Documents to be submitted
- Cover letter, in English, expressing:
- interest in participating in the Zazibona process and information on whether the product is already registered in any Zazibona participating country;
- confirmation that the information submitted in the product dossier is “true and correct”;
- confirmation that the same dossiers and data have been submitted to all participating countries;
- consent to sharing of the product-related information, during pre-registration and in the post-registration assessment process, amongst Zazibona NMRAs, with WHO staff and with external experts, who support the process and are bound by confidentiality undertakings; 1.5. commitment to apply for the same variations in all Zazibona countries where the product is registered.