New requirements for manufacturers of medicinal products to place unique identifier and anti-tampering device on the packaging of most prescription medicines.
New EU rules on falsified medicines introduce two safety features, which must be placed on the packaging of most prescription medicines, namely (i) a unique identifier (a two-dimensional barcode) and (ii) an anti-tampering device.
The Commission Delegated Regulation describes the characteristics of the safety features, how the authenticity of medicines should be verified and by whom. The safety requirements took effect on 9 February 2019.
The safety features
The unique identifier consists of the following data elements:
- Product code
- Serial number
- National reimbursement number
- Batch number
- Expiry date
Neither the Falsified Medicines Directive nor the Delegated Regulation gives specific information on the anti-tampering device. There is no mandatory specification, but the anti-tampering device must allow verification of whether the packaging of a medicinal product has been tampered with.
The safety features are combined with an end-to-end EU-wide verification system (repositories system), which enables the relevant stakeholders to verify the authenticity of medicines.
Marketing authorisation holders are obliged to ensure that information relating to the unique identifier is uploaded to the system before the medicinal product is released for sale and that the information is kept up to date. When supplying medicinal products to the public, pharmacies, hospitals and healthcare institutions, they must verify the safety features and “decommission” the unique identifier.
In case there is reason to believe that the packaging of the medicinal product has been tampered with, or verification of the safety features shows that the product may not be authentic, the relevant competent authorities must be informed immediately.
Falsified medicines become more sophisticated and difficult to verify. The new safety measures guarantee medicine authenticity for the benefit of patients and businesses. However, the new EU rules also imply more administrative work for pharmaceutical companies. The Bech-Bruun life sciences team monitors the development within the field and is available for assistance in relation to pharma-regulatory matters.