Pharmacovigilance
What is Pharmacovigilance?
The term Pharmacovigilance encompasses all activities detection, assessment, understanding and prevention of undesirable adverse reactions or other problems related to the effect of drugs, risks arising from these conditions "real" use. Health care professionals, drug manufacturers and marketing authorization holders are together responsible and partners for the pharmacovigilance activity.
Adverse Reaction
Any unfavorable and unintended change in the structure (signs), function (symptoms) or chemistry (laboratory data) of the body temporally associated with any use of an medicinal product in humans whether or not considered related to the use of the product.
Serious Adverse Reaction
Adverse reaction that ends in death, as life-threatening, requires hospitalization or prolongation of hospitalization, causing disability or a persistent or significant disability, causes an anomaly / birth defect.
Adverse event
Any untoward occur in a patient or clinical trial, which was administered a drug which does not necessarily causally related to treatment
How do I report an adverse reaction?
1. For adverse reactions occurring in Romania
- Healthcare professionals (doctors, pharmacists, dentists, nurses and pharmacy) can report an adverse reaction using:
- "ADVERSE DRUG REACTION REPORTING FORM " (attached to the section "Forms": "Form FRAM" Farmex specific form, they can fax directly to the company
OR
- "ADVERSE DRUG REACTION REPORTING FORM " form of the National Agency for Medicines and Medical Devices (on site Farmex also attached to the "Forms", available on www.anm.ro)
!!! National Medicines Agency in collaboration with the College of Doctors in Romania, granted continuing medical education credits (EMC) for reporting physicians (10 CME credits for each reported adverse reaction). Each validated ANMDM adverse reaction is confirmed by a letter of thanks to the rapporteur doctor, accompanied by a form for reporting adverse reactions; Quarterly College in Romania is announced on the number of doctors in the ADRs reported for loans to be issued EMC.
- Patients may report an adverse reaction:
- Directly to the company by phone or email (contact us)
- Completing the "Data report adverse reactions to the patient" (attached to the section "Forms")
- In outside working hours, the telephone number is using an answering machine that provides all necessary information about the reporting of adverse reactions and where you can leave contact details of the caller to be contacted as soon as possible a Pharmacovigilance Department representative of SC Farmex Company SRL
2. For adverse reactions occurring in Moldova
- Healthcare professionals (doctors, pharmacists, dentists, nurses and pharmacy) can report an adverse reaction using:
- " ADVERSE DRUG REACTION REPORTING FORM " (attached to the section "Forms": "Form FRAM" Farmex specific form, they can fax directly to the company
OR
- "Communication form reporting physicians AR" form of the National Agency for Medicines and Medical Devices of Moldova (existing www.amed.md)
- Patients may report an adverse reaction:
- Directly to the company by phone or email (contact us)
- Completing the " ADVERSE DRUG REACTION REPORTING FORM " (attached to the section "Forms")
- " ADVERSE DRUG REACTION REPORTING FORM PRODUCTS " form of the National Agency for Medicines and Medical Devices of Moldova (existing www.amed.md)
Download Forms
Fisa pacientului pentru raportarea reactiilor adverse la medicamente ANM
Fisa pentru raportarea reactilor adverse la produsele medicamentoase ANM