Apply In Person

1. The application for Registration of Complementary Medicines shall be made to the Botswana Medicines Regulatory Authority (BoMRA), whose mandate is to implement, enforce and regulate the registration of all Drugs and Related Substances in Botswana. BoMRA Contact Details
2. Applicants are required to collect and complete the Registration Form for complementary medicines, obtainable at the BoMBA office or download it via the BOMBA website using this link , Registration Form for complementary medicines
3. The declaration form must be completed and signed by the responsible person in the manufacturing facility and applicant as specified.
4. Applicants are required to submit one hard copy of the signed and completed application form, The Soft copy (Word Format on the CD) of the application must be typed in font New Times Roman, font size 12. Attachments should be scanned and included in the CD arranged as per the guideline. Refer to the “Information that may help section” of this page to locate the BoMRA Guideline link.
5. The Completed application shall be submitted with a covering letter. To expedite the unpacking of documents the covering letter should itemize the contents of the submission.
6. Applicants should provide sealed samples (at least two samples) of the Finished Pharmaceutical Product (FPP) in its final container and labeling as intended for presentation to the Botswana market or closest reference packs when the labeling for marketing has not been finalized. The BoMRA may request more samples for testing. A screening fee, /Re-screening fee of 500 BWP is charged.
7. The BoMRA will conduct an inspection on the establishment where the product will be manufactured or stored to determine if it complies with the current Good Manufacturing Practices (cGMP) regulation at a prescribed fee by the BoMRA. Refer to the “Fee” section of this page to locate the BoMRA Regulatory Fees 2019 schedule and BoMRA Bank Details links.
8. A copy of the report 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.
9. 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). A Re-inspection fee is charged.
10. The application file, GMP status report, and the laboratory analysis of the product will be presented to the Drug Registration Committee for review and final decision making.
11. The Drugs Regulatory Unit evaluates registration applications. The recommendations are then submitted to the Board for the final resolution, The Board meetings are at intervals of approximately six to eight weeks.
12. Applicants are notified in writing about Board resolutions, regarding their applications.
13. If the authority is satisfied that there is the need to register the product and all requirements for its registration have been met, it will be registered and you will be issued with the certificate of registration, upon presenting the approval letter, identity document, and proof of payment of the registration fee to be validated by the BoMRA registrar.
14. The registration certificate is subjected to terms and conditions as the Authority deems fit. The holder of the certificate shall also be subjected to supervision and monitoring by the Authority.

Application by an Agent

1. If the applicant is a foreign company, you will appoint a local agent through whom an application will be submitted

• List of all the names and physical addresses of all the manufacturers
• Good Manufacturing Procedures (GMP) Certificate,
• Valid Manufacturing license or International Organization for Standardization (ISO) certificate for manufacturing sites
• List all the countries where the product is marketed and provide certificates or authorization letters of such.
• Package insert shall bear the following:
  • Approved name (as it appears on the label).
  • The local or common name by which easily known.
  • Composition.
  • What it is used for.
  • The direction of use.
  • Presentation (powder, mixture, cake, etc.)
  • Contra-indications/Warning /Known symptoms of over-dosage.
  • Storage information and shelf life.
  • Manufacturer and or Applicant.
• Authorization letters from the applicant to the agent/local representative indicating the responsibility of the agent/representative.

Note: All documents must be in English.

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 No: +267 318 6254
Email:  info@bomra.co.bw
BoMRA Contact Details
BoMRA Website

Ministry of Health & Wellness (MoH)
Office Address:
Plot 54609
24 Amos Street,
Government EnclaveGaborone
Botswana
Postal Address: Private Bag 0038Gaborone,
Botswana.
Toll-Free Customer: 0800600740
Inquiries: (+267) 3632500/3170585
Emergency Services: 997
Email address: health@gov.bw
MoH contact details
MoH Website
Working Hours: Monday-Friday from 8:00am-1:00pm and 2:00 pm -5:00 pm, expect during Public Holidays.

• Local and Foreign Organizations

BoMRA Regulatory Fees 2019
BoMRA Banking Details

• The Registration certificate validity is mentioned on the license. The license will remain valid for the duration stipulated, unless revoked, suspended, or canceled by the Authority.
• Upon expiring, the Registration certificate is subjected to renewal.

Registration Form for complementary medicines

Please attach sample completed documents that would help other people.

• The time frame accumulatively for processing the application is within 3 months.

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'.

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

Product and Applicant details

• Name, Address, Telephone and Fax numbers, and email address of Applicant
• The proprietary name of the product.
• INN or Botanical Name (e.g. Vitamin D, Gingko Biloba etc).
• Presentation, Strength, and dosage form.
• Pack size(s)
• Uses of the final product.
• Source (plant, chemical, animal, etc)
• Name and physical address of Manufacturer (s)
• Countries where the product is marketed
• Type of application (New or Renewal)
• Declaration by the applicant ( Name/position/Qualification/signature/ company stamp)

• Complementary/Alternative Medicines refers to a substance or mixture of substances used in supporting good health and without any reference to alleviation, treatment, modification, or prevention of ill health, such medicine need to be approved and registered by the Botswana Medicines Regulatory Authority (BoMRA).
• The aim of these is to maintain the integrity of the product for its intended purpose and avoid misleading the general public.
• No person/entity should produce, manufacture, supply, distribute or sell any complementary medicine that has not yet been approved, registered, and licensed by the BoMRA.

BoMRA Guideline for application for registration of complementary medicines

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

MoH Guideline for application for registration of complementary medicines

More information which might help people.