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Properties

Steps (15) arrow_drop_up arrow_drop_down
Obtain a pharmaceutical wholesale license  (4) expand_more expand_less
Obtain import visa  (2) expand_more expand_less
Obtain import license  (3) expand_more expand_less
Contracting a clearing agent  (1) expand_more expand_less
Clearance of consignment  (3) expand_more expand_less
Consignment inspection by FDA  (1) expand_more expand_less
Obtain good exit note  (1) expand_more expand_less

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Summary of the procedure

Institutions involved 7 expand_more expand_less

Bank of Kigali (x 2)
Rwanda Food and Drugs Authority (x 3)
Pharmaceutical Regulatory Information Management system (x 4)
Clearing agent
e-Single Window
Bank
Customs Service Department - Gatuna Office (x 3)

Results 4 expand_more expand_less

Pharmaceutical wholesale license
Import visa - med
Import license - med
Exit note - IM

Required Documents expand_more expand_less

Payment slip (x 2)
Application form wholesale pharmacy
Payment receipt
Certificate of domestic company registration (x 2)
Lease contract
Architectural plan
License to practice pharmacy profession
Pharmacy degree
Curriculum vitae
Employment contract
Written commitment to not practice cumulative medicine – pharmacy
Proof of identity
Proforma invoice
Proof of compliance to international standards or ISO or CE certificate
Certificate of conformity or quality control tests (x 2)
Invoice - med (x 2)
Packing list
Import license - med
Packing list
Assessment notice for import declaration
Payment confirmation - import declaration

Estimated cost RWF  303,000

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RWF expand_more expand_less
  • RWF Add Name Here
This is an estimate based on a series of assumptions which you can modify to calculate your own costs:

Cost detail

Estimate your cost

RWF 250,000
wholesale pharmacy authorisation fee
RWF 50,000
license fee
USD 0 -
USD  150 per declaration
The tariff of the clearing agencies handling fees is set by the Rwanda Freight Forwarders Association http://www.adrwanda.com/
+ VAT
RWF 3,000
processing fee
RWF 0 -
0 % Cost, Insurance & Freight (CIF) or customs value
for raw materials imported from outside EAC
RWF 0 -
18 % Cost, Insurance & Freight (CIF) or customs value
RWF 0 -
0.2 %
RWF 0 -
1.5 % Cost, Insurance & Freight (CIF) or customs value
RWF 0 -
0.2 % Cost, Insurance & Freight (CIF) or customs value

Total Duration 10d - 25d  expand_more expand_less

  Min. Max.
Total time (sum): 10d 25d
of which:
Waiting time in queue (sum): 0mn 1h. 50mn
Attention at counter: 1h. 40mn 3h. 55mn
Waiting time until next step (sum): 9d 24d

Laws 19 expand_more expand_less

East African Community Common External Tariff 2017 East African Community Common External Tariff 2017
East African Community Customs Management Act   East African Community Customs Management Act, 2004 (Revised 30th June 2019)
  Sections 41, 147, 148
FDA Guidelines on requirements and specifications for hand sanitisers FDA Guidelines on requirements and specifications for hand sanitisers
FDA Guidelines on requirements and specifications for masks FDA Guidelines on requirements and specifications for masks
FDA Notice to the public - 20 March 2020 FDA Notice to the public - 20 March 2020
FDA Regulation governing service fees, tariff and fines FDA Regulation governing service fees, tariff and fines annex I
LAW N°03/2012 OF 15/02/2012 GOVERNING NARCOTIC DRUGS, PSYCHOTROPIC SUBSTANCES AND PRECURSORS IN RWANDA Law N° 03/2012 of 15/02/2012 governing narcotic drugs, psychotropic substances and precursors in Rwanda
  Article 13
LAW N°03/2012 OF 15/02/2012 GOVERNING NARCOTIC DRUGS, PSYCHOTROPIC SUBSTANCES AND PRECURSORS IN RWANDA Law n° 03/2012 of 15/02/2012 governing narcotic drugs, psychotropic substances and precursors in Rwanda
  Article icle 13
Law n° 19/2017 of 28/04/2017 establishing the levy on imported goods for financing African Union activities Law n° 19/2017 of 28/04/2017 establishing the levy on imported goods for financing African Union activities
  Article 4-6
Law n° 34/2015 of 30/06/2015 establishing the infrastructure development levy on imported goods Law n° 34/2015 of 30/06/2015 establishing the infrastructure development levy on imported goods
  Article 4-7
LAW No. 47/2012 OF 14/01/2013 RELATING TO THE REGULATION AND INSPECTION OF FOOD AND PHARMACEUTICAL PRODUCTS Law n° 47/2012 of 14/01/2013 relating to the regulation and inspection of food and pharmaceutical products
  articles 28, 34, 44, icle 26
Law nº 003/2018 of 09/02/2018 establishing Rwanda Food and Drugs Authority and determining its mission, organisation and functioning Law nº 003/2018 of 09/02/2018 establishing Rwanda Food and Drugs Authority and determining its mission, organisation and functioning
  articles 3, 8, 8.6, 9
LAW No. 47/2012 OF 14/01/2013 RELATING TO THE REGULATION AND INSPECTION OF FOOD AND PHARMACEUTICAL PRODUCTS Law nº 47/2012 of 14/01/2013 relating to the regulation and inspection of food and pharmaceutical products
  Article 35
Ministerial order nº 002/17/10/tc of 27/10/2017 determining the fees for registration of pharmaceutical products, medical devices and other related services Ministerial order nº 002/17/10/tc of 27/10/2017 determining the fees for registration of pharmaceutical products, medical devices and other related services
Official communique implementing ministerial order nº 002/17/10/tc of 27/10/2017 determining the fees for registration of pharmaceutical products, medical devices and other related services Official communique implementing ministerial order nº 002/17/10/tc of 27/10/2017 determining the fees for registration of pharmaceutical products, medical devices and other related services
  Article 2
Regional local clearing tariff Regional local clearing tariff
Regulations governing control of importation and exportation of pharmaceutical products and medical devices Regulations governing control of importation and exportation of pharmaceutical products and medical devices
Regulations governing licensing to manufacture pharmaceutical products or to operate as wholesaler or retailer seller of pharmaceutical products Regulations governing licensing to manufacture pharmaceutical products or to operate as wholesaler or retailer seller of pharmaceutical products
  articles 24, 25-35
The East African Community Customs Management Regulations, 2010 The East African Community Customs Management Regulations, 2010
  Article 39-56
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