Case Study: Registration of a Dietary Supplement in Spain

Registration of dietary supplements in spain: procedures and regulatory requirements

The registration of a dietary supplement in Spain is a key regulatory step for market entry. This process is overseen by the Spanish Agency for Food Safety and Nutrition (AESAN) and requires the submission of several documents demonstrating the product’s compliance with both European and national regulations.

This case study details the registration process for the product SOURCE, a dietary supplement based on plant extracts and vitamins, outlining the submitted documents and administrative requirements applied in Spain.

Steps and regulatory requirements

Competent Authority

The registration of dietary supplements in Spain is managed by AESAN (Agencia Española de Seguridad Alimentaria y Nutrición), under the jurisdiction of the Ministry of Social Rights, Consumer Affairs, and the 2030 Agenda.

Documents submitted for registration

The company submitted the following documents:

• Market Notification Form: Official declaration of the product to AESAN.
• Spanish Labeling: Compliance with local language requirements.
• Certificate of Market Placement in the EU: Proof that the product is already commercialized in France.
• Proof of Payment of Administrative Fees.

Product Information

• Commercial Name: SOURCE
• Packaging: Box of 60 capsules
• Pharmaceutical Form: Capsules
• Country of Manufacture: France
• Country of First Commercialization: France

Compliance Verification

The product’s labeling and composition are reviewed to ensure adherence to European and national standards for dietary supplements. The use of nutritional and health claims must comply with Regulation (EC) No 1924/2006.

Conclusion

The registration of dietary supplements in Spain follows a rigorous process aimed at ensuring safety and transparency for consumers. This case study illustrates the documents and steps required for the market placement of a dietary supplement in Spain.

Companies must:

• Submit complete documentation that complies with AESAN’s requirements.
• Ensure the accuracy of the information on labeling.
• Adhere to EU standards for the commercialization of dietary supplements.

Thorough preparation in advance facilitates approval and enables swift market entry while ensuring compliance with Spanish regulations.