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 these borderline products. As a part of the registration process of the NMRA Sri Lanka, borderline products require preliminary evaluation in terms of classifying the product (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 classification report.
Currently, in Sri Lanka, food supplements/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 Ministry of Health to ensure that the foods being imported to Sri Lanka are safe for human consumption. Freyr’s Regulatory experts assist in food product classification, formulation/ingredient assessment, label & claims review, technical dossier compilation, submission, and follow-up with the NMRA’s Sri Lanka and Food Control Administration (FCA), Ministry of Health (MoH).
- Preliminary Evaluation (Product Classification)
- Formula Review/Ingredients Assessment
- Food Safety Certification
- Food Label Review and Claims Review
- Claims Consultation
- NMRA Sri Lanka Food 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
- A strong relationship with different Health Authorities