View Procedure

Procedure Name

The Registration of Drugs

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.	Type of documents	Note
1	Application Form

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	NMRA checks whether product requires a NMQAL analysis report
Step 7	Evaluation to assess eligibility for registration
Step 8	Evaluator sends the evaluation report for review by a panel of three regulatory pharmacists in the NMRA
Step 9	Panel issue the reviewed report to CEO, NMRA
Step	NMRA issue the registration certificate

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

Category

Import

The following form/s are used in this procedure

Title	Description	Created Date	Updated Date	Issued By
National Medicine Regulatory authority Registration Of Product Dossiers	Application for Registration Of Product Dossiers	21-02-2018	21-02-2018

This procedure applies to the following measures

Name	Measure Type	Agency	Description	Comments	Legal Document	Validity To	Measure Class
Registration of a Drug	Registration Requirement		Standard Operating Procedure For Registration Of a drug	The basis for the regulatory control comes from the National Medicines Regulatory Authority Act, No. 5 Of 2015	National Medicines Regulatory Authority Act	31-12-9999	Good