A person who seeks to make a publication or an advertisement for a drug shall make an application to the Authority in writing on company letterhead and complete and attach to all the supporting documentation.

Step I: Submit a written application

1. A formal written application letter on a company letterhead should be submitted to the Botswana Medicines Regulatory Authority (BoMRA) this is the body that is responsible for issuing permission, Marketing authorization / and registration Department. BoMRA Office Location & Contact Details
2. A medical representative shall apply to the planning, and drug information department for drug promotion in mass media attaching the information to be promoted with the application form.
3. Only a medical representative who has been granted a certificate of competency from the authority is entitled to promote drugs to the health professional. Drug products should not be available to consumers without a prescription.
4. Any medical representative should have a place to keep promotional materials and other documents used for his/her work and An advertisement must clearly communicate the intended use of the product.
5. Prior to production and/or importation, distribution, or use of any Drug promotional material, or institution of arrangements to engage in any form of drug promotion activity, an application for authorization to publish or advertise shall be made by:
   • The holder of the patent of the drug
   • A licensed person
   • The manufacturer of the drug; or
   • An agent authorized by the manufacturer or the holder of the patent of the drug.
6. When describing product efficacy, they must be consistent with the terms of market authorization (TMA).
7. An advertisement must not be misleading as to the duration of use of the advertised product ie which can lead to overdose problems.
8. Drug advertising must be overtly directed to adults, so as not to mislead to suggest that a child is capable of making a rational decision regarding the use of the advertised product.
9. Botswana Medicines Regulatory Authority (BoMRA)must regulate commercial advertisements by monitoring the quality of the information in the advertisement routinely.
10. The government has the responsibility to ensure compliance with the regulations controlling advertisements in order to improve drug usage among the population.

Step 2: The application shall be accompanied by:

1. A sample of the material for which approval for publication or advertisement is sought. In case of material to be developed, the applicant submits electronic copies of the material artwork showing clearly the final material in its form, color, dimensions, and inscriptions.
2. The application shall also be accompanied by a proof of payment (print media BWP 500.00 Print Media/ BWP 1000.00 for Electronic Media), payable to the BoMRA Bank Account. Please refer to the “Fees” section of this page for more information.

Step 3. Evaluation and processing of the application.

1. Once an application has been accepted and evaluation fees paid the processing of the application will take place.
2. Wait for a few days for the reply from the department of publications and advertisements for drugs. The department, in reply to the application, shall give a proper decision within a month.

Step 4. Issue of the approval letter.

1. If the application is accepted, the authority shall write an approval letter to the concerned media on which the drug is to be promoted.
2. The information content of promotion in media for Analgesics, and Anthilemntics shall include the right source of availability and shall state that the advice of a health professionals is required.

• A formal application letter by the Superintending Pharmacist / Pharmacist in Charge of the company, as registered with the BoMRA, addressed to “The Registrar, Botswana Medicines Regulatory Authority (BoMRA)” detailing the proposed advertisement to be carried out.
• Proof of up-to-date registration of the company that wishes to advertise with the BoMRA.
• Proof of up-to-date registration of the product to be advertised with the BoMRA.
• A receipt of the prescribed fee per proposed advertisement, per medium of advertisement, per product advertised towards application. (paid at our Accounts Office)
• Copy of updated ‘annual practice license’ of the Superintending Pharmacist / Pharmacist in Charge of the company.
• List of active ingredients (contents) in the medicine to be advertised.

If the advertisement is to be:

• Aired on television, in addition to the above:
  • A detailed storyboard of the proposed advertisement or one CD copy of the final advertisement proposed to be aired.
  • Six printed scripts of the messages that will be viewed on TV.
• Aired on radio, in addition to the above:
  • One CD copy of the proposed advertisement.
  • Six printed scripts of the messages heard.
• Published in the print media, in addition to the above:
  • Six printed scripts of the final proposed advertisement.

Note:

• All CDs submitted should be CD-R discs.
• Documents such as video clips should be viewable via Windows Media Player compatible with Windows 2000 version and thereafter.
• Storyboards and scripts are viewed by BoMRA in preparation for the final advertisement.
• The final prepared advertisement will be required to be submitted and necessary approval obtained prior to airing or printing in the respective media.
• At no time will approval of the storyboards or scripts serve as a substitute for the approval of the final proposed advertisement. Current work permit for non-citizens.

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 & 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.

• Individuals/Drug Companies wishing to advertise drugs in Botswana are eligible to make the application.

• BoMRA Fees Schedule
  
• BoMRA Bank Account Details
  

• All approved advertisements are valid for one year from the date of approval apart from calendars and diaries whose expiries shall be 31st December of the year of granting approval.

Please attach documents that can be used by people. e.g. links

Please attach sample completed documents that would help other people.

• Once an application has been accepted and evaluation fees paid the processing of the application will take a maximum of 30 working days.

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'.

• Applications for the advertisement of any drug or poison shall be made to the Authority in the prescribed form and shall be accompanied by the prescribed fee.

Conditions for drug advertising.

• No person shall advertise any medicine except with the written permission of the Botswana Medicines Regulatory Authority (BoMRA).
• No product shall be promoted unless it is registered by the Botswana Medicines Regulatory Authority (BoMRA).
• Advertisements should be accurate, factual up-to-date, reliable, truthful, informative, balanced, and capable of substantiation and in good faith.
• All packaging and labeling materials shall provide information that is consistent with that approved during the registration of the product.
• Bonus offers and discounts offered directly to the public are not permissible.
• Claims of superiority over other brands will not be permitted.
• Once an advert has been approved, no changes however small can be made to it without the approval of the Authority.
• Companies must provide evidence of acceptance to use some information in their adverts e.g music clips from tracks by artists.
• Adverts should clearly inform the public about the risks associated with the use of the product e.g the Use of aspirin-containing products may lead to peptic ulcer diseases.

• Name of applicant
• BoMRA registration number
• Name of company pharmacist
• Reg no of company pharmacist
• Name of proposed advert/promotion
• Proposed medium of promotion: (Television/ radio/ print media/ Other (provide details)
• Type of document submitted: (final proposed advertisement / promotion/story board / script for review/other (provide details))
• Name of product to be/Advertised/ BoMRA registration Number/Active ingredient(s)
• Payment details
• Signature of superintendent pharmacist

No person/ company is permitted to advertise drugs through any mass media communication platform in Botswana, unless he has been issued a written Authorization by the Authority responsible i.e BoMRA

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

Botswana Drugs and Related Substances Acts-1992

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