Distributors of acellular material
Please see below for a number of frequently asked questions from a specific category. Simply select one of the questions of interest, the answer will then appear below. For the complete list of categories please visit the main FAQs page.
After completing a review of the HTA’s policy on the regulation of acellular material, the HTA decided, in December 2008, to licence establishments involved in the import, export, distribution and / or storage of acellular human tissue-derived products.
More information on the HTA’s decision to license this material can be found in the position statement.
Acellular products are tissue-derived products that have been formed by cells but have been rendered acellular during processing. These products therefore fall within the licensing remit of the HTA.
The European Tissues and Cells Directive (2004/23/EC) states that it applies to “…manufactured products derived from human tissues and cells intended for human applications”.
The UK’s Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended) defines ‘tissue’ as ‘all constituent parts of the human body formed by cells’.
Examples of acellular products include:
- demineralised bone matrix;
- sterile bone chips;
- irradiated cancellous bone;
- acellular skin material.
Please note: this list is not exhaustive
Yes. As storage is the primary licensable activity for acellular distributors, the HTA has taken the decision that qualifications in quality management and / or business management, alongside a minimum of two years practical experience, would be considered appropriate.
However, DIs that do not possess medical or biological qualifications must follow the Guide to Quality and Safety Assurance of Human Tissues and Cells for Patient Treatment as implemented by HTA Directions 002/2018 and ensure that they have access to a nominated registered medical practitioner and / or a scientific advisor, as the HTA considers appropriate.
Further information on the Human Tissue (Quality and Safety for Human Application) Regulations 2007 can be found on our licensing and inspection webpages.
DIs without medical or biological qualifications must have access to a nominated registered medical practitioner and / or a scientific advisor, as the HTA considers appropriate. This person should be suitably qualified and possess sufficient knowledge of the licensable activities so that they can advise the DI about related matters (for example, regarding a serious adverse event).
Contact arrangements should be formalised and include alternative arrangements for the provision of advice in the event that the original scientific adviser or registered medical practitioner is unavailable.
The HTA will not usually ask to see documents evidencing these relationships during the desk-based inspection; however this information may be requested during a site-visit inspection. We would expect the DI to be able to explain to our inspectors why their advisor is appropriate and provide details of their contact arrangements.
Yes. In general, all standards are applicable to an establishment carrying out licensable activities.
Even if procurement, testing and processing of material does not take place on an establishment’s premises, the DI is still responsible for ensuring that all of the relevant HTA standards are met for any acellular products to pass through their premises. Therefore, we require the DI to assess the compliance of their premises and the premises of any procuring or processing organisations when providing a score for each of the HTA standards.
Establishments importing material from non-European Economic Area (EEA) states should refer to the Guide to Quality and Safety Assurance of Human Tissues and Cells for Patient Treatment as implemented by HTA Directions 002/2018, which detail the requirements.
Designated Individuals might also find it useful to refer to our FAQs on third party agreements.
The majority of HTA standards on the compliance report application should be answered as referring to both the licensed premises and the premises of the procuring organisation.
Distributors must ensure that the following are in place with end users:
- documented agreements to ensure that they record and store the data required by the Guide to Quality and Safety Assurance of Human Tissues and Cells for Patient Treatment as implemented by Directions 002/2018, including data retention periods.
- documented agreements specifying that the end users will report all serious adverse events and reactions to the licensed establishment, including reporting timelines.
- documented procedures for end users to report serious adverse events and reactions, including procedures for reporting outside of normal working hours. Agreements should include the need for end users to have documented reporting procedures in place and the establishment should provide end users with guidance on what incidents should be reported.
For the tissue and cells for patient treatment (human application) sector, there is a requirement for establishments to undergo a site-visit inspection at least every two years. Inspections for this sector are scheduled taking this and each establishment’s individual risk level into account, therefore some establishments may be inspected more often than others.
All site-visit inspections involve:
- visual inspection of areas where licensable activities take place (e.g. storage);
- document review;
- audit trail
- interviews wit;h key staff (e.g. DIs, Persons Designated etc).
As procurement, testing and processing are not carried out by acellular distributors, the document review will focus on understanding how DIs have satisfied themselves that these activities are being carried out under suitable agreements. Our inspectors will be looking to assure themselves from the available documentation that all licensable activities are fully compliant with HTA standards.
The documents that the inspectors would expect to see include:
- policies and standard operating procedures relating to the establishments licensable activities (e.g. covering the reporting of serious adverse events, disposal policy);
- risk assessments; including consideration of risks to staff, visitors and the products themselves;
- all contracts, written agreements, service level agreements and third party agreements relating to licensable activities. The written agreements with procuring companies and end users will be of particular interest;
- other relevant documents that the HTA’s standards require the establishment to have in place (e.g. recall procedure).