Adverse Drug Reaction

In Malta, both patients and consumers as well as healthcare professionals (HCPs) can report side effects that are experienced while taking a medicine.

 

For HCPs; The Adverse Drug Reactions (ADR) reporting form (for use by Healthcare Professionals) is avialable 

Ways HCPs can report: HCPs may fill in the ADR form electronically using MS Word and send via email to postlicensing.medicinesauthority@gov.mt

OR

HCPs may fill in the ADR form in ink, scan and then send via email to postlicensing.medicinesauthority@gov.mt

OR

HCPs can send the ADRs to the Marketing Authorisation Holder on the address that can be found on the medicine's package(in such cases do not send the same report to the Medicines Authority to avoid creation of dublicate reports).

 

For Patient and consumers; Patients and consumers should use the online side effect report form which is sent directly to the Medicines Authority

 

For HCPs. Note published on 23/03/2020 RE COVID-19 and Free Post Paper Based Forms

In view of the current novel coronavirus pandemic, the Medicines Authority has implemented measures to mitigate the spread of coronavirus disease (COVID-19) in Malta. To this effect employees have been advised to work from home. Hence to ensure that Adverse Drug Reaction (ADR) reports are processed in a timely way, Healthcare Professionals (HCPs) are being advised to submit all ADR reports electronically to the Medicines Authority via postlicensing.medicinesauthority@gov.mt and the paper based self-addressed postal forms should not be used during this time.

 

Additional Information 

Background information for Patient on what Side effects are is available  here

HCPs may refer to the Adverse Drug Reaction Reporting & Pharmacovigilance Guidance Notes for Healthcare Professionals for further background and instruction on how to report ADRs. The ADR form for HCPs also contains an instruct sheet overleaf