Table 4. Compassionate use programs in North European countries (Ref. 12,31,47–58).

Items	Estonia	Denmark	Ireland	Lithuania	Finland	Latvia	Sweden
Authority involved	State Agency of Medicines (SAM)	Lægemiddelstyrelsen-Danish Medicines Agency	Health Products Regulatory Authority (HPRA)	State Medicines Control Agency	Finnish Medicines Agency (Fimea)	State Agency of Medicines of Latvia	Läkemedelsverket/Medical Product Agency (MPA)
Laws and regulations	No CUP as in EMEA/27170/2006 but NPP processed by national regulations	Section 29 (1) of the Danish Medicines Act	No specific legislation for CUP. However, it can fall under the Irish clinical trial regulations SI 190 of 2004 or SI 540 of 2007 Also, named patient regime exists which transposes Article 5(1) of Directive 2001/83/EC for EU countries	Regulations for CUP are absent. Further information unavailable	Medicines Decree 693/1987, 1184/2002 and 868/2005	Regulations for CUP are absent.	§5 of the Medicine Act no 859 of 1992, recently updated the 28th August 2012 Lakemedelsverkets foreskrifter (LVFS) Nominative
Overview	CUP not formally authorized as per national legislation NPP exists	Under special conditions, after application, the sale or dispensing of medicinal products in limited amounts (not covered by marketing authorization or not marketed in Denmark) may be authorized	Named patient and clinical trial regimes exist, but not CUP. Further information unavailable.	Information unavailable	Compassionate use is permitted in exceptional cases where no other treatments are appropriate or produce the anticipated effect. Medicines available through CUP are prescription based only. Permission for CUP is needed for: An individual patient in an outpatient care — individual applications for permission A cohort of patients in an institution - health care institutions to apply for permission The permission is valid for one year, starting from the date of issue.	Compassionate use exists through the Latvian hospitals. However, it is unclear if it is on a named-patient basis or CUP. Further information unavailable.	An unauthorized medicinal product can be available for compassionate use in Sweden to increase patients' access to drugs being developed in the EU and to enable a common EU procedure. The MPA introduced CUP in 2012 for the Swedish health care as a complement to licensed prescription.