Food supplements/dietary supplements fall under the borderline category, as they have combined characteristics of foods along with medicine. According to the National Medicines Regulatory Authority (NMRA) Act No. 05 of 2015, the NMRA Sri Lanka is responsible for the regulation and control of registration, licensing, manufacture, importation, and all other Regulatory aspects pertaining to borderline products. As part of the process of the NMRA Sri Lanka, borderline products require preliminary evaluation in terms of classifying the product (Product classification). The validity period of Preliminary Evaluation Report (Classification Report) is one year, and the product registration dossiers should be submitted within the validity period of the classification report.
In Sri Lanka, currently food supplements/dietary supplements need to comply with the Food Advertising and Labeling Regulations on health, structural and content claims. Food import control procedure is implemented at the borders by the Sri Lankan Food Control Administration Unit (FCAU) of Ministry of Health, to ensure that the foods being imported to Sri Lanka are safe for human consumption. Freyr’s Regulatory experts assists in food product classification, formulation/ingredient assessment, label & claims review, and technical dossier compilation, submission and follow up with the NMRA Sri Lanka and Food Control Administration (FCA), Ministry of Health (MoH).
- Preliminary Evaluation (Product Classification)
- Formula Review/Ingredients Assessment
- Food Label Review and Claims Review
- Claims Consultation
- NMRA Product Registration
- Compilation, Gap Analysis and Submission of Dossier
- Interaction with the FCA and NMRA Sri Lanka
- Legal Representation Services
- Regulatory Support Report
- End-to-end Regulatory consultation
- Qualified team of experts with hands-on experience across all categories of foods like health supplements, dietary supplements, nutraceuticals, health functional foods, health functional beverages, foods for special dietary use, etc.
- Support for region-specific Regulatory activities
- Extensive partner network across the globe
- Strong relationship with different Health Authorities