Registering Safe, Quality and Effective Health Products in Zambia Product Registration is the regulatory process through which ZAMRA evaluates and approves medicines, medical devices, cosmetics, veterinary medicines, and allied substances before they can be imported, distributed, supplied, or sold in Zambia. This process ensures that all regulated products meet the required standards of quality, safety, […]

Good Manufacturing Practice (GMP) is a system of quality assurance that ensures medicines, medical devices, cosmetics, and other regulated health products are consistently manufactured and controlled according to established quality standards. GMP is designed to minimize risks associated with production that cannot be eliminated through testing of the final product alone. Compliance with GMP ensures […]

Medical Devices and Allied Substances are regulated to ensure they meet the required standards of safety, quality, and performance before they are manufactured, imported, distributed, sold, or used within the country. Effective regulation protects patients, healthcare professionals, and the public while supporting access to safe and reliable healthcare technologies. Medical devices include instruments, apparatus, machines, […]

Import and Export of Pharmaceutical Products The import and export of pharmaceutical products are regulated to ensure that only safe, effective, and quality medicines and health products enter or leave the country. Regulatory oversight helps protect public health by preventing the circulation of counterfeit, substandard, or unregistered products while facilitating legitimate international trade. Importers and […]

Premises Licensed premises are facilities authorized to manufacture, store, distribute, dispense, or sell regulated medicines, veterinary medicines, medical devices, cosmetics, and other health-related products. Licensing ensures that these facilities operate in compliance with national legislation and regulatory standards designed to protect public health and safety. The regulatory authority conducts inspections, licensing, and continuous monitoring to […]

The Laboratory Services Directorate provides scientific testing, analysis, and evaluation services to support regulatory decision-making and ensure the quality, safety, and efficacy of regulated products. The laboratory conducts analytical testing of medicines, vaccines, medical devices, cosmetics, and other regulated products to verify compliance with established quality standards. The Directorate plays a critical role in post-market […]

The Monitoring the Safety of Medicines programme is responsible for the continuous assessment and monitoring of the safety of medicines after they have been authorized for use. Through pharmacovigilance activities, ZAMRA collects, evaluates, and responds to reports of adverse drug reactions, medication errors, product quality issues, and other medicine-related safety concerns. The programme works closely […]

The Cosmetic Regulation Directorate is responsible for overseeing the registration, importation, distribution, and marketing of cosmetic products in Zambia. The Directorate ensures that cosmetic products available on the market comply with applicable regulatory requirements and do not pose risks to consumer health when used as intended. The Directorate evaluates product information, ingredient composition, labeling requirements, […]

The Veterinary Regulation Directorate oversees the regulation of veterinary medicines and animal health products to ensure they meet standards of quality, safety, and efficacy. The Directorate is responsible for the evaluation, registration, licensing, importation, and post-market surveillance of veterinary medicinal products used in the prevention, diagnosis, and treatment of animal diseases. By regulating veterinary products, […]