View Procedure

Procedure Name

The Registration of Cosmetic

Description

Category

Permit/license

Responsible Agency

National Medicine Regulatory Authority

Address: 120, Norris Canal Road, Colombo 10, Sri Lanka

Phone: +94 11 2698896/7

Legal base of the Procedure

National medicines regulatory authority act, no. 5 of 2015

Required Documents

No.	Document type	Note
1	Application
2.	A copy of business registration certificate of the applicant with the detail list of Board of directors
3	Valid letter of authorization from the manufacturer appointing the local agent
4	Copy of free sale certificate issued by the health authority of the country of origin/Chamber of Commerce or any other government institution but it should be certified by Sri Lankan embassy of the exported country
5	Original/Certified Analysis report	If the SLS specification report is available for the relevant cosmetic it should be submitted as it is. If not it will not be accepted.
6	Master Formula with the detailsof the ingredients
7	Copy of the sample Import licence
8	Original label with secondary and primary packaging	If the lable mention *therapeutic* claims the product will be accepted as borderline products Please refer the NMRA act to check the definition of a borderline product.

Process Steps

Step 1	Submission of registration application and two samples of the product to NMRA
Step 2	Process the Application
Step 3	Issue letter for payment of processing fee provided the application is complete.
Step 4	Pay the fee
Step 5	NMRA issues a specific File number and an Acknowledgement to the customer
Step 6	Evaluation to assess eligibility for registration
Step 7	Evaluator sends the evaluation report for review by a panel of three regulatory pharmacists in the NMRA
Step 8	Panel issue the reviewed report to CEO, NMRA
Step 9	NMRA issue the registration certificate

*This information may be subject to change in the future by the NMRA