In Peru, the regulation and registration of food supplements are primarily managed by two authorities:
General Directorate of Environmental Health and Food Safety (DIGESA): Oversees supplements in conventional food forms without health claims.
General Directorate of Medicines, Supplies, and Drugs (DIGEMID): Regulates supplements presented in pharmaceutical forms or those making health claims.
Registration Requirements
Before importing and selling food supplements classified as dietary products, the following steps are necessary:
- Local Representation: Foreign companies must register as a pharmaceutical establishment with DIGEMID or appoint a legal representative based in Peru, known as a Peruvian Registration Holder (PRH).
- Sanitary Registration: An application for sanitary registration must be submitted to DIGEMID, including technical and regulatory documentation. This process ensures that the product meets Peru’s standards for quality, safety, and efficacy.
Documentation for Registration:
The registration application should include:
- Product Information: Name, strength, dosage form, quantitative and qualitative composition, shelf life, retail packaging, batch numbering system, and storage conditions.
- Manufacturer Information: Company name and address.
- Technical Documents and Certificates: Finished product specifications, stability studies, proposed labeling, instructions for use, Free Sale Certificate, and Good Manufacturing Practice (GMP) certificate.
It’s important to note that approvals from regions like the European Union or the United States do not automatically guarantee registration in Peru.
Import Documentation:
For the importation process, the following documents are typically required:
- Customs Merchandise Declaration (DAM).
- Commercial invoice.
- Airway bill or bill of lading.
- Packing list.
- Insurance letter.
Additionally, a sanitary registration issued by DIGESA is necessary for processed food products.
Labeling Requirements:
Imported packaged foods must carry a Spanish-language label before reaching the point of sale. This label should include the importer or distributor’s contact information and taxpayer number (RUC).
Compliance and Enforcement:
Peru’s regulatory framework is rigorous, aiming to guarantee the quality, safety, and effectiveness of food supplements available in the market.
By meticulously following these guidelines and collaborating with local regulatory experts, companies can ensure their food supplements comply with Peruvian regulations, facilitating successful market entry and distribution.
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Our company holds all necessary certifications, including BRC and NSF GMP, ensuring that our manufacturing processes meet the highest quality standards.
