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.
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.