When do HTA Directions 004/2007 apply to import and export activity?
HTA Directions 004/2007 are made to ensure compliance with Regulation 15 (1) of the Quality and Safety Regulations, to secure that all imports of tissues and / or cells intended for human application from countries which are not member states of the EEA meet standards of quality and safety, equivalent to those provided for in those Regulations. Establishments must comply with the HTA’s Code of Practice (HTA Import and Export Code) on import and export of human bodies, body parts and tissue, as appropriate.