Table 2.

National legal frameworks for off-label use in selected European Union (EU) countries.

Country	Legal provision	Institution	Reimbursement	Legal basis
France	Temporary recommendations for use (RTU) scheme	National Agency for Medicines and Health Products Safety (ANSM)	Yes, even if authorized alternative medicinal products exist (for economic reasons)	Art L5121-12-1 and Art R5121-76-1 and following of the Public Health Code
Hungary	Individual authorization for off-label prescribing upon request of treating physician	National Institute for Quality and Organizational Development in Healthcare and Medicines (GYEMSZI)	Yes, but on an individual basis within the named patient-based reimbursement system	Section 25 of Act No. XCV of 2005 and Decree No. 44/2004 of the Ministry for Health Care, Social Affairs, and Family
Italy	Permissions for off-label use under certain conditions	Italian Medicines Agency (AIFA)	Yes, if included in AIFA “List 648.” Even if authorized alternative medicines exist	Law no. 648/1996, Law no. 94/1998 Art 3(2), Law no. 79/2014
Greece	Permissions for off-label use under certain conditions	National Organization for the Provision of Health Services (EOPYY)	Yes, if included in therapeutic protocols and approved by National Healthcare Council (KESY) or upon individual request of healthcare practitioner	Ministerial Decision No. ΔΥΓ3(α)/οικ. ΓΥ/154 and Article 47 of Law 4316/2014
Germany	Recommendations for off-label prescribing by four “off-label expert panels”	Federal Joint Committee (G-BA)	Yes, if included in part A of Appendix VI of pharmaceutical directive	Article § 35c(1) of the SGB V