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Properties

Steps (69) arrow_drop_up arrow_drop_down
Register with Pharmacy and Poisons Board (PPB) online service portal  (3) expand_more expand_less
Obtain wholesale dealer's licence and certificate of premise registration  (6) expand_more expand_less
Register with KESWS  (4) expand_more expand_less
Obtain drug sample permit  (3) expand_more expand_less
Drug sample clearance  (6) expand_more expand_less
Obtain certificate of analysis  (4) expand_more expand_less
Obtain certificate of good manufacturing practices  (5) expand_more expand_less
Obtain product registration certificate  (4) expand_more expand_less
Obtain pharmaceutical import permit  (5) expand_more expand_less
Obtain import declaration form  (2) expand_more expand_less
Pre-clearance documentation  (1) expand_more expand_less
Obtain delivery order  (4) expand_more expand_less
Obtain KEBS consignment document  (1) expand_more expand_less
Obtain passed clearance entry  (3) expand_more expand_less
Obtain PPB release  (2) expand_more expand_less
Obtain import health certificate  (4) expand_more expand_less
Obtain Port Health release  (1) expand_more expand_less
Obtain KEBS release  (2) expand_more expand_less
Obtain KRA release  (3) expand_more expand_less
Obtain KPA release  (4) expand_more expand_less
Obtain gate pass  (2) expand_more expand_less

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Summary of the procedure

Institutions involved 16 expand_more expand_less

Pharmacy and Poisons Board (PPB) Online Services Portal (x 2)
Pharmacy and Poisons Board (PPB) Trade Portal (x 4)
Kenya Trade Network Agency (KenTrade) (x 3)
Kenya Electronic Single Window System: KESWS (x 8)
Courier Service Provider (x 5)
Mission for Essential Drugs Supplies (MEDS) (x 4)
Clearing Agent
Shipping Agent (x 3)
Pharmacy and Poisons Board (PPB) (Kilindini) (x 2)
Port Health Services Kenya (Kilindini) (x 2)
Kenya Bureau of Standards (KEBS) (CFS) (x 2)
Kenya Revenue Authority (KRA) Kipevu Container Terminal (CT 2) (Kipevu) (x 3)
Kenya Revenue Authority (KRA), Containerised Cargo and Container Freight Station (CFS)
Kenya Ports Authority (KPA) (x 3)

Results 12 expand_more expand_less

User credentials
Wholesale dealer's licence
Certificate for registration of premises
Annual practice licence for pharmacists
User credentials
Drug sample
Certificate of analysis
Certificate of good manufacturing practices
Product registration certificate
Commercial medicines import permit
Import declaration form (IDF)
Gate pass

Required Documents expand_more expand_less

Identity card (x 2)
Company PIN certificate
Individual PIN certficate
List of shareholders (Form CR-12)
Certificate of incorporation (x 2)
Form CR 2
Academic qualification
Request for company registration
Company PIN
Wholesale dealer's licence (x 5)
Invoice
Drug sample permit
Bank deposit slip (x 2)
Sample analysis request
Laboratory client registration form
Test request form
Certificate of analysis
Site master file (x 2)
Pharmacy and Poisons Board (PPB) invoice (x 4)
Pharmacy and Poisons Board (PPB) receipt (x 3)
Certificate of good manufacturing practices authorization letter
Application for registration of a drug - Form 1
Certificate of analysis (x 3)
Certificate of good manufacturing practices
Certificate of pharmaceutical product
Product registration certificate (x 4)
Submitted commercial medicines import permit
Authorization for payment for commercial medicines import permit (x 2)
Bill of lading (x 5)
Proforma invoice (x 2)
Letter of indemnity
Valid port pass (x 2)
Import declaration form (IDF) (x 4)
Commercial invoice
Passed clearance entry (x 4)
Packing list (x 3)
Commercial medicines import permit (x 2)
Medical device import permit
Medical device listing
Form C - Import authorization and certificate of official approval of import
Certificate of analysis
Passed clearance entry stamped stop by PPB
Certificate of quality
Material safety data sheet
Health certificate (x 2)
Phytosanitary certificate (x 2)
Plant import permit
Fumigation certificate (x 4)
GMO free certificate (x 2)
Import health certificate
Packing list
Laboratory analysis report
Certificate of conformity (COC)
KRA receipt
Clearing agent authorization letter
Marine cover insurance
Bankers cheque
KPA invoice
Pick up order
Position slip
Passed clearance entry stamped goods released by KEBS
Position slip endorsed by KPA
Quadruplicate entry
Position slip stamped by KRA

Estimated cost KES  91,750 +USD  4,070

expand_more expand_less

KES expand_more expand_less
  • KES 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

