1. Full procedures
  2. Import
  3. Licit drugs
  4. Licit drugs import procedure through JKIA
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Steps (66) 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  (1) expand_more expand_less
14 Obtain unique consignment reference
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★ Apply for drug sample permit Optional
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★ Obtain drug sample permit Optional
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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 import declaration form  (2) expand_more expand_less
Obtain commercial medicines import permit  (6) 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
Pre-clearance documentation  (4) expand_more expand_less

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Summary of the procedure

Institutions involved 13 expand_more expand_less

Pharmacy and Poisons Board (PPB) (x 12)
3 6 7 8 26 27 28 29 31 32 39 40
Kenya Trade Network Agency (KenTrade) (x 3)
10 11 13
Kenya Electronic Single Window System: KESWS (x 3)
12 38 41
Courier Service Provider (x 5)
15 16 17 19 20
Bank (x 2)
18 43
Mission for Essential Drugs Supplies (MEDS) (x 4)
21 22 23 24
Pharmacy and Poisons Board (PPB) Trade Portal
36
Kenya Revenue Authority (KRA) (Handling Shed) (x 6)
45 46 47 48 49 53
Handling Shed (x 7)
50 51 52 54 62 65 66
Kenya Bureau of Standards (KEBS) (JKIA)
55
Kenya Bureau of Standards (KEBS) (Handling Shed) (x 3)
56 57 58
Port Health Services Kenya (Handling Shed) (x 3)
59 60 61
Clearing Agent
63

Results 13 expand_more expand_less

User credentials
3
Wholesale dealer's licence
9
Certificate for registration of premises
9
Annual practice licence for pharmacists
9
User credentials
13
Drug sample
20
Certificate of analysis
24
Certificate of good manufacturing practices
29
Product registration certificate
33
Import declaration form (IDF)
35
Commercial medicines import permit
41
Release order stamped by KEBS
58
Release order approval
62

Required Documents
Representatives
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Identity card (x 2)
2 66
Company PIN certificate (x 2)
2 63
Individual PIN certficate
2
List of shareholders (Form CR-12)
2
Certificate of incorporation (x 3)
2 4 63
Form CR 2
4
Academic qualification
8
Request for company registration
10
Company PIN
12
Drug sample permit
16
Bank deposit slip (x 3)
19 52 54
Sample analysis request
21
Laboratory client registration form
23
Test request form
23
Certificate of analysis
23
Site master file (x 2)
25 27
Pharmacy and Poisons Board (PPB) invoice (x 4)
26 27 31 32
Pharmacy and Poisons Board (PPB) receipt (x 2)
27 32
Certificate of good manufacturing practices authorization letter
29
Application for registration of a drug - Form 1
30
Certificate of analysis
30
Certificate of good manufacturing practices
30
Certificate of pharmaceutical product
30
Commercial medicines import permit
34
Invoice (x 8)
34 38 42 45 53 54 56 59
Application letter
36
Certificate of analysis
36
Proforma invoice
36
Wholesale dealer's licence (x 2)
36 38
Product registration certificate (x 2)
36 38
Form C - Import authorization and certificate of official approval of import
38
Authorization for payment for commercial medicines import permit
40
Commercial medicines import permit (x 2)
42 45
Air waybill (x 7)
42 50 52 53 54 56 62
Certificate of conformity (COC) (x 4)
42 45 55 56
KRA e-slip
43
Passed clearance entry (x 2)
45 55
Import declaration form (IDF) (x 7)
45 53 54 55 56 59 64
KRA receipt
45
Notification of arrival
45
Release order stamped by HVO
49
Release order stamped by VO (x 3)
50 52 53
Handling shed invoice
51
Packing list (x 2)
53 59
Release order stamped by customs border control
54
Delivery notification
54
KEBS consignment document (x 2)
55 56
Release order stamped by handling shed
56
Stamped plant import permit
59
Clearance entry
59
Phytosanitary certificate
59
Import health certificate
59
Release order stamped by KEBS (x 2)
61 62
Valid e-slip
61
Representatives
Authorization letter
66

Estimated cost KES  91,000 + USD  4,000.33

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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.
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.
0 mode_edit
KES 0 -
KES  25 per kilogram
per day
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KES 0 -
KES  35 per kilogram
per day
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KES 0 -
KES  55 per kilogram
per day
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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.
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KES 0 -
0.75 % Freight on board (FOB)
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KES 250
For airline concession fee.
KES 0 -
1.5 % Cost, Insurance & Freight (CIF) or customs value
Railway development levy.
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KES 0 -
2 % Cost, Insurance & Freight (CIF) or customs value
For import duty.
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USD 0.18
For handling charges.
USD 0.15
For storage charges per day.
KES 0 -
1 % goods-value
Clearing agent fees - estimate.
0 mode_edit

Total Duration 182 d - 959 d expand_more expand_less

  Min. Max.
Total time (sum): 182 d 959 d
of which:
Waiting time in queue (sum): 2h. 25mn 7h. 40mn
Attention at counter: 5h. 10mn 14h. 55mn
Waiting time until next step (sum): 182 d 958 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 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, 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 2019 Finance Act 2019
  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 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, 6, 7
Miscalleneous Fees and Levies Miscellaneous Fees and Levies
  Sections 7, 8
Narcotic Drugs and Psychotropic Substances Control Act CAP 245 Narcotic Drugs and Psychotropic Substances Control Act CAP 245
  Sections 16
Notice on implementation of legal notice 127 Notice on Implementation of Legal Notice 127
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)
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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