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  1. Full procedures
  2. Export
  3. Pharmaceutical products
  4. Export pharmaceutical products through the Namanga One Stop Border Post (OSBP)
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Steps (52) arrow_drop_up arrow_drop_down
Register with Pharmacy and Poisons Board (PPB) online service portal  (3) expand_more expand_less
Obtain certificate of analysis  (4) expand_more expand_less
Obtain wholesale dealer's licence and certificate of premise registration  (6) expand_more expand_less
Obtain certificate of good manufacturing practices  (6) expand_more expand_less
Obtain product registration certificate  (4) expand_more expand_less
Register with KESWS  (4) expand_more expand_less
Obtain registration letter  (3) expand_more expand_less
Obtain pharmaceuticals export permit  (2) expand_more expand_less
31 Apply for export permit
language
32 Obtain export permit
language
Pre-clearance documentation  (1) expand_more expand_less
Obtain EAC certificate of origin  (5) expand_more expand_less
Obtain passed clearance entry  (2) expand_more expand_less
39 Lodge a customs entry
language
40 Obtain passed entry
language
Enter the OSBP  (1) expand_more expand_less
Obtain PPB release  (2) expand_more expand_less
Obtain Port Health Services release  (6) expand_more expand_less
Obtain KRA release  (3) expand_more expand_less

arrow_drop_up arrow_drop_down
Summary of the procedure

Institutions/Systems involved 13 expand_more expand_less

Pharmacy and Poisons Board (PPB) (x 11)
3 10 11 12 15 16 17 18 19 21 22
Mission for Essential Drugs Supplies (MEDS) (x 4)
4 5 6 7
Kenya Trade Network Agency (KenTrade) (x 3)
24 25 27
Trade Facilitation Platform (TFP)
26
Kenya Revenue Authority (KRA) (Rules of Origin Section) (x 5)
28 30 34 36 38
Warehouse
29
Clearing Agent
33
Bank (x 2)
35 45
Typesetting Company
37
Integrated Customs Management System (iCMS) (x 2)
39 40
Kenya Revenue Authority (KRA), One Stop Border Post (OSBP) (Namanga) (x 4)
41 50 51 52
Pharmacy and Poisons Board (PPB), One Stop Border Post (OSBP) (Namanga) (x 2)
42 43
Port Health Services Kenya, One Stop Border Post (OSBP) (Namanga) (x 3)
46 47 49

Results 13 expand_more expand_less

User credentials
3
Certificate of analysis
7
Wholesale dealer's licence
13
Certificate for registration of premises
13
Annual practice licence for pharmacists
13
Certificate of good manufacturing practices
19
Product registration certificate
23
User credentials
27
Registration letter
30
Pharmaceutical export permit
32
Authenticated EAC certificate of origin
38
Cargo manifest stamped released by KRA
52
Passed clearance entry stamped released by KRA
52

Required Documents expand_more expand_less

Identity card
2
Company PIN certificate (x 3)
2 33 34
Individual PIN certficate
2
List of shareholders (Form CR-12)
2
Certificate of incorporation (x 4)
2 8 28 33
Sample analysis request
4
Laboratory client registration form
6
Test request form
6
Certificate of analysis
6
Form CR 2
8
Academic qualification
12
Site master file (x 2)
14 16
Pharmacy and Poisons Board (PPB) invoice (x 4)
15 16 21 22
Pharmacy and Poisons Board (PPB) receipt (x 2)
16 22
Certificate of good manufacturing practices authorization letter
19
Application for registration of a drug - Form 1
20
Certificate of analysis
20
Certificate of good manufacturing practices
20
Request for company registration
24
Company PIN
26
Rules of origin exporter registration form
28
Sector specific license
28
Wholesale dealer's licence
31
Product registration certificate
31
Invoice (x 8)
31 37 38 39 41 44 46 50
Certificate of analysis (x 2)
31 42
KRA payment authorization slip (x 2)
35 38
Bank deposit slip (x 2)
36 38
EAC certificate of origin form (x 2)
37 50
Typed certificate of origin form
38
Customs entry in under control status (x 5)
41 43 46 49 50
Passed clearance entry stamped release by Port Health
42
Pharmaceutical export permit
42
Proforma invoice
42
Packing list (x 2)
42 50
Public health recommendation
44
Phytosanitary certificate
44
Food hygiene licence (x 2)
44 46
Cargo manifest (C2)
50
Permit
50
Passed clearance entry stamped by verification officer
52
Cargo manifest stamped by verification officer
52

Estimated cost KES  88,500 +USD  1,003

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 42,000
For sample analysis - estimate.
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.
USD 1,000
For a certificate of good manufacturing practices.
USD 0 -
USD  500 per product
For product registration, for local products.
0 mode_edit
KES 0 -
1 % goods-value
Clearing agent fees - estimate.
0 mode_edit
USD 3
For issuance of certificate of origin
KES 1,500
For issuance of export health certificate.

Total Duration 123d - 472d  expand_more expand_less

  Min. Max.
Total time (sum): 123d 472d
of which:
Waiting time in queue (sum): 1h. 55mn 5h. 50mn
Attention at counter: 5h. 35mn 3d 1/2
Waiting time until next step (sum): 122d 467d

Laws 15 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 (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, 194
Food, Drugs and Chemicals (General) Regulations Food, Drugs and Chemical Substances (Food Hygiene) Regulations, 1978
  Section  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
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 4, 19
Public Health Rules Public Health Act CAP 242 Public Health (Fees) Rules 1st Schedule
The Cotonou Agreement The Cotonou Agreement
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, 35B, 35A, 35, 35K, 44 (1) (k)
World Customs Organization (WCO) Guidelines on Certification of Origin World Customs Organization (WCO) Guidelines on Certification of Origin
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