Delegated act: clock starts ticking for safety feature compliance

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

Announcing the publication, the European Commission said the addition of the safety features "will protect European citizens against the health threat of falsified medicines, which may contain ingredients, including active ingredients 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," it adds.

The publication in the Official Journal today means that the regulation will now enter into force on February 9, 2019. From that date, all medicine packs sold in the EU must carry a serialized unique identifier (UI) code within a 2D datamatrix barcode, an anti-tampering device on the outer packaging, and be verified at the point of dispensing to the patient.

It is one of the pillars of the Falsified Medicines Directive (2011/62/EU) which also included provisions to make it easier for EU consumers to buy medicines online safely - thanks to an online pharmacy verification scheme - and measures to ensure only safe and high-quality ingredients are used to make pharmaceutical products.

While many of the larger pharmaceutical companies are already well on the way to complying with the delegated act requirements, there have been concerns that smaller companies and contract manufacturers may leave it too late to come into compliance by the deadline.

Estimates are that making the necessary changes to packaging lines and IT systems to incorporate serialization - and verify that the systems are working properly - can take as long as two years from start to finish.

Companies must understand "the timescales … in place for EU member States [and] which products will be affected," according to Craig Stobie of Domino Printing Sciences, which recently became part of the Brother group.

Companies must develop "the capability to achieve onsite coding, reading and data management requirements in line with the new regulations," he added.

Furthermore, although not explicitly stated in the delegated act, Stobie recommends that manufacturers look beyond 2019 in their planning to anticipate aggregation - in other words linking the individually coded packaging levels to cartons, cases and pallets used in shipping.

"While not currently mandated by the FMD, aggregation does form part of similar schemes elsewhere in the world and we believe it is the next logical step for the industry," said Stobie.

"Building aggregation into planning now will ensure that when the time comes, manufacturers have a straightforward upgrade route."

Meanwhile, the chief executive of Aegate - Mark De Simone - said that the publication of the delegated regulation means the work now starts "to ensure that the investment that manufacturers have already made in packaging, serialisation and tamper proofing is not wasted, or worse dwarfed by the costs of an authentication service that does not work."

The publication comes just ahead of the annual Pharmapack Europe exhibition, which gets underway in Paris, France, tomorrow.