Counterfeit Medicines in the Legal Supply Chain

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The Drug Commission of German Pharmacists (AMK - Arzneimittelkommission) regularly informs about batch recalls which are - for example - due to quality defects. Now, there have been more and more reports about batch recalls due to counterfeit medicines. According to a report of the German newspaper "Deutsche Apotheker Zeitung" edition 5/2017, the company axicorp Pharma is facing such a counterfeits case. Actually, the company has already had similar cases in the past.

According to the AMK, axicorp asked for the following announcement: We have information that with regard to the batch mentioned, falsified packages have been identified.  For this reason, the batches of Votrient 400 mg (Pazopanib), 60 film-coated tablets are being recalled. Pharmacists are required to check their stocks and to inform their patients immediately if the packages affected have been delivered. The batch numbers are: JN5W, MY2A, P64U.

This case of counterfeit medicines reaching patients through the legal supply chain to the pharmacy shows how essential the mandatory requirements on serialisation (2D Matrix Code) are: they will start applying as of February 2019. Some companies have already established the systems. Yet, others are still unprepared or not sufficiently prepared. Beside the necessary investments in technical infrastructure, enormous organisational tasks have to be solved. Experts say that a 12-month test phase will be necessary after the complete technical implementation to ensure a smooth "Track & Trace" process. In particular the connection to the so-called hubs for the transmission of the serialisation data raises a wide range of challenges. Therefore, companies should have completed all the required implementation measures by the end of this year at the latest to be able to supply the market as of February 2019.