Thursday, November 7, 2013

Interesting Info: Track and Trace Regulations Posted by Oliver Nuernberg Nov 7, 2013


I would like to give some insight into drug counterfeiting and the current and looming regulations regarding Track & Trace (other regulations) that especially apply to the Pharmaceutical Industry. I won’t get into underlying technology (yet) but would like to point out the nice blogs from Vivekanandan
Vijayaraghavan
 ( Part 1 and Part 2).

Motivation:
Drug Counterfeiting is becoming a global issue. I don’t go into details here…just go to youtube and search for “Drug Counterfeiting” and you’ll get plenty of hits, showing sites where criminals are producing counterfeited drugs. The United Nations have already established a Task Force to combat Drug Counterfeiting worldwide (IMPACT:http://www.who.int/impact/en) and you can find a nice summary with some statistics published at an OECD event:http://www.oecd.org/sti/ind/35650404.pdf

Consequence:
Lots of different attempts are being made to combat drug counterfeiting, e.g. applying seals to the packaging to prevent repackaging or special holographic labels. As another consequence governments throughout the world have established or will establish legislation to enable seamless tracking and tracing of each single pack of medication from the manufacturer to the point of dispensing the drug to a patient (Pharmacy, Hospital). This will be achieved through serialization of each individual packaging unit. Ultimately a consumer or pharmacist should have the ability to take a single package of any drug, scan it and get the information whether this package is genuine (Check out thesecurPharm video: … in German…sorry!).

continue to read here

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