When applying for a product registration through the ZAZIBONA collaborative process, applicants are requested to submit an ‘application for registration’ to each participating country that they wish to market their products in. Applications for registration comprise of the following.
- A covering letter (clearly indicating interest to participate in the ZAZIBONA process). In addition to the expression of interest to use the ZAZIBONA pathway, the covering letter should also contain the following.
- declaration whether the product is already registered in a ZAZIBONA participating country,
- confirmation/attestation that the information submitted in the product dossiers is “true and correct”,
- confirmation/attestation that the same dossier and data have been submitted to all participating countries of interest,
- 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 undertakings; and
- commitment to apply for the same variations and post-registration changes in all ZAZIBONA participating countries where the product is registered
- application fees, any statutory forms and product samples with labelling in compliance with individual country requirements
- a product dossier in English and in the Common Technical Document (CTD) format (identical modules 2 to 5 and country specific module 1). Paper and/or electronic copies of the dossier should be submitted as per national requirements.
- For generic medicines, 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, if applicable. Details are specified in the relevant guidelines that reflect the harmonized SADC position.
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 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.