New European guideline for serialized authentication of pharmaceutical products

New European guideline for serialized authentication of pharmaceutical products started on February 9th!

To put an end to harmful illicit drug trafficking, the European Union has launched a new EU Directive (2011/62/EU) on the serialization of prescription drugs and certain OTC medicines. Since February 9th, 2019, this will be mandatory for all pharmaceutical packaging in the EU. Packages that have been released for marketing before the appointed date do not yet have to comply with the new requirements and may be released until the date of expiry. If a pharmaceutical manufacturer does not meet the requirements, he will no longer be able to market prescription drugs on the European market. The authenticity and integrity of a drug unit is ensured by two required features:

  • The first security feature is a randomized, unique serial number, which is issued once and must be placed on the outside of the packaging along with a machine-readable code. Assigned serial numbers are stored on a protected central data storage and the authenticity of each package is verified by the pharmacies. Thus, these drugs can easily be traced to their origin and possible counterfeits can be taken out of circulation.
  • The second required safety feature is a tamper-evident seal on the outer package. To recognize that a package has not yet been opened, the package is sealed with a sticker or by sticking the packing flap together.

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The implementation of this guideline poses a huge challenge for both pharmaceutical producers and pharmacies, as existing processes have to be adapted accordingly. Denk Pharma GmbH & Co. KG has adapted the internal processes and the complete infrastructure and was able to implement the new requirements. In the next few years, governments of other countries such as South Africa, Brazil and Russia are planning to serialize medicines. Other countries are currently working on a binding legal text to establish a timeline for implementing serialization of prescription drugs.