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Properties

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
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Obtain EU certificate of origin  (6) expand_more expand_less
Pre-clearance documentation  (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  (5) expand_more expand_less

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Summary of the procedure

Institutions involved 12 expand_more expand_less

Mission for Essential Drugs Supplies (MEDS) (x 4)
Kenya Trade Network Agency (KenTrade) (x 3)
Kenya Electronic Single Window System (KESWS)
Kenya Revenue Authority (KRA) (Rules of Origin Section) (x 6)
Warehouse
Bank (x 2)
Typesetting Company
Clearing Agent
Pharmacy and Poisons Board (PPB) (Customs & Border Control Cargo Terminal) (EIA) (x 2)
Port Health Services Kenya (Customs & Border Control Cargo Terminal) (EIA) (x 3)
Kenya Revenue Authority (KRA) (Customs & Border Control Cargo Terminal) (EIA) (x 4)

Results 12 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
User credentials
Registration letter
Pharmaceutical export permit
Authenticated EU certificate of origin
Certificate of export

Required Documents expand_more expand_less

Identity card
Company PIN certificate (x 4)
Individual PIN certficate
List of shareholders (Form CR-12)
Certificate of incorporation (x 4)
Sample analysis request
Laboratory client registration form
Test request form
Certificate of analysis
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
Request for company registration
Company PIN
Rules of origin exporter registration form
Sector specific license
Wholesale dealer's licence
Product registration certificate
Certificate of analysis (x 2)
KRA payment authorization slip (x 2)
Bank deposit slip (x 2)
EU certificate of origin form
Typed certificate of origin form
Passed clearance entry (x 5)
Pharmaceutical export permit (x 2)
Proforma invoice
Packing list (x 2)
Public health recommendation
Food hygiene licence (x 2)
Phytosanitary certificate
Clearance entry
KRA receipt
Air waybill
Passed clearance entry
Passed clearance entry stamped by HVO

Estimated cost KES  88,500 +USD  1,003

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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.
USD 3
For issuance of certificate of origin
KES 0 -
1 % goods-value
Clearing agent fees - estimate.
KES 1,500
For issuance of export health certificate.

Total Duration 131d - 497d  expand_more expand_less

  Min. Max.
Total time (sum): 131d 497d
of which:
Waiting time in queue (sum): 2h. 5mn 5h. 50mn
Attention at counter: 6h. 30mn 4d
Waiting time until next step (sum): 129d 492d

Laws 12 expand_more expand_less

Customs and Excise Regulations Customs and Excise Regulations (2010)
  Sections 14, 15, 127C, 127, 128B, 199
Drug registration - Guidelines to submission of applications Drug registration - Guidelines to submission of applications
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
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
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
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, 35, 35K, 44 (rule 3), 44 (1) (k)
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