View Procedure

Procedure Name

The Sample Import Licence for Drugs, medical Devices, Cosmetics and Borderline products

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 for Drugs

No.	Type of documents	Note
1	Application Form
2	Letter of authorization from the manufacturer appointing the local agent
3	Whole sale licence
4	Pharmaceutical Firms licence
5	A copy of the letter signed by the Secretary, Medicines Evaluation Committee (MEC) along with a copy of a letter approving Company profile	In case of New Molecular Entity (NCE)/ Therapeutic Biological / Biotechnological products

Required Documentation For medical devices

No.	Document type
1	Schedule 5 Application
2.	A copy of business registration certificate of the applicant with the detail list of Board of directors
3	Valid letter of authorization from the manufacturer appointing the local agent
4	Copy of free sale certificate issued by the health authority of the country of origin

Required Documentation For Cosmetics

No.	Document type	Note
1	Application
2.	A copy of business registration certificate of the applicant with the detail list of Board of directors
3	Valid letter of authorization from the manufacturer appointing the local agent

Required Documentation For Borderline Products

No.	Document type
1	Application
2.	A copy of business registration certificate of the applicant with the detail list of Board of directors
3	Valid letter of authorization from the manufacturer appointing the local agent
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	Classification form issued by NMRA with the approved formulation
6	Catalogue (If a Device)

Process Steps

Step 1	Submits the application with relevant documentation
Step 2	NMRA informs customer to make the payment required for obtaing import licence
Step 3	Customer makes the payment
Step 4	Issues the sample import License

*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 Issuing The Sample Import Licence	Application for Issuing The Sample Import Licence	22-02-2018	22-02-2018	National Medicines Regulatory Authority
SCHEDULE – V Application for a licence to import a limited quantity of any Device(s) for test , examination ,distribution as samples , Analysis or clinical trial.	SCHEDULE – V Application for a licence to import a limited quantity of any Device(s) for test , examination ,distribution as samples , Analysis or clinical trial.	05-07-2018	05-07-2018	National Medicines Regulatory Authority
Application for a licence to import a limited quantity of any Borderline product(s) for test , examination ,distribution as samples , Analysis or clinical trial.	Application for a licence to import a limited quantity of any Borderline product(s) for test , examination ,distribution as samples , Analysis or clinical trial.	05-07-2018	05-07-2018	National Medicines Regulatory Authority
Application for Sample licence to clear the Cosmetics for Test/Registration Purposes	Application for Sample licence to clear the Cosmetics for Test/Registration Purposes	05-07-2018	05-07-2018	National Medicines Regulatory Authority

This procedure applies to the following measures

Name	Measure Type	Agency	Description	Comments	Legal Document	Validity To	Measure Class
The Sample Import Licence for Drugs, medical Devices, Cosmetics	Licensing Requirement	National Medicines Regulatory Authority	Procedure for obtaining The Sample Import Licence for Drugs, medical Devices, Cosmetics	The basis for the regulatory control comes from the Cosmetics, Devices and Drugs Act No. 27 of 1980.	National Medicines Regulatory Authority Act	08-12-9999	Good