Once published the delegated regulations of Directive 62/2011, the countdown begins after a long waiting period. The regulations clearly specify the technological and organisational requirements for compliance with the directive in the application of measures in the packaging of medicines that are marketed in the European environment.
The document details the specifications that the unique identifier printed on the packaging must comply with, how it must be verified and the data to be incorporated into the repositories.
As expected, the proposed identifier is 2D that will contain a serial number, the product code, lot number and the expiration date, plus a national number. The identifier must be printed by the producer and verified at the moment of dispensing to the patient, in what has come to be called an “end-to-end” system.
The repository system containing unique identifiers should be implemented and managed by stakeholders, while health authorities will have access to it for monitoring.
As foreseen, the medicines affected by this regulation are those of medical prescription, however, others not subject to prescription are being considered, “black list“, which should also be subject to these measure due to their high risk of counterfeiting. Likewise, there is the “White list”, in which those specified medicines, despite being subject to prescription, will not incorporate the unique identifier. Both lists are contained in the annexes of the directive.
The delegated regulations of Directive 62/2011 also contain the evaluation and notification procedures to the authorities of the medicines desired to be excluded from the norm, or on the contrary, those medicines that have to be included because of the considered risk.
In addition to this unique identifier, the regulations have another feature that the packaging must have: the inclusion of a secure opening system that shows whether the product has been previously manipulated. This system is known in the industry as the Tamper Evidence device and can be of different types: Included in the design of the box, which can be closed again, with the application of a security tag. There are currently in the market a large variety of solutions, in which the adoption will depend largely on the packaging machines of the pharmaceutical companies, and obviously on the investments that implementing this requirement entails for the organisation.
In this section dedicated to Directive 62/2011, we’ll post updates as they occur regarding this issue, as we shall delve into each provision of the Directive for better understanding and implementation of measures arising from its adoption.
Nekicesa Packaging. March 2016.