Tagged with Czech Republic

Europe Rock-bottom prices, regulatory red tape, and intense competition from Asia have made life difficult for Europe’s generics and biosimilar producers. Yet a handful of companies are not just surviving this squeeze but thriving in it – through diversification, geographic focus, R&D intensity, or sheer scientific specialisation. Here’s how four of…

Pharma Legal Handbook 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 and the State Institute for Drug Control. Along with these two main regulatory…

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 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 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 119.   1. What are the regulatory requirements…

Pharma Legal Handbook 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 119.   1. What types of liability are recognized…

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

Pharma Legal Handbook 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 119.   1. Are there proposals for reform or…

Pharma Legal Handbook 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 119.   CANNABINOID DRUGS 1. Are Cannabinoid…

Pharma Legal Handbook 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 119.   1. What is the…

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

Pharma Legal Handbook 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 119.   1. Are biosimilar medicines considered the same as generic…