KES 30,000
For wholesale dealer licence.
KES 10,000
For certificate of registration of premises.
KES 5,000
For annual practice licence for a pharmacist.
KES 250
For airline concession fees.
KES 800
For KEBS inspection. For goods worth KES 50 000 and below.
KES 1,200
For KEBS inspection. For goods worth KES 50 001 - KES 100 000.
KES 1,500
For KEBS inspection. For goods worth KES 100,001 - KES 500,000.
KES 0 -
1.5 % goods-value
For KEBS inspection. For goods worth KES 500,000 and above.
KES 0 -
KES  25 per kilogram
per day
KES 0 -
KES  35 per kilogram
per day
KES 0 -
KES  55 per kilogram
per day
KES 42,000
For sample analysis - estimate.
USD 4,000
For a certificate of good manufacturing practices.
USD 0 -
USD  1,000 per product
For product registration, for foreign products.
KES 0 -
0.75 % Free on board (FOB)
USD 70
Documentation fees - estimate.
KES 0 -
16 % Cost, Insurance & Freight (CIF) or customs value
For Value Added Tax.
KES 0 -
2 % Cost, Insurance & Freight (CIF) or customs value
For import declaration form.
KES 0 -
1.5 % Cost, Insurance & Freight (CIF) or customs value
For railway development levy.
USD 0 -
USD  1.75 per weight in tons
For a 20 feet container to a maximum of 5 tons per TEU. For merchant shipping levy.
USD 0 -
USD  2 per weight in tons
For a 40 feet container to a maximum of 6 tons per TEU. For merchant shipping levy.
KES 1,000
For issuance of import health certificate.
USD 0 -
USD  105 per container
For shore handlingcharges.
USD 0 -
USD  70 per container
For wharfage charges.
USD 0 -
USD  160 per container
For shore handling charges.
USD 0 -
USD  105 per container
For wharfage charges.

Total Duration 184d - 958d  expand_more expand_less

  Min. Max.
Total time (sum): 184d 958d
of which:
Waiting time in queue (sum): 2h. 25mn 1d 1/2
Attention at counter: 5h. 30mn 3d 1/2
Waiting time until next step (sum): 183d 953d

Laws 25 expand_more expand_less

Customs and Excise Regulations Customs and Excise Regulations (2010)
  Sections 25, 30
Drug registration - Guidelines to submission of applications Drug registration - Guidelines to submission of applications
East African Community Customs Management Act (2004) East African Community Customs Management Act (2004)
  Sections 34, 35, 36, 41, 82, 123, 145, 146, 187, 188, 189, 234, 235
East African Community Customs Management Regulations, 2010 East African Community Customs Management Regulations (2010)
  Sections 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49
Finance Act 2019 Finance Act 2019
  Section  6
Food, Drugs and Chemicals (General) Regulations Food, Drugs and Chemical Substances (Food Hygiene) Regulations, 1978
  Section  8
Guidelines for good distribution practices for phamarceuticals Guidelines for good distribution practices for phamarceuticals
Guidelines for registration of premises and issuance of wholesale dealer's licence Guidelines for registration of premises and issuance of wholesale dealer's licence
Kenya Ports Authority Tariff book Kenya Ports Authority (KPA) Tariff book
KPA tariff book KPA tariff book
  Section  III
KRA Public Notice KRA Public Notice
Legal Notice 120 -The Customs and Excise Act (Cap 472.) Legal Notice 120 -The Customs and Excise Act (CAP 472)
Legal Notice 78 of  2020 - Verification of Conformity to Kenya Standards of  Imports Order Legal Notice 78 of 2020 - Verification of Conformity to Kenya Standards of Imports Order
  Sections 3, 5, 7, 8
Merchant Shipping (Fees) Regulation, 2011 Gazette Notice CXIV - No. 1 Merchant Shipping (Fees) Regulation, 2011 Gazette Notice CXIV - No. 1
Miscalleneous Fees and Levies Miscellaneous Fees and Levies
  Sections 7, 8
Pharmacy and Poisons (Registration of Drugs) Rules Pharmacy and Poisons (Registration of Drugs) Rules
  Sections 4, 6
Pharmacy and Poisons Rules Pharmacy and Poisons Act Rules
  Sections 3, 4, 19
Public Health Act 2012 Public Health Act CAP 242
  Sections 131, 135
Public Health Rules Public Health Act CAP 242 Public Health (Fees) Rules 1st Schedule
Public Notice Public Notice - Kenya Bureau of Standards (KEBS)
PvoC Program Operations Manual PvoC Program Operations Manual
  Sections 3, 4, 10
Standards Act Standards Act
  Sections 4, 14
The Pharmacy and Poisons Act CAP 244 The Pharmacy and Poisons Act CAP 244
  Sections 7, 8, 9, 19, 20, 23, 24, 27, 35A, 35B, 35K, 35, 44 (K), 44 (1) (k)
Value Added Act Cap 476 Value Added Act CAP 476 First schedule
  Sections 5, 6, 9
World Customs Organization Recommendation of UCR World Customs Organization Recommendation of UCR
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