Expected standards (Directions)
Under the Human Tissue Act, the HTA has the power to issue its expected standards (or Directions) to establishments. This means that the HTA can issue general Directions to establishments to take into account changes in policy and legislation. The HTA may also make Directions that are specific to a particular establishment.
The HTA aims to issue Directions twice yearly rather than on an ad-hoc basis - either in April or September each year. This should assist establishments to plan ahead and is also intended to minimise any impact of changes to practices and procedures.
Directions 001/2006
Directions implementing the requirements of the EU Tissue and Cells Directive (the parent directive) and the European Commission's first technical directive of the parent directive.
These Directions have been amended by Directions 002/2007 (see below) as a result of the implementation of the Human Tissue (Quality and Safety for Human Application) Regulations 2007. Directions 001/2006 should not be read in isolation and must now be read in conjunction with Directions 002/2007.
Directions 001/2006
Directions 002/2006
Directions bringing into force certain HTA Codes of Practice.
Directions 002/2006
Directions 001/2007
Directions on licence fee structure 2006/07 and 2007/08
Directions 001/2007
Directions 002/2007
Directions given under the Human Tissue Act 2004 implementing the Human Tissue (Quality and Safety for Human Application) Regulations 2007 which implement the requirements of the EUTCD (the parent directive) and the European Commission's first and second technical directives of the parent directive.
These Directions amend Directions 001/2006 (see above).
Directions 002/2007
Directions 003/2007
Directions on bringing into force the HTA's Import and Export Code of Practice
Directions 003/2007
Directions 004/2007
Directions issued to comply with Regulation 15 (1) of the Human Tissue (Quality and Safety for Human Application) Regulations 2007. These Directions come into force on 7 October 2007 and apply only to imports from non European Economic Area (EEA) states.
Directions 004/2007
Directions 001/2008
Directions on interim licence fee structure for procurement for human application licences 2008/09
See also
Links
- European Parliament and Council Directive 2004/23/EC (Parent Directive)
- Commission Directive 2006/17/EC (First Technical Directive to Parent Directive)
- Commission Directive 2006/86/EC (Second Tecnical Directive to Parent Directive)