Product Registration
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, and efficacy in accordance with the Medicines and Allied Substances Act No. 3 of 2013.
Our Product Registration Services
- New Product Registration – Registration of new human medicines, veterinary medicines, medical devices, cosmetics, and allied substances.
- Renewal of Product Registration – Renewal of existing product registrations before they expire.
- Variation Applications – Approval of changes to registered products, including manufacturing sites, formulation, packaging, labelling, and product information.
- Product Information Assessment – Review of product labels, package inserts, patient information leaflets, and other product literature.
- Fast-Track Registration – Accelerated review of eligible products that address priority public health needs.
- Transfer of Product Registration – Processing changes in product ownership or registration holder.
- Product Deregistration and Withdrawal – Management of voluntary withdrawals and regulatory cancellations where applicable.
- Registered Products Database – Access to information on products registered and approved for the Zambian market.
Products Eligible for Registration
ZAMRA registers a wide range of regulated products, including:
- Human Medicines
- Veterinary Medicines
- Vaccines
- Medical Devices
- In Vitro Diagnostic (IVD) Medical Devices
- Cosmetics
- Nutritional Supplements
- Disinfectants and Antiseptics
- Allied Substances
Product Registration Process
- Create or log in to the ZAMRA online service portal.
- Complete the Product Registration application.
- Upload the required technical documentation.
- Pay the applicable registration fees.
- ZAMRA conducts administrative screening and scientific evaluation.
- Respond to any queries raised during the assessment.
- Upon approval, the product is issued a Product Registration Certificate and added to the Register of Approved Products.
Required Documentation
Applicants may be required to submit:
- Product registration application form
- Technical dossier
- Quality, safety, and efficacy documentation
- Good Manufacturing Practice (GMP) evidence
- Product labels and package inserts
- Manufacturer’s licences and certificates
- Certificate of Pharmaceutical Product (where applicable)
- Proof of payment of the prescribed fees
Why Product Registration is Important
Product Registration ensures that only safe, effective, and quality-assured health products are made available in Zambia. It protects public and animal health, promotes regulatory compliance, and enhances confidence in healthcare products supplied to the public.