Advice
Regulatory information
Regulatory information
EpiFix is regulated under the European Union Tissue and Cells Directives (2004/23/EC, 2006/17/EC, 2006/86/EC and 2012/39/EU) and the Human Tissue (Quality and Safety for Human Application) Regulations 2007 in the UK. EpiFix was launched in the UK in January 2016, under HTA licence #22,512 (granted in February 2012).
No safety-related alerts were identified in the preparation of this briefing.