Product Evaluation and Registration

Mandate

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.

Registration Procedure

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.

 

Scope of products

Any medicine meeting the criteria of being an essential medicine is invited for submission to be considered for registration via the Zazibona collaborative process. Special consideration may be given to medicines that are vital to effective treatment and to expanding treatment programmes, where there are currently limited options for health practitioners in the participating countries. This includes medicines identified for special regional programmes and initiatives.
Focus will however be on the 10 priority disease conditions identified by SADC reproductive health products.

Top conditions/diseases in SADC with an overall regional priority ranking

HIV/AIDS

1

Tuberculosis

2

Malaria

3

Acute respiratory infections

4

Diarrhoea

5

Diabetes

6

Pneumonia

7

Cardiovascular

8

Cancer

9

Obstetrics

10

Gastroenteritis & colic

10

Any other medicines that are important from a public health perspective may be considered on a case-by-case basis.

Other eligibility criteria

Medicines that are already registered in any participating country or other products jointly accepted by participating authorities are eligible for the collaborative process, provided there is an agreement between the participating countries.

Innovator products which have not been registered by SRAs may be accepted for the procedure.

To be eligible for the Zazibona collaborative process an application should have been lodged with at least to two (2) Zazibona participating countries.

Applications not eligibles

The invited generic products exclude those which have been prequalified by the World Health Organization (WHO) and/or registered by Stringent Regulatory Authorities (SRA), for which other accelerated registration mechanisms can be applied.

Applicants are encouraged to make pre-submission consultations on eligibility of their products with their respective national authorities.

Application submission process

As a condition for a medicines dossier to be included in the collaborative process an application should be submitted according to current Zazibona requirements which include an agreement to consent to information sharing among participating regulatory authorities. All participating countries shall treat the shared information as confidential in line with applicable national legislation and arrangements.

Potential applicants are further advised that Zazibona participating countries reserve the right to accept or refuse submissions to be considered for this collaboration. Each Zazibona authority retains the right to assess submitted data and organize site inspections to the extent they deem appropriate. Inclusion in the collaborative process may be affected by the available Zazibona capacity. Medicines that are not selected follow regular national registration procedures.

Applicants are encouraged to submit applications for inclusion in the Zazibona process at least 1 month before the meeting of assessors which considers applications received and assignment of rapporteurs. Early submissions facilitate the administrative screening of applications before the meeting of assessors. Assessment meeting dates are published on participating authority websites.

Documents to be submitted

  1. Covering letter, in English, expressing

    1.1. interest in participating in the Zazibona process and information, whether the product is already registered in any Zazibona participating country,

    1.2. confirmation/attestation that the information submitted in the product dossiers is "true and correct",

    1.3. confirmation/attestation that the same dossier and data have been submitted to all participating countries,

    1.4. consent to sharing of the product related information during registration and in the post-registration period among Zazibona participating authorities and with WHO staff and external experts, who support the process and are bound by a confidentiality undertaking; and

    1.5. commitment to apply for the same variations and post-registration changes in all Zazibona participating countries where the product is registered.

  2. Product dossier, in English, organized in CTD format for submitting product data and information. For the purpose of generic medicine registration, data demonstrating quality of raw materials (Active Pharmaceutical Ingredients and Excipients) and FPP are necessary, as well as demonstration of bioequivalence with an acceptable comparator. Details are specified in the relevant guidelines that reflect the harmonized SADC position. Paper and electronic copies of the dossier should be submitted as per national requirements.
  3. A product sample (for example a package of 100 tablets), for evaluation of product appearance, container material and labelling, as well as to enable, under exceptional circumstances, chemical and pharmaceutical analysis. Where sample labelling does not comply with national requirements or the proposed final labelling, mock-up labels demonstrating design of final labelling should be submitted.
  4.  A site master file, for each manufacturing site of the medicine, in the requisite format.
  5.  The national specific requirements include especially:

    I. Application fees

    II. Statutory forms to be completed and to accompany a specific national application

    III. Country specific labelling requirements

Further details on requirements for the Zazibona collaboration process, mechanisms of the Zazibona work-sharing and interactions with applicants are specified in other documents.

The Zazibona collaborative process is designed to achieve registration within a total time of 11 months, during which the applicant will have two windows of opportunity to respond to consolidated lists of regulatory assessment questions within a period of 60 days. Total regulatory time is therefore 210 days, which corresponds to regulatory deadlines of established regulatory authorities. Timelines for Zazibona process starts at the point of allocation of rapporteurship i.e. within 1 month of the submissions, followed by 10 weeks for initial assessment, 2 weeks for sharing assessment report, 8 weeks for the manufacturer/supplier or applicant to respond, and 2 weeks to process response. Products are only considered for 2 review cycles (for the responses) thereafter a final recommendation should be made. A country reserves the right to make a final determination on the submissions or request further information.

For Further information email This email address is being protected from spambots. You need JavaScript enabled to view it. and This email address is being protected from spambots. You need JavaScript enabled to view it.

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

For more information contact: This email address is being protected from spambots. You need JavaScript enabled to view it.

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