Zambia Medicines Regulatory Authority - ZAMRA

STRENGTHENING REGULATION IN VETERINARY MEDICINES AND ALLIED SUBSTANCES FOR ANIMAL AND PUBLIC HEALTH

From 26th–29th May 2026, the Zambia Medicines Regulatory Authority (ZAMRA) conducted a Stakeholders Sensitisation Training on Regulatory Requirements for Veterinary Medicines and Allied Substances, bringing together key players in the veterinary medicines sector.

Speaking at the beginning of the training, Acting Director-General Mr. Lyoko Nyambe highlighted that the rapid growth of Zambia’s livestock sector and companion animal care presents both opportunity and regulatory responsibility.

"Effective regulation protects your reputation, safeguards animal welfare, prevents the threat of antimicrobial resistance, and ensures that our farmers and pet owners can trust the products they use."

Over the four days, participants engaged in discussions on critical regulatory requirements under the Medicines and Allied Substances Act, including:
- Registration of veterinary products before market entry
- Good distribution practices to maintain product integrity
- Labelling and advertising standards
- Adverse event reporting
- Marketing Authorisation procedures and timelines
- Post-Marketing Surveillance (PMS)
- Requirements for clinical trials
- Import and export permit requirements
- Navigation of the Integrated Regulatory Information Management System (IRIMS)
- Requirements for food supplements, feed additives, and premixes

The training also provided an important platform for stakeholder engagement, helping to build a robust and practical regulatory system while promoting compliance and creating a level playing field for all industry players.

At the end of the training, Doctor Daniel Ndambasiya thanked the stakeholders for their input and reiterated ZAMRA's commitment to combating non-compliance, protecting animal and public health, as well promoting food safety.

ZAMRA STAKEHOLDER ENGAGEMENT: STRENGTHENING MEDICINE ADVERTISING & PROPMOTION GUIDELINES

ZAMRA convened crucial Technical Working Group (TWG) and stakeholder meetings from 26th – 28th May 2026 to review and validate the Draft Guidelines on the Promotion, Marketing, and Advertisement of Medicines and Allied Substances.

Acting Director-General Lyoko Nyambe emphasized ZAMRA’s mandate to ensure that medicines and allied substances in Zambia are safe, effective, and of high quality and that their promotion and advertising are conducted responsibly and ethically.

The guidelines set clear standards for all forms of communication, including print, electronic media, social media, outdoor advertising, and promotional materials. They aim to prevent misleading or exaggerated claims that could jeopardize public health by encouraging inappropriate medicine use or undermining trust in the health system.

Key points highlighted include:
✔️ All advertising must be truthful, balanced, clear, and accurate.
✔️ Prior written authorization from ZAMRA is mandatory before
any medicine or allied substance is advertised or promoted.
✔️ Stakeholder input is vital to ensure the guidelines are practical,
clear, enforceable, and supportive of compliance.

ZAMRA sends its gratitude to all stakeholders who attended the meeting for their valuable contributions and remains committed to safeguarding public health by regulating medicine advertising and promotion effectively.

Together, we can ensure that the public and healthcare professionals receive reliable information that supports the rational use of medicines and allied substances.

📢 ATTENTION !! Local Responsible Persons, Applicants and
Marketing Authorisation Holders (MAHs)

Effective 1st June 2026, all requests for additional information (queries) related to applications for Grant of Marketing Authorisation (MA) for Allied Substances for human use will be processed exclusively through the ZAMRA Integrated Regulatory Information Management System (IRIMS) Online Portal.

🔹 No physical (hard copy) or email submissions will be accepted
after this date.
🔹 Applicants must regularly monitor their IRIMS accounts and
email notifications to ensure timely responses.
🔹 Failure to submit required information within the stipulated
timelines may result in application closure or rejection.

