Prior placement of a product: medical device, medicine, or food supplement on Serbian market, authorization must be obtained.

Each aspect regarding pharmaceuticals in Serbia is heavily regulated and in general, in compliance with EU regulations.
There are different regulatory bodies involved and there is also certain level of bureaucracy and preparation of local documents according to local regulatory requirements.
Polifarm, as your local regulatory partner has access to important regulatory bodies and necessary institutions.

Polifarm provides full support:
  • Prior submission - preparing and organizing documentation according local regulatory requirements
  • During submission - full support in case of additional requests by authorities
  • Post MA approval- packaging and labeling approval, variations, renewals, notification
  • Monitoring of local regulations and providing updates
  • Ensure of compliance with Serbian regulatory requirements
We meet the client needs in the following product areas:
  • Pharmaceuticals / medicinal products (well established use (WEU), generics, hybrid, biosimilar…)
  • Medical devices
  • Dietary supplements

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

Fully respecting uniqueness of each client, we can customize and modify service packages.

Feel free to contact us for more information.

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