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Properties

Steps (39) 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
Obtain pharmaceuticals export permit  (2) expand_more expand_less
language
language
Enter the OSBP  (1) expand_more expand_less
Obtain Port Health Services release  (8) expand_more expand_less
Obtain PPB release  (2) expand_more expand_less
Obtain KRA release  (3) expand_more expand_less

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Summary of the procedure

Institutions involved 6 expand_more expand_less

Mission for Essential Drugs Supplies (MEDS) (x 4)
Kenya Revenue Authority (KRA), One Stop Border Post (OSBP) (Namanga) (x 4)
Bank
Port Health Services Kenya, One Stop Border Post (OSBP) (Namanga) (x 3)
Pharmacy and Poisons Board (PPB), One Stop Border Post (OSBP) (Namanga) (x 2)

Results 10 expand_more expand_less

User credentials
Certificate of analysis
Wholesale dealer's licence
Certificate for registration of premises
Annual practice licence for pharmacists
Certificate of good manufacturing practices
Product registration certificate
Pharmaceutical export permit
Cargo manifest stamped released by KRA
Passed clearance entry stamped released by KRA

Required Documents expand_more expand_less

Identity card
Company PIN certificate (x 2)
Individual PIN certficate
List of shareholders (Form CR-12)
Certificate of incorporation (x 2)
Sample analysis request
Laboratory client registration form
Test request form
Certificate of analysis
Memorandum of association - Form CR 2
Academic qualification
Site master file (x 2)
Pharmacy and Poisons Board (PPB) invoice (x 4)
Pharmacy and Poisons Board (PPB) receipt (x 2)
Certificate of good manufacturing practices authorization letter
Application for registration of a drug - Form 1
Certificate of analysis
Certificate of good manufacturing practices
Wholesale dealer's licence
Product registration certificate
Certificate of analysis (x 2)
Passed clearance entry (x 5)
Public health recommendation
Phytosanitary certificate
Food hygiene licence (x 2)
Valid E-slip
Passed clearance entry stamped release by Port Health
Pharmaceutical export permit
Proforma invoice
Packing list (x 2)
Cargo manifest (C2)
Permit
EAC certificate of origin
Passed clearance entry stamped by verification officer
Cargo manifest stamped by verification officer

Cost KES  88,500 + USD  1,000 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 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.
KES 1,500
For issuance of export health certificate.

Total Duration 121 d - 461 d expand_more expand_less

  Min. Max.
Total time (sum): 121 d 461 d
of which:
Waiting time in queue (sum): 1h. 25mn 4h. 15mn
Attention at counter: 3h. 50mn 22h.
Waiting time until next step (sum): 121 d 459 d

Laws 14 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)
  Section  235
East African Community Customs Management Regulations, 2010 East African Community Customs Management Regulations (2010)
  Section  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
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 Recommendation of UCR World Customs Organization Recommendation of UCR
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