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Territory – Zambia
Ministry of Health
Language – English
Territory – Zambia
Zambi Medicines Regulatory Authority
Language – English
The Zambia Medicines Regulatory Authority is a Statutory Body established under an Act of Parliament; the Medicines and Allied Substances Act No. 3 of 2013 to Regulate and Control the Manufacture, Importation, Storage Distribution, Supply, Sale and Use of Medicines and Allied Substances.
The main objective of the Authority is to ensure that all Medicines and Allied Substances being made available to the Zambian people consistently meet the set standards of Quality, Safety and Efficacy.
Medicines regulation is a combination of Legal, Administrative, and Technical Measures taken to ensure the Quality, Safety and Efficacy of Medicines, as well as the relevance and accuracy of product information. The Legal requirements for Medicines Control provide for effective implementation of various regulatory processes and framework for compliance.
ZAMRA incorporates several mutually reinforcing activities all aimed at promoting and protecting Public and Animal Health. This is accomplished through a range of regulatory activities throughout the supply chain, including: Marketing Authorisation, Inspection of facilities, Advertising and Promotion, and Post Marketing Surveillance.
To support implementation of the MASA, the following regulations have been developed and in use;
REGULATIONS
- Act No.2 of 2016 – Constitution of Zambia (Amendment), 2016
- Act No.3 of 2013 – Medicines and Allied Substances Act ,2013
- SI No.38 of 2016 – Fees Regulations
- SI No.10 of 2016 – Agro-Veterinay Shop Permit Regulations
- SI No.11 of 2016 – Dispensing Certificate Regulations
- SI No.12 of 2016 – Health Shop Regulations
- SI No 57 of 2017 Importation and Exportation Regulations
- SI No 58 of 2017 Certificate of Registration
- SI No 79 of 2019 The Medicines and Allied Substance Regulations
DOCUMENTS AND GUIDELINES
- Guidelines on the Establishment of a Pharmaceutical Retail Business (Amendment) 2023
- Guidelines on the Establishment of a Pharmaceutical Wholesale Business
- Guidelines on the Establishment of a Pharmaceutical Retail Outlet
- Guidelines on the Establishment of an Agro-Veterinary Shop
- Guidelines on the Establishment of a Health Shop
- Guidelines on Good Distribution Practices
- Guidelines on Good Manufacturing Practices (WHO)
- WHO good manufacturing practices for pharmaceutical products: Main Principles
- 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