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Botswana - Apply for Exemption of Medicines from Registration

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ProcedureEdit

Apply Online (Email)

  1. The application for Exemption of Medicines from Registration, may be applied for, only under special circumstances, such as when there is no registered product and/or no registered alternatives available for sale in Botswana market, to the Botswana Medicines Regulatory Authority (BoMRA). BoMRA Contact &Map Location Details
  2. Application can either be wholesale based or Patient based, and is required to collect and complete the, Application for Registration Exemption form - Wholesale - BoMRA/ER/EX/P02/F02 or application for Registration Exemption form - Patient - BoMRA/ER/EX/P02/F01, obtainable at the BoMRA office or download it via the BoMRA website, BoMRA Exemption Application Forms
  3. For a wholesale-based exemption application, the applicant is the Responsible Pharmacist whose role is to ensure that all the information is included in the application form and all the documents are attached to the application. Quantity requested should be supported by orders from the facilities and copies of the orders should be attached.
  4. For a patient-based exemption application, the prescriber is the applicant whose role is to ensure that all the required information is included in the application form. The dispensing pharmacist is to check whether the information provided by the prescriber is correct and complete.
  5. Applications should be emailed to: [email protected] .The applicants will be required to submit the duly completed application form in all respect and the relevant supporting documents as mentioned under the “Required Documents” section of this page. Any omission of the required documents and information will render the application process incomplete.
  6. The Authority will communicate the outcome of the application within 48 hours. However, where the application does not meet the Authority’s requirements, queries will be sent to the applicant within 48 hours. Applicants will be given 24 hours to address the queries following which the Authority will make a regulatory decision.
  7. If approved, the registrar will draw up the permit as directed by the committee and sent it to the applicant via mail.


NOTE:

  • The maximum supply for approval is 7 months for patient-based exemptions.



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Required DocumentsEdit

Wholesale-based Exemption Application

  • Completed application for Registration Exemption form - Wholesale - BoMRA/ER/EX/P02/F02.
  • Proof of payment for application for registration exemption (P350 fee)
  • Orders from facilities received by the wholesaler. If the quantity requested in the application form is more than the orders from facilities, evidence to justify the excess quantity must be attached to the application.
  • Provide evidence of out of stock of the registered product. Evidence must be from manufacturers, applicants, or sole distributors of the registered alternative.
  • cGMP certificate if the physical site of the product does not appear in the blue book.
  • For a Sterile product, a valid cGMP certificate for the Finished Pharmaceutical Product manufacturing site, issued by either ICH member countries prior to 23 October 2013 or regulatory authorities that participate in the PIC/S or WHO or National Medicines Regulatory Authorities in Zambia, Zimbabwe, Tanzania, and Uganda. This is not required if the physical site of the product is appearing in the blue book for any of the registered injectable.
  • For a Biologic /Bio-similar product, a valid Registration Certificate for the product must be provided from ICH member countries as defined prior to 23 October 2013 or WHO.
  • For a Public Health Emergency product, a valid Registration Certificate/Approval/Emergency Use Authorization for the product must be provided from ICH member countries as defined prior to 23 October 2013 or WHO.


Patient-Based Exemption Application

  • Completed application for Registration Exemption form - Patient - BoMRA/ER/EX/P02/F01
  • Valid Prescription from a registered prescriber in Botswana


NOTE:
All documents must be in English.

Office Locations & ContactsEdit

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 Number: +267 318 6254
Email Address:  [email protected]
BoMRA Contract &Map Location Details
BoMRA Website

Ministry of Health & Wellness (MoH) Physical Address:
Ministry of Health & Wellness
Plot 54609
24 Amos Street
Government Enclave
Gaborone
Postal Address:
Ministry of Health & Wellness
Headquarters
Private Bag 0038
Gaborone

TOLL Free Customer: 0800600740
Enquiries: 3632500/3170585
Emergency Services: 997

Email Address: [email protected]
MoH Contact & Map Details
MoH Website
Business hours: Monday-Friday from 8:00am-1:00pm and 2:00 pm -5:00 pm, closed during Public Holidays.

EligibilityEdit

  • For a wholesale-based exemption application, the applicant is the Responsible Pharmacist.
  • For a patient-based exemption application, the prescriber is the applicant.



FeesEdit

BoMRA Regulatory Fees 2019
BoMRA Banking Details

ValidityEdit

  • Exemption approval is valid for the quantity to which it was approved and for 6 months from the date of issue.



Documents to UseEdit

BoMRA Exemption Application Forms

Sample DocumentsEdit

Please attach sample completed documents that would help other people.



Processing TimeEdit

  • The Authority will communicate outcome of the application within 48 hours. However, where the application does not meet the Authority’s requirements, queries will be sent to the applicant within 48 hours. Applicants will be given 24 hours to address the queries following which the Authority will make a regulatory decision.



Related VideosEdit

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'.



InstructionsEdit

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



Required InformationEdit

  • Name of the drug or related substance
  • Approved name(s) of active ingredient(s)
  • Dosage form
  • Strength(s)
  • Name and address of manufacturer
  • Country (ies) where registered and registration number(s)
  • Motivation for exemption
  • Name, address and qualifications of the applicant
  • Declaration (Signature of applicant/date)



Need for the DocumentEdit

  • The Exemption of Medicines from Registration, may be applied for, only under special circumstances, such as when there is no registered product and/or no registered alternatives available for sale in Botswana market, to the Botswana Medicines Regulatory Authority (BoMRA).



Information which might helpEdit

Enter other informations which might help.


Other uses of the Document/CertificateEdit

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



External LinksEdit

MoH Guidelines on Drug Registration Applications in Botswana
MoH Guidelines on Good Manufacturing Practices

OthersEdit

More information which might help people.



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