In 2011 the European Union introduced a directive to protect patients from receiving medicines that may appear authentic but are actually not so. This could be the wrong dosage or ingredients of bad or toxic quality. Obviously, they can pose a serious risk to health. In 2013 the directive was applied.
In February 2019 further regulation was introduced that required full traceability of authentic medications. This required safety features on the outer packaging of medicines that consisted of a unique identifier (UI) and an anti-tampering device. This device is a label which would contain the UI. This label has to spoil or destruct in some way when the package is opened so the following can be used:
- A paper label with a strong adhesive as this would tear if the package were to be opened.
- Void Permanent Label as this would leave clear evidence of tampering.
- Ultra-Destruct as this label destructs easily when tampered with.
- Perforated Label (either paper or synthetic) as it will tear across the perforation.
The unique identifier is contained in a 2-dimensional barcode on the label, and the data element has to also be human readable as an added precaution. For more information see here: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/reg_2016_161/reg_2016_161_en.pdf
See the Prescription/Dosage Labels section to find out more information on the use of dosage labels used in chemists, veterinaries, pharmacies etc…