A. Pre-approval checks
1. Approval of marketing authorization for medicinal products for human and veterinary use
Four approval processes apply:
Ethniki
It concerns the granting of a marketing authorization only in Greece.
Mutual recognition
Once a proprietary medicinal product has been approved in one Member State of the European Union, it can be submitted for approval in other Member States with the exact same pharmaceutical and clinical documentation. In case of disagreement, it is referred to arbitration for a final decision by the European Commission.
Decentralized process
A procedure similar to the reciprocal one, with the difference that the product has not been approved in any member state of the European Union.
Central process
The authorization is issued by the European Commission following an application to the European Medicines Agency (EMEA), an evaluation by experts and an opinion from the institutionalized Committee for Proprietary Medicinal Products (CPMP), which is composed of two representatives from each member state, or the Committee for Veterinary Medicinal Products (CVMP), which is also composed of two representatives from each member state.
2. Monitoring clinical trials
The Hellenic Medicines Authority approves the conduct of clinical trials and monitors and inspects compliance with their legal execution in accordance with National regulations, Community Guidelines and the Declaration of Helsinki.
3. Approval and marketing procedure for other products under the jurisdiction of EOF
For cosmetics
A simplified procedure is followed. Their circulation is notified to the EOF and those responsible are obliged to keep a file with information on the production, control and safety of their products, which is at the disposal of the EOF in accordance with the relevant directives of the European Commission.
Medical aids
They circulate freely, as long as certain procedures are followed in accordance with European Directives (CE marking, etc.).
For biocides
National regulations are followed where marketing authorization is required and granted, while the relevant European Commission directive is soon to be incorporated into Greek legislation.
For foods for special nutritional uses and for certain food supplements
A marketing authorization is granted by the Hellenic Medicines Authority, based on the safety of their use and the documentation of their indications.
B. Post-approval audits
Pharmacovigilance
The pharmacovigilance system consists of the continuous monitoring of the safety of medicines in circulation and is uniform for all countries of the European Union. It is based on the collection and evaluation of adverse reactions and interactions recorded in the special confidential form of the Yellow Card by healthcare professionals (doctors, pharmacists, dentists, nurses) as well as pharmaceutical companies through the pharmacovigilance officers they employ.
The evaluation of adverse reactions is carried out by the Pharmacovigilance Committee of the Hellenic Medical Authority (EOF) and the resulting data is sent to the World Health Organization and discussed in the European Pharmacovigilance Committee, where decisions are made that are binding on all member states (e.g. restriction of indications, addition of new adverse reactions, suspension of marketing).
Controls of production and circulation units
Control of production units (Inspections)
In Greece, there are approximately 60 production units for human and veterinary medicines, 100 for cosmetics, 200 for animal feed, and 15 for medical gases. Control is carried out in accordance with the good manufacturing practices that apply throughout the European Union (Good Manufacturing Practice-GMP).
The accreditation process has already started in accordance with the European Standard EN 45004. Accreditation demonstrates the technical competence of inspectors to act in accordance with specific procedures, which are described in the above Standard. The accreditation process started in April 1997 and is in the phase of practical implementation. Accreditation is necessary within the Community framework, so that the results of the audits carried out are acceptable throughout the European Union.
Traffic control
Samples are collected from the market for the purpose of laboratory testing or checking the legality of their circulation. All complaints submitted by health professionals, hospitals or consumers regarding the quality and legal circulation of products are examined.
Consumption monitoring - Coverage of deficiencies - Authenticity certificate
The production, import and sales of pharmaceutical products are monitored on a monthly basis. According to the data obtained, prescription trends and the impact of price levels on consumption are detected. EOF distributes the authenticity tape to companies. The authenticity tape is affixed to each medicine package, thus ensuring the authenticity of each medicine and the proper functioning of the financial performance system of the funds.
Finally, an important social contribution of EOF is the coverage of the basic shortages in the market for medicines.
3. Laboratory Tests
With the aim of protecting Public Health and ensuring the Public Interest, more generally, in the field of Medicines and other related Products, EOF performs - through its Laboratories - a multitude of Physicochemical, Microbiological, Pharmacotechnical and other Tests on Pharmaceutical Raw Materials, Pharmaceutical Products for Human and Veterinary Use, as well as on Cosmetics, Medicated Feed, Dietary Supplements and Medical Devices.
These Laboratory Controls are part of the annual regular Post-Authorization Control program of the Internal Market by the EOF or of the European Market by the European Directorate for the Quality of Medicines ((EDQM: European Department Quality Medicines), which operates under the auspices of the Council of Europe) with which the EOF collaborates. At the same time, Laboratory Controls are carried out on Products under the responsibility of the EOF on the basis of Complaints originating mainly from the Executives of the Health System of the country (Doctors, Pharmacists, etc.).
Laboratory Accreditation Establishment of a Unified Quality System ISO 17025
In order to document their Technical Adequacy and to guarantee the unquestionable Reliability of the results-conclusions of the Laboratory Tests they perform, the EOF Laboratories had begun in 1997 the design and implementation of an appropriate Quality System.
After many years of arduous preparation, in November 2003, they submitted an application to the National Accreditation System (ESYD) in order to achieve Accreditation, in accordance with the requirements of the ELOT EN ISO/IEC 17025 standard, of the most important of the Laboratory Tests they perform.
In March 2004, the Preliminary Report was prepared by the appointed ESYD Evaluation Team.
and in June 2004 the Pre-Evaluation of the
Laboratories. The Final Assessment was carried out in early March 2005 and the relevant Accreditation Certificate according to ELOT EN ISO/IEC 17025 was granted in March 2006.
Furthermore, the continuous and consistent adherence to high Quality requirements is monitored, among other things, through the participation of Laboratories in International Interlaboratory Programs for the Assessment of their Technical Proficiency as well as through the annual surveillance of the Quality System by ESYD.
The EOF Laboratories participate in the Network of Official European Medicines Control Laboratories (OMCL), which is coordinated by the European Directorate for the Quality of Medicines (EDQM). This cooperation covers the Post-Authorisation Control of Products which are placed on the European Market and have been authorised through the Central or Mutual Procedure. It also covers Inter-Laboratory Studies to demonstrate the Technical Adequacy of the Laboratory as well as other Studies relevant to the European Pharmacopoeia.
Both the achievement of EOF Laboratory Accreditation and the maintenance and continuous satisfaction of the strict requirements of the Quality System that it entails require the commitment of increased human and material resources. However, any increased requirements are fully offset by the effective and reliable defense of Public Health..
C. Information-EOF Publications
It is the sector through which EOF serves transparency and information on the rational use of medicines and pharmacovigilance.
The Organization's publications include the National Formulary, the Veterinary Formulary, the Greek Pharmacopoeia and the periodical Drugs and Prescription.
Since 2000, in consultation with the Panhellenic Medical Association (PIS), the Organization has been publishing in “Iatriko Vima”, the official organ of the PIS, the “EOF News”, an informative page with up-to-date information on the operation of the Organization and urgent news on products under its jurisdiction.
