Wikiprocedure

Botswana - Apply for Drug License (Retail and Wholesale Pharmacy)

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ProcedureEdit

Apply In-Person

  1. The application for Drug License (Retail and Wholesale - Pharmacy) shall be made to the Botswana Medicine Regulatory Authority (BoMRA) office, whose mandate is to regulate, register, and license medicines, medical devices, and cosmetics, to promote human and animal health.
  2. Interest applicants are required to collect and complete the Premises Registration Form, obtainable at the BoMRA Pharmaceutical Inspectorate Department office or download it directly from the BoMRA website using these links-
  3. Submit the relevant supporting documentation as mentioned under the “Required Documents” section of this page, in addition to the duly completed relevant application form(s), in all respect, to the Botswana Medicine Regulatory Authority (BoMRA) office. Any omission of these documents will render the application process incomplete.
  4. Upon receipt of the application, the receiving officers will check for discrepancies or ineligibility in the application documents. If a discrepancy that cannot be immediately corrected exists in any of the documents, the application and all the submitted documents will be returned to the applicant and should not be re-submitted until the discrepancy has been rectified.
  5. If everything is in order the application will be registered for processing and consideration by the Botswana Medicine Regulatory Authority (BoMRA) board/Licensing Committee.
  6. Applicants will be required to pay a prescribed fee as mentioned on Botswana Medicine Regulatory Authority (BoMRA) fee schedule, refer to the “Fees” section of this page, which is payable by depositing it into the Botswana Medicine Regulatory Authority (BoMRA) account.
  7. Applicants will be issued with a payment receipt and an acknowledgment letter, which serves as proof of submission of the application and for inquiry referencing if the need arises.
  8. The Botswana Medicine Regulatory Authority (BoMBA) board/Licensing Committee for purposes of ascertaining whether the premise to be used is suitable for the purpose and will be operated in accordance with standards of good practice, may request additional information relevant to the application. In such a case, the information must be submitted within the stipulated time from the date of notification. Where the applicant fails to submit the required information, the Authority board/Licensing Committee shall reject the application.
  9. If necessary the Authority shall schedule a premise inspection visit with the applicant to determine if the information provided is accurate.
  10. During the Inspection visit, any discrepancies will be brought to the attention of the applicant and corrective action must be taken before a license is issued.
  11. Upon successful implementation of any discrepancies noted during the inspection visit, a follow-up inspection may be conducted by the inspection team to ascertain the effectiveness of the implementation (where applicable).
  12. Notice of the decision (Approval, Deferral, or Rejection) for the application will be communicated to the client in writing.
  13. Where the board/Licensing Committee is not satisfied that an applicant meets the registration requirements, it shall reject the application and notify the applicant in writing, stating the reasons for the rejection.
  14. Where the board/Licensing Committee is satisfied that an applicant meets the requirements, it shall notify the license issuing officer, who will then draw up the license as directed by the board/licensing committee and present it to a senior officer to be certified (signed/stamp) and made available to be issued to the client.
  15. While collecting the license, the applicant will be required to produce a proof of identity document, approval letter, and the proof of payment of the license fee as mentioned on the BoMRA fee schedule.


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Required DocumentsEdit

  • Properly completed Application form for Premises Licence OR Application form for licensing of Veterinary Medicine Products (VMP) premises
  • valid identification document
  • 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 & ContactsEdit

Botswana Medicine Regulatory Authority (BoMRA)
Telephone: +267 373 1720
Toll Free No: 0800 600 216
Fax No: +267 318 6254
Email: [email protected]
BoMRA Map Location and Contact Details
BoMRA Website

Ministry of Health & Wellness (MoH)
Physical Address:
Ministry of Health & Wellness
Plot 5460924
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: [email protected]
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.

EligibilityEdit

Any person /company that intends to operate a drug retail or whosesale pharmancy in Botswana are eligible to apply.

FeesEdit


ValidityEdit

  • The license validity is mentioned on the license. The license will remain valid for the duration stipulated, unless revoked, suspended, or cancelled by the Authority.
  • Prior to the expiration date, the 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 UseEdit


Sample DocumentsEdit

Please attach sample completed documents that would help other people.


Processing TimeEdit

Please explain the processing time taken in obtaining the document/certificate.


Related VideosEdit

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 dkisplayed.
e.g In the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.


InstructionsEdit

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


Required InformationEdit

  • Applicant’s name
  • Reg. No
  • Email address
  • Cell phone No
  • ID/passport/alien ID No
  • Nationality
  • Premise name & address
  • Premise location, county, town, road and building
  • Signature of the applicant


Need for the DocumentEdit

No person is allowed to operate a Retail or wholesale drug shop/pharmancy unless he has been granted a license by the Botswana Medicine Regulatory Authority (BoMRA).

Information which might helpEdit

Enter other information which might help.


Other uses of the Document/CertificateEdit

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


External LinksEdit


OthersEdit

More information which might help people.


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