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 [1].

Compliance reporting: I do not hold a medical or biological qualification; can I still act as the Designated Individual (DI) of an acellular product distribution establishment?

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 [2]as implemented by HTA Directions 002/2018 [3] and ensure that they have access to a nominated registered medical practitioner and / or a scientific advisor, as the HTA considers appropriate.

Compliance reporting: Do I need to provide details of my scientific advisor or medical practitioner to the HTA?

All DIs 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.

Compliance reporting: As an establishment that only distributes acellular products, but does not carry out any other licensable activities, do I have to provide answers to all of the compliance report questions?

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 [4] as implemented by HTA Directions 002/2018 [3], which detail the requirements.

Designated Individuals might also find it useful to refer to our FAQs on third party agreements [5].

Compliance reporting: Which compliance report questions relate to my establishment’s premises or to the premises of my suppliers?

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.

Compliance reporting: What arrangements should my establishment have in place with the end users of acellular products?

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 [4]as implemented by Directions 002/2018 [3], 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.

Site-visit Inspections: When can my establishment expect its first site-visit inspection?

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.

Site-visit Inspections: What does the HTA expect to see on a site-visit inspection of my premises?

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).