National Medicines Regulatory Authority (NMRA)
Link for RA:
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
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
- The application for registration must be submitted in Schedule IV Form A of the Cosmetics, Devices, and Drugs Regulations, along with the relevant papers.
- The registration documentation must be written in English and provided in a hard file cover.
- Registration documents are only processed if they are complete.
- 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].
- Foreign manufacturer’s products must be presented through a local representative.
- 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.