After registration process is done, certain product categories (medicine, biologics, medical device or food supplement) require additional activities in order to be placed on Serbian market.

Especially having in mind complexity of regulatory requirements in Serbia in the area of pricing, reimbursement and approval of marketing material by national authority, having a reliable partner who can offer right advice at a right time is crucial.

Polifarm is there to provide support, depending on client wishes and regulatory requirements:

• Preparation and processing of documentation for pricing applications and also monitoring and maintenance
• Preparation and processing of documentation for reimbursement applications and also monitoring and maintenance
• Regulatory support for marketing, educational and patient support material
• Validation and submission of relevant material to national authorities and timely follow-up
• Advertising regulatory support
• Administrative support at all levels

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.

Area of market access is vast and complex one, and is dictated not only by client needs but also by Serbian regulatory requirements.

Feel free to contact us for more details.