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To comply with the European Regulatory system for medicines, (EU) 2016/161, which came into effect on February 9th, 2019, all medicinal products must have an anti-tampering device (ATD) and unique identifier (UI). These safety features ensure the identification and authentication of the medicinal product through end-to-end verification.
The Threat of Counterfeit Agrochemicals
The ATD should guarantee that the medicinal product has never been opened or tampered with, and the choice of the most appropriate device is up to the manufacturer. Holograms can serve as a tamper-proof feature and a first opening guarantee, as they will be destroyed when attempting to remove them.
The UI must be carried by a 2D barcode (DM ECC200) and printed in minimum quality and in a human-readable format. It should contain the product code (ISO 15459), serial number, national reimbursement or identification number, batch number, and expiry date.
- Additionally, the UI must contain the following criteria:
- Product code: ISO-compliant (ISO 15459); < 50 characters; globally unique; issued by ISO-compliant coding agencies
- Serial number (max 20 characters; specific randomised)
- A national reimbursement or identification number
- Batch number
- Expiry date
3D AG can help you comply with the EU 2016/161 Regulation by providing security holograms that meet the ATD requirement. We can also assist with generating and managing unique identifiers in partnership with other systems.
Our expertise in high-security solutions and partnerships with specialized companies ensure that we can find the best solution for your needs.
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