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The prevention of falsified medicines is a critical responsibility under the EU Good Distribution Practice (GDP) Guidelines. Falsified medicinal products pose a serious risk to patient safety, public health, and trust in the pharmaceutical supply chain. EU GDP, therefore, requires wholesale distributors to implement robust controls that prevent falsified medicines from entering or re-entering the legal supply chain. At MVS Pharma GmbH, the prevention of falsified medicines is integrated into daily operations through strict supplier qualification, systematic verification, and robust oversight by the Responsible Person (RP).
EU GDP Expectations for Prevention of Falsified Medicines
EU GDP requires wholesalers to source medicinal products only from authorized manufacturers and wholesale distributors and to maintain vigilance throughout all distribution activities. Key expectations include:
- verification of supplier authorization
- purchasing only from approved partners
- inspection of packaging and labeling
- batch and expiry verification
- documentation and traceability
- immediate action when falsification is suspected
Any suspicion of falsification must be escalated promptly and handled through established procedures.
MVS Pharma’s Risk-Based Approach to Falsified Medicines Prevention
- Authorized Supplier Verification
MVS Pharma ensures that medicinal products are sourced exclusively from authorized and approved suppliers. Supplier licenses and regulatory status are verified using official sources such as the EudraGMDP database. This verification is an essential preventive measure and forms the first barrier against falsified medicines.
Only suppliers that have been qualified and approved under the Quality Management System are permitted to supply products.
- Visual Inspection During Receipt and Inspection
At goods receipt and during the quarantine and inspection phase, trained personnel perform detailed visual checks to identify any signs that could indicate falsification. These checks include:
- packaging integrity
- consistency of labeling
- absence of tampering or unusual markings
- alignment of product presentation with known reference standards
Any unusual observation is immediately documented and escalated.
- Batch and Expiry Verification
Batch numbers and expiry dates are verified against delivery documentation and internal records. This ensures traceability and helps detect inconsistencies that may indicate unauthorized or falsified products.
Products with unclear, inconsistent, or suspicious batch information are not released and remain under quarantine until fully assessed.
Controlled Handling of Suspected Falsified Medicines
- Immediate Segregation and Quarantine
If falsification is suspected at any stage, the affected products are immediately segregated and clearly identified. These products remain blocked from further distribution and are physically and administratively separated from approved stock.
- Investigation and Responsible Person Oversight
All suspected cases are escalated to the Responsible Person (RP) without delay. A documented investigation is initiated to assess:
- the nature of the suspicion
- potential impact on product quality and patient safety
- supply chain integrity
The RP determines the appropriate course of action, which may include rejection, return to the supplier, or further regulatory escalation.
- Documentation and Traceability
All activities related to suspected falsified medicines are fully documented, including inspection findings, investigation outcomes, and final decisions. Records are maintained under the Digital Quality Management System in accordance with ALCOA+ data integrity principles.
This ensures transparency and allows for effective review during audits or regulatory inspections.
Continuous Awareness and Preventive Controls
- Training and Vigilance
Personnel involved in receipt, inspection, storage, and dispatch are trained to recognize indicators of potential falsification. Training programs reinforce awareness, encourage vigilance, and ensure prompt escalation of concerns.
Supplier performance and inspection trends are reviewed periodically to identify emerging risks and strengthen preventive measures.
Conclusion
MVS Pharma GmbH is committed to protecting the pharmaceutical supply chain from the risks posed by falsified medicines. Through strict supplier authorization checks, systematic verification processes, rapid escalation mechanisms, and strong Responsible Person oversight, MVS ensures that only authentic, compliant, and traceable medicinal products are distributed in accordance with EU GDP requirements.
