print

Preview & Print

Properties

Preview & Print

Properties

Steps (45) 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 dangerous drugs authorization export permit  (2) expand_more expand_less
Obtain pharmaceutical export permit  (2) expand_more expand_less
language
language
Obtain EAC certificate of origin  (8) expand_more expand_less
Enter the OSBP  (1) expand_more expand_less
Obtain PPB release  (2) expand_more expand_less
Obtain KRA release  (3) expand_more expand_less

arrow_drop_up arrow_drop_down
Summary of the procedure

Institutions involved 8 expand_more expand_less

Mission for Essential Drugs Supplies (MEDS) (x 4)
Kenya Trade Network Agency (KenTrade) (x 3)
Kenya Revenue Authority (KRA) (Rules of Origin Section) (x 6)
Bank
Typesetting Company
Kenya Revenue Authority (KRA), One Stop Border Post (OSBP) (Isebania) (x 4)
Pharmacy and Poisons Board (PPB), One Stop Border Post (OSBP) (Isebania) (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
User credentials
Pharmaceutical export permit
Authenticated EAC certificate of origin

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 3)
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
Request for company registration
Company PIN
Application letter
Pharmaceutical import permit
Certificate of analysis (x 3)
Wholesale dealer's licence (x 2)
Dangerous drugs authorization (DDA) export permit
Rules of origin exporter registration form
Sector specific license
KRA payment authorization slip (x 2)
Bank deposit slip (x 2)
EAC certificate of origin
Typed certificate of origin
Passed clearance entry (x 4)
Pharmaceutical export permit
Proforma invoice
Packing list (x 3)
Cargo manifest (C2)
Permit (x 2)
Passed clearance entry stamped release by KRA
Cargo manifest stamped released by KRA

Estimated cost KES  87,000 + USD  1,003

expand_more expand_less

USD expand_more expand_less
  • USD 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

Total Duration 134 d - 515 d expand_more expand_less

  Min. Max.
Total time (sum): 134 d 515 d
of which:
Waiting time in queue (sum): 1h. 10mn 3h. 40mn
Attention at counter: 4h. 35mn 24h. 5mn
Waiting time until next step (sum): 134 d 513 d

Laws 12 expand_more expand_less

COMESA (Manual) Protocol on Rules of Origin COMESA (Manual) Protocol on 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 (2004)
  Sections 34, 41, 235
East African Community Customs Management Regulations, 2010 East African Community Customs Management Regulations (2010)
  Section  187
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
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
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)
Powered by eRegulations ©, a content management system developed by UNCTAD's Business Facilitation Program and licensed under Creative Commons License