View Procedure
| Procedure Name | The Registration of Cosmetic |
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| Description |
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Category
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Permit/license
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Responsible Agency
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National Medicine Regulatory Authority
Address: 120, Norris Canal Road, Colombo 10, Sri Lanka
Phone: +94 11 2698896/7
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Legal base of the Procedure
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National medicines regulatory authority act, no. 5 of 2015
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Required Documents
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No.
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Document type
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Note
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1
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Application
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2.
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A copy of business registration certificate of the applicant with the detail list of Board of directors
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3
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Valid letter of authorization from the manufacturer appointing the local agent
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4
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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
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5
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Original/Certified Analysis report
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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.
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6
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Master Formula with the detailsof the ingredients
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| 7 |
Copy of the sample Import licence |
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| 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
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Step 1
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Submission of registration application and two samples of the product to NMRA
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Step 2
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Process the Application
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Step 3
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Issue letter for payment of processing fee provided the application is complete.
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Step 4
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Pay the fee
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| 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
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| Category | Import |
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The following form/s are used in this procedure
This procedure applies to the following measures
