Delegated Regulation (EU) 2016/161 requires two safety features on the packaging of prescription drugs for human use:
- An anti-tampering device that shows whether the outer packaging of a pharmaceutical is fully intact. This safety feature must be implemented independently by each pharmaceutical entrepreneur. For this purpose, ISO 21976 provides an international consistent standard.
- A unique identifier that renders each package unique and unmistakably identifiable via the included product code. This unique identifier represents the basis for authentication through the securPharm system.