Strategic Regulatory Partner for Success in Spain

  • Tailored Regulatory Support
  • Product Maintenance & Compliance
  • Flexible Regulatory Teams

Greetings from
Freyr Spain

With positive economic prospects making the Spanish landscape favorable for investments, Spain stands a good bet for foreign medicine and medical device manufacturers. To enter the region, manufacturers must obtain approvals from The Spanish Agency for Medicines and Medical Devices, an authority oversees the registrations, licenses and pharmacovigilance across the region. With the Spanish Regulatory system quite specific about the Regulatory requirements, foreign manufacturers should be compliant ready before in-hand for successful and in-time market authorizations and approvals.  

Freyr, as a specialized global Regulatory partner, provides Regulatory affairs consulting across Spain enabling manufactures be compliant for product registrations and market authorizations in a timely manner. Freyr’s end-to-end Regulatory capabilities for Spain span across:

Industries We Serve in Spain

The Spanish pharmaceutical market, despite its modest outset, predicts a consistent demand for medicinal products. Any drug or biological product to be marketed in Spain must be approved by the Spanish Agency of Medicines and Medical Devices (AEMPS). As per the Directive 2001/83/EC, any new medicinal product shall be registered through a Marketing Authorization Application (MAA) following certain procedures:

Spain is a significant market for food supplements in the EU, attracting companies in the sector. National regulations governed by the Spanish Royal Decree No. 1487/2009, 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 Spain. 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
  • Regulatory Submissions
  • Dossier preparation, review and management

Freyr Advantages

  • 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

Looking for Regulatory Support in Spain

Contact us now for Expert Guidance and Support