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Procedure Name

Product Classification 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	500 USD

Required Documents

No.	Document type	Note
1	Covering Letter including the contact details of the local agent
2.	Valid letter of authorization from the manufacturer appointing the local agent
3	Certification of Analysis for a finish products
4	Copy of free sale certificate issued by the health authority of the country of origin/Copy of COPP/ or a copy of certificate to prove registration status in country of origin
5	Formulation
6	Packaging and promotional material
7	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
Product Classification For Borderline products	Permit Requirement		Product Classification For Borderline products for foreign products.	Product Classification For Borderline products for foreign products.	National Medicines Regulatory Authority Act	08-12-9999	Good