Reporting

Pharmacovigilance

Through this service, healthcare professionals can report any suspected Adverse Reaction (AR), Medication Error (ME) and Adverse Event Following Immunization (AEFI) experienced from any of the drug product within the stipulated timeframe as defined in DoH policies, even if reporters are not certain that the particular medicinal product was the cause. Unintended adverse effects, drug abuse, overdose, interaction (including drug-drug and drug-food interactions) and unusual lack of therapeutic efficacy are all considered to be reportable suspected Adverse Reactions (AR).

Furthermore, The pharmacovigilance program also receives medical device (MD) reports of adverse effects, harms, and all problems that result from the use of medical devices, including issues related to manufacturing quality, from healthcare professionals, manufacturers, distributors, suppliers, or the person in charge of placing the device in market .

In addition through this service you can report any drug or medicinal product that is suspected to have a quality problem; Suspect counterfeits, Product contamination, Poor packaging, Product mix-up, Labeling concerns, Therapeutic failures.

Process description

Option 1: (Online Reporting)

• Click here to access the e-Notification system
• Log in using your facility account information
• Select notification then Pharmacovigilance then select type of report
• Fill out all the required information
• Click ‘’Submit “

Option 2: (Email)

1. Click one of the below PDF forms

• Defective Medicinal Products and Dietary Supplements Reporting Form
• Medical Device Reporting Form for Healthcare Professional/Providers
• Medical Device Reporting Form for Manufacturers, marketing authorization holder, importers, authorized agents/ representatives, distributors, suppliers and registrants or any other person who is responsible for placing the device on the market.
• Adverse Reaction Reporting (AR) Form (in case any technical difficulty in using option1)
• Medication Error (ME) Reporting Form (in case any technical difficulty in using option1)

Note: in order to fill the forms, you need version 7 or newer versions from Adobe Reader, click here to install the latest.

2. Fill out all the required information
3. Send a copy of the completed form to the following email address PVE@doh.gov.ae .