Pharmacovigilance Services β Safety and Continuous Monitoring
We monitor the safety of pharmaceutical products to ensure compliance with legislative requirements and respond promptly to any adverse reactions.
Adverse Reaction Reporting for Consumers
The World Health Organization (WHO) defines pharmacovigilance as the science and activities related to the detection, assessment, and prevention of adverse reactions or any other safety issues related to medicines.
- Details about the person who had the adverse reaction (ADR) (name and surname, age, gender, weight).
- Description of the adverse reaction (when it occurred, how long it was administrated, what symptoms were manifested, measures taken to reduce the adverse reaction).
- Details of the product that caused the ADR (name and surname, dose, series, pharmaceutical form, active substance, dosage, manufacturer, indications for use).
- Details of the reporter (name, surname, contact details).
Report an adverse reaction
Prompt reporting helps us maintain a high level of safety for all patients.
Please note that all information will be used confidentially (in accordance with Law No. 133 of 08-07-2011 on Personal Data Protection) and exclusively for Pharmacovigilance purposes.
Once the information is processed, our specialists will contact you.
Other reporting methods:
π© Send the report to: farmacovigilenta@dita.md
π Report by phone (24/7): +373 22 527 474
Partnership for Safety β Professional Pharmacovigilance Services
Dita Estfarm is a pharmacovigilance (PV) service provider in the territory of the Republic of Moldova and offers a full range of pharmacovigilance services (monitoring of efficacy and safety), carrying out activities related to the detection, assessment and prevention of adverse reactions or any other safety issues concerning medicinal products, having the necessary technical equipment and qualified personnel to qualitatively perform these activities.
24/7 Adverse Reaction Reporting Line
Dita Estfarm provides a dedicated 24/7 hotline for reporting adverse reactions related to medicines, dietary supplements, cosmetics, and medical devices.
π Phone (24/7): +373 22 52 74 74
π© Email: farmacovigilenta@dita.md
We ensure that all reports are handled promptly, contributing to the safety and effectiveness of the products used.
- Collecting, translating (if necessary), and reporting all adverse events (AE) and/or adverse reactions (AR), as well as special cases related to medication use, recorded in Moldova, and taking any necessary follow-up actions.
- Assisting in communication with the Regulatory Authority (receiving requests, letters, notifications, translating if necessary, and forwarding them to the Partner).
- Ensuring 24/7 availability of the Pharmacovigilance system.
- Submitting consolidated reports (Periodic Safety Update Reports, Risk Management Plans, etc.) to the Regulatory Authority and ensuring confirmation of submission.
- Submitting CIOMS reports to the Regulatory Authority and ensuring confirmation of delivery.
- Providing information on local pharmacovigilance legislation and updates to regulatory requirements.
- Assisting and supporting the reconciliation process between the Partner and the Regulatory Authority.
- Consulting Services.
- Submitting educational materials and DHPC (Direct Healthcare Professional Communications) for approval to the Regulatory Authority.
- Monitoring of the local literature and web pages in order to identify information related to the Partner’s products safety.
- Support in carrying out the inspection from the RA.
- Analyzing and validating of the identified safety signal.
- Continuous improvement of PV personnel qualifications.