Fully established pharmacovigilance system is required for all subjects involved in medicines in Serbia. Field of pharmacovigilace in Serbia is in most part harmonized with pharmacovigilance requirements in EU, however Serbian local rules and regulations apply. This is the most evolving field in terms of medicinal products.

All marketing authorization holders (MAHs) in Serbia must appoint a local qualified person for pharmacovigilance (local QPPV), and this is why local PV expertise plays a crucial part.

Polifarm provides full PV support:

• Establishing and maintenance of local pharmacovigilance system
• Full time (24/7) pharmacovigilance service, local QPPV
• In-time case reporting
• Local medical literature screening
• Medical Information Requests
• Direct Healthcare Professional Communication (DHCP)
• Aggregate Safety Reports (PSUR/PBRER, Periodic Safety Evaluations, Annual Safety Reports)
• Update to local safety information
• Acts as a liaison between manufacturer/local MAH/national regulatory body
• Providing local Pharmacovigilance System Master File (PSMF) necessary for MA obtaining and post approval processes

Upon request, Polifarm also provides high quality expert translations from English to Serbian and vice versa.

Besides services and activities listed above, Polifarm also offers customized pharmacovigilance agreements in compliance with local regulatory requirements.

Scope and the amount of PV support by Polifarm is especially tailored to meet every client need.

Feel free to contact us for more details.