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Properties

Steps (48) 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  (1) expand_more expand_less
Consignment 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 import declaration form  (2) expand_more expand_less
Obtain pharmaceutical import permit  (5) expand_more expand_less
Obtain PPB release  (2) expand_more expand_less
Obtain KEBS release  (5) expand_more expand_less
Obtain KRA release  (4) expand_more expand_less
Obtain KRA final release -At the Malaba OSBP  (1) expand_more expand_less

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Summary of the procedure

Institutions involved 7 expand_more expand_less

Courier Service Provider (x 5)
Bank (x 2)
Mission for Essential Drugs Supplies (MEDS) (x 4)
Pharmacy and Poisons Board (PPB), One Stop Border Post (OSBP) (Malaba) (x 2)
Kenya Bureau of Standards (KEBS), One Stop Border Post (OSBP) (Malaba) (x 4)
Kenya Revenue Authority (KRA), One Stop Border Post (OSBP) (Malaba) (x 5)

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
Import declaration form (IDF)
Commercial medicines import permit
Passed clearance entry stamped (gate stamp) by KRA

Required Documents expand_more expand_less

Identity card
Company PIN certificate
Individual PIN certficate
List of shareholders (Form CR-12)
Certificate of incorporation (x 2)
Memorandum of association - Form CR 2
Academic qualification
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
Certificate of good manufacturing practices
Certificate of pharmaceutical product
Commercial medicines import permit
Wholesale dealer's licence (x 4)
Product registration certificate (x 3)
Submitted commercial medicines import permit
Authorization for payment for commercial medicines import permit (x 2)
Passed clearance entry (x 5)
Import declaration form (IDF) (x 2)
Commercial medicines import permit
Certificate of analysis
Retention certificate
Export permit
Proforma invoice
Packing list (x 3)
Pharmaceutical import permit
Clearance entry
KEBS consignment document
EAC certificate of origin
Certificate of quality
Certificate of conformity
Demand note
Stamped demand note by the bank
Certificate of export
Cargo manifest (C2)
Permit
Preferential certificate of origin
Passed clearance entry endorsed by KRA Verification Officer
Passed clearance entry released by KRA

Cost KES  90,750 + USD  4,265 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 -
15 % customs value
For destination inspection fees.
USD 265
Importers will be required to pay whichever is higher of the $265.00 or 0.6% of the customs value with a maximum fee payable of $2,700 for destination inspection fees.

Total Duration 182 d - 949 d expand_more expand_less

  Min. Max.
Total time (sum): 182 d 949 d
of which:
Waiting time in queue (sum): 2h. 25mn 6h. 45mn
Attention at counter: 4h. 15mn 13h.
Waiting time until next step (sum): 182 d 948 d

Laws 16 expand_more expand_less

COMESA Rules of Origin COMESA Protocol on the Rules of Origin
Customs and Excise Regulations Customs and Excise Regulations (2010)
  Sections 14, 15, 25, 30, 127C, 127, 128B, 199
Drug registration - Guidelines to submission of applications Drug registration - Guidelines to submission of applications
East African Community Customs Management Act East African Community Customs Management Act (Revised Edition, 2012)
  Sections 34, 41, 235
East African Community Customs Management Regulations, 2010 East African Community Customs Management Regulations (2010)
  Section  187
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
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 5, 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, 19
Standards Act Standards Act
  Sections 4, 14
EAC Rules of origin The East African Community (EAC) Customs Union (Rules of Origin) Rules
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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