Starting with February 9th, 2019, the medicine pack as we knew it, changed.
The novelty elements brought by the implementation of the Falsified Medicines Directive: the Unique Identifier, encoded in the 2D Data Matrix code, and the anti-tempering device have proven of crucial importance in protecting patients’ safety.
According to the Commission Delegated Regulation (EU) 2016/161, the verification of the authenticity of the Unique Identifier aims at ensuring that the medicinal product originates from the legitimate manufacturer, whilst the verification of the integrity of the anti-tempering device shows whether the packaging has been opened or altered since it left the manufacturer, thereby ensuring that its content is authentic.
As per the “Questions and Answers” document on “Safety Features for Medical Products for Human Use”, available on the European Commission’s website, there are no mandatory specifications for the anti-tampering device. The standard EN ISO 21976:2020 “Packaging – Tamper verification features for medicinal product packaging” is available for manufacturers to take into consideration (question 1.14).
The 2D Data Matrix code, that mixture of black and white modules as seen with the human eye, contains a considerable amount of information and it can be read at a fast speed when using a scanner equipped for processing that type of information.
According to the EU legislation, manufacturers are required to print the barcode on the packaging on a smooth, uniform, low-reflecting surface.
Furthermore, manufacturers need to use a printing quality which ensures the accurate readability of the Data Matrix throughout the supply chain until at least one year after the expiry date of the pack or five years after the pack has been released for sale or distribution in accordance with Article 51(3) of Directive 2001/83/EC, whichever is the longer period.
It can be stated that the introduction of the safety features on the medicines’ packaging has constituted the foundation in the current protection of the legal supply chain and will represent the basis for future improvements which may arise, having as a focal point: patient safety.
