Greetings from
Freyr Belgium
In order to enter the Belgium region, foreign medicinal product or medical device manufacturers should need an authorized representative from anywhere in the European Union (EU). Manufacturers should notify the local regulatory body - the Federal Agency for Medicines and Health Products (FAMHP) - to get the market access. Located at the heart of the EU, Belgium can be a distribution touchpoint and offers excellent market opportunities for foreign manufacturers. However, apart from must-to-obtain CE marking, the challenge for foreign manufacturers is to navigate the region’s regulatory system in a time-critical registration and approval processes.
With an in-depth understanding of EU Directives, Freyr as a global partner assists manufacturers to enter the region with ease. Freyr's end-to-end Regulatory Affairs consulting for Belgium span across:
- Drugs
- Medical Devices
- Cosmetics
Industries We Serve in Belgium
Belgium is an economically developed nation with due credit to its industrial progress and huge healthcare spends. Drug and biological products must be authorized by the Federal Agency for Medicines and Health Products before distribution and marketing for human use in Belgium. As per the Directive 2001/83/EC, any new medicinal product shall be registered through a Marketing Authorization Application (MAA) following certain procedures:
Freyr Offerings
- Strategic Regulatory Consulting
- Regulatory roadmap for market access
- Regulatory Affairs & Regulatory intelligence
- Regulatory submissions
- eCTD and NeeS
- CMC
- CE Marking
- Labeling
- MRP, DCP
Freyr Advantages
- Strategic and well-versed local regulatory knowledgebase
- Team with 25+ years of proven RA expertise
- 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