Forms

ZAMRAForms

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Marketing Authorisation
Permits and Licenses

Marketing Authorisation

ZAMRA - Biowaiver BCS Application Form

ZAMRA - Quality Information Summary Form

ZAMRA - Bioequivalence Trial Information Form

ZAMRA - Biowaiver - Additional Strengths Form

ZAMRA - Quality Overall Summary - Product Dossier

ZAMRA - Clinical Data for Registration of Human Medicines

ZAMRA - Renewal Summary of Key Product Information - Annex 2

ZAMRA - Quality Overall Summary-Product Dossier (QOS-PD)- Biologicals

Permits and Licenses

Annual Return - No Change Return Form

Pharmaceutical Product Reporting Form (Part I) And Recall Notification Form (Part II)