Botswana
Official Name: Republic of Botswana
Capital: Gaborone
Independence Day: 30 September 1966
Currency: Pula (BWP)
Indicators
Regulatory Framework
The Botswana Medicines Regulatory Authority (BoMRA) was established through the Medicines and Related Substances Act (2013) to oversee the regulation of medicines, medical devices, cosmetics and promote human and animal health in Botswana (BoMRA,2020). This Act replaced the Drugs and Related Substances Act No. 18 (1992), which was supervised by the Drugs Regulatory Unit of the Ministry of Health and Wellness.
Product Registration/Market Authorization
According to the BoMRA website, the product evaluation and registration department ensures that all medicines (human, veterinary and complementary) and other healthcare products are registered and approved for use in Botswana. These medicines and healthcare products must meet the standards of safety, quality and efficacy, set by the Authority. The guidelines for product registration are available on the website for the public and applicants to follow the due process. The standard process for registration takes about thirty-six months, according to guidelines found on the website.
Product Registration/Market Authorization
According to the BoMRA website, the product evaluation and registration department ensures that all medicines (human, veterinary and complementary) and other healthcare products are registered and approved for use in Botswana. These medicines and healthcare products must meet the standards of safety, quality and efficacy, set by the Authority. The guidelines for product registration are available on the website for the public and applicants to follow the due process. The standard process for registration takes about thirty-six months, according to guidelines found on the website.
Inspections Module for both GDP and GMP
BoMRA conducts inspections of medicines to assess compliance with Good Manufacturing Practices (GMP), Good Distribution Practices (GDP) and Good Pharmacy Practices (GPP) along in the medicines supply chain. These practices should be in with the Medicines and Regulated Substances Act (2013).
The Department of Inspection and Licensing oversees this section. They conduct countrywide inspections and licensing of new premises for both human and veterinary facilities. The assessment of facilities is carried out at least once annually. There is no information regarding the use of technology in this module on the BoMRA website.
The Department of Inspection and Licensing oversees this section. They conduct countrywide inspections and licensing of new premises for both human and veterinary facilities. The assessment of facilities is carried out at least once annually. There is no information regarding the use of technology in this module on the BoMRA website.
Pharmacovigilance
BoMRA undertakes pharmacovigilance, which is located under patient safety monitoring. Before registering products or market authorization, BoMRA ensures that a pharmacovigilance system is in place. The Authority conducts pharmacovigilance inspections, evaluates safety reports and examines procedures.
This helps to analyze and recommend action on suspected adverse drug reaction reports, carry out and complete safety audits, carry out post-market surveillance, train health workers on pharmacovigilance, among others. Once a citizen identifies an adverse drug reaction, he or she must contact their healthcare provider who would then fill the ADR form and send it to BoMRA on their behalf. The postal address, telephone number, fax and email of BoMRA is available for reporting.
There is also an ADR reporting portal available to stakeholders. There is also an app available for adverse drug reaction reporting to the Botswana Medical Regulatory Authority. This is the MedSafety Mobile application, and it is available on both android and apple application stores for download. Guidelines on how to download the application are available on the website.
This helps to analyze and recommend action on suspected adverse drug reaction reports, carry out and complete safety audits, carry out post-market surveillance, train health workers on pharmacovigilance, among others. Once a citizen identifies an adverse drug reaction, he or she must contact their healthcare provider who would then fill the ADR form and send it to BoMRA on their behalf. The postal address, telephone number, fax and email of BoMRA is available for reporting.
There is also an ADR reporting portal available to stakeholders. There is also an app available for adverse drug reaction reporting to the Botswana Medical Regulatory Authority. This is the MedSafety Mobile application, and it is available on both android and apple application stores for download. Guidelines on how to download the application are available on the website.
Laboratory Information Management System
The BoMRA has a laboratory unit that is responsible for the analysis of medicine, related substances as well as medical devices. This is done to test their fitness for purpose and verify the claims of the manufacturer in terms of safety, quality and efficacy.
The website talks of the need for a laboratory quality management system that would be based on set ISO certifications and WHO guidelines. The laboratory will help inform key decisions on product marketing. However, it is not informed on the website if this system is already in place.
The website talks of the need for a laboratory quality management system that would be based on set ISO certifications and WHO guidelines. The laboratory will help inform key decisions on product marketing. However, it is not informed on the website if this system is already in place.
Post Market Surveillance
As of the time the website was accessed, there was no information under the post-market surveillance section of the website; however, Medicines and Related Substances Act regulations outline the various processes under post-market surveillance. A health care professional or prescriber should report any issue to the Authority regarding the safety, quality and efficacy of a drug or related substance.
The Authority will also conduct risk-based inspections of the pharmaceutical operations of companies and take sample medicines, medical products or cosmetics on the market for testing and investigations. This would help ensure the set standards of quality, efficacy and safety. If a product fails the test, the Authority gives the Authority a written warranty to the market authorisation holder or importer.
