PV Bulletin

Reporting Side Effects to Medicines (ConSERF) or Vaccines (AEFI)

The NPRA in Malaysia has established detailed procedures for the public to report suspected side effects from medicines and vaccines.

Primary source: Cancellation of Notified Cosmetic Products

PV Impact Brief

Urgency: HighConfidence: high

What changed

New reporting requirements have been established for consumers to report suspected side effects of medicines and vaccines through the ConSERF form.

Why it matters

This initiative enhances drug safety monitoring by increasing consumer engagement and compliance with safety reporting protocols.

Action needed

Implement operational changes to assess and process consumer reports on side effects, ensuring additional resources are allocated for evaluations.

Relevant for
Medical Safety Lead
Processes impacted
Signal ManagementCountry Compliance
Owner

Regulatory Intelligence Lead

Review cadence

Review in the next regulatory intelligence cycle.

Regulatory action details

Action type
reporting_requirement
Publication date
2026-08-16T06:36:19.000Z

PV internal implications

Implement operational changes to assess and process consumer reports on side effects, ensuring additional resources are allocated for evaluations.

View regulator source

Source document details

Exact policy details

Consumer Reporting of Side Effects
Reports can be made directly to the NPRA through the ConSERF form.
Applies to: Applicable to all consumers experiencing side effects from registered medicines and vaccines.
If you, or someone you care for, experience any side effects to medicines or vaccines, please report to the NPRA. · p. 1 · High · Source
Definition of Side Effect
A side effect is defined as any unintended effect of a medicine which occurs at the normal dose used.
Applies to: Applicable when reporting any suspected adverse effect from a medicine or vaccine.
A side effect is defined as any unintended effect of a medicine which occurs at the normal dose used. · p. 1 · High · Source
Reporting Channels
Individuals can report online or through a printed form.
Applies to: Applicable for consumers who wish to report side effects.
You may report directly to the NPRA using the ConSERF form above. This form is used to report a suspected side effect. · p. 1 · High · Source

Workflow rule impacts

Country ComplianceNPRA

This may necessitate additional resources for evaluating and processing consumer reports.

Increased consumer engagement in reporting side effects.

Your reports help improve the safe use of medicines in Malaysia. · p. 1 · High · Source

Extracted documents

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Evidence and confidence

Confidence: highSource updated: Aug 16, 2026

Full briefing

Practical implication

Implement operational changes to assess and process consumer reports on side effects, ensuring additional resources are allocated for evaluations.

The National Pharmaceutical Regulatory Agency (NPRA) of Malaysia has introduced a consumer side effect reporting mechanism called ConSERF. This allows consumers to report suspected adverse drug reactions (ADRs) or adverse events following immunization (AEFI) either online or via a printed form. Detailed instructions and a dedicated reporting form are available on their website.

What changed: New reporting requirements have been established for consumers to report suspected side effects of medicines and vaccines through the ConSERF form.

Why it matters: This initiative enhances drug safety monitoring by increasing consumer engagement and compliance with safety reporting protocols.

Practical implication: Implement operational changes to assess and process consumer reports on side effects, ensuring additional resources are allocated for evaluations.

View original source

  • Source: NPRA (Malaysia) - Press Releases
  • Published at source: 2026-08-16T06:36:19.000Z
  • Discovered by monitor: 2026-08-16T06:37:45.155Z

Published from the regulator source ingestion pipeline after PV impact triage.

#Safety Signals#Reporting Requirement#Malaysia#Npra.gov.my#Source-ingestion#Regulator-monitor

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