This move aims to:
✔️ Increase transparency by allowing real-time tracking of queries
and assessments
✔️ Improve efficiency by reducing turnaround
✔️ Ensure data integrity with a secure, centralized electronic
record system

For support or inquiries:📧 IRIMS technical support: [email protected]📧 Marketing Authorisation Department (Allied Substances): [email protected]📞 Tel: +260 211 432 350 / 351 / 352

Access formal Notice herehttps://www.zamra.co.zm/wp-content/uploads/2026/05/Notice.pdf

ZAMRA remains committed to ensuring quality, safety, and effectiveness of all Allied Substances on the Zambian market.
Stay informed. Stay compliant.

ZAMRA STRENGTHENS FIGHT AGAINST ILLEGAL, SUBSTANDARD,
AND FALSIFIED MEDICAL PRODUCTS

On 27th May 2026, ZAMRA held a successful quarterly meeting of the Single Point of Contact (SPOC) Network, a powerful alliance of government agencies, border authorities, and civil society dedicated to combating illegal, substandard, and falsified (SF) medical products in Zambia.

Since its formation in September 2025, the SPOC Network has moved from planning to action, reinforcing Zambia’s commitment to protecting public health and consumer rights.

ZAMRA Acting Director-General Mr. Nyambe Lyoko emphasized that the proliferation of these dangerous products is a global crisis that threatens not only health but also national security, linking pharmaceutical crime to terrorism.

The meeting saw official appointments within the Network and held deep discussions on joint investigations and enforcement progress made over the last quarter.

Together, with partners including the Zambia Police Service (Intellectual Property Unit); Competition and Consumer Protection Commission (CCPC); Zambia Revenue Authority (Customs);Zambia Airports Corporation Limited; Ministry of Health ; Ministry of Justice; Medicines Research and Access Platform (MedRAP); Drug Enforcement Commission (DEC);Department of Immigration; Ministry of Fisheries and Livestock; Zambia Medicines and Medical Supplies Agency (ZAMMSA); Zambia Pharmaceutical Business Forum, ZAMRA is dedicated to safeguarding the Zambian market and ensuring safe, quality medical products for all.

Building Preparedness, Protecting Lives: ZAMRA Staff Undergo Fire Fighting Training 🔥

The difference between a small, manageable fire incident and a catastrophic loss often comes down to whether the people on the ground are trained, prepared, and equipped to respond in those critical first moments.

With this in mind, from 19th to 22nd May 2026, the Zambia Medicines Regulatory Authority hosted a Fire Fighting Training facilitated by the Zambia National Fire Brigade for selected members of staff.

Speaking on behalf of ZAMRA Director-General Mr. Makomani Siyanga, Director of Laboratory Services, Bonaventure Chilinde emphasized the importance of preparedness in protecting both people and essential operations.

“We are here because the safety of our staff, our offices, laboratory, records, medicine samples, and ultimately the services we provide to safeguard public health, matters deeply.”

Mr. Chilinde noted that in any emergency, trained personnel become a critical asset, while lack of preparedness can allow small incidents to escalate into disasters.

He encouraged participants to approach the training with the seriousness it deserves and to carry the knowledge forward in their respective workspaces.

During the training, participants were equipped with practical knowledge and skills to:
✅ Identify common causes of fires in the workplace
✅ Recognise and properly use fire-fighting equipment, including fire extinguishers, hose reels, sand buckets, and water sources
✅ Understand safe escape and evacuation procedures
✅ Learn the correct methods of responding to different types of fires
✅ Develop the calm, disciplined mindset needed to prevent panic and respond effectively during emergencies

By investing in fire safety training, we continue strengthening our preparedness to protect lives, property, and the critical public health services entrusted to us.

📢 Attention Stakeholders!

The Zambia Medicines Regulatory Authority (ZAMRA) is pleased to announce the release of its Newsletter for the First Quarter of 2026. This edition highlights key activities, updates, and achievements that are shaping the future of medicine regulation in Zambia.

Stay informed and up to date with the latest from ZAMRA by reading the full Newsletter available now on our official website.

👉 Access the Newsletter here:https://www.zamra.co.zm/wp-content/uploads/2026/05/ZAMRA-Q1-2026-NEWSLETTER.pdf

We encourage all stakeholders to review this important publication and stay connected with ZAMRA’s ongoing efforts to ensure safe and effective medicines for all.