Medical and Pharmaceutical Industry

We hold a wide experince in this domain, as a result of direct involvment of our attorneys in the daily business of companies acting in this field.

Services.

The services we provide for our clients include:

– Drafting legal opinions on the interpretation of the pharmaceutical legislation in Romania, in compliance with EU regulations and directives;

– Consultancy on Claw-Back tax issues.

– Legal support for setting up and authorization of pharmaceutical units (open circuit pharmacies, pharmaceutical stores, drugstores), drafting documentation and obtaining the necessary permits authorizing the operation;

–  Drafting and revising contracts specific to the pharmaceutical field;

– Legal assistance and representation in negotiation, conclusion and execution of contracts;

– Consultancy in the process of obtaining necessary permits for the operation of the company on the pharmaceuticals market;

– Legal support in licensing and marketing of new pharmaceuticals;

– Legal assistance regarding the development of policies on sales and various promotions in accordance with current legal provisions;

– Legal assistance and representation before the competent authorities in pharmaceuticals (Ministry of Health, the National Health Insurance House, etc.)

– Legal assistance and representation in proceedings concerning the recovery of debts from state & local health units (hospitals, etc.) before national courts of law and arbitration, in all trial stages.