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Properties

Steps (35) 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 pharmaceutical export permit  (5) expand_more expand_less
Consignment clearance  (7) expand_more expand_less

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Summary of the procedure

Institutions involved 5 expand_more expand_less

Mission for Essential Drugs Supplies (MEDS) (x 4)
Bank
Customs Shed (x 3)
Airline

Results 9 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
Certificate of export number

Required Documents expand_more expand_less

Identity card
Company PIN certificate
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
Application letter
Pharmaceutical import permit
Certificate of analysis (x 2)
Wholesale dealer's licence (x 2)
Dangerous drugs authorization (DDA) export permit
KRA e-slip
Passed clearance entry
Pharmaceutical export permit
Air waybill (x 2)
Passed clearance entry stamped by HVO (x 2)

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 250
For airline concession fees.
  Min. Max.
Total time (sum): 127 d 485 d
of which:
Waiting time in queue (sum): 50mn 2h. 30mn
Attention at counter: 3h. 5mn 18h. 20mn
Waiting time until next step (sum): 127 d 484 d
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)
  Sections 34, 35, 36, 38, 41, 73, 74, 75, 82, 123
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
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
Kenya Airports Authority Act Kenya Airports Authority Act
  Section  12
Narcotic Drugs and Psychotropic Substances Control Act CAP 245 Narcotic Drugs and Psychotropic Substances Control Act CAP 245
  Sections 16
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
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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