Legal & Regulatory > Romania

The ins and outs of biosimilars and biologics in Romania. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 75. 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 in a different manner biosimilars and generics. As per the local…

The ins and outs of localization in Romanian pharma. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 75.   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…

All legal aspects surrounding the orphan drugs and rare diseases in Romania. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 75.   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…

All about cannabinoid drugs, medicinal cannabis and opioid drugs in Romania. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 99.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? According to the national catalogue of medicines in Romania published by NAMMD, currently there are no cannabinoid medicinal products authorized for marketing in the country. By law, certain psychotropic substances extracted…

The ins and outs of regulatory reforms in Romania. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 75.   1. Are there proposals for reform or significant change to the healthcare system? The Romanian authorities announced their intention to implement certain reform or significant change to changes in the pharmaceutical legislation, including in relation to: healthcare system? improving the legal framework for…

A brief overview of the situation regarding patents and trademarks in Romanian Pharma. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 75.   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…

Product liability in Romanian Pharma – a legal guide. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 75.   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…

The key facts about traditional medicines and OTC products in Romania. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 75.   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…

Marketing, manufacturing, packaging & labeling, advertising in Romanian Pharma – a comprehensive legal overview. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 75.   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,…

An intro to the legal situation for preclinical and clinical trial requirements in Romanian Pharma. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 75.   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…

The legal framework for regulatory, pricing and reimbursement in Romanian Pharma. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 75.   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/);…