Clinical trials and applicable Polish law

Laboratory research in science and medical setting.

Fast development of health sector in Poland provides the opportunities to use the results of medical research. The most significant effect can be visible on the example of clinical trials, which are being increasingly more often conducted in Poland (over 40 thousands of patients in Poland take part in clinical trials almost every year). The clinical trials verify the effectiveness and the safety of new medicinal products, taking into account, among others, ethic rules resulting from Good Clinical Practice, WMA Declaration of Helsinki, Regulation (EU) No 536/2014, Polish Pharmaceutical Law or Polish Medical Profession Act. The text focuses on legal regulations applicable to the Polish market of clinical trials and discusses the advantages that the Polish market offers for clinical trials, also involving foreign investors.


See the link to the article in Polish:,Prawo-badan-klinicznych-w-Polsce.html 


The information was prepared by Anna Bednarska of KG Legal Polish Law Firm. KG Legal provides specialised legal assistance to IT, Life Science as well as investment processes in Poland and organises networking between Polish and international companies and research centres.

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Polish start-ups in new technologies and biotechnology and relevant Polish law

20161205_100129The article was prepared by KG LEGAL KIEŁTYKA GŁADKOWSKI based in Cracow, Poland, specialising in cross border cases, with its focus on new technologies, IT and life science, discusses start-ups, differences between business secret and know-how and the value of these for a company being a start-up, protection of intellectual property, the importance of patent law for start-ups, protection of biotechnological inventions, copyright, the patentability of inventions, protection of IT solutions, procedures for obtaining a patent and rights granted under a patent.

See the link to the article in Polish:,2,Polskie-startupy-w-IT-i-biotechnologii-ochrona-prawna.html

The information was prepared by Kamil Trzaskoś of KG Legal Polish Law Firm. KG Legal provides specialised legal assistance to IT, Life Science as well as investment processes in Poland and organises networking between Polish and international companies and research centres.

See our specialisations


BioLaw Europe FmbA – a new life science organisation with its registered office in Denmark, comprising law firms from EU and EFTA area

abilThe association BioLaw Europe FmbA is a new initiative of the European law firms with extensive recognition in life science specialisation.

The strength of this organization is the fact that is comprises the law firms from the European Union and EFTA having thorough expertise in life science area. The founders of the organization are three law firms from Denmark, the UK and Spain.

BioLaw Europe aims to create a platform for professional marketing, collaboration, education, training and communication for the entities related to broadly understood life science sector.

The association will attempt to encourage the entities operating in different jurisdictions in the field of life science to cooperate and work on mutual projects.

Due to the fact that Atty. Jakub Gładkowski has been appointed the auditor of the Management Board of BioLaw Europe for 2015, KG Legal has created a new thematic portal BIOLAW EUROPE Life Science, which is a response to the current information needs of the organization and the place for publications on the issues related to life science sector.


KG Legal Law Firm joins BRITISH INSTITUTE OF EXPORT based in London

IOE Institut of ExportKG Legal Law Firm has obtained the membership of the British Institute of Export which is the professional membership body representing and supporting the interests of everyone involved in importing, exporting and international trade. The Institute is the leading authority in best practice and competence for businesses trading globally.

The membership in IOE will help KG Legal to provide professional support to the expansion of foreign business entities in the Polish jurisdiction.

Małgorzata Kiełtyka, Jakub Gładkowski





Bio Law Europe F.m.b.A.

BioLawEuropeBioLawEurope F.m.b.A. (“BioLawEurope”) comprises a network of independent law firms, i.e. a collective number of licensed attorneys operating nationally under a common trademark or name, but not necessarily in the form of a corporation, and individual attorneys registered and licensed in one or more European jurisdictions and specialized in the rendering of legal services to commercial as well as non-profit based natural and legal persons, including universities and organizations operating, investing in and/or servicing biotech, pharma, food supplement, medical device and/or dentistry industry related.

BioLawEurope is registered in Denmark by the Danish Business Authority under CVR No. DK 3630 6092, as a limited liability association.

The Members of the Alliance are dedicated to rendering high quality personalized tailormade legal services to clients within the European Economic Area and Switzerland, giving their clients the opportunity to have specialist advice rendered in and for one or more of these jurisdictions.