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Ars Pharmaceutica (Internet)

On-line version ISSN 2340-9894


CASTILLO-RODRIGUEZ, Carlos del  and  ENRIQUEZ-FERNANDEZ, Silvia. New legal framework for the eradication of falsified medicines: the new safety devices. Ars Pharm [online]. 2020, vol.61, n.1, pp.39-43.  Epub July 20, 2020. ISSN 2340-9894.


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).


A literature review of this new legislation enacted by various Community institutions has been carried out with the aim of analyzing developments in the scope of the medicinal product.


The Community regulation sets out the guidelines for verifying those medicinal products which have 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, which will be recognized in all Community countries and it has information on the medicinal product. Each drug is authenticated from the Pharmacies by verifying and deactivating the identifier code at the time of dispensing it.


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.

Keywords : Legislation; Counterfeit drugs; Safety devices; Verification.

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