- negotiating, drafting or, as the case may be, reviewing industry-specific contracts;
- legal assistance with respect to the regulatory aspects of medicines authorisation;
- advising clients on pricing aspects, including reimbursement;
- legal assistance with the regulatory aspects of the advertising of medicines;
- advising and representing clients on issues related to the clawback tax;
- managing the relationship with the National Agency for Medicines and Medical Devices of Romania, the Ministry of Health and the National Health Insurance House.
Examples of projects in which I was involved:
- reviewing and amending an agency agreement for one of the world's largest pharmaceutical manufacturers;
- reviewing and amending a sub-distribution agreement with a foreign distributor;
- drafting a legal analysis on parallel importation of medicines and on the exhaustion of trademark rights;
- drafting a legal analysis on the withdrawal and on the granting of a marketing authorisation for one of the world's largest pharmaceutical manufacturers;
- assisting a client in the pharmaceutical industry in the process of cancelling tax rulings (clawback tax);
- drafting a legal analysis on the donation of medicines for one of the world's largest pharmaceutical manufacturers;
- drafting a legal analysis on the registration with the tax authorities and on the payment of the cost-volume tax;
- drafting sponsorship contracts with medical staff;
- drafting a legal analysis on fees charged by the National Agency for Medicines and Medical Devices of Romania for an association of drug manufacturers.