Our lawyers have extensive experience in legal assessment of all types of clinical and non-clinical projects. We also assess whether a given test procedure can constitute a therapeutic experiment within the meaning of the Polish law.
Contrary to common understanding, a pharmaceutical company may encounter clinical tests not only before marketing the product. The obligation to conduct such tests may be imposed by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products also after marketing the drug (including PASS and PAES).
What is more, the company can independently conduct safety or efficiency tests after marketing the drug. Where such test meets certain legal requirements (e.g. the use of the drug complies with the registration dossier), such a test shall not be subject to the legal requirements related to the full clinical test (registration, insurance, documentation, etc.).
The pharmaceutical company also has the full right to conduct non-clinical tests (e.g. research on prescription habits, marketing research, sales research, etc.). The help of a lawyer is useful at the stage of designing research and building advertising claims based on such research.