title: [The use of medicinal products "off-label use" in the pediatric population--the border risk, or reasonable diligence?].
abstract: Any medicinal product marketed in the country has its registration, under which are strictly defined indications and the extent to which a product can be used. It is of significance that the use of the product which is registered in the given range produces an effect similar to or identical to that effect, which is obtained after applying the product having a registration in a given indication. Relied on to justify the use of a medicinal product or medical product "off-label use" in Poland, there is also the fact that the same product has a registration in a particular indication in another EU member state or outside the Community. It is worth noting that the medicinal product may be used in therapeutic management of omitting or reducing the principles resulting from the SPC. However, this applies only to cases where the use of the medicinal product "off-label use" dictated by the necessity of saving life or health of the patient, and the previous ways and methods of treatment with the use of registered medicines have proved ineffective or insufficient to achieve the desired therapeutic effect.
authors.affiliation: Zakład Prawa Medycznego, Miedzyuczelniana Katedra, Nauk Humanistycznych Uniwersytet Medyczny w Łodzi. justyna.zajdel@umed.lodz.pl
authors.forename: Justyna
authors.initials: J
authors.lastname: Zajdel
mesh_terms: D002648:Child; D005062:European Union; D006801:Humans; D056687:Off-Label Use / Q000941:ethics / Q000331:legislation & jurisprudence; D011044:Poland; D010818:Practice Patterns, Physicians' / Q000592:standards*