Impact on Pharmaceutical Wholesalers of the Delegated Regulation complementing the EU Falsified Medicines Directive
EDITOR NOTE: This update is not directly related to Cold Chain BioPharma, however these products are in scope of the Regulation, and it covers the important topic of Supply Chain Security, a topic of growing interest for BioPharma.
The European Falsified Medicines Directive (2011/62/EU) introduces obligatory “safety features” – a unique identifier and an anti-tampering device – to allow for the verification of the authenticity of medicinal products subject to prescription, which helps protect patients from the risks of falsified medicines.
The Delegated Regulation ((EU) 2016/161) detailing the characteristics of the safety features and how medicine authenticity should be verified was published on 9th February 2016.
The medicines verification system requires marketing authorization holders to affix a unique identifier on medicinal products and to upload the identifier on a repository system (database). Itmandates persons authorized or entitled to supply medicinal products to the public to verify the authenticity of the medicinal products against the information stored in the repository system and to decommission the unique identifier (remove from the repository system).
This medicines verification system is an end-to-end verification system, supplemented by risk-based verifications by wholesale distributors. Medicines at higher risk of falsification (returned medicines or medicines not being distributed directly by marketing authorization holders or entities acting on their behalf) will be verified at the wholesale level.
The end-to-end medicines verification system foresees that the verification and decommissioning of the unique identifier takes place at the end of the supply chain (point of dispense). However, certain packs of medicinal products may not be supplied to the public, but instead, may leave the supply chain. This is the case when products are to be distributed outside the EU, intended for destruction, requested as samples by competent authorities, or are returned products that cannot be returned to saleable stock. In these instances, wholesale distributors are required to decommission the unique identifier.
Furthermore, in order to accommodate the particular characteristics of the supply chain in the Member States, wholesalers may be asked by their national authorities to decommission the unique identifier when distributing products to persons authorized or entitled to supply medicinal products to the public who do not operate within a healthcare institution or within a pharmacy. This can comprise: veterinarians; dental practitioners; optometrists and opticians; paramedics; police and armed forces; universities; prisons; schools; hospices; and nursing homes.
Lastly, should there be a reason to believe that the medicinal product verified is not authentic, wholesalers are not allowed to supply or export the product and are required to inform the relevant competent authorities.
Author: Mihai Rotaru, Corporate Affairs Manager, GIRP European Healthcare Distribution Association