South Asia · Sri Lanka
What does it take to sell cosmetics in Sri Lanka? Entry route, responsibility, labeling
Mandatory pre-market registration with NMRA – Provisional Registration (1–2 years) then F…; Responsible person: A Sri Lankan authorised agent/Marketing Authorisation Holde…; Labeling: NMRA-approved label artwork with INCI ingredients….
Latest change 2025-05-19 — NMRA issued a revised 11-document checklist for new cosmetic registrations by importers, effective 2025-06-01, including a heavy-metal CoA, steroid-free declaration, ISO 22716/GMP certificate and Safety Assessment Report. Source
Factory-side digest; the official text prevails; not legal advice.
- Authority
- National Medicines Regulatory Authority (NMRA)
- Main regulation
- NMRA Act No. 5 of 2015; Extraordinary Gazette No. 2144/20 (9 Oct 2019); NMRA new-application checklist effective 2025-06-01 · National Medicines Regulatory Authority Act No. 5 of 2015 (replacing the Cosmetics, Devices and Drugs Act No. 27 of 1980) and the cosmetics regulations/gazettes made under it
- In force
- 2015
- Market entry
- Mandatory pre-market registration with NMRA – Provisional Registration (1–2 years) then Full Registration (5 years) – and imported consignments undergo sampling, testing and inspection for a Certificate of Conformity.
- Responsible person
- A Sri Lankan authorised agent/Marketing Authorisation Holder with an import licence and a brand-owner Letter of Authorization (not older than 3 years) must apply.
- Safety file
- Embassy-attested Free Sale Certificate, finished-product CoA with heavy metals (Pb, As, Hg, Cd) from accredited labs, full composition (INCI, CAS, %, function), steroid-free declaration for leave-on skincare, ISO 22716/GMP certificate and Safety Assessment Report.
- Labeling
- NMRA-approved label artwork with INCI ingredients, batch, expiry and manufacturer/importer details; English accepted, with Sinhala/Tamil rules not verified.
- Animal testing
- No statutory ban identified.
- Ingredient lists
- NMRA evaluates formulations against international references (EU/ASEAN lists) plus its own steroid and heavy-metal restrictions; no published national annexes were found.
- Notes
- NMRA pages could not be fetched; the title of the 2019 cosmetics gazette and label-language rules are unverified, and in_force_since is the year of the NMRA Act.
- Official text
- https://www.nmra.gov.lk/pages/cosmetics
Changes 2025–2026
- Sri Lanka NMRA revises document requirements for new cosmetic registrations
A new 11-document checklist for importers (heavy-metal CoA, steroid-free declaration, ISO 22716/GMP certificate, Safety Assessment Report, embassy-attested FSC) applies from 2025-06-01. Source
FAQ
Does Sri Lanka require notification or registration before sale?
Mandatory pre-market registration with NMRA – Provisional Registration (1–2 years) then Full Registration (5 years) – and imported consignments undergo sampling, testing and inspection for a Certificate of Conformity.
Is a local responsible person mandatory in Sri Lanka?
A Sri Lankan authorised agent/Marketing Authorisation Holder with an import licence and a brand-owner Letter of Authorization (not older than 3 years) must apply.
What are the labeling requirements in Sri Lanka?
NMRA-approved label artwork with INCI ingredients, batch, expiry and manufacturer/importer details; English accepted, with Sinhala/Tamil rules not verified.
What changed recently in Sri Lanka cosmetic regulation?
2025-05-19 NMRA issued a revised 11-document checklist for new cosmetic registrations by importers, effective 2025-06-01, including a heavy-metal CoA, steroid-free declaration, ISO 22716/GMP certificate and Safety Assessment Report.
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