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Strategic Regulatory Partner for Success in Spain

Greetings from

Pharma Wizard Spain

With strong economic potential, the Spanish market is an attractive destination for foreign pharmaceutical and medical device manufacturers. To enter the region, manufacturers must secure approvals from the Spanish Agency for Medicines and Medical Devices, the authority responsible for registrations, licensing, and pharmacovigilance. As Spain’s regulatory system has well-defined requirements, foreign manufacturers must be compliance-ready in advance to achieve timely market authorizations and approvals.
Pharma Wizard, as a dedicated global regulatory partner, offers regulatory affairs consulting throughout Spain, helping manufacturers ensure compliance for product registrations and timely market entry. Pharma Wizard’s comprehensive regulatory services for Spain cover:

Industries We Serve in Spain

Medicinal Product Regulatory Support in Spain

The Spanish pharmaceutical market, though moderate in size, continues to show steady demand for medicinal products. Any drug or biological product intended for commercialization in Spain must receive approval from the Spanish Agency of Medicines and Medical Devices (AEMPS). In accordance with Directive 2001/83/EC, any new medicinal product must be registered via a Marketing Authorization Application (MAA), following specific regulatory procedures.

Food Supplements Regulatory Support in Spain

Spain serves as a key market for food supplements within the EU, drawing attention from global companies in the sector. National regulations, defined under Spanish Royal Decree No. 1487/2009, in line with Directive 2002/46/EC, govern the classification of food supplements. A product categorized as a food supplement in other countries may not be recognized as such in Spain or the broader EU. Strict compliance with approved ingredients, maximum permitted levels, and prohibited substances is essential. Accurate food labeling, responsible advertising, and verification of health claims are critical to ensure safety and prevent regulatory penalties, product withdrawals, or recalls.

Pharma Wizard 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

Pharma Wizard Advantages

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