Baden-Württemberg, Germany – MVS Pharma, a German pharmaceutical company with a branch in India, is taking a stand in response to Germany’s critical amoxicillin shortage. Following the rejection of its application to import the essential antibiotic, MVS Pharma plans to pursue legal action, underscoring the importance of quick access to medication amidst a national shortage crisis. The company’s efforts and perspective were recently highlighted by a journalist (Lilith Teusch) from Apotheke adhoc.
MVS Pharma initially aimed to import amoxicillin from its Indian branch to help alleviate the supply issues in Germany. However, the application was denied by the Stuttgart Regional Council (RP) despite the company meeting the specific regulatory standards outlined in Section 79 (5) of the German Medicines Act (AMG). The law allows medicines to be introduced under exceptional circumstances if shortages threaten the population’s access to necessary treatments. “We meet all the necessary requirements under AMG and the German Medicines Act’s decree to introduce the drug, yet our efforts have faced considerable administrative challenges,” stated Rainer Proksch, CEO of MVS Pharma.
Navigating Regulatory Barriers in Crisis Situations
The RP’s rationale was based on the broader interpretation of Section 72 AMG, typically governing the import of medicines from EU countries. Medicines from outside the EU, such as those from India, require extensive certification and inspection processes, even when the medication is manufactured according to stringent GMP (Good Manufacturing Practice) standards. A representative from RP acknowledged the ongoing nature of the case, emphasizing the cautious approach taken to safeguard medication quality.
Quality Assurance and Public Interest (Amoxicillin Shortage Germany)
Proksch criticized the RP’s interpretation of Section 72 AMG, noting the public’s urgent need for amoxicillin and pointing to the robust GMP-compliant standards MVS Pharma already follows. “Our production standards meet international benchmarks, and we adhere to additional EU retesting protocols to ensure the safety and quality of our product,” he said. The company highlighted that every effort is made to comply with both German and EU standards, including packaging in German, patient-friendly dosing tools, and simplified pharmacy billing solutions.
For MVS Pharma, the safety of the product and patient usability are paramount. “Quality assurance extends beyond the product itself to safe handling and clear instructions,” Proksch emphasized. “What good is a quality product if it’s not used correctly?”
With Germany’s Federal Institute for Drugs and Medical Devices indicating potential stock improvements for some antibiotics, the broader shortage remains a critical issue for patients and healthcare providers nationwide. MVS Pharma’s commitment to bridging the supply gap underscores the need for adaptive regulatory approaches in times of healthcare crises.
About MVS Pharma GmbH
MVS Pharma GmbH is a forward-thinking pharmaceutical company based in Leinfelden-Echterdingen, Germany, with a branch in India. Founded in 2021, the company specializes in providing high-quality, safe, and effective pharmaceutical solutions to address critical health challenges. MVS Pharma is driven by its commitment to patient safety, transparency, and regulatory compliance.
MVS Pharma is a manufacturer, with its own team of professionals and experts in each field. And because the main goal of the company is the well-being of its customers, it makes sure to create all its products using only the best raw materials, free from heavy metals, pesticides, plastic, etc. In addition, MVS Pharma is also working on further clinical research into rose hips for a natural treatment of osteoarthritis and pure fish oil, purified from heavy metals, protected against oxidation, and packaged under 7 other steps, which will guarantee its high quality.
For press & media inquiries, please contact:
Mihaela Ahchieva
Head of Public Relations
MVS Pharma GmbH
mihaela.ahchieva@mvs-pharma.com
