Overview

In Sri Lanka, food/dietary supplements fall under the borderline category as they have combined characteristics of foods along with medicines. 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 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.

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 the Ministry of Health, to ensure that the foods being imported to Sri Lanka are safe for human consumption.

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