Tagged with legal

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil.  1. Please describe the main cost containment policies in place in your country and their fundamental principles a. Pricing and impact of generic/biosimilar approval Generic drugs must have their PF 35% cheaper than the corresponding…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil.  1. Has an essential or priority drug list been published in your country? (If so provide the link)   Yes. In Brazil, the National List of Essential Drugs (“RENAME”) provides the selection and standardisation of…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil.  1. What is the definition of an orphan drug in your country? There is no specific definition for orphan drug in Brazilian current rules. However, we understand that it corresponds with the definition of rare…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil.  1. What is the definition of a vaccine in your country? As per ANVISA Resolution RDC 55/2010, vaccines are immunobiological drugs which contain one or more substances (antigens) that, when injected into an individual, stimulate…

India Drawing on a unique background in both medicine and law, Dr Milind Antani today leads the pharma and healthcare practice at Nishith Desai Associates, covering everything from regulatory work to corporate transactions, intellectual property matters, and dispute resolution. Dr Antani highlights the dynamic M&A landscape in Indian healthcare and pharmaceuticals…

Pharma Legal Handbook An intro to the legal situation for regulatory, pricing and reimbursement of drugs in Croatia. Prepared in association with Danijel Pribanić, a leading global law firm, this is an extract from The Pharma Legal Handbook: Croatia, available to purchase here for GB 119.   1. What are the regulatory authorities…

Pharma Legal Handbook An insight into regulatory, pricing and reimbursement overview in Czech Republic. Prepared in association with PRK Partners, a leading law firm in Czech Republic, this is an extract from The Pharma Legal Handbook: Czech Republic, available to purchase here for GBP 119.   1. What are the regulatory authorities with…

Pharma Legal Handbook An intro to the legal situation for regulatory, pricing and reimbursement in Slovakian Pharma. Prepared in association with PRK Partners, a leading global law firm, this is an extract from The Pharma Legal Handbook: Slovakia, available to purchase here for GBP 75.   1. What are the regulatory authorities with jurisdiction over…

Pharma Legal Handbook Preclinical & clinical trial requirements in Czech Republic – an overview. Prepared in association with PRK Partners, a leading law firm in Czech Republic, this is an extract from The Pharma Legal Handbook: Czech Republic, available to purchase here for GBP 119.   1. Are clinical trials required to be…

Pharma Legal Handbook Preclinical and Clinical Trial Requirements in Croatia – an overview. Prepared in association with Danijel Pribanić, a leading global law firm, this is an extract from The Pharma Legal Handbook: Croatia, available to purchase here for GB 119.   1. Are clinical trials required to be conducted locally as a…

Pharma Legal Handbook Key legal info on marketing, manufacturing, packaging & labeling, advertising in Czech Republic. Prepared in association with PRK Partners, a leading law firm in Czech Republic, this is an extract from The Pharma Legal Handbook: Czech Republic, available to purchase here for GBP 119.   1. What is the authorization process…

Pharma Legal Handbook An insight into marketing, manufacturing, packaging & labeling, and advertising in Croatia. Prepared in association with Danijel Pribanić, a leading global law firm, this is an extract from The Pharma Legal Handbook: Croatia, available to purchase here for GB 119.   1. What is the authorization process for the marketing…