Verification of medicinal products - wholesalers' obligations

Verification of medicinal products - wholesalers' obligations

Poster

Margarita Hristova, Emil Hristov, Kalina Andreevska
Faculty of Chemistry and Pharmacy, Sofia University "St. Kliment Ohridski", Bulgaria

Introduction: Counterfeit medicines are a huge problem and pose risks to patients and healthcare systems worldwide. To prevent the entry and distribution of counterfeit medicines in the legitimate distribution chain, the pharmaceutical sector in the EU is joining forces in developing a serialization and verification system to ensure that medicinal products are authentic. Aim: To study the legislative framework for serialization and verification of medicinal products. Method: Documentary method and content analysis were used. Results: The Directive and the Regulation require the establishment of a national system for the verification of medicinal products in each EU Member State, which stores information on individual identification marks and allows pharmacy verification of each package dispensed to a patient. The national systems are connected in a single pan-European system for the verification of medicinal products and function in synchrony. The new regulations mainly cover prescription medicinal products. New processes and parameters are introduced in the drug distribution system: Verification; Disabling the unique identifier; Serialization; Safety indicators of medicinal products. Conclusion: The introduction of the verification and serialization of medicinal products is a serious challenge for the entire pharmaceutical sector, both in Bulgaria and across the EU level. According to the European and national legislative framework, all participants in the legal drug supply chain are responsible for complying with their obligations, guaranteeing the authenticity of medicinal products dispensed in pharmacies.
Keywords: verification, medicinal product, counterfeit