The National Organization for Medicines of Greece (EOF) was established in 1983, and is a public entity of the Ministry of Health and Social Solidarity. EOF’s mission is to ensure public health and safety with regard to the following products marketed in Greece: medicinal products for human and veterinary use, medicated animal foods and food additives, foodstuffs for particular nutritional use, food supplements, biocides, medical devices, and cosmetics.
The Validation of Applications & Marketing Authorization Division (DDYEP) is the Organization’s first-stop in assessing the quality, efficacy and safety of pharmaceutical products and authorizing their sale in Greece. Prior to their submission for scientific assessment, all applications are physically accepted and reviewed for completeness and quality by the Division’s Assessors. The validation process often required multiple visits from the interested parties (Pharmaceutical Companies), both for the purpose of documentation review and delivery of guidance through which to meet National and European regulatory requirements. Applicants are located both in Attica (Athens) as well as the provinces of Greece.
The time required to review an application and to grant a marketing authorization is critical both to Pharmaceutical Companies, and the citizens for which the pharmaceutical product is intended. Delays in the review process imply a lost market opportunity for the Pharmaceutical Company and unavailable medicinal products for the citizen / patient. Further, regulatory requirements mandate timeframes in which applications are to be assessed and a decision relative to market authorization rendered. Time allocated for the purpose of application documentation review needs to be balanced with time spend for scientific assessment in order to ensure the safety, quality and efficacy of the pharmaceutical product, as well as the timely execution of the review process.
Prior to the implementation of the e-appointment system, Pharmaceutical Companies telephoned DDYEP’s Administrative Control Sector’s personnel to arrange for visits. Appointments were scheduled and tracked with the use of personal calendars. This “manual scheduling system” provided little evidence relative to the processes’ objectivity, transparency, and effectiveness, an issue often raised by the Pharmaceutical Companies. Further, the manual scheduling system proved to be cumbersome for Pharmaceutical Companies, given that a scheduled visit required multiple attempts to arrange (one to five calls) and that the duration of the visit was not standardized. Fifty percent (50%) of the time, the scheduled visit was not on the day or time originally requested by the Pharmaceutical Companies’ representative. Finally, the Division’s personnel utilized in excess of twenty percent (20%) of their time answering telephone calls concerning scheduled visits, a time which was lost from the total time spend in the validation process. This time was neither documented nor measured.
The driving force behind the development and implementation of the “e-appointment system” within DDYEP was to cope with the increasing pressure on existing resource, to meet the challenges of orienting its approaches to be more customer-focused, to seek out and make use of available technologies, to maximize efficiency, to promote transparency and equity and to continuously improve on existing systems, while preparing for future challenges.
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