Tagged with EG

Pharma Legal Handbook 1. What types of liability are recognized in your jurisdiction? The failure to comply with the Romanian pharma legislation can trigger disciplinary, civil, material, contraventional or criminal liability, depending on the case. Additionally, the competent authorities in various fields can apply fines and other sanctions when the breach is related…

Pharma Legal Handbook 1. What are the basic requirements to obtain patent and trademark protection? As a rule, a patent or a trademark protection can only be obtained by registration with the State Office for Inventions and Trademarks (“OSIM”), based on the specific provisions stipulated by Law no. 84/1998 on trademarks and geographical…

Pharma Legal Handbook 1. Are there proposals for reform or significant change to the healthcare system? The Romanian authorities announced their intention to implement certain changes in the pharmaceutical legislation, including in relation to: the new advertising norms for medical devices, which will bring significant changes in connection with the marketing and advertising…

Pharma Legal Handbook Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? According to the national catalogue of medicines in Romania published by NAMMD, currently there is one medicinal product authorized for marketing in the country having as active substance cannabidiolum. By law, certain narcotic or psychotropic substances extracted from cannabis, such…

Pharma Legal Handbook 1. What is the definition of Rare Diseases in your country? Regulation (EC) no. 141/2000 on orphan medicinal products (“Regulation no. 141/2000”), which is directly applicable in Romania, specifies that a medicinal product could be designated by the European Medicines Agency as an orphan medicine when: (i) it is intended…

Pharma Legal Handbook 1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies? Romania has a favourable tax regime for companies, which encourages many businesses to set up and to operate subsidiaries in Romania. However, there are no…

Pharma Legal Handbook 1. Are biosimilar medicines considered the same as generic medicines in your country? The biosimilar medicinal products are not considered the same as generic medicinal products, since the Romanian legislation regulates biosimilars and generics in a different manner. As per the local legislation, a biosimilar is a biologic medicinal product…

Puerto Rico In a rapidly evolving global landscape, medtech manufacturer Copan Industries (part of Copan Group) has strategically chosen Puerto Rico as a key hub for its expansion in the Americas, attracted by the island’s skilled workforce and strong institutional support. As COO Efraín Rodriguez explains, with over $100 million invested, the…

Saudi Arabia Mohamed Fawzy, Country President for Pfizer Saudi Arabia, discusses the company’s evolving role in supporting the Kingdom’s rapidly transforming healthcare sector. He shares insights on Pfizer’s local footprint, its contributions to public health through innovative vaccines and oncology treatments, and the company’s commitment to talent development and localization. Fawzy also…

Puerto Rico Basil Khalil, with an impressive 28-year career at FedEx, discusses the significant investments the company has been making to its infrastructure and the implementation of innovative solutions in Puerto Rico to meet the needs and complex logistics of the pharmaceutical industry. Khalil also addresses the evolving demands of the pharmaceutical…

Puerto Rico José F. Oramas, Caribbean GEO Country Manager for UPS, highlights the company’s strategic role in Puerto Rico and the Caribbean, particularly within the life sciences and logistics sectors. With nearly four decades of experience at UPS, Oramas shares his perspectives on navigating challenges, leveraging Puerto Rico’s unique geographic and economic…

Europe European pharma is at a turning point, with rising cost pressures, regulatory shifts, and supply chain vulnerabilities reshaping the industry. As the new president of Medicines for Europe, STADA’s Stephan Eder is now at the forefront of driving the change that Europe needs. In this new role as head of…