Sri Lanka to Implement Single File Submission for Up to Ten Colour Variants within the Same Cosmetic Product Series

On May 23, 2025, Sri Lanka’s National Medicines Regulatory Authority (NMRA) announced the rollout of a Single File Submission policy for new registration and re-registration applications of cosmetic products containing multiple colour variants. Effective June 1, 2025, the new process permits the inclusion of up to ten colour variants within the same product series under a single application file.

This policy applies to a wide range of colour cosmetics, including but not limited to:

• Nail Polish

• Eye pencil

• Hair Dye

• Mascara

• Hair colour

• Concealer

• Lipstick

• Colour corrector

• Lipliner

• Contour

• Eye Shadow

• Foundation

• Eye Liner

• Face Powder

To qualify for this streamlined submission, all product attributes—except for colour—must be identical, including the formulation, packaging, and other product features. Applicants are required to submit the formulation details, labeling, and test reports for each of the ten colour variants within the single file.

Despite the administrative consolidation, the application fee for a single file remains equivalent to the cumulative cost of ten individual submissions.

The NMRA emphasized that the change aims to streamline the regulatory process and enhance the efficiency of submission and evaluation procedures for cosmetic products.