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Properties

Preview & Print

Properties

Steps (17) arrow_drop_up arrow_drop_down
Register a human medicinal product  (3) expand_more expand_less
Obtain a pharmaceutical wholesale license  (4) expand_more expand_less
Obtain export license  (3) expand_more expand_less
Contracting a clearing agent  (1) expand_more expand_less
Obtain EAC certificate of origin  (2) expand_more expand_less
Clearance of consignment  (4) expand_more expand_less

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Summary of the procedure

Institutions involved 7 expand_more expand_less

Bank of Kigali (x 3)
Rwanda Food and Drugs Authority (x 5)
Pharmaceutical Regulatory Information Management system (x 2)
Clearing agent
e-Single Window (x 2)
Transit, export and outstation division (x 2)
Customs Service Department - Gatuna Office

Results 6 expand_more expand_less

Certificate of medical product registration
Pharmaceutical wholesale license
Export license - pharmaceutical products
Contract
EAC certificate of origin
Validated cargo manifest (C2)

Required Documents expand_more expand_less

Payment slip (x 3)
Payment receipt (x 3)
Application letter - med registration
Application form - med registration
Certificate of analysis (laboratory analysis results)
Application form wholesale pharmacy
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
Invoice
Packing list (x 3)
Import permit (Kenya pharmaceuticals)
Invoice
Invoice (export)
EAC certificate of origin
Export license - pharmaceutical products
Cargo manifest (C2)

Estimated cost RWF  675,000

expand_more expand_less

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 400,000
registration fee for human medicine
RWF 250,000
wholesale pharmacy authorisation fee
RWF 25,000
export 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

Total Duration 189d - 294d  expand_more expand_less

  Min. Max.
Total time (sum): 189d 294d
of which:
Waiting time in queue (sum): 0mn 2h. 20mn
Attention at counter: 2h. 25mn 6h. 50mn
Waiting time until next step (sum): 188d 293d

Laws 13 expand_more expand_less

EAC Rules of origin 2015 EAC Rules of origin 2015 (Rule 17)
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 73 - 75, 75, 105, 147, 148
Guidelines on submission of documentation for registration of human medicinal products FDA Guidelines on submission of documentation for registration of human medicinal products annex III-X
FDA Notice to the public - 20 March 2020 FDA Notice to the public - 20 March 2020
FDA Regulation Governing Registration of Medicinal Products FDA Regulation governing registration of medicinal products
  articles 1-14, 14-18
FDA Regulation governing service fees, tariff and fines FDA Regulation governing service fees, tariff and fines annex I
Guidance document on import control of health commodities Guidance document on import control of health commodities
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, 9
Regional local clearing tariff Regional local clearing tariff
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
Single Custom Territory Procedure Manual Single Custom Territory Procedure Manual Part 5
The East African Community Customs Management Regulations, 2010 The East African Community Customs Management Regulations, 2010
  Section  88 - 89
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