If you’re reading this post, you are likely aware that pharmaceutical supply chains in European Union member states must comply with the Falsified Medicines Directive (EUFMD) by 9 February 2019. That date, known as the “big bang,” affects every member of the pharmaceutical value chain, from the marketing authorization holder all the way to the dispenser of the medicine (i.e., hospitals and pharmacies).
The compliance requirements for each stakeholder in the pharma supply chain are specific and can be complicated, depending on the stakeholder’s role. In the coming weeks, this series will focus on demystifying EU FMD requirements for European wholesalers and distributors with the following functions:
- full-line distributors
- parallel importers and distributors
In this first blog post, we’ll examine how the EU FMD requirements apply to full-line wholesalers, which are businesses that engage in a wide range of activities including purchasing, warehousing, storage, order preparation and delivery of medicines. Full-line pharma wholesalers carry and distribute the complete assortment of products in a given geographical area and maintain a central position in the EU supply chain, distributing nearly 75 percent of all medicinal products sold in Europe.
While marketing authorization holders are responsible for packaging and serializing the drug product, which includes reporting data to the European Medicines Verification Organisation and National Verification Systems, wholesalers and distributors must verify the authenticity of a unique identifier associated with certain medicinal products in their physical possession according to Article 20 of the EU FMD. These products include:
- Medicinal products returned by persons authorised or entitled to supply medicinal products to the public or by another wholesaler
- Medicinal products received from a wholesaler that is neither the manufacturer nor the wholesaler holding the marketing authorization, nor a wholesaler that is designated by the MAH, by means of a written contract, to store and distribute the products covered by the marketing authorisation on the wholesaler’s behalf
In other words, all products not received directly from the manufacturer or the manufacturer’s official distributor, including all returns, must be verified by the full-line wholesaler under the EU FMD.
Just as importantly, Article 21 of the EU FMD outlines exemptions from article 20(b). Full-line wholesalers do NOT need to verify the authenticity of the UID of a medicinal product in these situations:
- The medicinal product changes ownership but remains in the physical possession of the wholesaler
- The medicinal product is distributed within an EU member state between two warehouses that belong to the same wholesaler, and no sale takes place
The crux of Article 21 is that verification of a unique identifier is NOT required if products change ownership but remain in the physical possession of the same wholesaler, or if products move between physical locations (warehouses) of the same wholesaler/legal entity AND no sale takes place.
While verifying the authenticity of a medicinal product is one aspect of the EU FMD, decommissioning (i.e., withdrawing) the product is another key responsibility of pharma value chain stakeholders. Article 22 of the EU FMD stipulates that wholesalers must decommission a unique identifier attached to a product when the product:
- Will be distributed (exported) outside the EU
- Is returned to the wholesaler and cannot be returned to saleable stock
- Will be destroyed
- While in the wholesaler’s possession is requested as a sample by competent authorities
- Will be distributed to persons or institutions outlined in Article 23, as required by national legislation
Because EU member states may need to accommodate unique characteristics of the supply chain in their territory, Article 23 spells out provisions to accommodate particular characteristics of EU member states’ supply chains. For example, a wholesaler must verify the safety features and decommission the unique identifier of medicinal products before supplying that medicinal product to any of the following persons or institutions:
- Those authorized to supply medicinal products to the public who do not operate within a healthcare institution or a pharmacy
- Veterinarians and retailers of veterinary medicinal products
- Dental practitioners
- Optometrists and opticians
- Paramedics and emergency medical practitioners
- Armed forces, police and other governmental institutions maintaining stocks of medicinal products for the purposes of civil protection and disaster control
- Universities and higher education establishments using medicinal products for the purposes of research and education, with the exception of healthcare institutions
- Prisons, schools, hospices and nursing homes
Another key requirement of the EU FMD legislation is that the product be sealed in a way that visibly enables tamper verification. Article 24 of the EU FMD clarifies actions wholesalers must take if they suspect tampering or falsification of a medicinal product has taken place. Simply put, a wholesaler may not supply or export medicinal product if they have reason to believe that a package has been tampered with, or where the verification of the product’s safety features indicates that the product may not be authentic. In these cases, a wholesaler must immediately inform the appropriate authorities.
It’s important to note that distributors and wholesalers in the EU will have different requirements based on where their product originated. Primary wholesalers that buy from the original manufacturer do not need to conduct risk-based verification because the product is coming from a trusted source. Secondary wholesalers that buy product from other wholesalers must complete risk-based verification, just like a pharmacy dispenser.
Furthermore, any wholesaler that sells outside of either the European Union or the markets they serve must decommission unique identifiers, per Articles 22 and 23. Distributors must complete risk-based verification for saleable returns before reselling the product, regardless of the product source (per Article 20), and for all returns and products not directly received from the manufacturer or the manufacturer’s official distributor.
Even though compliance with EU FMD regulations can seem like an arduous task, OPTEL’s serialisation and traceability experts can explain the benefits of our full-stack, end-to-end traceability offering that can help pharmaceutical and healthcare organisations achieve EU FMD compliance rapidly and with less friction.
Watch for the next two installments of this blog series that will cover what re-packagers and parallel importers and distributors are responsible for under EU FMD and will illuminate the case for aggregation.
Want to know how OPTEL’s serialization and traceability expertise can help you meet your requirements under EU FMD? Our KOMPANO™ solution includes a multiple decommissioning feature to streamline and improve the the decommissioning process for wholesalers and 3PL.
If you are a pharmacy, go to https://www.optelgroup.com/healthcare-ready-set-comply/to receive an analysis of your daily workflow operations, along with our suggestions regarding a cost-effective solution for your organisation.