Unlicensed Use
The English term unlicensed use (translation: "not approved use") means in drug law treatment with a drug that has no drug approval in the country in which it is used. This includes, for example, finished medicinal products that are approved in another country and are imported from there (for example in Germany on the basis of Section 73 of the Medicines Act ). Treatment with investigational medicinal products (which do not require approval) outside of clinical studies in compassionate use indications is also considered unlicensed use .
In contrast, treatment with investigational drugs in clinical studies does not count as unlicensed use . The extent to which the use of prescription and non-licensed drugs , which are also not subject to authorization, can be assigned to unlicensed use , differs from country to country: in the Netherlands these are drugs in unlicensed use , in Germany not. The small-scale pharmaceuticals that are differentiated in Switzerland into Formula officinalis and Formula magistralis do not count as unlicensed use there either .
The application of drugs in unlicensed use is important for reasons of liability law.
See also
Individual evidence
- ↑ a b Consequences of off-label, unlicensed and compassionate use for the drug laws and regulations of various EU member states and non-European countries , Exposé, October 2006.
- ↑ "Off label use" of pharmaceuticals ( Memento of July 14, 2014 in the Internet Archive ) (PDF file; 270 kB), in: Blickpunkt Apotheke (series of publications by the Cantonal Pharmacy Zurich), 1st edition May 2007, p. 4