OUR SPECIALIZATION

The team of Stepanovski, Papakul and Partners. Legal services LLC has been working for many years on case of various cases of various complexity in the field of healthcare and pharmaceutics.

The sectoral practice includes both achievement of the practical objectives of our pharmaceutical sector clients and cooperation with coordinators and such associations of pharmaceutical manufacturers, as the AIPM, on enhancement of the sectoral legislation.  The team’s multi-year experience of such cooperation facilitates achievement of non-conventional objectives of the pharmaceutical business in Belarus.

SUPPORT OF PHARMACEUTICAL PRODUCT ENTRY INTO THE BELARUS PHARMACEUTICAL MARKET AND MARKETING ASSISTANCE

We help our Clients register medicines, localize medicine production in Belarus; we discuss issues of changing the holders of registration certificates by:

• advising on medicine production arrangement in the Republic of Belarus including partial production organization for acquiring the domestically-made medicine’ status;
• advising on medicine registration/re-registration including issues of changing registration certificate holders;
• reviewing the completeness of registration file documents, if the holder is denied official registration/re-registration of a medicine or another pharmaceutical product.

We assist our Clients with pharmaceutical product distribution and promotion by:

• providing support with filing applications for participation in public procurement procedures, challenging the procurement outcomes in the Client’s interests;
• conducting a due diligence of documentation on promotion of the activities of pharmaceutical companies’ representative offices in Belarus;
• drafting and adapting various internal policies for pharmaceutical companies in Belarus including anti-corruption, promotional and marketing activities, the rules of client reception, documentation, and healthcare workers’ professional codes of ethics;
• reviewing and adapting advertising materials concerning pharmaceutical products manufactured/imported by Clients.

We support our Clients in the event of infringements upon their rights and legitimate interests in the Republic of Belarus by:

• providing assistance with shaping the tactics and drafting documents necessary for ensuring safeguards against illegitimate actions of competing companies, such as generic producers;
• providing consultations in the event of administrative barriers for individual producers to accessing the Belarus pharmaceutical market;
• reviewing advertising materials and advertisement activities of competing companies in the Republic of Belarus.

HEAD OF DIRECTION