Tagged with Pharma

Global Over the past year, PharmaBoardroom has spoken to pharma executives the world over, collecting unique perspectives from all sides of the industry. Here are the ten most-read interviews of 2022 that range from conversations with one of Korea’s top CDMOs to the American generics association and the Italian regulatory agency,…

Europe Based on current discussions by the European Commission, launch conditionalities would not account for the distinct nature of small and mid-sized companies, OMPs and ATMPs. EUCOPE’s Alexander Natz breaks down this aspect of the revision of the general pharmaceutical legislation and why it would prove unsustainable for smaller companies and…

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

Pharma Legal Handbook All legal aspects surrounding preclinical and clinical trial requirements in Polish Pharma. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, available to purchase here for GBP 119.   1. Are clinical trials required to be conducted…

Pharma Legal Handbook All about marketing, manufacturing, packaging & labeling, advertising in Polish Pharma. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, available to purchase here for GBP 119.   1. What is the authorization process for the marketing…

Pharma Legal Handbook The legal framework for traditional medicines and OTC products in Polish Pharma. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, available to purchase here for GBP 119.   1. What are the regulatory requirements for traditional,…

Pharma Legal Handbook The legal framework for product liability in Poland. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, available to purchase here for GBP 119.   1. What types of liability are recognized in your jurisdiction? Under Polish…

Pharma Legal Handbook All legal aspects surrounding patents & trademarks in Poland. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, available to purchase here for GBP 119. 1. What are the basic requirements to obtain patent and trademark protection?…

Pharma Legal Handbook All legal aspects surrounding cannabinoid drugs, medicinal cannabis and opioid drugs in Poland. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, available to purchase here for GBP 119. Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in…

Pharma Legal Handbook All legal aspects surrounding orphan drugs and rare diseases in the Polish pharma market. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, available to purchase here for GBP 119. 1. What is the definition of Rare…

Pharma Legal Handbook All legal aspects surrounding localization in the Polish pharma market. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, available to purchase here for GBP 119. 1. Are there any rules or regulations requiring and/or encouraging localization…

Pharma Legal Handbook 1. Are biosimilar medicines considered the same as generic medicines in your country? Under the Pharmaceutical Law, a product is deemed as generic with respect to the reference product if it has the same qualitative and quantitative composition of active substances and the same pharmaceutical form as the reference product,…