Reporting ADR / AEFI

  • Please report ALL suspected Adverse Drug Reactions (ADRs) (including those for traditional products) and Adverse Events Following Immunisation (AEFIs) to the National Centre for Adverse Drug Reactions Monitoring.
  • Do not hesitate to report if some details are not known.
  • The identities of Reporter, Patient and Institution will remain confidential.
  • Kindly report ADR/AEFI through only ONE channel:
    • PhIS version 1.7 & above*, OR
    • online web form, OR
    • manual submission by mail/fax/email.

Repeated submission using multiple channels is NOT necessary.

*Note: If your facility is equipped with PhIS version 1.7 & above, your PhIS ADR report will be automatically pushed to NPRA. For any enquiries related to PhIS reporting, please contact PhIS Helpdesk.

IMPORTANT NOTES FOR ONLINE REPORTING:

  • Please use 'Google Chrome' as your web browser.
  • Mandatory fields (marked with *): Please fill in all mandatory fields in order to successfully submit the form.
  • Non-mandatory fields: Please give as much information as you can. If the relevant information is not known, kindly leave the field(s) blank.
  • Numeric fields: Please fill in whole numbers only (no decimal points) [Refer user guide for details]
  • Please read this user guide BEFORE proceeding to complete the online reporting form.

ADR/AEFI Web Form

To report an adverse event online, click Online Reporting as below.

Manual ADR/AEFI Reporting Form

To report an adverse event via ADR/AEFI Reporting form, click Download ADR/AEFI Reporting Form as below. You may:

a) Print the form and fill in manually, or
b) Fill in the form via Adobe Acrobat (recommended) and click "Save As" to save your completed form.

 
Please email your completed form to fv@npra.gov.my.

For AEFIs related to COVID-19 vaccines, kindly email your completed form directly to mycovid.aefi@npra.gov.my.

Guide for ADR Reporters

  • Definitions
  • Checklist for ADR Reporters
  • Submitting Samples for Laboratory Testing of Suspected Adulterated Products
  • VigiAccess: A Public Gateway to the WHO ADR Database
  • ADR Reports on AntiTB drugs

Adverse Drug Reaction (ADR) / Adverse Event Following Immunisation (AEFI) Reporting: Manual for Healthcare Providers

(First Edition, August 2021)

  • This guideline, which is intended for healthcare providers, outlines the requirements and procedures of reporting for ADR as well as reporting and investigation of AEFI.
  • This guideline has also included the new causality assessment for AEFI.

Malaysian Guidelines on Good Pharmacovigilance Pratices (GVP) for Product Registration Holders

(First Edition, August 2021)

  • This guideline, which is intended for PRHs, outlines the requirements and procedures of Good Pharmacovigilance Practices (GVP) activities including but not limited to the submission of ADR and adverse event following immunisation (AEFI) reports, and the submission of information regarding product safety to the DCA.
  • This guideline has also included one (1) new part (Part 6) related to Pharmacovigilance System Master File.
  • The chapter on “Submission of ADR Reports by Healthcare Professionals” has been taken out and issued as a separate guidance.

 

Cutaneous Adverse Drug Reaction (ADR) Classification

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti (Jalan Profesor Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

DISCLAIMER

The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

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  • Last Modified: Thursday 30 June 2022, 13:07:58.
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