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Properties

Steps (42) 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

arrow_drop_up arrow_drop_down
Summary of the procedure

Institutions involved 8 expand_more expand_less

Pharmacy and Poisons Board (PPB) Online Services Portal (x 2)
Pharmacy and Poisons Board (PPB) Trade Portal (x 4)
Kenya Trade Network Agency (KenTrade) (x 3)
Kenya Electronic Single Window System: KESWS (x 8)
Courier Service Provider (x 5)
Bank
Mission for Essential Drugs Supplies (MEDS) (x 4)

Results 11 expand_more expand_less

User credentials
Wholesale dealer's licence
Certificate for registration of premises
Annual practice licence for pharmacists
User credentials
Drug sample
Certificate of analysis
Certificate of good manufacturing practices
Product registration certificate
Commercial medicines import permit
Import declaration form (IDF)

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)
Form CR 2
Academic qualification
Request for company registration
Company PIN
Wholesale dealer's licence (x 4)
Invoice
Drug sample permit
Bank deposit slip
Sample analysis request
Laboratory client registration form
Test request form
Certificate of analysis
Site master file (x 2)
Pharmacy and Poisons Board (PPB) invoice (x 4)
Pharmacy and Poisons Board (PPB) receipt (x 3)
Certificate of good manufacturing practices authorization letter
Application for registration of a drug - Form 1
Certificate of analysis
Certificate of good manufacturing practices
Certificate of pharmaceutical product
Product registration certificate (x 3)
Submitted commercial medicines import permit
Authorization for payment for commercial medicines import permit (x 2)
Permit

Estimated cost KES  90,750 +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.
KES 0 -
KES  25 per kilogram
per day
KES 0 -
KES  35 per kilogram
per day
KES 0 -
KES  55 per kilogram
per day
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.
KES 0 -
0.75 % Free on board (FOB)

Total Duration 184d - 954d  expand_more expand_less

  Min. Max.
Total time (sum): 184d 954d
of which:
Waiting time in queue (sum): 1h. 3h. 10mn
Attention at counter: 3h. 10mn 1d 1/2
Waiting time until next step (sum): 183d 952d

Laws 9 expand_more expand_less

Drug registration - Guidelines to submission of applications Drug registration - Guidelines to submission of applications
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)
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, 35A, 35B, 35K, 35, 44 (K), 44 (1) (k)
World Customs Organization Recommendation of UCR World Customs Organization Recommendation of UCR
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