BASIC STAGES OF THE ON-BOARDING PROCESS TO THE EUROPEAN SYSTEM FOR VERIFICATION OF THE MEDICINAL PRODUCTS
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Date
2021-01-01
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https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85117887458&origin=inward
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Abstract
Falsified medicines are a major threat to public health and safety. Since the falsifications become more sophisticated, the risk of falsified medicines to be proposed to patients in the EU increases every year. Such medicines represent a serious threat to global health and call for a comprehensive strategy both at European and international level. With the Falsified Medicines Directive and its supplementing Delegated Regulation the legislator has taken the necessary steps to preven falsified medicines from entering the legal supply chain. One of the measures that is being undertaken to achieve this goal is to mandate pharmaceutical companies and parallel distributors of mainly prescription medicines to apply safety features to their outer packaging. This guideline provides all manufacturers and parallel distributors with assistance in the upcoming implementation of the required measures for protection against falsification and describes in detail the on-boarding process to the European system against falsified medicines