Trade of Medicinal Products Regulations, also known as the Arzneimittelhandelsverordnung (AM-HandelsV), or Regulation on the Trade of Medicinal Products governs the wholesale distribution of medicinal products to ensure their quality, safety, and efficacy throughout the supply chain. For MVS Pharma GmbH, a pharmaceutical company specializing in importing and distributing medicines, compliance with the AM-HandelsV is integral to its operations.
Purpose and Scope of AM-HandelsV (Trade of Medicinal Products Regulations)
The AM-HandelsV is designed to:
- Protect public health by ensuring the integrity of medicinal products.
- Establish mandatory practices for the safe handling, storage, and distribution of medicines.
- Prevent the infiltration of falsified medicines into the supply chain.
At MVS Pharma, this regulation directly affects how we manage our import and distribution processes, particularly for medicines sourced from countries like India. By aligning with AM-HandelsV requirements, we ensure the delivery of high-quality products to our customers while adhering to EU standards.
Legal Foundations and Relevance to MVS Pharma
The AM-HandelsV stems from the German Medicines Act (AMG) and harmonizes with European regulations such as:
- Directive 2001/83/EC: Governing the sale and distribution of medicinal products.
- EU Good Distribution Practices (GDP): Ensuring quality and safety in the supply chain.
- Falsified Medicines Directive (2011/62/EU): Combatting counterfeit medicines.
For MVS Pharma, these foundations guide our importation and storage procedures. Our processes are designed to maintain product quality and traceability, meeting both German and EU Regulatory Standards.
How MVS Pharma Implements AM-HandelsV Requirements (Trade of Medicinal Products Regulations)
There are several stages to how our company implements the AM-HandelsV Requirements, they are as follows:
Quality Management System (QMS)
MVS Pharma operates a systematic Quality Management System that complies with AM-HandelsV and GDP guidelines. We thoroughly assess suppliers in India to ensure compliance with EU Good Manufacturing Practices (GMP). Our Standard Operating Procedures (SOPs) cover every step, from receiving shipments to final distribution. With respect to Risk Management, potential risks in storage, transportation, or supply chain disruptions are systematically identified and mitigated.
Responsible Person (RP)
At MVS Pharma, a dedicated Responsible Person oversees compliance with GDP requirements, ensuring that all activities align with AM-HandelsV mandates. The RP along with QMR supervises the QMS and Regulatory Affairs, conducts risk assessments, and approves critical operations like product returns and recalls. Our RP is trained in GDP principles and has extensive experience in pharmaceutical distribution.
Documentation and Record-Keeping
MVS Pharma prioritizes transparency and traceability in every transaction. We have an electronic documentation and centralized system that records batch numbers, supplier details, and storage conditions. Our QM documentation and records are consistently updated and easily accessible for regulatory inspections.
Storage and Transport Conditions
Our warehouse is equipped with temperature and humidity sensors to maintain the conditions specified in the Marketing Authorization. Deviations are immediately flagged and addressed to prevent product quality issues. We work with GDP-compliant logistics providers to ensure products remain within controlled conditions during transit.
Inspection and Reporting Obligations
MVS Pharma actively collaborates with regulatory authorities, such as the BfArM, to ensure compliance. We conduct self-inspection on a yearly basis to prepare for official inspections. Any quality defects or suspected falsified medicines are promptly reported and addressed in accordance with AM-HandelsV.
Imports and Supplier Verification
MVS Pharma specializes in importing medicines from India. To meet AM-HandelsV standards, we only work with manufacturers certified under EU GMP. We perform batch testing before distribution; imported products undergo batch testing at an EU-certified laboratory.
Conclusion
The AM-HandelsV serves as a crucial regulatory framework for ensuring the safe trade and distribution of medicinal products in Germany. By embedding AM-HandelsV principles into our processes, we uphold our commitment to quality, safety, and transparency in the pharmaceutical supply chain.
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.).
