Pharmacy Practice Case - a sub-standard medicinal product in the legal distribution chain

Pharmacy Practice Case - a sub-standard medicinal product in the legal distribution chain

Oral presentation

Simeon Georgiev1, Radostina Tzankova1, Emil Hristov2
1Open type pharmacy
2Faculty of Chemistry and Pharmacy, Sofia University “St. Kliment Ohridski”

Contemporary medicinal regulation based on Directive 2001/83 / EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. The essential aim is to place on the EU market only qualitative, safe and efficient medicinal products and all rules for the production, distribution and use of medicinal products must guarantee the protection of public health. Each participant in the legal distribution chain and its activities - manufacturers / importers, parallel dealers, intermediaries, wholesalers and retailers (pharmacies and drugstores) is or is subject to authorization. Such authorization is required even when the medicinal products intended for export. In order to ensure the protection of the health of the individual citizen and of society as a whole, all activities are cover by the so-called Good Practices: Good Manufacturing Practice, Good Clinical Practice, Good Laboratory Practice, Good Distributor Practice, Good Pharmacy Practice, Good Donation Practice, etc. Despite the presence of strong regulatory control and self-control occasionally medicinal products with quality deviation can be placed on the market. We present a case of real pharmacy practice - an established sub-standard medicinal product in the legal distribution chain. What are the legal actions and what algorithm should be follow by the stakeholders?
Keywords: quality, safety, efficacy, medicinal products, sub-standard product, algorithm