Botswana - Apply for Drug/Medicine Registration

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Procedure

Apply In-Person

1. You should contact Ministry of Health Head Quarters Department of Drugs Regulatory, for more information on how to file the application with the department.
2. Application form and Guidelines can be obtained for the above offices, fill in the form and attach all the requirements.
3. The application should then submit in from of a hard copy and a soft copy to the department for screening to check for completeness at the front desk.
4. You will then be required to pay the application fees, head to Room 6 or 8 in Block B to make payment, upon which you will be issued with a receipt as proof of payment.
5. Submit the complete soft copy and hard copy to the office noted below, accompanied by the required documents with proof of payment and samples.
6. Your application will then be assessed by the department and you will be notified regularly on the progress of your application until a final assessment report is generated.
7. The final assessment report will then be tabled at the Drugs Advisory Board meeting for decision and recommendation to the Director of Health Services.
8. The decision of the Director will then be communicated to you through mail (letter).
9. If the Director of Health Services is satisfied with the report from the Drugs Advisory Board, assuring him/her that you have complied with all the requirement in regards to the application and that the product (drug/medicine) is of benefit to the general public and is harmless, the product will be registered with the registry and you will be issued with a certificate of registration.

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Required Documents

• A Certificate copy of analysis, accompanying reports and batch manufacturing records.
• Cover letter
• Sealed Sample (at least one samples), in the actual distribution container shall be submitted
• Proof of payment (receipt)
• Signed Declaration Form
• List all the countries where the product is marketed and provide certificates or authorization letters of such.
• Authorization letters from the applicant to the agent/local representative indicating the responsibility of the agent/representative
• Any other document that the department may request.

Note

• All documents must be in English

Office Locations & Contacts

Ministry of Health Head Quarters – Drugs Regulatory Unit
Plot 54069
24 Amos Street
3rd floor, Block D
Private Bag 0038
Gaborone
Botswana
Tel. (+267) 3632500
Fax. (+267) 3170169
Email: [email protected]

Eligibility

This service is open to all businesses and organizations within Botswana dealing with the manufacturing of drugs in Botswana or outside the country

Fees

The application fee is 800 BWP

Validity

Explain the time until which the certificate/document is valid.
e.g. Birth Certificate Valid Forever

Documents to Use

Guidelines Document

Sample Documents

Please attach sample completed documents that would help other people.

Processing Time

This service will take 12 months to complete from the date of submission of all required documentation.

Related Videos

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'.

Instructions

• The applicant shall submit one hard copy of the completed application including all required attachments.
• 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.
• The manufacturing of the drug or medicine may be done in Botswana or outside the country, but the registration of the medicines must be done in Botswana before the products can be marketed in Botswana.
• Please clearly label all documents that are part of the Application package.

Required Information

• Applicant details
• The details of the product should include:
• The approved name
• Dosage-form (tablets, capsules, mixture etc)
• Colour
• Strength per dosage unit
• Package size(s)
• Name and physical address of all the manufacturers
• List all the references used

Need for the Document

• The Ministry of Health in Botswana regulate all drug/medicine manufactured in Botswana or abroad through registration to ensure that all drug/medicine comply with the provisions of the Medicines and Related Substances Act.
• The Act stipulate that all Drug/Medicines that are manufactured, distributed, stored, dispensed, imported into, or exported from Botswana are safe, effective and of good quality for public consumption

Information which might help

Note: Both soft and hard copies of the Application Form are required as some of the documents are too bulky for electronic submission. Please clearly label all documents that are part of the Application package.

Other uses of the Document/Certificate

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

External Links

link

Others

More information which might help people.