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Properties

Steps (64) 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
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  (6) expand_more expand_less
Obtain import declaration form  (2) expand_more expand_less
Pre clearance documentation  (4) expand_more expand_less
Obtain passed clearance entry  (3) expand_more expand_less
Obtain KRA release  (10) expand_more expand_less
Obtain KEBS release  (4) expand_more expand_less
Obtain port health release  (3) expand_more expand_less
Obtain KRA final release  (1) expand_more expand_less

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Summary of the procedure

Institutions involved 10 expand_more expand_less

Courier Service Provider (x 5)
Bank (x 2)
Mission for Essential Drugs Supplies (MEDS) (x 4)
Clearing Agent
Kenya Revenue Authority (KRA) (Handling Shed) (x 6)
Kenya Bureau of Standards (KEBS) (JKIA)
Kenya Bureau of Standards (KEBS) (Handling Shed) (x 3)
Port Health Services Kenya (Handling Shed) (x 3)

Results 11 expand_more expand_less

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

Required Documents expand_more expand_less

Identity card
Company PIN certificate (x 3)
Individual PIN certficate
List of shareholders (Form CR-12)
Certificate of incorporation (x 3)
Memorandum of association - Form CR 2
Academic qualification
Wholesale dealer's licence (x 4)
Invoice
Drug sample permit
Bank deposit slip (x 3)
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
Certificate of good manufacturing practices
Certificate of pharmaceutical product
Product registration certificate (x 3)
Submitted commercial medicines import permit
Authorization for payment for commercial medicines import permit (x 2)
Commercial medicines import permit (x 3)
Import declaration form (IDF) (x 6)
Certificate of conformity (x 4)
KRA e-slip
Passed clearance entry
KRA receipt
Release order
Release order stamped by HVO
Release order stamped by VO (x 3)
Handling shed invoice
Packing list (x 2)
Release order stamped by customs border control
Delivery notification
KEBS consignment document (x 2)
Release order stamped by handling shed
Stamped plant import permit
Clearance entry
Valid E-slip (x 2)
Phytosanitary certificate
Import health certificate
Release order stamped by KEBS (x 2)

Cost KES  91,000 + USD  4,000.33 expand_more expand_less

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)
KES 0 -
1 % goods-value
Clearing agent fees - estimate.
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 0.18
For handling charges.
USD 0.15
For storage charges per day.

Total Duration 182 d - 951 d expand_more expand_less

  Min. Max.
Total time (sum): 182 d 951 d
of which:
Waiting time in queue (sum): 2h. 30mn 7h. 50mn
Attention at counter: 5h. 5mn 14h. 25mn
Waiting time until next step (sum): 182 d 950 d

Laws 22 expand_more expand_less

Drug registration - Guidelines to submission of applications Drug registration - Guidelines to submission of applications
East Africa Community Common External Tarrif East Africa Community Common External Tarrif
East African Community Customs Management Act East African Community Customs Management Act (Revised Edition, 2012)
  Sections 34, 35, 36, 38, 41, 82, 123, 145, 146, 187, 188, 189, 235
East African Community Customs Management Regulations, 2010 East African Community Customs Management Regulations (2010)
  Sections 36, 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
KQ Tariff Charges KQ Tariff Charges
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  2005 Verification of conformity to Kenya standards of Imports Order Legal Notice 78 of 2005 Verification of Conformity to Kenya Standards of Imports Order
  Sections 3, 5, 6, 7
Miscalleneous Fees and Levies Miscellaneous Fees and Levies
  Sections 7, 8
Notice on Inspection of cargo for issuance of certificate of conformity Notice on Inspection of cargo for issuance of certificate of conformity
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, 19
Pre-Export Verification of Conformity to Standards Partners Pre-Export Verification of Conformity to Standards Partners
Public Health Act 2012 Public Health Act CAP 242
  Section  135
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)
World Customs Organization Recommendation of UCR World Customs Organization Recommendation of UCR
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