Greetings from
Freyr Germany
With its universal healthcare system, Germany offers a good deal of business opportunities for medicines / medical device manufacturers. The Federal Institute for Drugs and Medical Devices, Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) oversees / regulates respective Regulatory activities in the region. With the world’s oldest healthcare system and with many reforms followed by, the Regulatory regime in Germany stands one of the toughest to deal with while approaching for necessary registrations and approvals.
Freyr with an exclusive operational center in Germany, assists foreign manufacturers with localized Regulatory Affairs and operational support for needed Regulatory activities. Freyr’s end-to-end Regulatory affairs consulting for German region span across:
Industries We Serve in Germany
Pharmaceutical market in Germany has displayed a continued growth over the years. As a prominent member of European Union (EU), Germany requires a Market Authorization (MA) granted by the country’s Ministry of Health (MoH) to market and distribute medicinal products locally. As per the Directive 2001/83/EC, any new medicinal product shall be registered through a Marketing Authorization Application (MAA) following certain procedures:
Germany is the second-largest market for food supplements in the EU, attracting companies in the sector. National regulations governed by the German Food Supplement Ordinance of May 24, 2004, implementing Directive 2002/46/EC, oversee the classification of food supplements. The classification of a product as a food supplement in other markets does not automatically classify it as such in the EU or Germany. Compliance with permitted substances, maximum levels, and banned substances is crucial. Ensuring accurate food labeling, advertising, and health claims verification is necessary to maintain food safety in Germany, and to avoid sanctions, product withdrawal, or recalls.
Freyr Offerings
- Strategic Regulatory Consulting
- Strategic business development focusing on the European market
- Regulatory roadmap for market access
- Regulatory Affairs & Regulatory intelligence
- Registration pathways and license management services
- End-to-end operational support
- Dossier preparation, review and management
- Regulatory Submissions
- Market assessments
- Public relations and marketing
- In-country representation
Freyr Advantages
- Strategic local health authority contacts – with Federal Ministry of Health
- Expert Regulatory team with proven global RA expertise
- Proactive and Collaborative approach
- Quick turnarounds and faster time-to-market
- Keeping abreast with region-specific legislation and Regulatory guidelines
