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Otoritas

National Medicines Regulatory Authority (NMRA)

Regulasi utama

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

Berlaku

2015

Masuk pasar

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.

Orang yang bertanggung jawab

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.

Dokumen keamanan

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.

Pelabelan

NMRA-approved label artwork with INCI ingredients, batch, expiry and manufacturer/importer details; English accepted, with Sinhala/Tamil rules not verified.

Pengujian pada hewan

Tidak ditemukan larangan menurut undang-undang.

Daftar bahan

NMRA evaluates formulations against international references (EU/ASEAN lists) plus its own steroid and heavy-metal restrictions; no published national annexes were found.

Catatan

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.

Teks resmi

https://www.nmra.gov.lk/pages/cosmetics

Sumber: 1234

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