ZAMRA Releases July 2026 Guidelines for Animal Feed Additives and Veterinary Allied Substances

The Zambia Medicines Regulatory Authority (ZAMRA) formally published comprehensive regulatory guidelines on July 24, 2026, governing the marketing authorisation of nutritional supplements and feed additives for animal use.

The regulatory release closes long-standing loopholes that allowed specialized animal feed additives, livestock nutritional supplements, and veterinary allied substances to circulate without standardized pre-market evaluation. Operating under the Medicines and Allied Substances Act No. 3 of 2013, ZAMRA affirmed that all animal health inputs distributed in Zambia must comply with strict product quality, efficacy, and safety standards.

The Enforcement Timetable and Transition Deadlines

The regulatory release establishes operational requirements and submission milestones for veterinary pharmaceutical distributors, commercial premix blenders, and agribusiness importers:

• July 24, 2026 (Statutory Publication Date): ZAMRA officially gazetted the Guidelines on the Application for Grant of Marketing Authorisation of Nutritional Supplements and Feed Additives for Animal Use in Zambia, alongside revised dossier submission checklists.

• Q3–Q4 2026 (Compliance Audit Window): Importers and local manufacturers must audit active product catalogues, assemble Common Technical Dossiers (CTD), and initiate formal marketing authorization filings.

• 2027 Enforcement Horizon: Port of entry health inspectors and cross-border customs units will halt commercial shipments of veterinary allied substances lacking active ZAMRA marketing authorisations or formal submission waivers.

Statutory Scope Under Act No. 3 of 2013

The updated regulatory framework brings veterinary allied substances under the strict product quality standards historically applied to conventional veterinary pharmaceuticals.

Under Act No. 3 of 2013, "allied substances" encompass animal feed supplements, growth-promoter additives, diagnostic reagents, antiseptics, and veterinary disinfectants. The new guidelines mandate that applicants submit comprehensive stability testing data, verified manufacturing flowcharts, analytical validation reports, and full quantitative breakdowns of active and inactive constituents. Regulators emphasized that livestock supplements carrying unverified health or therapeutic claims will face immediate marketing bans.

Commercial and Supply-Chain Liabilities

Agribusiness enterprises, feed millers, and veterinary importers face substantial financial and administrative liabilities if unapproved products remain in distribution channels.

Distributing or marketing an unregistered allied substance constitutes a criminal offense under the Medicines and Allied Substances Act, exposing corporate officers to administrative fines, product confiscations, and operational facility shutdowns. Furthermore, ZAMRA's updated protocol binds all marketing authorisation holders to rigorous traceability, master data sharing, and mandatory post-market recall reporting frameworks.

Corporate compliance teams, veterinary supply-chain managers, and commercial livestock feed suppliers must secure the July 24 guidelines from ZAMRA’s portal, review active SKUs against the new dossier submission checklist, and initiate formal registration filings to avert supply disruptions at borders and retail hubs.