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Botswana - Obtain Pharmaceutical Wholesale License


Procedure

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Apply In Person

  1. The application for a Pharmaceutical Wholesale License shall be made to the Botswana Medicines Regulatory Authority (BoMRA). BoMRA Contract &Map Location Details
  2. The Application forms and checklist can be obtained, free of charge, from the BoMRA Pharmaceutical Inspectorate Department or download via the BoMRA website, BoMRA Application Document Checklist, BoMRA Application form for Registration of Premises
  3. The application form should be completed in triplicate, attached to the supporting documentation as mentioned under the “Required Documents” section of this page, should be delivered in person to the BoMRA office, or alternatively sent by email to inspections@bomra.co.bw. Any omission of the required documents or information will render the application incomplete
  4. Upon submission of the application documents, the applicant shall pay non-refundable application fees as mentioned under the “Fees” section of this page or as may be prescribed by the Board. Which is payable either by depositing it into the BoMRA account or can be received through the Point of Sale (POS) machine (swiping machine) at the BoMRA offices. Alternatively, you can pay by cheque written in favour of the Botswana Medicines Regulatory Authority.
    Note: The applicant is advised to submit a sketch plan of premises to BOMRA for approval, before making structural changes to the warehouse.
  5. Applicants will be issued with an acknowledgment receipt or receive an acknowledgment email, that serves as proof of submission of the application and for inquiry referencing if the need arises.
  6. Upon receipt of the duly filled application forms and documents, the same will be evaluated and the applicant advised in writing on whether the application was successful.
  7. In conducting the evaluation, the Board may arrange an interview for the applicant (superintendent) by the Practice Committee of the Board.
  8. If the interview is successful, an inspection of the proposed company’s premises will be conducted by a pharmaceutical inspector to assess the suitability for the intended business within ten (10) working days after the submission of an application, the applicant shall be notified of the date and time prior to inspection. The inspection report will be presented in the prescribed inspection form.
  9. Having considered all factors and matters relating to the application the Board will either, approve the issue of a pharmaceutical wholesale license or advice the applicant in writing, in case of an unsuccessful application, and clearly state the reason the application was unsuccessful.
  10. In the case of an unsuccessful application, the applicant will be given further opportunities to revise and comply. Where the applicant is able to revise the application and comply with the requirements, the issue for the license will be approved, after a re-inspection on the premise by the pharmaceutical inspector to ascertain the effectiveness of the implementation (where applicable).
  11. If approved, the board will direct the BoMRA registrar to register the premises and draw up the registration license to be issued to the applicant against the approval letter, identity document, and proof of payment of the license fee.
  12. The license shall be subjected to terms and conditions as the Authority deems fit and should be displayed at a conspicuous place in the precincts of the facility.



Required Documents

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  • A covering letter summarising the business prospects.
  • Certified copy of identity card or passport
  • Registration certificate of the pharmacist from Botswana Health Profession Council.
  • At least two references and a brief C.V. of the pharmacist.
  • A declaration letter for personal supervision of a pharmacist.
  • A sketch/plan of the premises.
  • Copy of a valid Blue card (BHPC card)
  • Private Practice license (For community pharmacy)
  • A copy of the payment receipt from BoMRA
  • Any other documents as may be deemed necessary or as may be prescribed by the Board




Office Locations & Contacts

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Botswana Medicines Regulatory Authority (BoMRA)
Office Address: Plot 112, Gaborone International Finance Park,
Gaborone
Postal Address: Private Bag 2, Gaborone Station, Botswana
Telephone: +267 373 1720
Toll-free no: 0800 600 216
Fax Number: +267 318 6254
Email Address: info@bomra.co.bw
BoMRA Contract & Map Location Details
BoMRA Website

Ministry of Health & Wellness (MoH)
Physical Address:
Ministry of Health & Wellness
Plot 54609
24 Amos Street
Government Enclave
Gaborone
Postal Address:
Ministry of Health & Wellness
Headquarters
Private Bag 0038
Gaborone

Toll-Free Customer: 0800600740
Inquiries: 3632500/3170585
Emergency Services: 997
Email Address: health@gov.bw
MoH Contact & Map Details
MoH Website
Business hours: Monday-Friday from 8:00 am-1:00 pm and 2:00 pm -5:00 pm, closed during Public Holidays.



Eligibility

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  • A sole proprietor or a partnership or a limited company is eligible to apply.


Fees

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Validity

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  • The Registration license validity is mentioned on the license. The license will remain valid for the duration stipulated, unless revoked, suspended, or cancelled by the Authority.
  • Upon expiring, the Registration license is subjected to renewal. Application for renewal of an existing license shall be submitted three (3) months prior to license expiry.
  • License renewal shall be inspected within twenty-one (21) working days after the date of application.


Documents to Use

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Sample Documents

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Please attach sample completed documents that would help other people.  

Processing Time

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  • The time frame for processing the application is within 2 weeks.


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Videos explaining the procedure or to fill the applications. 
Attach videos using the following tag <&video type='website'>video ID|width|height<&/video&> from external websites. 	
Please remove the '&' inside the tags during implementation.
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver, 
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed.
e.g In the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.  


Instructions

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Please provide other instructions related to the certificate/documents.
e.g. The state office holds birth records since january 1908.  

Required Information

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  • Type of application
  • Name of applicant (of person representing the company)
  • Address of applicant
  • Qualifications (profession/education)
  • The premises location (address)
  • Declaration (Signature of applicant/date)



Need for the Document

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  • Businesses or companies that wish to operate a pharmaceutical wholesale business are required to be registered and licensed by the Botswana Medicines Regulatory Authority (BoMRA) to be able to operate.




Information which might help

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Enter other informations which might help.



Other uses of the Document/Certificate

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Please explain what are other uses of obtaining this document/certificate.
e.g. Birth Certificate can be used as proof of identity.



External Links

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Others

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More information which might help people.
 




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