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Procedure Name

Registration Of Company Profiles(NMRA)

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	Submits the application with relevant documentation
Step 2	NMRA informs customer to make the payment
Step 3	Aftre the payment is made, allocates a serial number to the dossier and an acknowledgement letter is returned to the applicant.
Step 4	The application is forwarded for evaluation
Step 8	After evaluation applicant is informed the additional data needed or of its approval or rejection.
Step 9	Health Management Assistant handovers the document to applicant. If the document is not collected within two weeks, document should be posted to the applicant.

*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 Company Profiles	Application for Registration Of Company Profiles(NMRA)	21-02-2018	08-05-2018

This procedure applies to the following measures

Name	Measure Type	Agency	Description	Comments	Legal Document	Validity To	Measure Class
Approval of a Company Profile	Licensing Requirement		Standard Operating Procedure For Registration Of Company Profiles	The company profile should be approved by NMRA	National Medicines Regulatory Authority Act	31-12-9999	Good