Tagged with Romania

Pharma Legal Handbook 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The regulatory authorities competent in these fields are: the Ministry of Health (http://www.ms.ro/); the National Agency for Medicines and Medical Devices (https://www.anm.ro/); and the National Health Insurance House (http://www.cnas.ro/).   2. What is…

Pharma Legal Handbook 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? The Romanian law does not expressly provide such limitation as to the performing of clinical trials solely in Romania in view of obtaining the marketing authorization for a certain medicinal product.  …

Pharma Legal Handbook 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over the-counter medications, and other medicinal products? In order to be placed on the Romanian market, a medicinal product needs a marketing authorization, which can be issued by NAMMD at local level (under the national…

Pharma Legal Handbook 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? The Health Law transposed into the national legislation the provisions of Directive 2001/83/EC on the Community code relating to medicinal products for human use, and provides specific rules for the traditional herbal medicinal products and…

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…

CEE A roundup of some of the top news coming out of the Central and Eastern European (CEE) region’s pharma industry, including Poland’s first draft of a national critical medicines list; Polpharma’s acquistion of the dermatological firm Ziołolek; Sopharma’s sale of its logistics unit, Farmalogistika; Horus Pharma’s significant stake in Romania’s…