30/06/2019
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/); and the National Health Insurance House (http://www.cnas.ro/). 2. What is the regulatory framework for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices? The main enactment in the pharmaceutical and healthcare fields in Romania is Law no. 95/2006 on healthcare reform, as republished and further amended and supplemented (the “Health Law”), which regulates, amongst others: for medicinal products (including biologicals): the marketing authorization, manufacturing, import, distribution, labelling,…
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 USD 99. Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? According to…
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?…
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…
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…
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…
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…
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…
20/04/2021
15/04/2021
