Customer qualification is crucial for wholesale distributors of pharmaceutical products because it ensures that only authorized entities, like licensed pharmacies or hospitals, can purchase medications, thereby safeguarding the supply chain, preventing potential misuse of drugs, and maintaining the integrity of the pharmaceutical market by adhering to regulatory standards like Good Distribution Practices (GDP).
Legal Background
According to chapter 5.3. of the EU GDP Guidelines (Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use – 2013/C 343/01), the following applies:
Wholesale distributors must ensure they supply medicinal products only to persons who are themselves in possession of a wholesale distribution authorisation or who are authorised or entitled to supply medicinal products to the public.
Checks and periodic rechecks may include: requesting copies of customer’s authorisations according to national law, verifying status on an authority website, requesting evidence of qualifications or entitlement according to national legislation.
Wholesale distributors should monitor their transactions and investigate any irregularity in the sales patterns of narcotics, psychotropic substances or other dangerous substances. Unusual sales patterns that may constitute diversion or misuse of medicinal product should be investigated and reported to competent authorities where necessary. Steps should be taken to ensure fulfilment of any public service obligation imposed upon them.
Key Reasons for Customer Qualification
Compliance with Regulations
Regulatory bodies mandate that pharmaceutical distributors only sell to qualified customers who possess the necessary licenses to handle and distribute medications.
Preventing Diversion
By verifying customer legitimacy, distributors can minimize the risk of drugs being diverted to unauthorized channels, such as black markets, which could compromise patient safety.
Traceability
Customer qualification allows for better tracking of drug distribution, enabling identification of potential issues and facilitating recalls if necessary.
Quality Control
Ensuring customers have proper storage facilities and handling practices is vital to maintain the quality and efficacy of medications.
Risk Mitigation
Thorough customer qualification helps identify potential high-risk customers and take necessary precautions to mitigate the risk of drug misuse.
What Does Customer Qualification Entail?
- Verification of licenses: Checking if the customer holds a valid wholesale distribution license or pharmacy license.
- Business registration details: Confirming the legal status and legitimacy of the customer’s business.
- Storage capabilities: Assessing the customer’s storage facilities and ability to maintain proper temperature control for sensitive medications.
Order patterns analysis: Monitoring order quantities and patterns to identify suspicious activity.
MVS Pharma’s Commitment to Customer Qualification
As part of our commitment to regulatory compliance and product integrity, we have defined protocols for customer verification system in our SOP. We ensure all customers possess valid and up-to-date wholesale or pharmacy licenses, positive regulatory history and financial stability.
By maintaining strict qualification protocols, MVS Pharma guarantees that our pharmaceutical products are supplied only to responsible and authorized entities, reinforcing our commitment to safety, compliance, and excellence in distribution.
Conclusion
In summary, it is about safeguarding the supply chain of medicinal products and reducing the risk of products being misdirected or misused. It is also intended to minimize the risks of products not being stored and transported to appropriate GDP standards. This is to protect patients, as incorrect storage and transport may have negative impact on the quality of medicinal products.
Disclaimer:
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MVS Pharma GmbH will soon be launching an omega-3 dietary supplement onto the European market that has been developed for the highest quality standards in terms of oxidation avoidance and therefore greatest bioavailability. In addition, in vitro studies are currently underway at the University of Ulm, in which Professor Dr. Rüdiger Groß tested a patented mouth and nose spray (Virudol) that can eliminate various flu viruses based on natural substances. In addition, MVS has a wholesale license and has specialized in sourcing much-needed medicines such as Amoxicillin, Salbutamol, etc. from India through its local branch with a focus on local quality and safety testing, compliance with international GMP regulations and the highest quality level of user security (examples of local language brochures, identical units of measurement, batch control and full tracking, etc.)
