Counterfeit medicines: the green light to new EU legislation
was approved this morning by the European Parliament document agreed by Ministers in December of Health of the Member States.
packs labeled, regolamentazione più stringente dell’import-export con Paesi terzi e autorizzazione speciale per le farmacie on line: queste le misure che dovranno impedire l’ingresso di farmaci contraffatti nel mercato Ue.
16 FEB - Si è concluso l’iter di approvazione della nuova normativa europea sui medicinali contraffatti. Con 569 voti a favore, 12 contrari e 7 astenuti, questa mattina il Parlamento europeo ha infatti approvato il testo uscito dall’accordo dei ministri della Salute degli stati membri lo scorso dicembre. Rimane un ultimo passo da compiere: l’approvazione formale del Consiglio. A quel punto gli Stati membri avranno 24 mesi di tempo per apportare le modifiche indicate dal testo alla loro legislazione nazionale.
The legislation contains all the measures to be put in place to prevent the entry of counterfeit drugs into the legal supply chain by introducing traceability, as well as penalties for counterfeiters. Pay special attention to Internet sales.
Satisfaction was expressed by the rapporteur for the measure, the Portuguese Member of the United Left, Marisa Matias, "The counterfeit medicines are" silent killers "because they have no effect or because they contain toxic substances that can damage or even kill, those who take them. The absence of a framework law encourages counterfeiting, which is a crime. We have witnessed a growth of this huge criminal activity, an increase since 2005 of 400% of seizures of counterfeit drugs. Protect patient safety is the main objective of this Directive ".
The first innovation of this rule on certification of authenticity of the drugs that will be guaranteed by a labeling system that also allows the tracking of packages. The rule will apply to prescription drugs, and only in exceptional cases (ie for products with a high risk of counterfeiting), also non-prescription medicines.
The law also has an obligation for Member States to set up an alert system that immediately come into action in cases where the certificate is the entry of counterfeit drugs into the net.
Additional requirements are expected to regulate the import and export of medicines to third countries.
The chapter, however, was the most anticipated Internet, which is one of the main channels through which counterfeit drugs are consumed in the EU market.
In Member States where they are allowed (the legislation does not oblige it to open the sector to this channel), online pharmacies must obtain special permission to provide products to the public via the web. For sites there is a common logo, to be recognized throughout the EU to help consumers identify the licensed pharmacies. It is also provided that all Internet pharmacies with their authorization is linked to a central site at the national level is in turn connected to a central server in Europe. Finally, the new document states that citizens are adequately informed about the risks of buying drugs over the Internet.
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