Table 1

EU countries with requirements on medicinal package information for medicines for hospital use

Country	Text on the legal status	Symbol
Bulgaria	Prescription only Special prescription (narcotics) Limited prescription (for hospital use only) For hospital use OTC	Two red/blue stripes
France	Prescription only Special prescription +additional considerations For hospital use On hospital prescription Initial hospital prescription Prescription by a specialist Use by specialist Urgent use	Red or green rectangle in which the warning text is placed
Hungary	Prescription only OTC Prescription only for ambulatory use Prescription only for ambulatory use under supervision of a specialist Special prescription for hospital use On special prescription, narcotic/psychotropic content On special prescription, could lead to misuse or abuse On special prescription, new medicine with not enough known about ADR	N/A
Germany	Prescription only OTC, only in pharmacy For hospital use	N/A
Italy	OTC OTC for self-treatment Prescription only Prescription only for unique dispensing On special prescription On special prescription for unique dispensing for a certain patient On special prescription, narcotic/psychotropic content For hospital use Use by specialist	N/A
Poland	OTC Prescription only On limited prescription On special prescription For hospital use	OTC Rp and Rpz Rpw Lz
Slovenia	For hospital treatment For health institution treatment For diagnosis in hospital and ambulatory treatment For ambulatory treatment OTC, available in pharmacy only OTC	H ZZ H/Rp Rp/Spec
Spain	Prescription only For hospital use For diagnosis in hospital Prescription only for ambulatory use under supervision of a specialist Hospital package Long-term treatment	H DH ECM

ADR, adverse drug reaction; OTC, over the counter.