Biofrontera, an international biopharmaceutical company, has implemented all necessary safety measures defined in the new Commission Delegated Regulation (EU) 2016/161 to fight medicine falsifications.
Image: Biofrontera Management. Photo: Courtesy of BIOFRONTERA AG.
Since the Regulation came into force on February 9, 2019, only prescription drugs for human use with the safety features of the Commission Delegated Regulation (EU) 2016/161 may be released for marketing. Product batches released before February 9, 2019 may still be sold.
“The implementation of the Falsified Medicines Directive throughout the pharmaceutical supply chain will contribute to one thing in particular: the safety of prescription drugs. The safety standard is already at a very high level in Germany, but is being driven even further by the EU-wide laws,” explains Prof. Dr. Lübbert, CEO of Biofrontera AG.
“With the new Regulation, a further and significantly higher hurdle has now been created for drug counterfeiters. Patients will now be even better protected against counterfeit drugs of low quality or incorrect dosage of active substances.”
The Commission Delegated Regulation (EU) 2016/161 essentially provides for the introduction of two security features. A unique identifier in form of a serialized number combined with a product code, batch number and expiry date make each package unique and individually identifiable.
A so-called “anti-tampering device” protects the outer packaging against manipulation and allows verification of whether the packaging has been tampered with before the first use.
Source: Company Press Release.