EU Anti-Counterfeiting Legislation On Its Way

Jul 01, 2010
Volume 22, Issue 7

The full version of this counterfeiting feature can be read in the July issue of our digital magazine: http://www.pharmtech.com/ptedigital0710

With the increasing financial and technical means of counterfeiters, the number of counterfeit pharmaceuticals in the supply chain is growing at an alarming rate. Counterfeiters now have the ability to produce higher quality packages, which enables fake medicines to slip into supply chains more easily.

To combat this threat, the European Parliament and the Council of the EU are amending the current anti-counterfeiting directive (Directive 2001/83/EC), which is due to be completed before the end of 2010, to include a requirement for features that enable the identification, authentication and traceability of prescription medicines. Once this legislation is passed, all European member states will have to implement local legislation within 24 months. Given the legislation's short timeframe, it is imperative that pharmaceutical manufacturers begin to examine and invest in a solution as soon as possible.

Examples of authentication and data integrity
The only way a specific product can be identified, authenticated and traced effectively throughout the supply chain is to give it a unique identity. As such, serialisation, which assigns a unique identity via a unique identification number to each product through a vehicle such as RFID or 2D barcode, is the only solution that can comply with the directive.

Identification, authentication and traceability

Combined, identification, authentication and traceability initiatives make it significantly more difficult for counterfeit drugs to enter the supply chain and reach patients.

Identification allows a specific item to be tracked to the date and batch number that it was manufactured on.

Authentication is the ability to verify that a drug product genuinely came from the manufacturer or other legalised source within the supply chain. To authenticate a product, the pharmacy reads its serialisation code, which when linked to a database, can identify an individual pack and determine that it has not been copied, is in date, has not been recalled and is legally available for sale.

Traceability allows authorised individuals to verify samples of packs to confirm their authenticity before they are distributed, as well as locate and remove the packs from the supply chain if issues are detected. It can also help identify where in the supply chain a counterfeit drug entered.

Identification, authentication and traceability require very high quality serialisation data. If the data are not 100% accurate when the manufacturer applies the serialisation code to a product, then authentication by the pharmacy will be inaccurate. Aside from simply placing a unique number on a package, serialisation technology must also allow a manufacturer to know which numbers have been assigned and placed on which of their products and batches; to be aware of which serialised products are in the supply chain or have been consumed; and to obtain updates regarding the status of specific serialisation numbers in the case of recall, illegal importation or theft.

For serialisation technology to provide such a high quality of data, it must have the ability to maintain control of the product throughout the packaging process. Because such large amounts of data are involved, companies need excellent quality control procedures regarding data integrity; otherwise, for example, there may be problems associated with missing information or overlapping ranges of serialisation numbers. To ensure data integrity is maintained throughout the packaging process, serialisation solutions must:

  • control the numbers issued to a particular packaging line for a particular process
  • assign and verify unique identification numbers at the item level, track items through the packaging process, and establish relevant parent-child relationships between item, case, and pallet
  • assign numbers randomly rather than in sequential order
  • accurately account for numbers that may have been assigned to packages that were rejected during packaging both on and off of the line
  • associate serial numbers to the correct lot/batch information.

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