Botswana - Obtain a Certificate for Pharmaceutical Products

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Procedure

Apply In Person

1. The application to obtain a Certificate for Pharmaceutical Productsshall 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.Botswana Medicine Regulatory Authority (BoMRA) Map Location and Contact Details
2. The application shall be made in writing using the Application Form to Register Human Medicines, obtainable at the Botswana Medicine Regulatory Authority (BoMRA)office, or download it via the BoMRA website Application Form to Registera Human Medicines.
3. If the applicant is not a manufacturer, the applicant must submit evidence of empowerment of power of attorney.
4. Submit the supporting documentation as mentioned under the “Required Documents” section of this page, in addition to the duly completed application form in all respect (both soft copy and electronic card), to theBotswana Medicine Regulatory Authority (BoMRA) . Any omission of these documents will render the application process incomplete.
5. Both paper and electronic copy submissions must comply fully with the Common Technical Document as regards the presentation and content of the dossier.An application not submitted in the appropriate format, incomplete or illegible will be rejected. Any documents submitted on CD /DVD have to be declared identical to that in the paper submission.
6. Upon receipt of the application, the AuthorityLicensing and Registration office 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 corrected.
7. If the Botswana Medicine Regulatory Authority (BoMRA) office is satisfied that all the requirements have been met for the application,the application is registered for processing and consideration by the Botswana Medicine Regulatory Authority (BoMRA) board/Licensing Committee.
8. Applicants will be required to pay a prescribed fee as mentioned on the BoMRA fee schedule, refer to the “Fees” section of this page,which is payable by depositing it into the Botswana Medicine Regulatory Authority (BoMRA) account.
9. Applicants will be issued with a payment receipt and an acknowledgment letter,which serves as proof of submission of the application and for inquiry referencing if the need arises.
10. The 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 additional information 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 board/Licensing Committee shall reject the application.
11. After the successful screening of the submitted documents,a 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 satisfied that an applicant meets the requirements, it shall notify the license issuing officer, who will then draw up the pharmaceutical product certificate as directed by the board/licensing committeeand present it to a senior officer to be certified (signed/stamp) and made available to be issued to the client.
14. While collecting the certificate, the applicant will be required to produce a proof of identity document, approval letter, and proof of payment of the certificate fee as mentioned on the BoMRA fee schedule.

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Required Documents

• Electronic copy declaration.
• Curriculum vitae of the qualified person for pharmacovigilance
• API change control.
• Copy of EMA certificate for a Vaccine Antigen Master File (VAMF).
• Copy of EMA certificate for a Plasma Master File (PMF)
• Copy of certificate(s) of the suitability of the European Pharmacopoeia (CEP)
• Copy of confirmation of API prequalification document (CPQ)
• Letter of access from the APIMF holder, CEP holder, or CPQ holder
• Quality Information Summary (QIS)
• Letter of authorization signed by the person responsible for the overall management and control of the business.
• valid identification document
• Proof of payment of the applicable fees.
• Any required documents as request for by the BoMRA.

Office Locations & Contacts

Botswana Medicine Regulatory Authority (BoMRA)
Telephone: +267 373 1720
Toll Free No: 0800 600 216
Fax No: +267 318 6254
Email: [email protected]
Botswana Medicine Regulatory Authority (BoMRA) Map Location and Contact Details
Botswana Medicine Regulatory Authority (BoMRA) Website

Ministry of Health & Wellness (MoH)
Physical Address
Ministry of Health & WellnessPlot 5460924
Amos StreetGovernment EnclaveGaborone

Postal Address:
Ministry of Health & Wellness
HeadquartersPrivate Bag 0038Gaborone
TOLL-Free Customer: 0800600740
Inquiries: 3632500/3170585
Emergency Services: 997
Email Address: [email protected]
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.

Eligibility

• Pharmaceutical products that need to be registerd and certified by the Botswana Medicine Regulatory Authority (BoMRA).

Fees

Botswana Medicine Regulatory Authority (BoMRA) Regulatory Fees 2019
BoMRA Banking Details

Validity

• The validity of the certificate will be mentioned on the certificate and it shall remain valid for that period of time unless suspended, cancelled, or revoked by the authority.
• The certificate should be renewed at least thirty days before it expires.

Documents to Use

Application Form to Register Human Medicines.

Sample Documents

Please attach sample completed documents that would help other people.

Processing Time

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

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

Instructions

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

Required Information

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

Need for the Document

• The Certificate of a Pharmaceutical Product is a certificate which is presenting several details on a registered finished medicinal product.
• The Certificate of a Pharmaceutical Product is needed by the importing country when the product in question is intended for registration (licensing, authorization) or renewal (prolongation) of registration, with the scope of commercialization or distribution in that country.
• It is issued in the format recommended by the Ministry of Health and awareness in Botswana, in collaboration with the World Health Organization (WHO), which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country.

Information which might help

Guidelines on Drug Registration Applications in Botswana

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

Medicine Regulatory Authority (BoMRA) Product Registration Process
Ministry of Health

Others

More information which might help people.