New Concept Paper of the European Commission on the Use of Safety Features against Falsified Medicinal Products

On 18 November 2011, the European Commission published a concept paper entitled "Delegated Act on the Detailed Rules for a Unique Identifier for Medicinal Products for Human Use, and its Verification".

The document refers to Directive 2011/62/EU which deals with safety features for medicinal products. The concrete implementation - which is expected for 2014 - will then be set out through so-called "delegated acts". Regarding the possible implementation, following technical characteristics are being discussed:

• Linear barcodes
• 2D-Barcodes
• RFID

Linear barcodes are currently used for the serialisation of medicinal products in Belgium, Greece and Italy. Appropriate readers are now available in almost every pharmacy in Europe. However, the amount of information contained in this code is restricted.

2D-Barcodes are being used increasingly. The advantage of 2D-Barcodes is that numerous data can be carried on a small label. Yet, only a few pharmacies in Europe are equipped with the suitable reader.

At present, RFID is seen as an expensive alternative compared to the other two options. Moreover, little information is available about the impact of RFID on the quality of certain drugs.

The concept paper also focuses on the criteria to consider for calculating the risks of possible falsification of a medicinal product (price, sales volume, previous incidents, specific characteristic of the medicinal product, i.e. some drugs are only delivered to hospital pharmacies, etc.). Hereby, criteria for a black list and a white one must be defined. While on a white list no safety characteristic is necessary, a black list absolutely requires safety measures to be taken.

The involvement of wholesale distributors and pharmacies is also mentioned in the document.

Comments on the concept paper should be made not later than 27 April 2012. The delegated acts will be based on the feedback received.

Please also see the complete concept paper "Delegated Act on the detailed Rules for a unique Identifier for medicinal Products for Human Use, and its Verification."

Author:
Dr Günter Brendelberger
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)