The cosmetic products industry in Sri Lanka has recorded gradual growth over the past few years, with an increase in the supply of cosmetic products in the market. With rise in per capita income, urbanization, and Internet use, consumers have become much more aware of their skin types and are now much more knowledgeable of cosmetic trends within and outside their country. This has resulted in an increased demand for both locally made private label cosmetics and imported cosmetics in Sri Lanka.
In Sri Lanka, cosmetic products can only be registered if the manufacturer (the foreign brand owner company) is registered with the National Medicines Regulatory Authority (NMRA). Manufacturers must conduct the Registration process through a Legal Representative (LR) in Sri Lanka, who shall act as the cosmetic registration certificate holder and importer of the product.
Before applying for Cosmetic Registration in Sri Lanka, manufacturers must obtain a cosmetic import license, also known as the sample import license. Moreover, the evaluation of samples along with necessary documents is carried out by a Cosmetic Evaluation Subcommittee (CESC), appointed by the Cosmetics, Devices, and Drugs (CDD) Technical Advisory Committee (TAC).
Manufacturers intending to place their cosmetic products in the Sri Lankan market must apply for a Cosmetic Registration Certificate. The Cosmetic Notification is completed by submitting a cosmetic application via Form A & B, Schedule I of the NMRA. Based on the inputs from the CESC, including the cosmetic product safety assessment, a Provisional Registration (PR) is issued in the first year for any product falling under the “drug, device, cosmetics, etc.” category. If the Evaluation Committee considers the submitted documents satisfactory, the PR is issued. Post that, the committee issues a Full Registration (FR) for two (02) or five (05) years. Usually, an FR is issued for five (05) years. In case the documents are not deemed satisfactory or if the dossier lacks any documents, the committee can still issue a PR. However, they would require the applicant to submit the pending documents along with the FR application documents eventually. If the documents are not submitted or are unsatisfactory, the committee can reject the cosmetic application altogether, stating their reason for rejection.
- Cosmetics classification, as per the NMRA cosmetic guidelines.
- Cosmetic formulation review/cosmetic ingredient review.
- Cosmetic claims review.
- Cosmetic Registration in Sri Lanka.
- Label review, as per the Sri Lankan cosmetic labeling regulations/cosmetic labeling requirements.
- Sample import license.
- Dossier compilation.
- Cosmetic Registration application with the NMRA.
- PR services.
- FL services.
- LR and import services.
- Regulatory support services.
End-to-end cosmetic Regulatory consultation.
A qualified team of experts with hands-on experience across all cosmetic categories such as skincare, haircare, baby care, oral care, beauty products, etc.
Support in region-specific Regulatory complexities.
Strategic local Health Authority (HA) contacts.
A structured and cost-effective approach to ensure product compliance.
Quick turnarounds and a faster time to market.