The healthcare sector is one of the most challenging areas of innovation, characterized by high complexity, strict regulations, high development costs and cultural diversity in different countries. Despite technological progress, fragmentation of innovation ecosystems in digital health is a significant barrier to effective cooperation and implementation of new solutions. The COHES.io project (Connected Health Ecosystems via Open Innovation), which aims to create an interregional space for open innovation in digital health, is the response to these challenges.
In recent years, there has probably been no more dynamically developing market sector than that closely related to the production of drugs, their testing and introduction to consumer circulation. Especially during the COVID-19 pandemic caused by the SARS-CoV-2 coronavirus, all the efforts of pharmacists around the world have been focused on developing an effective formula for a vaccine protecting against infection with this disease, producing it, testing it and making it available to people, and in the longer term on developing a formula for a drug that could be widely used, e.g. in hospitals. No less important at that time were the problems and legal issues related to obtaining permission to produce drugs. In this article, there will be discussed detailed regulations related to the procedure for obtaining consent to manufacture drugs, which is regulated in the Act of 6 September 2001 – Pharmaceutical Law (Journal of Laws of 2024, item 686; amended: Journal of Laws of 2025, item 129), as well as to present the requirements imposed on drug factories in terms of building equipment and production principles, which are regulated in other sub-statutory legal acts.
KIELTYKA GLADKOWSKI KG LEGAL AGAIN CONFIRMS ITS LEADING POSITION IN POLAND
We are honoured and very pleased to inform that according to the new ranking of the Legal500 for 2025 KIELTYKA GLADKOWSKI KG LEGAL has been ranked as the leading law firm in Poland. We have been ranked in three major categories: Data Privacy and Data Protection; Healthcare and Life Sciences; Private Client.
Intellectual property (IP) is playing an increasingly important role as a component of business value. Modern companies base their operations on intangible assets such as patents, trademarks, copyrights or trade secrets. Proper valuation of intellectual property plays an important role both in shaping business strategy and in transaction processes – especially mergers and acquisitions, as well as in technology licensing. Proper estimation of IP value also affects tax and investment aspects. For this reason, companies must pay special attention to the analysis of their intangible assets in order to fully use their potential. This raises questions about how to effectively value IP and how EU and national regulations address this issue.
Authorised Economic Operator (AEO) is a status granted by customs authorities to economic operators who meet certain requirements in the area of compliance with customs rules, proper accounting, financial solvency and security standards. The AEO concept was introduced in the European Union within the framework of the Community Customs Code and its implementing provisions, and currently its legal basis is the Union Customs Code, established by Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013, OJ EU.L.2013.269.1 and delegated and implementing acts, in particular Commission Delegated Regulation (EU) 2015/2446 of 28 July 2015, OJ L. U.EU.L.2015.343.1 and Commission Implementing Regulation (EU) 2015/2447 of 24 November 2015, OJ EU.L.2015.343.558.
