New legal framework for the eradication of falsified medicines: the new safety devices
Keywords:
Legislation, Counterfeit drugs, Safety devices, Verification.Abstract
Introduction: Falsified medicines are an emerging problem in today’s society. One of the main strategies to combat them is the use of law. That is why the Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 was enacted by the relevant European institutions, which supplements Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed provisions relating to safety features appearing on the external packaging of medicinal products for human use (industrial manufacturing).
Method: A literature review of this new legislation enacted by various Community institutions has beencarried out with the aim of analyzing developments in the scope of the medicinal product.
Results: The Community regulation sets out the guidelines for verifying those medicinal products whichhave an increased risk of been falsified, using safety features consist of two parts: an anti-tampering device that allows to view that the packaging has not been altered, and a unique identifier code, whichwill be recognized in all Community countries and it has information on the medicinal product. Eachdrug is authenticated from the Pharmacies by verifying and deactivating the identifier code at the timeof dispensing it.
Conclusions: This new regulation aims to avoid the possible entry of falsified medicines into the legal supply chain of medicinal products. Its main advantages are ensuring to the patient the veracity of the drugs dispensed in the Pharmacy and improving the traceability of them.
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Copyright (c) 2020 Carlos del Castillo-Rodríguez, Silvia Enríquez Fernández
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