Tagged with Croatia

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 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 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…

Pharma Legal Handbook All about traditional medicines and OTC products 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 requirements for traditional, herbal, complementary, or alternative…

Pharma Legal Handbook Key legal info on product liability 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 types of liability are recognized in your jurisdiction? Types of liability…

Pharma Legal Handbook Patents and trademarks in Croatia – a comprehensive legal 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. What are the basic requirements to obtain patent and trademark…

Pharma Legal Handbook An insight into upcoming regulatory reforms affecting Croatia pharma. 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 there proposals for reform or significant change to the healthcare…

Pharma Legal Handbook All legal aspects surrounding cannabinoid drugs, medical cannabis and opioids 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.   Cannabinoid Drugs   1. Are Cannabinoid Drugs authorized in…

Pharma Legal Handbook Orphan drugs & rare diseases in Croatia – a legal guide. 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 definition of Rare Diseases in your…

Pharma Legal Handbook Want to know more about localization in Croatia? Read on! 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 GBP 119.   1. Are there any rules or regulations requiring and/or encouraging localization…

Pharma Legal Handbook Key legal info on biosimilars & biologics 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. Are biosimilar medicines considered the same as generic medicines in your…

Pharma Legal Handbook Key legal info on litigation 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.Who has the burden of proof in litigation for drug side effects? The burden…