Rwanda - Import Pharmaceutical Products

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Procedure

How to Import

1. Apply and obtain pharmaceutical wholesale license through the Rwanda Food and Drugs Authority Board (FDA).Refer to wikiprocedure to view the procedure in details “Rwanda-Obtain Pharmaceutical Wholesale License”
2. Register a human medicinal product through the FDA and obtain the Certificate of medical product registration
3. Apply for the Import visa online through the Pharmaceutical Regulatory Information Management System (PRIMS): PRIMS and submit required documents (Proforma invoice which should be stamped originally showing manufacturers name, quantity, full address of exporter company and country of origin, a Proof of compliance to international standards or ISO or CE certificate issued by certified regulatory body and Certificate of conformity or quality control tests issued by the manufacturer) Or you can also be submit the import visa application via this email: [email protected]. In this case, the import visa will also be sent to you via email.
4. Obtain import license for medicine by paying the application fee and submitting your application to FDA online via the PRIMS: online
5. Contact a clearing agent to assist you with the custom processes that require a registered clearing agent. View the list of approved clearing agencies via this link: clearing agent
6. Clear the consignment by:
   • Having your clearing agent declare the goods through the E-SINGLE WINDOW portal: E-WINDOW and obtain the Home consumption declaration - IM 4 and Assessment notice for import declaration
   • Pay the import tax and declaration fee as recommended in the Assessment notice for import declaration at the bank and obtain the Payment confirmation - import declaration
   • Upon payment the consignment will be inspect by a custom officer who will assess the declared value of the consignment and when necessary amend the value on the declaration, which can lead to a variation in the amount of tax to be paid.
7. Then the Rwanda Food and Drugs Authority (FDA) will send their inspector to checks whether the consignment is still in good conditions and if it is accompanied with all necessary authorisations or permits.
8. Once the FDA Inspection Officer has checked the consignment and import documents, the officer signs and puts a stamp on the declaration document and validates in the electronic single window.
9. The customs officer in charge counts the good to ensure the number matches what is written on the declaration note and issue you an exit note releasing the pharmaceutical products to enter Rwanda

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Required Documents

• Import license for medicine
• Invoice for amount revalued by the customs officer
• Packing list
• Import visa
• pharmaceutical wholesale license
• Certificate of medical product registration

Office Locations & Contacts

CUSTOMS SERVICE DEPARTMENT
KK 532 St P.O Box 3987 Kigali, Kigali
Tel: +250 788 185 712
Email: [email protected]
Website:Rwanda Revenue Authority

Eligibility

• Registered business owner who wish to import a consignment of pharmaceutical product

Fees

• It is after the declaration stage, the taxes to be paid on the goods is calculated and the importer is informed of how much taxes they have to pay.

Validity

Explain the time until which the certificate/document is valid.
e.g. Birth Certificate Valid Forever

Documents to Use

Please attach documents that can be used by people. e.g. links

Sample Documents

• Assessment notice for import declaration
• Exit note IM

Processing Time

• Within 300 days

Related Videos

Videos explaining the procedure or to fill the applications.
Attach videos using the following tag <&video type='website'>video ID|width|height<&/video&> from external websites.
Please remove the '&' inside the tags during implementation.
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver,
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed.
e.g In the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.

Instructions

• During the testing process by the FDA, the consignment will remain in the entry warehouse or at importer's warehouses and will only be released if found complying. Goods found not complying shall be rejected and detained. You may be allowed to re-export or destroy the consignment, under supervision of a Revenue Investigation and Enforcement Department officer.

Required Information

• Names
• Registration Number
• Nationality
• Address
• Goods details
• Date and signature

Need for the Document

• Imported products must be declared and comply with the customs rules and FDA standard requirement to be allowed entry into Rwanda

Information which might help

• Guidelines on submission of documentation for registration of human medicinal products: Guidelines

Other uses of the Document/Certificate

Please explain what are other uses of obtaining this document/certificate.
e.g. Birth Certificate can be used as proof of identity.

External Links

• Trade portal

Others

More information which might help people.