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Zambia
GUIDELINES FOR APPLICATION FOR GRANT OF MARKETING AUTHORISATION OF ANTISEPTICS AND DISINFECTANTS
These guidelines, issued by the Zambia Medicines Regulatory Authority (ZAMRA), prescribe the information needed to apply for marketing authorization of antiseptics and disinfectants to be placed on the Zambian market. They are intended to ensure that all antiseptics and disinfectants manufactured locally or imported into the country are safe, effective, and of acceptable quality.
Use Cases
- Applicants: The document provides information on the content and format of the dossier for those who intend to submit applications for Marketing Authorisation of these products.
- ZAMRA (the Authority): It sets the framework for ZAMRA to assess and grant marketing authorization to products that meet quality, safety, and efficacy standards.
- Prospective Marketing Authorisation Holders: It enables them to market their products on time and make them available to consumers in Zambia.
Key takeaways you'll learn
