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Properties

Steps (3) arrow_drop_up arrow_drop_down
Obtain import license  (3) expand_more expand_less

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Summary of the procedure

Institutions involved 2 expand_more expand_less

Bank of Kigali
Pharmaceutical Regulatory Information Management system (x 2)

Results 1 expand_more expand_less

Import license - med

Required Documents expand_more expand_less

Payment slip
Invoice - med
Packing list
Certificate of conformity or quality control tests

Estimated cost RWF  50,000

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RWF expand_more expand_less
  • RWF Add Name Here
RWF 50,000
license fee

Total Duration 1d 1/2 - 8d  expand_more expand_less

  Min. Max.
Total time (sum): 1d 1/2 8d
of which:
Waiting time in queue (sum): 0mn 10mn
Attention at counter: 15mn 35mn
Waiting time until next step (sum): 1d 7d

Laws 9 expand_more expand_less

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
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 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
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
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
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