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Procedure Name

Import Permit for Medicines and Allied Substances

Description

Category

Medicines and Allied Substances Import Permit

Responsible Agency

Zambia Medicines Regulatory Authority

Address:Tuleteka Road, Off Makishi Road
P.O. Box 31890
Lusaka , Zambia
Phone : +260 211 220 429
Email : pharmacy@zamra.co.zm

Legal base of the Procedure

The Medicines and Allied Substances Act,2013 (MASA)

Fee

Application Fee ZMW 100

Preclearance Fees for Quality Assurance (QA) of imports for commercial consignments, Government ministries departments, Programs projects, and similar institutions	1.5% of FOB invoice value
Preclearance Fees for Quality Assurance (QA) of imports for unregistered medicines and Allied substance for commercial consignments, Government Ministries Departments, Programs projects and Similar institutions	5% of FOB invoice value
Preclearance Fees for Quality Assurance (QA) of imports for Donations	1% of FOB invoice value
Preclearance Fees for Quality Assurance (QA) of imports for Active Pharmaceutical Ingredients (API), Bulk finished products and intermediates	1% of FOB invoice value

Required Documents

No.	Type of information	Note
1	Application form l for commercial use	Documents necessary for the application
2	Application form ll for personal use
3	Application fee Proof of payment

Process Steps

Step 1	Importer proceeds to complete the application form. That is Form I which is found in the Schedule if importing for commercial use. Form II is used if a person is importing for personal use. The trader must also gather all supporting documentation.
Step 2	Importer pays the prescribed application fees into a bank, who will then issue proof of payment. This must be presented to the relevant accounts department at ZAMRA who will then issue a receipt that must be submitted along with the application and supporting documents.
Step 3	The approving section conducts an administrative and technical review of the application and if they have no objection to the application, then it is returned to the receiving officer.
Step 4	The issuing section processes the application and then issues the Import Permit on the prescribed Form V if the permit is for commercial use or Form VI if the permit is for personal use.
Step 5	The receiving officer then registers the import permit on the prescribed Form XI.
Step 6	The trader collects the import permit and may proceed to import the products into the country.

Category

Import

The following form/s are used in this procedure

Title	Description	Created Date	Updated Date	Issued By
Importation or Exportation of Medicines Permit or Medicine or Allied Substance Form I	Application for Importation or Exportation of Medicines for Commercial use	07-11-2019	07-11-2019	Zambia Medicines Regulatory Authority
Application for Importation or exportation of Medicines and Allied Substances for personal use Form II	Application for Importation or exportation of Medicines and Allied Substances for personal use	07-11-2019	07-11-2019	Zambia Medicines Regulatory Authority
Zambia Medicines Regulatory Authority Schedule of fees as per SI No. 38	Prescribed fees payable	07-11-2019	07-11-2019	Zambia Medicines Regulatory Authority

This procedure applies to the following measures

Name	Measure Type	Agency	Description	Comments	Legal Document	Validity To	Measure Class
Import Permit requirement for Medicines and Allied Substances	Permit Requirement	Zambia Medicines Regulatory Authority	No person shall import any medicine or allied substance without an export permit issued by Zambia Medicines Regulatory Authority.	An import permit is required for the importation of medicines and allied substances.	The Medicines and Allied Substances Act, 2013	09-09-9999	Good