On 12 August 2015, the European Commission published its long awaited discussion draft of the European Union Delegated Act (EUDA) addressing safety features to appear on the outer packaging of medicinal products for human use. The EUDA was a response to the 2011 Falsified Medicines Directive and will require manufacturers and repackagers in the European pharmaceutical market to implement safety features on most drugs three years after the legislation is finalized. Falsified medicines are fake medicines that pass themselves off as real, authorized medicines. They may contain ingredients of poor quality or extreme dosages of active ingredients, both of which present major threats to public health. The term “falsified” is used to distinguish the infringement to intellectual property rights, i.e., with counterfeits.
The purpose of this draft EUDA is to invite discussion about how to prevent the entry chain of falsified pharmaceutical products into the supply by requiring the indication of security (traceability) features on their packaging. There are two key safety features that are mandates for all drug packages: (1) unique identifiers and (2) anti-tampering devices. The unique identifiers are described as codes consisting of the product code, a serial numbers, a national reimbursement number, batch number and expiration date. There are no details, however, about anti-tampering devices.
In a nutshell, the Delegated Act sets out:
- The characteristics and technical specifications of the unique identifier that enables the authenticity of medicinal products to be verified and individual packs to be identified.
- The modalities for the verification of the safety features.
- Rules for the establishment, management and accessibility of the repository system where the information on the safety features will be kept.
- The list of medicinal products and product categories subject to prescription that are exempt from the measure.
- The list of medicinal products and product categories not subject to prescription that are subject to the safety features.
- The procedures for the notification to the European Commission by the competent Member State authorities of non-prescription medicinal products judged at risk of falsification and prescription medicinal products not deemed at risk of falsification.
- The procedures for a rapid evaluation of, and decision on the notifications by the Member State authorities to the Commission.
Interested stakeholders are invited to provide comments on the draft Delegated Regulation by 11 October 2015, so there could be some changes or tweaks to the proposed requirements. If the EUDA is finalized by the end of this year, manufacturers and repackagers in the European pharmaceutical market will need to implement the safety features by the end of 2018.