The Zazibona collaboration does not represent the replacement of the need to submit applications for registration in participating countries in line with national requirements. There is no centralized submission of dossiers to Zazibona. To be eligible for the Zazibona collaborative process an application should have been lodged with at least to two (2) active Zazibona participating countries. 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.

In applying for a product registration through the Zazibona collaborative process , applicants should submit a covering letter (clearly indicating their interest to participate in the Zazibona process), a product dossier, in English, organized in in the Common Technical Document (CTD) format and  product samples to all the participating countries according to the individual national requirements.

Potential applicants are further advised that Zazibona participating countries reserve the right to accept or refuse submissions to be considered for this collaboration on a case by case basis.  Each Zazibona authority retains the right to assess submitted data 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.

Documents to be submitted together the Product Dossier

A covering letter, expressing

  1. Interest in participating in the Zazibona process and information, whether the product is already registered in any Zazibona participating country,
  2. Confirmation/attestation that the information submitted in the product dossiers is "true and correct",
  3. Confirmation/attestation that the same dossier and data have been submitted to all participating countries where the product has been submitted,
  4. Consent with respect to sharing of the product related information during assessments 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 confidentiality undertaking; and
  5. Commitment to apply for the same variations and post-registration changes in all Zazibona participating countries where the product is registered.

 Member States Registration Requirements

  1. Botswana:
  2. Democratic Republic of Congo:
  3. Malawi:
  4. Mozambique:
  5. Namibia:
  6. South Africa:
  7. Tanzania:
  8. Zambia:
  9. Zimbabwe: