OMC Medical
OMC Medical

Cosmetics Registration in Sri Lanka

Regulatory Authority:

National Medicines Regulatory Authority (NMRA)

Link for RA:

https://nmra.gov.lk/index.php?lang=en

Local regulation:

Cosmetics, Devices  and  Drugs  Act  No.  27  of  1980  and  Cosmetics,  Devices  and Drugs Regulations

Who can register :  

Data to be communicated : 

  • Certified copy of sample import licence
  • Original or certified for a free sale Certificate
  • Original Certificate of Analysis
  • Master Formulation, verified by an authorised authority, containing the composition in percentages and the functions of all the constituents.
  • The list of countries where the cosmetic has been approved or registered for sale.
  • Cosmetics labels in the form that is intended to be marketed, fully packaged samples, and cosmetics labels in the form that is designed to be marketed
  • Stability data

Process:

Pre-requisites for registration of a cosmetic

Obtaining a Sample Import License through the submission of

  • A copy of the applicant’s business registration certificate
  • A letter from the manufacturer designating the local agent
  • A local agent’s request
  1. The application for registration must be submitted in Schedule IV Form A of the Cosmetics, Devices, and Drugs Regulations, along with the relevant papers.
  2. The registration documentation must be written in English and provided in a hard file cover.
  3. Registration documents are only processed if they are complete.
  4. Each cosmetic to be registered should be filed as a separate application, i.e. items with the same components but different formulations (in terms of ingredient strength/content, form, description, etc.) or manufactured by another company].
  5. Foreign manufacturer’s products must be presented through a local representative.
  6. When a product application has met the registration requirements, the authority will assign an identifying number.

Timeframe and fees: 

The processing fee for the registration of cosmetics is Rs.500 (five hundred) + VAT.

  • The Full Registration of a product is mentioned in the certificate and is valid for five years.
  • The Provisional Registration of a product is indicated in the certificate and is valid for one year.
  • If the product is Temporarily Rejected, the holder of the market licence must provide further information requested by the authority within three months to permit further review.

Additional information: