Tagged with Legal Handbook

Pharma Legal Handbook 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 119.   1. Are there any rules or regulations requiring and/or encouraging localization in…

Pharma Legal Handbook 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 119.   1. What is the definition of Rare Diseases in…

Pharma Legal Handbook 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 119.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? According…

Pharma Legal Handbook 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 119.   1. What are the basic requirements to obtain…

Pharma Legal Handbook 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 119.   1. Are there proposals for reform or significant change to the healthcare system?…

Pharma Legal Handbook 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 119.   1. What types of liability are recognized in your jurisdiction? The failure to…

Pharma Legal Handbook 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 119.   1. What are the regulatory requirements for traditional, herbal, complementary, or…

Pharma Legal Handbook 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 119.   1. What is the authorization process for the…

Pharma Legal Handbook 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 119.   1. Are clinical trials required to be…

Pharma Legal Handbook 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 119.   1. What are the regulatory authorities with jurisdiction over…

Pharma Legal Handbook The ins and outs of biosimilars & biologics in Peru. Prepared in association with Osterling Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Peru, available to purchase here for GBP 119.   1. Are biosimilar medicines considered the same as generic medicines in…

Pharma Legal Handbook Key legal info on orphan drugs & rare diseases in Peru. Prepared in association with Osterling Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Peru, available to purchase here for GBP 119.   1. What is the definition of Rare Diseases in your…