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 |
|
|
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 |
|
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:
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. |