Product Evaluation and Registration
Product Evaluation & Registration department is responsible for protecting and promoting human and veterinary public health by ensuring that medicines (human, veterinary and complementary medicines) and other healthcare products registered/approved for use in Botswana are safe and effective for their intended use and that they meet established quality standards.
In order to register your product, you will be required to submit a full product dossier for evaluation to determine whether the medicine is safe, of good quality and efficacious. The dossier is first submitted for screening together with the applicable fee. Our assessors will screen the dossier to determine whether all the appropriate sections of the dossier have been submitted. This is not full assessment but checking for completeness of the submission. If there is outstanding information, communication will be sent and an updated dossier will be requested. After passing screening, applicants will be advised to pay application fees, submit samples of the product and an application form signed by the applicant. Please refer to our Service Standards for the timelines. After evaluation, you will receive a letter communicating any outstanding issues with a deadline to respond. Once all queries are addressed, the application is presented before the Registration Committee who will make a regulatory decision based on the provided quality, safety and efficacy data.
Zazibona collaborative process
BOMRA invites applicants to submit Expressions of Interest (EOIs) for evaluation of applications through the Zazibona collaborative process.
The Zazibona process is a collaboration between national medicines regulatory authorities (NMRAs) in Zambia, Zimbabwe, Botswana, Namibia, South Africa, Tanzania, Malawi, DRC, Mozambique and Malawi (active countries) as well as Eswatini, Angola, Seychelles and Madagascar (non-active).
The vision of the Zazibona process is:
- A region in which good-quality medicines are available to all those who need them;
- To significantly reduce time taken to grant marketing authorisation in the individual countries; and
- Efficient utilisation of resources within regional national regulatory through work sharing.
The process’ objective is to promote a collaboration model to facilitate access to good-quality medicines through work-sharing in assessment of medicines and inspection of medicine manufacturing and testing facilities. Products that meet assessment criteria are then granted marketing authorisation in the participating countries, in which applications for registration would have been submitted. As and when agreed by the respective countries, variations to the products which have been registered under this collaboration may be handled through the same process.
The Zazibona collaboration does not represent the replacement of the need to submit applications for registration in participating countries in line with national requirements. However, as described in this document, in order to facilitate cooperation among Zazibona authorities, certain modifications are expected. Although there is close collaboration on assessments and inspections, final national registration decisions are the responsibility of individual participating authorities.
It is envisaged that manufacturers of needed medicines will benefit from accelerated registration processes, a single set of questions during the registration process and in principle harmonized registration decisions, which will facilitate easier review of any post-registration variations. Applications may be submitted by any person that qualifies to be an applicant in each participating country as per national requirements.
Who Prequalification Of Medicines Programme
The Collaborative Registration Procedure (CRP) for WHO-prequalified products is one of the registration pathways that applicants can utilise when submitting applications for registration. The link below directs interested parties to the WHO website for more information on the procedure: https://extranet.who.int/prequal/content/collaborative-registration-faster-registration
Non-routine MA of products for Public Health Emergency- Emergency Assessment Pathway
BoMRA has provision for non-routine marketing authorisation (MA) of products availed in response to public health emergencies
To qualify for an Emergency Assessment Pathway (EAP), the use of the product must meet the following criteria:
- The disease for which the product is intended has been declared by the WHO to be a Public Health Emergency of International Concern (PHEIC) and there is no licensed product for this disease.
- The disease for which the product is intended has been declared by the Ministry of Health and Wellness to be a Public Health Emergency (PHE) and there is no licensed product for this disease.
- The product is manufactured in compliance with current Good Manufacturing Practices (GMP).
- The applicant attests that it intends to complete the development of the product. In the ideal situation, the remaining clinical trials and other requisite testing will already be underway at the time of the application.
Products meeting the criteria will be prioritised for assessment. Screening and assessment will be conducted simultaneously. The assessment will be conducted in accordance with the WHO Emergency Use Listing procedure and BoMRA registration guidelines
Applicants should consult BoMRA to confirm eligibility and for applicable fees/ payment arrangements for EAP products.
Please see the WHO Emergency Use Listing for further guidance https://www.who.int/teams/regulation-prequalification/eul