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Home / Adverse Drug Reaction

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 available here

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 it is advised not to send the same report to the Medicines Authority to avoid creation of duplicate reports).

 

For Patient and consumers; 

For Patients:

Patient may choose to report a side effect themselves or may ask a trusted HCP to report on their behalf.

Patients can use the below forms to report directly to the Medicines Authority

Patient / Consumer Side Effect Reporting form - Word Version 

Patient / Consumer Side Effect Reporting form - PDF Version 

The form can by sent free post [no stamp required] to the Medicines Authority. Fold, staple and post this form.

Alternatively, the form can be submitted electronically to Post Licensing at Medicines Authority: postlicensing.medicinesauthority@gov.mt, after filling in the form using ink and scanning or filled in MS Word.

In case of difficulty write to postlicensing.medicinesauthority@gov.mt

 

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