1. Full procedures
  2. Import
  3. Medical products
  4. Import licit drugs through JKIA
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Properties

Steps (73) 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 training certificate  (6) expand_more expand_less
Register with KESWS  (4) expand_more expand_less
Obtain drug sample permit  (1) expand_more expand_less
20 Obtain unique consignment reference
language
★ Apply for drug sample permit Optional
language
★ Obtain drug sample permit Optional
language
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  (7) 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 11 expand_more expand_less

Pharmacy and Poisons Board (PPB) (x 12)
3 6 7 8 32 33 34 35 37 38 46 47
Kenya Trade Network Agency (KenTrade) (x 7)
11 13 14 15 16 17 19
Bank (x 3)
12 24 54
Courier Service Provider (x 5)
21 22 23 25 26
Mission for Essential Drugs Supplies (MEDS) (x 4)
27 28 29 30
Clearing Agent
49
Handling Shed (x 6)
51 61 62 63 65 73
Kenya Revenue Authority (KRA) (Handling Shed) (x 6)
56 57 58 59 60 64
Kenya Bureau of Standards (KEBS) (JKIA)
66
Kenya Bureau of Standards (KEBS) (Handling Shed) (x 3)
67 68 69
Port Health Services Kenya (Handling Shed) (x 3)
70 71 72

Results 12 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
19
Drug sample
26
Certificate of analysis
30
Certificate of good manufacturing practices
35
Product registration certificate
39
Import declaration form (IDF)
41
Commercial medicines import permit
48
Release order stamped by KEBS
69

Required Documents expand_more expand_less

Identity card (x 2)
2 15
Company PIN certificate (x 2)
2 49
Individual PIN certficate
2
List of shareholders (Form CR-12)
2
Certificate of incorporation (x 3)
2 4 49
Memorandum of association - Form CR 2
4
Academic qualification
8
Bank deposit slip
13
Training status notification
15
KenTrade receipt
15
Request for company registration
16
Company PIN
18
Drug sample permit
22
Bank deposit slip (x 3)
25 63 65
Sample analysis request
27
Laboratory client registration form
29
Test request form
29
Certificate of analysis
29
Site master file (x 2)
31 33
Pharmacy and Poisons Board (PPB) invoice (x 4)
32 33 37 38
Pharmacy and Poisons Board (PPB) receipt (x 2)
33 38
Certificate of good manufacturing practices authorization letter
35
Application for registration of a drug - Form 1
36
Certificate of analysis
36
Certificate of good manufacturing practices
36
Certificate of pharmaceutical product
36
Commercial medicines import permit
40
Invoice (x 8)
40 45 53 56 64 65 67 70
Application letter
43
Certificate of analysis
43
Proforma invoice
43
Wholesale dealer's licence (x 2)
43 45
Product registration certificate (x 2)
43 45
Form C - Import authorization and certificate of official approval of import
45
Authorization for payment for commercial medicines import permit
47
Import declaration form (IDF) (x 6)
50 56 64 65 67 70
Commercial medicines import permit (x 2)
53 56
Air waybill (x 7)
53 61 63 64 65 67 73
Certificate of conformity (x 4)
53 56 66 67
KRA e-slip
54
Passed clearance entry
56
KRA receipt
56
Release order
56
Release order stamped by HVO
60
Release order stamped by VO (x 3)
61 63 64
Handling shed invoice
62
Packing list (x 2)
64 70
Release order stamped by customs border control
65
Delivery notification
65
KEBS consignment document (x 2)
66 67
Release order stamped by handling shed
67
Stamped plant import permit
70
Clearance entry
70
Valid E-slip (x 2)
70 72
Phytosanitary certificate
70
Import health certificate
70
Release order stamped by KEBS (x 2)
72 73

Cost KES  101,000 + 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 10,000
For training
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
0 mode_edit
KES 0 -
KES  35 per kilogram
per day
0 mode_edit
KES 0 -
KES  55 per kilogram
per day
0 mode_edit
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.
0 mode_edit
KES 0 -
0.75 % Freight on board (FOB)
0 mode_edit
KES 0 -
1 % goods-value
Clearing agent fees - estimate.
0 mode_edit
KES 250
For airline concession fee.
KES 0 -
1.5 % Cost, Insurance & Freight (CIF) or customs value
Railway development levy.
0 mode_edit
KES 0 -
2 % Cost, Insurance & Freight (CIF) or customs value
For import duty.
0 mode_edit
USD 0.18
For handling charges.
USD 0.15
For storage charges per day.

Total Duration 185 d - 982 d expand_more expand_less

  Min. Max.
Total time (sum): 185 d 982 d
of which:
Waiting time in queue (sum): 2h. 35mn 8h. 20mn
Attention at counter: 5h. 30mn 15h. 35mn
Waiting time until next step (sum): 185 d 981 d

Laws 25 expand_more expand_less

Training Approval Approval from National Industrial Training Authority (NITA) to Kentrade as a training provider
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
Narcotic Drugs and Psychotropic Substances Control Act CAP 245 Narcotic Drugs and Psychotropic Substances Control Act CAP 245
  Sections 16
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)
Training charges Training Charges
World Customs Organization Recommendation of UCR World Customs Organization Recommendation of UCR
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