MVS Pharma’s Pharmacovigilance System: Pharmacovigilance is ‘the science of monitoring and improving the safety of medicines’ and plays a critical role in protecting public health. While Marketing Authorization Holders (MAHs) bear the primary responsibility for pharmacovigilance, wholesale distributors like MVS Pharma GmbH are essential partners in ensuring the integrity and safety of medicinal products throughout the supply chain.
As a pharmaceutical distributor, MVS Pharma integrates pharmacovigilance practices into its operations, demonstrating a commitment to the safe handling and distribution of medicines.
MVS Pharma’s Pharmacovigilance System
Wholesale distributors act as intermediaries between manufacturers, healthcare providers, and patients. This unique position demands strict adherence to regulatory requirements to maintain product quality and facilitate the identification and resolution of safety concerns. Below are the 6 steps we, at MVS Pharma follow to uphold MVS Pharma’s Pharmacovigilance System:
1. Adherence to Good Distribution Practices (GDP)
At MVS Pharma, our facilities and processes comply fully with GDP guidelines, ensuring that medicines retain their intended safety and efficacy during transit and storage.
Key measures include:
- Monitoring storage conditions, such as temperature and humidity, to meet product-specific requirements.
- Defined protocols for conducting regular evaluations to ensure that all supply chain partners meet GDP standards.
2. Streamlined Adverse Drug Reaction (ADR) Reporting
While wholesale distributors are not primarily responsible for collecting pharmacovigilance data, they play an essential role in forwarding ADR information reported by customers or healthcare providers.
MVS Pharma’s approach includes:
- RP trains key staff members to recognize and document suspected ADRs.
- Establishing clear communication channels with MAHs for timely reporting.
3. Efficient Recall and Safety Notice Procedures (MVS Pharma’s Pharmacovigilance System)
In the event of a product recall or safety notice, distributors act as the operational backbone, ensuring that affected products are quickly withdrawn from the market.
At MVS Pharma, we have developed a recall management system, which features:
- Advanced Odoo software to trace product batches and notify customers efficiently.
- A dedicated recall responsibility to RP to oversee the entire process and maintain compliance with regulatory requirements.
4. Counterfeit Medicine Prevention
Counterfeit medicines pose a significant risk to patient safety and undermine trust in the pharmaceutical supply chain. MVS Pharma has implemented measures to combat this threat.
If you want to read more about this, see our article “Handling of Falsified Medicinal Products in Supply Chain”.
5. Continuous Training and Awareness
Our RP and QMR receive regular training to ensure a deep understanding of pharmacovigilance principles, including:
- The importance of maintaining product integrity.
- Protocols for handling ADRs and executing recalls.
This training empowers them to act swiftly and decisively when safety concerns arise.
6. Regulatory Compliance and Inspections
MVS Pharma operates in full compliance with European regulations, including:
- EU Directive 2001/83/EC, which outlines the responsibilities of distributors in pharmacovigilance.
- GDP Guidelines, ensuring the safe and effective distribution of medicines.
We are also prepared for regular audits and inspections, which help maintain the integrity of our pharmacovigilance system and drive continuous improvement.
Conclusion
At MVS Pharma GmbH, we recognize that pharmacovigilance is essential to our role as a wholesale distributor. It is a shared responsibility in the pharmaceutical industry, and wholesale distributors play a vital role in supporting this system. By implementing quality controls, facilitating ADR reporting, preventing counterfeit medicines, and collaborating with stakeholders, we contribute significantly to the safety and well-being of patients. Our commitment and dedication ensure that we remain a trusted partner for manufacturers, healthcare providers, and patients alike.
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.).
