KG LEGAL | Polish law firm

specialising in cross border cases with its focus on life science, biotech, medtech, IT, new technologies and investment processes in Poland.

PHARMACEUTICAL, LIFE SCIENCES & HEALTHCARE LAW

Who are our Clients?

As a Polish law firm, we provide specialist expertise required by biotech companies, medtech entities, pharmaceutical companies, pharmacies, producers of medicinal products and pharmaceuticals, bio-it companies, hospitals, laboratories, r&d departments, telemedicine companies and distributors in the Polish market

 

Sale and distribution of medicinal products and medical devices in Poland:

  • Legal advice on respective models of distributing pharmaceuticals;
  • Authorisation for pharmaceutical wholesale;
  • Support in legal issues connected with direct and parallel import,
  • Recommendations on distribution channels;
  • Distribution to healthcare entities, taking into account public procurement regulations.

Marketing authorization of medicinal products and medical devices in Poland

  • Support in registering medicinal products and medical devices in Poland;
  • Legal advice in connection with administrative decisions in marketing authorisation;
  • Legal assistance in quality, effectiveness and safety of use;
  • Representing pharmaceutical companies in administrative proceedings concerning pharmacovigilance of medicinal products and monitoring their safety;
  • Representing clients before regulatory bodies in Poland.

 

Legal assistance to health care entities operating in the Polish market:

  • Legal assistance in public procurement to Polish healthcare entities;
  • Regulatory legal advice;
  • Representing health care entities in registration proceedings;
  • Legal advice in purchasing medicinal products and medical devices under Polish pharmaceutical law.

Legal advice in respect of Clinical Trials in Poland:

  • Tripartite clinical trial agreements with Polish companies,
  • Good clinical practice in operations in Polish market,
  • Securing sponsor’s legal interests in clinical trials in Poland under Polish pharmaceutical law,
  • Compliance,
  • CRF requirements,
  • Data protection issues,
  • Formal requirements of clinical trials in Poland
  • Sponsor’s and investigator’s duties in Poland.

 

Telemedicine (e-health) in Poland:

  • Legal support in remote monitoring procedures in health care;
  • Comprehensive assistance in legal issues connected with telenursing, telepharmacy and telerehabilitation;
  • Personal data protection issues;
  • Drafting and negotiating contracts in telemedicine.

Marketing of medicinal products and medical devices in Poland:

  • Marketing and advertising medicinal products and medical devices under Polish pharmaceutical law;
  • Advising on requirements in respect of providing information on medicinal products and medical devices in Poland;
  • Unfair competition issues.

 

Contracts in Polish pharmaceutical sector:

  • advising on distribution contracts, sale contracts, in-licensing, out-licensing contracts under Polish pharmaceutical law
  • legal support in the relations with Polish pharmaceutical entities.

Biotech:

  • Collaborations and partnering agreements;
  • Cross border agreements;
  • Research and development agreements;
  • Litigation;
  • Intellectual property;
  • Personalised medicine services for entities operating in life science.

 

UP