Food Supplement Registration in Sri Lanka - Overview

In Sri Lanka, food and dietary supplements fall under the “Borderline Category”, as they combine the characteristics of both foods and medicines. According to the National Medicines Regulatory Authority (NMRA) Act No. 05 of 2015, the NMRA is responsible for the regulation and control of food product registration in Sri Lanka, licencing, manufacture, import, and all other Regulatory aspects pertaining to borderline products. As part of the NMRA process, borderline products require a preliminary evaluation in terms of classifying the product, better known as the stage of product classification. The validity period of the Preliminary Evaluation Report (Classification Report) is one (01) year, and the Product Registration Dossiers should be submitted within the validity period of the report.

In Sri Lanka, food and dietary supplements need to comply with the Food Advertising and Labeling Regulations on Health, Structural, and Content Claims. The food import control procedure is implemented at the borders by the Sri Lankan Food Control Administration Unit (FCAU) of the Sri Lanka Ministry of Health to ensure that the food being imported to Sri Lanka is safe for human consumption.

Regulatory experts at Freyr assist in, food supplement registration in Sri Lanka, food product classification, formulation/ingredient assessment, label and claims review, technical dossier compilation, submission, and follow-up with the NMRA and Food Control Administration (FCA), Sri Lanka Ministry of Health (MoH).

Food Supplement Registration in Sri Lanka - Freyr Expertise

• Preliminary Evaluation (Food Product Classification).
• Formula Review/Ingredients Assessment.
• Food Label Review and Claims Review.
• Claims Consultation Support.
• NMRA Product Registration.
• Compilation, Gap Analysis, and Submission of Dossier.
• Interaction with the FCA and NMRA.
• Legal Representation (LR) Services.
• Food Regulatory Roadmaps.

Food Supplement Registration in Sri Lanka - Freyr Advantages

• End-to-end Regulatory consultation.
• A qualified team of experts with hands-on experience across all categories of foods like health supplements, dietary supplements, nutraceuticals, Health Functional Foods (HFFs), health functional beverages, Foods for Special Dietary Use (FSDU), infant foods, sports nutrition, probiotics, herbal supplements, etc.
• Support in region-specific Regulatory activities.
• An extensive partnership network across the globe.
• A strong relationship with various Health Authorities (HAs).