Sri Lanka Revises Document Requirements for New Cosmetic Registrations

On May 19, 2025, the National Medicines Regulatory Authority (NMRA) of Sri Lanka released an updated checklist of required documents for new cosmetic registration applications. The revised requirements will take effect from June 1, 2025.

Key Requirements

1. For Importers

Applicants are now required to submit 11 documents, as listed below:

1. Schedule I Form A & Form B

2. Original Letter of Authorization issued within three years by the product (brand) owner, clearly identifying the product (brand) owner, brand/product with the brand name, manufacturer, and local authorized agent

3. Copy of sample import license

4. Copy of business registration certificate

5. Valid and original Free Sale Certificate (FSC) issued by the cosmetic regulatory authority or chamber of commerce, attested by the Sri Lankan embassy in the issuing country

6. Finished product Certificate of Analysis (CoA) including specifications and results; heavy metal test results for Pb, As, Hg, and Cd is mandatory for skincare products

7. Composition with the INCI name, CAS number, quantity (% w/w) and the cosmetic related function of each ingredient

8. Declaration confirming that the product is free from steroids issued by the manufacturer (required for leave on skin care products)

9. Original or art work of the product labels

10. Valid ISO 22716:2007 certification or GMP certificate issued by the cosmetic regulatory authority in the country of origin for the cosmetics manufacturing plant

11. Safety Assessment Report

2. For Local Manufacturers

Local manufacturers must submit 8 mandatory documents, with additional requirements if the brand owner is not the manufacturer:

1. Schedule I form A & form B

2. Valid GMP certificate issued by NMRA, or ISO 22716:2007 certificate for the cosmetics manufacturing plant issued by a SLSI/SLAB-accredited laboratory

3. Copy of business registration certificate

4. Finished product COA as per the Sri Lanka Standard (SLS), issued by a SLAB accredited laboratory

5. Composition with the INCI name, CAS number, quantity (% w/w) and the cosmetic related function of each ingredient

6. Declaration confirming that the product is free from steroids issued by the manufacturer (required for leave on skin care products)

7. Original or art work of product labels

8. Safety Data Sheet (SDS) for the product

Note: If the brand owner is not the manufacturer, the application must be submitted by the brand owner. A legal agreement between the brand owner and the contract manufacturer must also be included.