Security features on medicinal products
As of 9 February 2019, the packaging of every prescription-only medicinal product must have a unique code on it. The manufacturers must also add measures against tampering such as a seal to every packaging. That is stated in the new European legislation. These security features are aimed at counteracting falsified medicines in the regular distribution channels.
Pharmacists use these security features for checking the identity and authenticity of medicinal products before they are handed over to the patients. Introduction of the mandatory security features is one of the measures from the Delegated Regulation (EU) 2016/161.
The unique identification information comprises a 2D data matrix code plus a unique and random serial number that the manufacturers apply to the packaging. This code is entered in the European Medicines Verification System (EMVS). The data is passed on from the European system to the national databases.
The anti-tamper device is a kind of seal that is applied by the manufacturer. It can be used for checking whether the packaging of a medicinal product has been opened and whether the contents may have been manipulated.
Medicinal products that are exceptions
A number of medicinal products do not have to be given security features. These exceptions are described in Appendices I and II of the Delegated Regulation. The packaging of certain medicines that are only available on prescription therefore do not have to have the security features, whereas the packaging of some over-the-counter products does.
The NMVO (Stichting Nederlandse Medicijnen Verificatie Organisatie, the Netherlands Medicines Verification Organisation Foundation) is responsible for setting up and implementing the national database in the Netherlands. They build, test and populate the national database (NMVS, National Medicines Verification System) and provide information about the process to all parties involved. The Ministry of Health, Welfare and Sport, the Medicines Evaluation Board and the Dutch Healthcare Inspectorate are involved in this process.
Questions and answers about the introduction of the security features on the packaging of medicinal products in the Netherlands can be found in this Q&A document (in Dutch) by the Ministry of Health, Welfare and Sport and the Dutch Healthcare Inspectorate.
In addition, the NMVO has published various questions and answers about the introduction of unique identifiers on the website.
Information for licence holders about e.g. submitting variations for the changes to the packaging can be found on the MEB website.
The European Commission also has a great deal of information about the implementation of the security features on its specific website about falsified medicines. The latest version of an extensive Q&A document can be found under the heading ‘Implementation’.