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.