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  1. Full procedures
  2. Import
  3. Pharmaceutical products
  4. Pharmaceutical products import procedure through Namanga One Stop Border Post (OSBP)
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Steps (61) 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  (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  (5) expand_more expand_less
Obtain import declaration form  (2) expand_more expand_less
Pre-clearance documentation  (1) expand_more expand_less
Obtain passed clearance entry  (3) expand_more expand_less
44 Lodge a customs entry
language
45 Pay taxes
46 Obtain passed entry
language
Enter the OSBP  (1) expand_more expand_less
Obtain PPB release  (2) expand_more expand_less
Obtain KEBS release  (2) expand_more expand_less
Obtain Port Health Services release  (6) expand_more expand_less
Obtain KRA release  (3) expand_more expand_less
Obtain KRA final release  (1) expand_more expand_less

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Summary of the procedure

Institutions/Systems involved 15 expand_more expand_less

Pharmacy and Poisons Board (PPB) Online Services Portal (x 2)
1 4
Pharmacy and Poisons Board (PPB) Trade Portal (x 4)
2 9 32 35
Pharmacy and Poisons Board (PPB) (x 15)
3 5 6 7 8 27 28 29 30 31 33 34 37 38 39
Kenya Trade Network Agency (KenTrade) (x 3)
10 11 13
Trade Facilitation Platform (TFP) (x 3)
12 36 40
Kenya Electronic Single Window System (KESWS) (x 5)
14 15 16 52 56
Courier Service Provider (x 5)
17 18 19 21 22
Bank (x 3)
20 45 53
Mission for Essential Drugs Supplies (MEDS) (x 4)
23 24 25 26
Integrated Customs Management System (iCMS) (x 3)
41 42 46
Clearing Agent
43
Kenya Revenue Authority (KRA), One Stop Border Post (OSBP) (Namanga) (x 5)
47 58 59 60 61
Pharmacy and Poisons Board (PPB), One Stop Border Post (OSBP) (Namanga) (x 2)
48 49
Kenya Bureau of Standards (KEBS), One Stop Border Post (OSBP) (Namanga) (x 2)
50 51
Port Health Services Kenya, One Stop Border Post (OSBP) (Namanga) (x 3)
54 55 57

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
22
Certificate of analysis
26
Certificate of good manufacturing practices
31
Product registration certificate
35
Commercial medicines import permit
40
Import declaration form (IDF)
42
Passed clearance entry stamped released by KRA
60
Cargo manifest stamped released by KRA
60

Required Documents expand_more expand_less

Identity card
2
Company PIN certificate (x 2)
2 43
Individual PIN certficate
2
List of shareholders (Form CR-12)
2
Certificate of incorporation (x 3)
2 4 43
Form CR 2
4
Academic qualification
8
Request for company registration
10
Company PIN
12
Wholesale dealer's licence (x 4)
15 36 37 39
Invoice
15
Drug sample permit
18
Bank deposit slip
21
Sample analysis request
23
Laboratory client registration form
25
Test request form
25
Certificate of analysis
25
Site master file (x 2)
27 29
Pharmacy and Poisons Board (PPB) invoice (x 4)
28 29 33 34
Pharmacy and Poisons Board (PPB) receipt (x 3)
29 34 39
Certificate of good manufacturing practices authorization letter
31
Application for registration of a drug - Form 1
32
Certificate of analysis (x 2)
32 52
Certificate of good manufacturing practices
32
Certificate of pharmaceutical product
32
Product registration certificate (x 3)
36 37 39
Invoice (x 10)
36 37 39 41 44 47 50 52 54 58
Submitted commercial medicines import permit
37
Authorization for payment for commercial medicines import permit (x 2)
38 39
Permit (x 2)
41 58
Certificate of conformity (COC) (x 2)
44 50
KRA e-slip
45
Customs entry in under control status (x 7)
47 48 49 50 54 57 58
Pharmaceutical import permit
48
Certificate of analysis
48
Proforma invoice
48
Packing list (x 3)
48 50 58
EAC certificate of origin form
50
Certificate of quality (x 2)
50 52
Import declaration form (IDF)
50
Phytosanitary certificate
52
Plant import permit
52
Food hygiene licence
54
Cargo manifest (C2)
58
Preferential certificate of origin
58
Passed clearance entry stamped by verification officer
60
Cargo manifest stamped by verification officer
60
Passed clearance entry stamped release by KRA
61
Cargo manifest stamped released by KRA
61

Estimated cost KES  91,750 +USD  4,000

expand_more expand_less

KES expand_more expand_less
  • KES 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 % Free on board (FOB)
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KES 0 -
1 % goods-value
Clearing agent fees - estimate.
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KES 0 -
2 % Cost, Insurance & Freight (CIF) or customs value
Railway development levy.
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KES 0 -
3.5 % Cost, Insurance & Freight (CIF) or customs value
For import duty.
0 mode_edit
KES 1,000
For issuance of import health certificate.

Total Duration 184d - 957d  expand_more expand_less

  Min. Max.
Total time (sum): 184d 957d
of which:
Waiting time in queue (sum): 2h. 15mn 6h. 45mn
Attention at counter: 5h. 15mn 2d 1/2
Waiting time until next step (sum): 183d 954d

Laws 23 expand_more expand_less

COMESA Rules of Origin COMESA Protocol on the Rules of Origin
Customs and Excise Regulations Customs and Excise Regulations (2010) Part XI
  Sections 14, 15, 25, 30, 127C, 127, 128B, 199
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 (2017) East African Community Customs Management Act (2017)
  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 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 187
Finance Act 2019 Finance Act 2019
  Section  6
Food, Drugs and Chemicals (General) Regulations Food, Drugs and Chemical Substances (Food Hygiene) Regulations, 1978
  Sections 8, 10
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)
  Sections 2 (5, 6)
Legal Notice 78 of 2020 - Verification of Conformity to Kenya Standards of Imports Order Legal Notice 78 of 2020 - Verification of Conformity to Kenya Standards of Imports Order
  Sections 5, 8
Miscellaneous Fees and Levies ACT(2020) Miscellaneous Fees and Levies Act (2020)
  Sections 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
Public Health Act CAP 242 (2012) Public Health Act CAP 242 (2012)
  Sections 131, 135
Public Health Rules Public Health Act CAP 242 Public Health (Fees) Rules 1st Schedule
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)
Value Added Tax Act (2013) Value Added Tax Act (2013) First schedule (Part I)
  Sections 14, 65
World Customs Organization Recommendation of UCR World Customs Organization Recommendation of UCR
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