Counterfeit medicines in the supply chain – how does the DPD system protect patients?

Counterfeit medicinal products are one of the most serious problems facing the modern pharmaceutical industry. A medicine lacking an active ingredient, containing it in the wrong concentration, or manufactured under uncontrolled conditions may not only fail to treat – it may kill. The Good Distribution Practice system is one of the key tools designed to prevent counterfeit products from entering the legal distribution chain and, consequently, reaching patients.

The scale of the problem and legal regulations

The problem of counterfeit medicines is global in scale – the World Health Organisation estimates that in low- and middle-income countries, as many as one in ten medical products is counterfeit or of poor quality. In Europe, the threat is lower but still real – particularly in online sales channels and through unverified intermediaries.

The EU’s response to this threat was Directive 2011/62/EU, known as the Falsified Medicines Directive, which tightened requirements regarding the safety of the medicines supply chain and imposed an obligation on all participants in the wholesale trade to take active measures to detect and report counterfeit products. This Directive forms the basis for DPD’s extensive requirements in this area – imposed on pharmaceutical wholesalers as well as brokers, importers and transport companies.

In Poland, supervision of supply chain safety is carried out by the GIF, which has the power to immediately suspend the distribution of suspect products, conduct unannounced inspections and impose administrative and criminal sanctions.

Medicines Verification System – EMVS and PLMVS

The most important technical tool in the fight against counterfeit medicines in the EU is the European Medicines Verification System (EMVS), implemented under Commission Delegated Regulation (EU) 2016/161. In Poland, its national implementation is the PLMVS (Polish Medicines Verification System), managed by the KOWAL Foundation.

The system is based on the serialisation requirement – every pack of a medicine covered by the system must bear a unique 2D code (Data Matrix), containing the batch number, expiry date, national medicinal product number and a unique serial number. Each package is registered in the system by the manufacturer at the time of manufacture and deactivated when dispensed to the patient – by a pharmacy or hospital.

Pharmaceutical wholesalers are required to verify 2D codes upon receipt and dispensing of products covered by the system and to immediately report any discrepancies – packages with an invalid code, reactivated or blocked products. A product whose code fails verification must be immediately isolated and may not be placed on the market until its status has been clarified.

Obligations of wholesalers regarding the detection and reporting of counterfeits

The DPD imposes specific obligations on pharmaceutical wholesalers in the event of a suspected or confirmed case of a counterfeit medicinal product.

• Immediate isolation of the suspected product – separation from other stock, labelling and securing against further distribution
• Reporting to the GIF – the Central Pharmaceutical Inspectorate must be informed immediately of any suspected case of falsification, regardless of the outcome of the internal investigation
• Notification of the manufacturer and the marketing authorisation holder – to verify authenticity and initiate any recall procedure
• Documentation of the entire process – from the moment the suspicion is detected to the final resolution and actions taken
• Traceability – the wholesaler must be able to identify the supplier of the suspected product and all recipients to whom it was distributed, which is essential for effectively limiting the scope of the potential risk

How does the DPD protect patients in practice?

The DPD system provides multi-layered protection against counterfeit products, which operates at every stage of the supply chain.

At the supplier qualification stage – a wholesaler may only purchase medicinal products from entities holding valid GIF authorisations or equivalent authorisations in other EU countries, verified in the EudraGMDP database. This is the first line of defence, eliminating unauthorised suppliers.

At the traceability level – every batch of a product can be traced in both directions: from the manufacturer to the pharmacy and vice versa. If counterfeiting is detected, the entire batch can be quickly identified and withdrawn from the market.

At the serialisation level – the PLMVS system verifies the authenticity of every package subject to serialisation requirements, preventing the marketing of a product without a valid, registered code.

At the audit and inspection level – regular internal audits and GIF inspections verify that procedures are actually being followed, not just recorded on paper. A system that exists only on paper does not protect the patient.

However, no system is perfect – the effectiveness of protection depends on the commitment of all participants in the supply chain, from the manufacturer to the pharmacy. The DPD establishes the framework and requirements, but those responsible for overseeing the quality system are also accountable for ensuring they function correctly, and their day-to-day decisions determine whether a counterfeit medicine reaches a patient or is intercepted at some stage in the distribution chain.