Legal & Regulatory > Poland

All legal aspects surrounding biosimilars and biologics 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 75. 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…

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 75. 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? No, there are no rules or regulations requiring or encouraging localisation in Poland. However, certain activities…

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 75. 1. What is the definition of Rare Diseases in your country? There is no legal definition of Rare Diseases in Poland. On official websites the government uses the definition recommended by the EU, i.e. a rare disease…

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 75. Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? In general, hemp herb other than fibre, containing more than 0.20% of the sum of delta-9-Tetrahydrocannabinol (THC) and Tetrahydrocannabinoleic acid (delta-9-THC-carboxylic acid) is not authorised in Poland. However,…

All legal aspects surrounding the regulatory reforms 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 75. 1. Are there proposals for reform or significant change to the healthcare system? Proposed legislation on medical devices At the beginning of 2020, a new act on medical devices was published on the website of the Polish Government Legislation…

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 75. 1. What are the basic requirements to obtain patent and trademark protection? 1.1. Patents An invention (which is patentable) is a new (on a global scale) solution of a technical nature, characterized by a degree of inventiveness (not obvious in prior art),…

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 75.   1. What types of liability are recognized in your jurisdiction? Under Polish law, the following types of liability are recognized: criminal liability; civil liability for breach of contract or torts. The injured party may seek compensation for damage before a civil law…

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 75.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Pharmaceutical Law provides for a simplified procedure for the marketing authorization of herbal medicinal products, provided that they meet criteria for traditional herbal…

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 75.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? a) Medicinal products Chapter 2 of the Pharmaceutical Law sets forth the rules relating to the marketing of…

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 75.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, there is no requirement to conduct clinical trials locally to receive marketing approval.   2. How are clinical trials…

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 75.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The President of the Office for the Registration of Medicinal Products, Medical Devices and Biocidal Products (Prezes Urzędu Rejestracji Produktów Leczniczych, Wyrobów…