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Procedure Name

Formulation Approval For Borderline products

Description

Category	Permit/license
Responsible Agency	Department of Import and Export Control 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
Processing Fee	200 USD

Required Documents

No.	Document type	Note
1	Covering Letter
2	Certification of Analysis for a finish products
3	Formulation
4	Packaging and promotional material
5	Clinical Evidence (if applicable)

Process Steps

Step 1	Submission of application with relevant documents
Step 2	Process the documents submitted and prepare a summary
Step 3	The Summary will be submitted for review and classification
Step 4	Classification report will be sent to the client

*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
Checklist for evaluation of borderline products	Checklist for evaluation of borderline products	05-07-2018	05-07-2018

This procedure applies to the following measures

Name	Measure Type	Agency	Description	Comments	Legal Document	Validity To	Measure Class
Formulation Approval For Borderline products	Permit Requirement		Formulation approval For Borderline products for foreign products.	Formulation approval For Borderline products for foreign products.	National Medicines Regulatory Authority Act	08-12-9999	Good