Pharmacovigilance

Pharmacovigilance in Lithuania, Latvia, and Estonia

UAB Eletis Medica provides professional pharmacovigilance services across the Baltic States – Lithuania, Latvia, and Estonia. Our goal is to ensure that every registered medicinal product is continuously monitored, and its safety data is properly documented and submitted to the relevant authorities. We have extensive experience in drug safety management and maintain close cooperation with health authorities and pharmaceutical companies throughout Europe. Our team consists of qualified experts authorized to act as pharmacovigilance (QPPV) specialists. We operate in full compliance with the regulations and guidelines set forth by the European Medicines Agency (EMA), ensuring complete conformity and data accuracy.

Our services include:

• Appointment of a Qualified Person Responsible for Pharmacovigilance (QPPV) for activities within the European Union.
• Registration in the EudraVigilance system.
• Preparation and submission of safety reports through the EudraVigilance system.
• Management of post-registration data within the EudraVigilance xEVMPD module.
• Conducting and analyzing periodic literature reviews.
• Preparation of Periodic Aggregate Safety Protocols (PASP).
• Preparation and updating of Risk Management Plans (RMP).
• Development, maintenance, and auditing of pharmacovigilance systems.
• Pharmacovigilance training for pharmaceutical professionals.

All our services are performed in accordance with the highest professional and legal standards, following the requirements of the European Medicines Agency (EMA) and the State Medicines Control Agency (SMCA). Our aim is to ensure transparent, safe, and high-quality drug safety supervision.

Reporting an adverse reaction

If you wish to report an adverse drug reaction, you can do so via the following channels:

Email: pv@eletis.lt

Tel. +370 37 370054

Fax: +370 37 370067