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Marketing Authorisation

Medical Gloves Guidelines
Guidelines On Application for Grant Of Marketing Authorisation Of NON-IVDS
Guildlines of Traceability of Medicines
Guidelines on Recall of Medicines and Allied Substance
Template for comments on Guidelines on Identification and Labelling of Medicines and Allied Substances and Master Data Sharing
Guildlines on Grant of Marketing Authorisation for Cosmetics
Guidelines on Renewal for Marketing Authorisation of Medicines and Allied Substances-ZAMRA_2019v2
Guidelines on Identification and Labelling of Medicines and Allied Substances and Master Data Sharing
Application for Grant of Marketing Authorisation of In-Vitro Diagnostic Devices for Human-v1
Guidance on submission of applications for Marketing authorisation in CTD format: Quality
Guidelines for grant of Marketing Authorisation of in-vitro diagnostic devices for Human use
Application for Marketing Authorisation of a Human Medicine for Human Use - Stability
Preparation and submission of Dossiers in Common Technical for Registration Quality
Application for Grant of Marketing Authorisation of Antiseptics and Disinfectants
Application for Marketing Authorisation CTD Format - Human Medicines
Detecting and Reporting Adverse Drug or Vaccine Reactions and Events
Guidelines for In-vitro Diagnostic Medical Device Market Authorisation
Essential Principles of Safety and Performance of Medical Devices-v1
Guidelines for Label and Instructions For Use for Medical Devices
Guidelines on the Principles of Medical Devices Classifications-v1
Amendment for Marketing Authorisation - Human Medicines
Application for Registration of a Veterinary Medicine
Temporary Guidelines for Hand Sanitizers
Application for Marketing Authorisation - Condoms
Guidelines for Registration of Nutritional Suppliment
Application for Registration a Biological Product
Application for Registration of a Herbal Medicine
Checklist for Submission of Dossiers
Guidelines on submission of applications in CTD Format
Guidelines on Bioavailability or Bioequivalence
Application for Clincal Trial Authorisation
Applicants Cover letter template_v0 - ZAZIBONA
Application acceptance letter - ZAZIBONA
Expression of Interest - ZAZIBONA
Assessment Process Workflow-v0 - ZAZIBONA
Roles of key players in Zazibona-process_v0 - ZAZIBONA
API FPP Assessment Template-LOQ_v0 - ZAZIBONA