Human Medicines
- Application for Marketing Authorisation of Medicines for Human Use - Stability
- Application for Marketing Authorisation CTD Format - Human Medicines
- Detecting and Reporting Adverse Drug or Vaccine Reactions and Events
- Guidelines on Renewal of Marketing Authorisation of Medicines and Allied Substances ZAMRA
- Guidelines on Recall of Medicines and Allied Substance
- Guidelines of Traceability of Medicines
- Amendment for Marketing Authorisation - Human Medicines​
- Template for comments on Guidelines on Identification and Labelling of Medicines and Allied Substances and Master Data Sharing
- Guidelines on submission of applications in CTD Format
- Guidelines on Bioavailability or Bioequivalence
- Application for Registration a Biological Product
- Checklist for Submission of Dossiers
- 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
- SI-No-57-of-2017-Importation-and-Exportation
- Preparation-and-submission-of-Dossiers-in-Common-Technical-for-Registration-Quality
- Quality Overall Summary-Product Dossier (QOS-PD)-Biologicals
- Quality Overall Summary -Product Dossier
- ZAMRA-QIS
- Guidelines on Categorization on Good Storage and Distribution Practices Inspection Deficiencies
- Guidelines for the Management of Controlled Substances
- Guidelines on Vaccines Quality Non-Clinical and Clinical Requirements
- Guidelines on The Preparation and submission of Dossiers in CTD Format
- Reliance Guideline for the Grant of Marketing Authorisation for Medicine
- Guidelines on Advertising Marketing and Promotion of Medicines and Allied Substances
- Guidance on Submission of Application for Amendment to MA in CTD Format Quality
- Guideline on Quality Efficacy Safety Aspects Included in the Product Information for Vaccines for Human Use
- Guidelines for MA of Medicines for Human Use
- Guidelines for Qualified Person for Pharmacovigilance
- Guidelines on Reliance and Recognition for Regulatory Decision Making
Veterinary Medicine
- Application for Marketing Authorisation CTD Format - Veterinary Medicines
- Detecting and Reporting Adverse Drug or Vaccine Reactions and Events
- Guidelines on Renewal of Marketing Authorisation of Medicines and Allied Substances ZAMRA_2019v3​
- Guidelines on Recall of Medicines and Allied Substance
- Guildlines of Traceability of Medicines
- Amendment for Marketing Authorisation - Veterinary Medicines
- Template for comments on Guidelines on Identification and Labelling of Medicines and Allied Substances and Master Data Sharing
- SI-No-57-of-2017-Importation-and-Exportation
- Application for Registration of a Veterinary Medicine​
- Checklist for Submission of Dossiers
- 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
- Guidelines on the Application for Grant of Marketing Authorisation of Nutritional Supplements and Feed Additives for Animal Use in Zambia
Goods Manufacturing Practices (GMP)
- GUIDELINES ON GOOD MANUFACTURING PRACTICES
- GUIDELINES FOR ESTABLISHMENT OF PHARMACEUTICAL MANUFACTURING FACILITIES IN ZAMBIA
- Guidelines on Goods Manufacturing Practices(WHO)
- WHO good manufacturing practices for pharmaceutical products: Main principles
- Guidelines on Goods distribution practices
- Temporary Guidelines for Hand Sanitizers
- Guidelines on Classification of GMP Deficiencies
- Guidelines for Manufacturing and Distribution of Medical Gases
- Guidelines on Licensing of Blood Establishments
Premise
- Agro-vert-shops-regulations
- Healthshop-regulations
- Guidelines on the Establishment of a Pharmaceutical Retail Business
- Guidelines on the Establishment of a Pharmaceutical Wholesale Business
- Guidelines on the Establishment of a Pharmaceutical Retail Outlet Amendment
- Guidelines on the Establishment of a Health Shop
- Guidelines for the Establishment of an Agro Veterinary Shop
- Guidelines on the Establishment of a Hospital Pharmacy
- Guidelines on Import and Export Permits for Medicines and Allied Substances
- Guidelines on Licensing of Blood Establishments
Allied Substances and Medical Devices
- Application for Marketing Authorisation Condoms
- Guidelines on the Principles of Medical Devices Classifications v1
- Guidelines for Label and Instructions For Use for Medical Devices
- Essential Principles of Safety and Performance of Medical Devices-v1
- Guidelines for grant of Marketing Authorisation of in vitro diagnostic devices for Human-use
- Application for Grant of Marketing Authorisation of In Vitro Diagnostic Devices for Human-v1
- List Item Guideline -for In vitro Diagnostic Medical Device Market Authorisation
- Medical Gloves Guidelines Final
- GUIDELINES ON APPLICATION FOR GRANT OF MARKETING AUTHORISATION OF NON IVDS
- Application for Grant of Marketing Authorisation of Antiseptics and Disinfectants
- Guidelines for In-vitro Diagnostic Medical Device Market Authorisation
- Guidelines for Registration of Nutritional Supplement
- Application for Registration of a Herbal Medicine
- SI-No-57-of-2017-Importation-and-Exportation
- Application for Grant of Marketing Authorisation of Condoms
- Guidelines for Authorisation of Clinical Investigation Involving Medical Devices in Humans
- Guidelines for Good Cold Chain Management Practices
- Guidelines on the Safe Disposal of Unfit Medicines and Allied Substances
- Guidelines on Advertising Marketing and Promotion of Medicines and Allied Substances
- Guidelines on Emergency Use Authorisation for Medicines and In-Vitro Diagnostics in Zambia
- Guidelines for Post Market Surveillance of Medicines and Allied Substances
- Guidelines on Safety Monitoring of Medicines and Allied Substances in Zambia