Legal & Regulatory > Czech Republic

Key legal info on biosimilars & biologics 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 99.   1. Are biosimilar medicines considered the same as generic medicines in your country? No, biosimilars are not regarded as generics of biological medicines. Czech legislation implements EU directives, and directly applicable EU regulations on biosimilars and biologics apply. EU…

Want to know more about localization 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 99.   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? As a general rule, there are no localization requirements relating to medicinal products in the…

An intro to the legal situation for orphan drugs and rare diseases 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 99.   1. What is the definition of Rare Diseases in your country? The relevant Czech regulation defines rare diseases as those with a very low incidence in the population, within the meaning of the relevant…

Cannabinoid drugs, medicinal cannabis and opioid drugs in Czech Republic – a legal guide. 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 99.   CANNABINOID DRUGS 1. Are Cannabinoid Drugs authorized in your country? Cannabinoid Drugs, i.e. drugs containing active compounds of cannabis, such as tetrahydrocannabinol (THC) or cannabidiol (CBD), can be authorized in the Czech Republic under the…

A brief overview of the situation regarding regulatory reforms 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 99.   1. Are there proposals for reform or significant change to the healthcare system? Digitalization With respect to Czech legislation, the main topic of proposed regulatory changes is the ongoing process of digitalization. The Ministry of Health is…

The legal framework for patents and trademarks in Czech Republic Pharma. 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 99.   1. What are the basic requirements to obtain patent and trademark protection? One can file for patent protection for any invention, in all fields of technology, provided the invention is new, involves an inventive step, and is capable…

Want to know more about product liability in Czech Republic? Read on! 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 99.   1. What types of liability are recognized in your jurisdiction? Two types of liability are recognized in the Czech Republic: contractual liability, arising from the failure to comply with one’s contractual obligations; non-contractual (civil) liability, arising as…

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 99.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? DRUGS The following authorization procedures are available in the Czech Republic for obtaining market authorization…

The ins and outs of traditional medicines and OTC products 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 99.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional herbal medicinal products and homeopathic medicinal products are subject to specific regulation set out in the Act on Drugs. Traditional…

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 99.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, clinical trials may be also conducted abroad. If a clinical trial was conducted in a country outside of…

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 99.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The main authorities with jurisdiction over drugs, biologicals, and medical devices in the Czech Republic are the Ministry of Health…