Apply In-Person

1. The application for a License to Manufacture Drugs for Sale 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.BoMRA Map Location and Contact Details
2. For any Drugs to be licensed for manufacturing, it first has to be registered by the Botswana Medicine Regulatory Authority (BoMRA); upon registration,a person who wishes to manufacture medicines shall apply for a premises license using an applicable prescribed form, obtainable at the Botswana Medicine Regulatory Authority (BoMRA)office, or download it via the BoMRA website,
   • Application form for Premises Licence OR
   • Application form for licensing of Veterinary Medicine Products (VMP) premises
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 theBotswana Medicine Regulatory Authority (BoMRA) office. Any omission of these documents will render the application process incomplete.
4. Upon submission, the application is checked for completeness and correctness by the BoMRA Licensing and Registration staff. If everything is in order the application will be registered for processing and consideration by theBotswana Medicine Regulatory Authority (BoMRA) board/Licensing Committee.
5. 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 theBotswana Medicine Regulatory Authority (BoMRA)account.
6. Applicants will be issued with a BoMRA payment receipt and an acknowledgment letter,which serves as proof of submission of the application and for inquiry referencing if the need arises.
7. The Botswana Medicine Regulatory Authority (BoMRA)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 in the manufacture and quality control of medicines may request additionalinformation 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.
8. If necessary, the Authority shall schedule a facility premise visit with the applicant to determine if,Good Manufacturing practices (GMP), Good Distribution Practices (GDP), Good pharmacy practices (GPP), during the packing, processing, storage, labeling, sterilizing, testing, dispatch, quality control, and quality assurance of the products is been practiced at an additional fee as mentioned on the BoMRA fee schedule.
9. After the inspection copy of the report, the finding will be given to the applicant and if any modification or upgrading is required, the Corrective Action and Preventive Action Report (CAPA) report will be issued and you will be required to rectify the problem.
10. Upon successful implementation of the CAPA, a follow-up inspection may be conducted by the inspection team to ascertain the effectiveness of the implementation (where applicable); at a prescribed fee.
11. Notice of the decision (Approval, Deferral, or Rejection) for the application will be communicated to the client in writing.
12. 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.
13. 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.
14. While collecting the license, the applicant will be required to produce a proof of identity document, approval letter, and proof of payment of the Manufacturing license fee as mentioned on the BoMRA fee schedule.
    

Please Note

Please refer to Wikiprocedure website, for the full procedure on how to register a Drug/Medicine. [Botswana - Apply for Drug/Medicine Registration]

• Properly completed Application form for Premises Licence OR form for licensing of Veterinary Medicine Products (VMP) premises
• List showing name of product, active ingredient, strength and dosage form, include formulations and manufacturing process.
• List showing the name, type and capacity of equipment.
• A covering letter summarising the business prospects
• Sketch plan/Layout of the premises
• Sketch plan/Layout of the premises
• Copy of a valid Blue card (BHPC card)
• Copy of pharmacist’s BHPC registration certificate
• At least two references and a brief C.V. of the pharmacist
• Declaration letter for continuous personal supervision by a pharmacist.
• Private Practice license (For community pharmacy)
• valid identification document
• Proof of payment of the license fee
  

Botswana Medicine Regulatory Authority (BoMRA)
Telephone: +267 373 1720
Toll Free No: 0800 600 216
Fax No: +267 318 6254
Email: info@bomra.co.bw
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 & WellnessHeadquarters
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.

Any person /company that intends to manufacture a medicinal substance in Botswana are eligible to apply.

• BoMRA Regulatory Fees 2019
  
• BoMRA Banking Details
  

• A manufacturing license shall be valid for a period of 12 months from the date of issue unless suspended, cancelled, or revoked by the authority.
• The license should be renewed at least thirty days before it expires.
  

• Application form for Premises Licence OR
  
• form for licensing of Veterinary Medicine Products (VMP) premises
  
• Application Documents Checklist
  

Please attach sample completed documents that would help other people.

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

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.gIn the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.

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

• Applicants 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
  

No person is allowed to manufacture any medicinal substance unless he has been granted a manufacturing license by theBotswana Medicine Regulatory Authority (BoMRA).

Enter other informations which might help.

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

• BoMRAInspections and Licensing
  
• Ministry of Health
  
• Guidelines on Drug Registration Applications in Botswana
  

More information which might help people.