Apply In Person:

1. An application for renewal of a Pharmaceutical Manufacturing Facility shall be made to the Botswana Medicines Regulatory Authority (BoMRA) at least three (3) months before the expiration of the current license. BoMRA Office Location & Contact Details
2. The application shall be made in a prescribed manner as may be set by the Authority, Application form for renewal of the manufacturing facility license are obtainable at the BoMRA Licensing and enforcement department/section.
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 receipt of the application, the BoMRA Registration & Licensing 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 the BoMRA Registration & Licensing officer is satisfied that all the requirements have been met for the application for the license, the application is registered for processing and consideration.
6. Applicants are required to deposit the prescribed renewal license fees to the BoMRA bank account, as per the BoMRA Fees Schedule and the proof of deposit of the renewal fee should be attached to the application file.
7. If the BoMRA officer is satisfied that all the requirements have been met for the application for the license, the application is registered for processing and consideration.
8. The applicant is issued/mailed with a BoMRA payment slip and an acknowledgment slip as proof of submission of the application and for inquiry referencing if the need arises.
9. After successful processing of the submitted documents, when all regulatory requirements for approval of the license are satisfactorily met, the Licensing officer shall prepare the renewed license that shall specify the validity and, shall also indicate the approval scope and limitations.
10. Notice of the decision (Approval, Deferral, or Rejection) for the application will be communicated to the applicant by phone or mail.
11. While collecting the license the applicants will be required to produce the BoMRA acknowledgment letter and identity document and proof of payment of the license fee to be validated by the licensing office, applicant will be required to surrender their expired license before being issued with the renewed license.

Please Note: Following the initial grant of the Pharmaceutical Manufacturing Facility licence, occasional inspections will be made by the Authority so as to certify that the licensee has continue practising good mafucaturing practise. Normally, prior notice will be given to the holder of the licence but inspections may take place without such prior notice.

• Certified copy of a valid identity document (passport for non-citizens/Identity card for citizens)
• Certified copy of a valid identity document (passport for non-citizens/Identity card for citizens).
• Registration certificate of the pharmacist from Botswana Health Profession Council.
• A declaration letter for personal supervision of a pharmacist.
• Copy of a valid Blue card (BHPC card)
• Copy of Expiring BOMRA Approval License (Renewal)
• A copy of the payment receipt.

Note: The BoMRA Registration & Licensing office reserve the right to request additional supporting documentation.

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 Office Location & 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: health@gov.bw
MoH Office location & Contact 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.

• Holders of a current/expired pharmacist license that wishes to renew their license are eligible to apply.

• Please consult with the BoMBA for the fees schedules.

• The Pharmaceutical Manufacturing Facility license validity for a specifified period. The license will remain valid for the duration stipulated, unless revoked, suspended, or cancelled by the Authority.
• The license is subjected to renewal. Application for renewal of an existing license shall be submitted three (3) months prior to license expiry.

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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)
• Current/expired license details
• Declaration (Signature of applicant/date)

• Individuals, Businesses, or companies that wish to operate a Pharmaceutical Manufacturing Facility are required to be registered and licensed by the Botswana Medicines Regulatory Authority (BoMRA) to be able to operate.
• This license needs to be renewed in time in order to keep enjoying the incentives that come with holding a valid license.

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BoMRA Licensing and Enforcement

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