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Preview & Print

Properties

Steps (52) arrow_drop_up arrow_drop_down
Register with Pharmacy and Poisons Board (PPB) online service portal  (2) expand_more expand_less
Obtain wholesale dealer's licence and certificate of premise registration  (6) expand_more expand_less
Obtain medical device listing  (3) expand_more expand_less
Register with KESWS  (4) expand_more expand_less
Obtain import declaration form  (2) expand_more expand_less
Obtain medical devices import permit  (5) expand_more expand_less
Obtain passed clearance entry  (3) 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 KEBS release  (2) expand_more expand_less
Obtain certificate of radioanalysis  (4) expand_more expand_less
Obtain Radiation Protection Board release  (1) 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 14 expand_more expand_less

Pharmacy and Poisons Board (PPB) Online Services Portal
Pharmacy and Poisons Board (PPB) (x 8)
Pharmacy and Poisons Board (PPB) Trade Portal (x 2)
Kenya Trade Network Agency (KenTrade) (x 3)
Kenya Electronic Single Window System: KESWS (x 4)
Clearing Agent
Shipping Agent (x 3)
Pharmacy and Poisons Board (PPB) (Kilindini) (x 2)
Kenya Bureau of Standards (KEBS) (CFS) (x 2)
Radiation Protection Board (Kilindini) (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 10 expand_more expand_less

User credentials
Wholesale dealer's licence
Certificate for registration of premises
Annual practice licence for pharmacists
Medical device listing
User credentials
Import declaration form (IDF)
Medical device import permit
Approved certificate of radio analysis
Gate pass

Required Documents expand_more expand_less

Identity card (x 2)
Individual PIN certficate
Company PIN certificate
List of shareholders (Form CR-12)
Certificate of incorporation (x 5)
Form CR 2
Academic qualification
ISO 13485 certificate
Certificate of free sale
Regulatory approval certificate
Certificate of analysis (x 2)
Pre - verification certificate
Product packaging
Instructions for use
Pharmacy and Poisons Board (PPB) invoice
Request for company registration
Company PIN
Commercial medicines import permit (x 4)
Medical device listing (x 4)
Submitted medical device import permit
Authorization for payment for commercial medicines import permit (x 2)
Pharmacy and Poisons Board (PPB) receipt
Air waybill
Certificate of conformity (COC) (x 2)
KRA e-slip
Bill of lading (x 5)
Proforma invoice (x 2)
Bank deposit slip
Letter of indemnity
Valid port pass (x 2)
Import declaration form (IDF) (x 5)
Commercial invoice
Passed clearance entry (x 5)
Packing list (x 3)
Wholesale dealer's licence
Product registration certificate
Medical device import permit
Form C - Import authorization and certificate of official approval of import
Passed clearance entry stamped stop by PPB
Permit (x 2)
Valid e-slip
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  48,250 + USD  70

expand_more expand_less

USD expand_more expand_less
  • USD 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.
USD 0 -
USD  100 per manufacturing site per year
For medical device registration.
KES 0 -
0.75 % Free on board (FOB)
For the medical device import permit.
KES 250
For airline concession fee.
KES 0 -
1.5 % Cost, Insurance & Freight (CIF) or customs value
Railway development levy.
KES 0 -
2 % Cost, Insurance & Freight (CIF) or customs value
For import duty.
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 2,000
For analysis of 0 to 100 metric tonnes.
KES 1,000
For analysis, for every 100 metric tonnes.
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 5 d - 217 d expand_more expand_less

  Min. Max.
Total time (sum): 5 d 217 d
of which:
Waiting time in queue (sum): 1h. 50mn 7h. 35mn
Attention at counter: 4h. 30mn 23h. 25mn
Waiting time until next step (sum): 5 d 215 d

Laws 23 expand_more expand_less

Customs and Excise Regulations Customs and Excise Regulations (2010)
  Sections 25, 30
East Africa Community Common External Tariff 2017 East Africa Community Common External Tariff 2017
East African Community Customs Management Act (2004) East African Community Customs Management Act (2004)
  Sections 34, 35, 36, 38, 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 2013 Finance Act 2013
  Section  6
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
Health Act 2017 Health Act 2017
  Sections 62, 63 ,  articles 62, 63
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 127 of  2018 - Verification of Conformity to Kenya Standards of  Imports Order Legal Notice 127 of 2018 - Verification of Conformity to Kenya Standards of Imports Order
  Sections 3, 5, 7, 8
Legal Notice 192 of 2010 - The Pharmacy and Poisons (Registration of drugs) Rules Legal Notice 192 of 2010 - The Pharmacy and Poisons (Registration of drugs) Rules
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 Rules Pharmacy and Poisons Act Rules
  Sections 3, 4, 19
Public Notice Public Notice - Kenya Bureau of Standards (KEBS)
PvoC Program Operations Manual PvoC Program Operations Manual
  Sections 3, 4, 10
Radiation Protection Act Cap243 Radiation Protection Act CAP 243
  Sections 11, 18
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, 44 (K), 44 (1) (k)
Value Added Act Cap 476 Value Added Act CAP 476 First schedule
  Sections 5, 6, 9
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