The person affected
Initials, age or age group, sex and relevant medical history, where known.
Patient safety · Pharmacovigilance
Report a suspected adverse reaction
Patients, caregivers, healthcare professionals and other reporters are encouraged to submit any suspected adverse reaction involving a medicinal product distributed by Mermisi in Georgia. You do not need to prove that the product caused the event.
Before reporting
A reasonable suspicion is sufficient
Please report the event even if the relationship with the medicinal product is not confirmed, some information is unavailable, or the reaction is already described in the product information.
If you are uncertain whether information should be reported, please submit it. Mermisi's Pharmacovigilance function will assess the information received.
Useful information
Include what is available to you
An incomplete report can still be valuable. Please do not delay reporting while trying to obtain every detail.
The medicinal product
Product name, strength, dose, treatment dates, batch number and reason for use.
The suspected reaction
What occurred, when it began, treatment required and the current status or outcome.
The reporter
Your name, contact details, reporter type and relationship to the person affected.
Other safety information
Other situations may also be reported
- Medication errors
- Accidental or intentional overdose
- Misuse or abuse
- Occupational exposure
- Exposure during pregnancy or breastfeeding
- Suspected lack of therapeutic effect
- Product-quality concerns associated with a possible safety risk
After submission
What happens after a report is received?
Receipt and review
The report is recorded and reviewed by the responsible Pharmacovigilance function.
Follow-up where required
Mermisi may contact the reporter to request relevant additional information.
Safety reporting
Information may be transmitted to the responsible manufacturer, marketing authorization holder or competent authority in accordance with applicable requirements.
Submission of a report does not mean that the medicinal product has been confirmed as the cause of the reported event.
Confidentiality
Personal and health information
Suspected adverse-reaction reports may contain personal and health-related information. Mermisi processes such information for pharmacovigilance, medicine-safety and applicable regulatory purposes.
Relevant information may be shared, where required, with the responsible manufacturer, marketing authorization holder, pharmacovigilance service provider or competent authority. Personal identifiers should not be disclosed more broadly than necessary for these purposes.
Do not send complete medical records, identity documents or other unnecessary personal information by ordinary email. If supporting documentation is required, Mermisi will advise you on an appropriate method of submission.
.png)