Greetings from
Freyr France
To gain access to France, foreign medicine and medical device manufacturers are obliged to get authorizations from the National Agency for Medicines and Health Products Safety (ANSM) under the Direction de l’évaluation des dispositifs médicaux. However, manufacturers need an authorized representative anywhere from the EU for obtaining registrations and gain market approvals. Navigating the time-critical approval processes and required Regulatory documentation, challenges market entrant’s compliance efforts.
Freyr, as a specialist global Regulatory partner, assists foreign manufacturers in decoding the local regulatory requirements and comprehensive product classification based on relevant ANSM Regulations. In addition, Freyr assists foreign manufacturers with mandatory Regulatory submissions for streamlined registrations and approvals. Freyr's end-to-end Regulatory Affairs consulting for France span across:
Industries We Serve in France
With advance healthcare provisions in place, market forecast for pharmaceuticals in France predicts a continued demand. For a medicinal product / drug to be marketed in France, a manufacturer must obtain a Marketing Authorization (MA) from the Ministry of Health (MoH) of France. As per the Directive 2001/83/EC, any new medicinal product shall be registered through a Marketing Authorization Application (MAA) following certain procedures:
France is a prominent market for food supplements in the European Union (EU), attracting companies in the sector. National regulations governed by French Decree No. 2006-352, implementing Directive 2002/46/EC, oversee the classification of food supplements. A product's classification in other markets does not automatically classify it as a food supplement in the EU or France. Compliance with permitted substances, maximum levels, and banned substances is crucial. Ensuring accurate food labeling, advertising, and health claims verification is necessary to maintain safety and avoid sanctions, product withdrawal, or recalls.
Freyr Offerings
- Strategic Regulatory Consulting
- Regulatory Affairs & Regulatory intelligence
- Registration pathways and license management services
- End-to-end operational support
- Gap analysis
- Dossier preparation, review and management
- Regulatory Submissions
- Drug Information Profile
- Assessment of MAA in the eCTD format for drugs
- Mutual Recognition Procedure (MRP)
- Temporary authorization of use (TAU)
- CE Marking
- Product Information File (PIF)
- Safety Assessment (SA) of cosmetics products
- Review of packaging data
- Literature search and documentation review
- Conversion/update into CTD/eCTD/EU-Nees format
- Management of variation, line extension and renewal dossiers
Freyr Advantages
- Strategic and well-versed local regulatory knowledgebase – with EMEA
- 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
