Health Professionals

ADR Reporting

Report suspected adverse drug reactions and adverse events following immunisation to the National Centre for Adverse Drug Reactions Monitoring.

What to report

Announcement: report ADRs and AEFIs through the online Google Form
  • Report all suspected Adverse Drug Reactions (ADRs), including those for traditional products, and Adverse Events Following Immunisation (AEFIs).
  • Do not hesitate to report if some details are not known.
  • The identities of the reporter, the patient and the institution remain confidential.
  • Report through one channel only - repeated submission through several channels is not necessary.

If your facility runs PhIS version 1.7 or above, your PhIS ADR report is pushed to NPRA automatically. For enquiries about PhIS reporting, contact the PhIS Helpdesk.

Choose one channel

How to report

PhIS 1.7 or above

If your facility runs PhIS 1.7 or above, your ADR report reaches NPRA automatically. Nothing further is needed.

Contact the PhIS Helpdesk

Online form

The ADR/AEFI reporting form, hosted on Google Forms. Read the notes below before you start.

Open the online form

By email

Fill in the PDF form and email it to fv@npra.gov.my. For AEFIs following COVID-19 vaccination, email mycovid.aefi@npra.gov.my instead.

Email your completed form

Forms and guidance

Download

Before you use the online form

  • Use Google Chrome.
  • Mandatory fields are marked with an asterisk and must all be completed for the form to submit.
  • Other fields: give as much information as you can, and leave a field blank if you do not know it.
  • Numeric fields: whole numbers only, no decimal points.
  • Read the User Guide for Online Reporting above before you start.

The Guide for ADR Reporters covers definitions, a reporter's checklist, submitting samples for laboratory testing of suspected adulterated products, VigiAccess (the public gateway to the WHO ADR database) and ADR reports on anti-TB drugs.

For product registration holders

Good Pharmacovigilance Practices.

Everything above is written for healthcare professionals. Product registration holders report under the GVP guidelines, which set out the requirements for ADR and AEFI submission, product safety information and the Pharmacovigilance System Master File.