The holder or importer would have to trace the cause of the defect and take actions to rectify the problem within a maximum of thirty days. There also no information regarding the use of any technology in executing tasks within this module.
The Authority will also conduct risk-based inspections of the pharmaceutical operations of companies and take sample medicines, medical products or cosmetics on the market for testing and investigations. This would help ensure the set standards of quality, efficacy and safety. If a product fails the test, the Authority gives the Authority a written warranty to the market authorisation holder or importer.
The holder or importer would have to trace the cause of the defect and take actions to rectify the problem within a maximum of thirty days. There also no information regarding the use of any technology in executing tasks within this module.
Clinical Trials
The clinical trials section did not have any information regarding the process when the website was accessed. However, the Medicines and Related Substances Act regulations contain details regarding the control of clinical trials in part five (5) of the Act regulations. Also, the website has available the register of approved medicines and premises.
Conversely, the technology or system used during the clinical trial process was not available as well. According to the Medicines and Related Substances Act, to conduct a clinical trial, the applicant must fill out and submit a form to the Authority accompanied by the necessary fee attached.
The Authority will issue a written approval for the use of medicines regulated under the Act. The trial will then be conducted based on the set standards and guidelines of the Authority. The application for clinical trial with the World Health Organization recognized clinical trial registry. The results of the clinical trial would then be submitted to the Authority in a detailed report once it has been completed.
Conversely, the technology or system used during the clinical trial process was not available as well. According to the Medicines and Related Substances Act, to conduct a clinical trial, the applicant must fill out and submit a form to the Authority accompanied by the necessary fee attached.
The Authority will issue a written approval for the use of medicines regulated under the Act. The trial will then be conducted based on the set standards and guidelines of the Authority. The application for clinical trial with the World Health Organization recognized clinical trial registry. The results of the clinical trial would then be submitted to the Authority in a detailed report once it has been completed.
Import and Export
BoMRA facilitates the import and export controls of drugs in Botswana through the issuance of import and export permits. The Authority is working on a new system for the issuance of import permits. It is anticipated that the new system would tracking and tracing of medicines as they are imported into the country.
With regards to habit forming drugs, BoMRA ensures that quotas are closely monitored to ensure that estimated quota is not exceeded. Through partnerships with the Port Health and the Botswana Unified Revenue Services, BoMRA can establish its presence at the Port of entry to verify the incoming and outgoing of consignments. According to the Medicines and Related Substances Act, to import, export, distribute or sell medicines in Botswana, the applicant shall apply to the Authority by filling the required and paying the accompanying fee.
The applicant must meet the necessary requirements laid out in the Act. Upon deliberation and review, the Authority will notify the Authority on whether their application has been approved or rejected. Current technologies used in issuing permits and the current guidelines for import and exports were not available when the website was accessed.
With regards to habit forming drugs, BoMRA ensures that quotas are closely monitored to ensure that estimated quota is not exceeded. Through partnerships with the Port Health and the Botswana Unified Revenue Services, BoMRA can establish its presence at the Port of entry to verify the incoming and outgoing of consignments. According to the Medicines and Related Substances Act, to import, export, distribute or sell medicines in Botswana, the applicant shall apply to the Authority by filling the required and paying the accompanying fee.
The applicant must meet the necessary requirements laid out in the Act. Upon deliberation and review, the Authority will notify the Authority on whether their application has been approved or rejected. Current technologies used in issuing permits and the current guidelines for import and exports were not available when the website was accessed.
Track and Trace Module
BoMRA currently does not have a track and trace system but has initiated plans in building a system that would help trace and track medicines being imported into Botswana. The rollout would first begin with veterinary medicines before human medicines are included.
Licensure – Professionals and Premises
BoMRA oversees the licensing of premises while the Botswana Health Professions Council gives licenses to professionals. The department of inspections and licensing in BoMRA oversees the licensing of premises for both human and veterinary activities.
The department provides licenses for a manufacturing facility, pharmacy, pharmaceutical wholesaler, dispensaries, among others. To request a license, an applicant must apply by filling a form together with its supporting documents to gather the proof of payment of the required fee.
The application could be sent by postal mail to the Botswana Medicine Regulatory Authority or could be submitted at the BoMRA office in person. Upon review and inspection, the applicant would receive a response from the department regarding the application. The technologies used in the review process were not available as at when the website was accessed.
The department provides licenses for a manufacturing facility, pharmacy, pharmaceutical wholesaler, dispensaries, among others. To request a license, an applicant must apply by filling a form together with its supporting documents to gather the proof of payment of the required fee.
The application could be sent by postal mail to the Botswana Medicine Regulatory Authority or could be submitted at the BoMRA office in person. Upon review and inspection, the applicant would receive a response from the department regarding the application. The technologies used in the review process were not available as at when the website was accessed.
Finance Module
On the BoMRA website, the banking details and the various regulatory fees for the outlined applications are available on the website for the applicants and other stakeholders to view.