market. It also promotes research and development in the pharmaceutical field (e.g., bioequivalence studies) and operates a production unit in which methadone is produced, among other products.

Research Center of Biological Materials (EKEVYL) SA

The primary functions of EKEVYL are certification, quality control, and research regarding medical devices. EKEVYL has been a Notified Body of the European Union since 1997.

Hellenic Industry of Hospital Materials (ELBIONY) SA

Manufactures gamma-sterilized disposable plastic syringes.

 

Resources

The resources of EOF include the fees for the various services provided (authorizations, renewals, variations of marketing authorization, production licenses, certifications, invoice endorsements) regarding products within its competence, the annual fee payable to cover the costs of sampling or analysis, the medical device readiness fee, the levy on sales of cosmetic products, the collection of fines of pharmaceutical legislation and the revenue from the distribution of scientific publications.

 

Author:

Kaliopi Karidi

Regulatory Affairs Specialist

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National Organization for Medicines in Greece (EOF)