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Alternative title:

The problem of using the summary of product characteristicsfor a purpose different than marketing authorization

Subject and Keywords:

summary of product characteristics   marketing authorization   prescribing drugs off-label


Tyt. zeszytu: Prawo wobec jednostki i społeczeństwa


Asuccessfully completed registration process of amedicament is associated with being granted national marketing authorization together with having the summary of product char-acteristics (SPC) approved. The article addresses problems that occur with the use of the SPC for purposes other than originally assumed, the marketing authorization of medicaments.Pharmaceutical companies wishing to register anew medicinal product are not required to provide all possible uses of the drug in the SPC, or to update the information contained therein. Meanwhile, the physician is required to exercise the profession as indicated by current medical knowledge. The concept of indications of current medical knowledge should be considered to be broader than the indications contained is the SPC, and the doctor should decide on the treatment outside of the registered indications, but in accordance with medical knowledge flowing from scientific sources. How to identify problems resulting from differences between the SPC indications and current medical knowledge? Firstly, what is SPC and how is it created? Who is bound by it, and under what circumstances? What is the relationship between the Polish drug reimbursement system and the SPC? What risks come from the reimbursement list being built based on that document? What are off-label drugs and what is the source of their phenom-enon? How is physicians’ liability shaped in connection with the SPC?

Place of publishing:



Wydawnictwo Uniwersytetu Wrocławskiego

Date issued:


Date copyrighted:



ISSN 1733-5779   ISSN 0239-6661




PAd 102060 II


eng   pol


Studenckie Prace Prawnicze, Administratywistyczne i Ekonomiczne, ISSN 1733-5779. Nr 30 (2019), s. 13-22

Is version of:

Czasopisma Naukowe w Sieci (CNS)

Rights holder:

Copyright by Wydawnictwo Uniwersytetu Wrocławskiego Sp. z o.o.

Autor opisu:

WR U/PAdbg