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 001/2021 [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: 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 [2] as implemented by Directions 001/2021 [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.