Legal & Regulatory > Croatia

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 of proof is on the plaintiff, there is no automatism. The parties are obliged to state all the facts on which their claims are based in the lawsuit and the…

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 condition (stated or implicit) for marketing approval? Clinical trials are not required to be conducted locally as a condition for marketing approval.   2. How are clinical trials funded? Clinical…

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 country? Simply put, an orphan drug is indicated for the treatment of a very rare disease. Such diseases are often caused by genetic defects and therefore children and newborns are…

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 system? Bill of Ordinance on benchmarks for the classification of medicinal products on basic and additional list of medicinal products of the Croatian Health Insurance Fund and on benchmarks on…

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 country? Biosimilar medicines are not the same as generic drugs (a drug that contains the same molecule as an existing non-biological medicine, such as aspirin). Namely, biological medicine, unlike non-biological…

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 medicines and devices? Regulatory requirements for traditional herbal or homeopathic medicinal products are regulated by the provisions of Medicinal Products Act and traditional herbal medicinal products are also regulated by…

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 in your country? What is the legal framework defining these localization rules and policies? There are not any specific rules or regulations regarding localization in Croatia. There are only general…

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 your country? Cannabinoid Drugs are authorized only in the form of Medicinal Cannabis.   2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs? Office for Suppression of Drug…

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 protection? In the territory of Croatia the State Intellectual Property Office (hereinafter: the Office) carries out patent and trademark granting procedure in compliance with the Patent Act (Official Gazette No.…

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 recognized in Croatian jurisdiction are civil liability as contractual liability and non- contractual (liability as a result of fault, liability for another person, liability for damage caused by dangerous thing…

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 of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? B) MEDICINAL PRODUCTS Only those medicinal products having a marketing authorisation granted by the Agency for Medicinal Products…

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 with jurisdiction over drugs, biologicals, and medical devices in your country? The regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in Croatia is the Agency for Medicinal products…

Lawyer Ira Perić Ostojić highlights recent regulatory updates in Croatia, where the legal status of cultivating and producing cannabis for medical purposes has been liberalised.   On 25 April 2019 the Amendments to the Act on Combating Drugs Abuse entered into force in Croatia, which liberalizes the cultivation and production of low THC cannabis for medicinal purposes. With the new law going into effect, companies which have a manufacturing authorization for drugs or active substances from the Croatian Agency for…

Lawyer Ira Perić Ostojić outlines two major new regulatory updates regarding pricing and reimbursement for drugs in Croatia.   Bylaw regulating the maximum permitted wholesale price of the prescription medicinal products The bylaw regulates the detailed criteria for determining the maximum permitted wholesale price of prescription medicinal products in Croatia and the calculation of such prices by the Croatian Agency for Medicinal Products and Medical Devices (HALMED). Generally, the calculation by HALMED is mandatory and is carried out: (i) when the…