As the regulatory affairs field is expanding in Romania, our clients’ need for assistance and counseling in the area is growing. Our team has developed a well-established practice in the domain and currently offers services which include assessment of regulatory compliance, communications and negotiations with state authorities, and requesting, advocating, determining or sometimes challenging in court specific decisions issued by the public authorities.
Our lawyers have good expertise in dealing with regulatory affairs. We have developed effective procedures for requesting, advocating, determining or sometimes challenging in court specific decisions of the competent public authorities affecting the economic interests of our clients.
⦁ Assisting two of the most important international medicines producers in relation to regulatory matters related to the pharma sector (drafting and registration of Freedom of Information Requests to the National Agency for Medicines and Medical Devices and the Ministry of Health, drafting and/or registration of notices and memorandums to the National Agency for Medicines and Medical Devices, the Ministry of Health and the National Health Insurance House regarding medicine pricing, potential regulatory consequences of patent infringement etc.);
⦁ Assisting two of the most important international medicines producers in relation to regulatory matters related to the pharma sector (drafting and registration of Freedom of Information Requests to the National Agency for Medicines and Medical Devices and the Ministry of Health, drafting and/or registration of notices and memorandums to the National Agency for Medicines and Medical Devices, the Ministry of Health and the National Health Insurance House regarding medicine pricing, potential regulatory consequences of patent infringement etc.);
⦁ Advising an important medicines manufacturer in respect of the compliance of its clinical studies activities with the applicable regulations;
⦁ Assisting and representing an important medicines producer in relation to regulatory and tax matters specific to pharmaceutical law, particularly matters related to the claw-back tax, including challenging decisions of the competent state entities;
⦁ Assisting a major soft beverages producer in respect of several regulatory matters: preparing and implementing an internal marketing regulation in compliance with consumer protection regulations, contractual negotiations with state entities, compliance with environmental regulations;