Serialisation Track and Trace

The Countdown Has Begun – EU Delegated Act Published

The EU delegated act on safety features has been published and pharmaceutical companies have three years to add unique identifiers and anti-tampering features to medicine packs.

The act introduces obligatory ‘safety features’ for medicines in the form of a unique identifier and an anti-tampering device.

Such safety features will protect European citizens against the health threat of falsified medicines, which may contain ingredients, including active ingredients, which are of low quality or in the wrong dosage.

The safety features will guarantee medicine authenticity for the benefit of patients and businesses, and will strengthen the security of the medicine supply chain – from manufacturers to distributors to pharmacies and hospitals.

The act in question supplements the Falsified Medicines Directive (2011/62/EU), which aims not only to close any existing gaps or loopholes which allow falsified medicines to reach patients, but also to allow EU citizens to buy medicines online through verified sources and ensure that only high quality ingredients are used for medicines in the EU.

The delegated Regulation will be applicable three years from today. To see the full act click here.

Team Horizon are actively engaged in the programme and project management of a number of serialisation implementations. We do so by using our expertise and PMBOK tools to guide and effectively manage the multi-faceted challenges that arises in early planning and throughout the project implementation whilst ensuring maintenance of product supply.

If you have immediate serialisation needs contact us today, e: t: 098 50600