What’s happening with PV regulations in Zambia?

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Industry PV teams have been trying to understand a recent circular from the Zambia Medicines Regulatory Authority (ZAMRA). The notice requires foreign-based MAHs to appoint a Local Responsible Person (LRP) resident in Zambia, who will be responsible—among other things—for implementing the pharmacovigilance (PV) plan on behalf of the MAH.

I received several questions about this circular, so I contacted ZAMRA directly to seek clarification.

Q: What is the notice actually about?

A: It relates to the regulation of marketing authorisation in Zambia.

Q: Is the Local Responsible Person equivalent to an LQPPV?

A: No. ZAMRA is developing PV guidelines that will define the minimum qualifications of an LQPPV for safety monitoring.

Q: Is the LQPPV required to be resident in Zambia?

A: No, not at the moment.

My advice to MAHs’ PV teams

• Engage your Regulatory Affairs (RA) team to understand the PV plan and any other PV-related information submitted during marketing authorisation renewal in Zambia. You’re not alone if PV teams are not always kept in the loop.
• The draft PV guidelines are expected to require LQPPVs to be resident in Zambia. Start onboarding an LQPPV based in Zambia now so you are ready once the guidelines become effective. ZAMRA has indicated that LQPPVs resident in SADC or other African countries will not be acceptable.

My two cents to ZAMRA

The PV responsibilities of the LRP will overlap with those of the LQPPV. I encourage ZAMRA to consider consolidating responsibility for implementing the PV plan under the LQPPV.

Resources

• Notice requiring foreign-based MAHs to appoint an LRP by 31 December 2025: https://lnkd.in/dYDhCzU7
• ZAMRA draft PV guidelines for MAHs: https://lnkd.in/dQx9V7kX
• Application for Renewal of Marketing Authorisation of Medicines Registered Before 2015 (see Section 3, Clause 1.7 [VIII]): https://lnkd.in/d3aTQE9t
• The Medicines and Allied Substances (Marketing Authorisation of Medicines) Regulations, 2019 (see Section 17, Clause 2): https://lnkd.in/dfDWinyc

Do you have other questions about PV regulations in Zambia? Shoot.

Written by

Odokonyero Kennedy

Pharmacist, Global Shaper at Kampala Hub and student of Msc. Pharmaceuticals and Health Supplies Management at Makerere University. [email protected]

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