The Regulations transposing EU import and coding Directives came into force on 1 April 2018. Changes to these Regulations affect all licensed establishments in the human application sector.
Revised Directions and changes to the Guide to Quality and Safety Assurance for Tissues and Cells for Patient Treatment
The HTA's Guide to Quality and Safety Assurance for Tissues and Cells for Patient Treatment (the Guide) is based on the Human Tissue (Quality and Safety for Human Application) Regulations 2007 and explains the requirements that licensed establishments in the human application sector must follow. The requirements set out in the Guide are implemented via HTA Directions 002/2018.
An updated version of the Guide was issued to establishments to account for the requirements brought into effect by the Amendment Regulations. The Guide was issued under a new set of Directions. These came into effect on the 1 April 2018 and revoked and replaced Directions 003/2010.
Changes to the licensable activity of ‘distribution’
The coding Directive introduced an additional definition for the distribution of tissues and cells; ‘released for circulation’, which is defined as ‘distribution for human application or transfer to another operator, e.g. for further processing with or without return’. In doing so, this distinguishes distribution for human application from release for circulation for other purposes.
Consequently, the Amendment Regulations were revised so that the licensable activity of ‘distribution’ only applies to tissues and cells that are distributed for end use (human application), but not to other instances of release for circulation.
This means that a licence for distribution will only be required when an establishment is responsible for distributing tissues and cells to the end user.
Modifications to licensing standards in the human application sector
We made some minor modifications to licensing standards in the human application sector that relate to import and traceability (GQ1n, GQ6 and GQ6a). We also updated all instances where the standards make reference to Directions 003/2010 to refer to the new set of Directions, 002/2018 (as mentioned above).
Changes to standard conditions on licences
All establishments in the human application sector are required to comply with the standard conditions that are included as Annex B of your licence certificate. If the HTA must vary these standard conditions, we do so by issuing a ‘notice of proposal’ to licence holders and DIs. We issued a ‘notice of proposal’ to vary some standard conditions that are currently included as Annex B to a human application licence certificate.
These changes included:
- Standard condition 14: We updated this standard condition with respect to the authorisation of licensable activities on a ‘per tissue type’ basis. This brought it in line with the requirements of the coding Directive, which requires all activities per tissue type, to be updated in real-time on the EU tissue establishment compendium for each establishment.
- We also added a standard condition that will apply to all licences that include the activity of ‘import’. This will reflect that importing establishments may only carry out the import of cells from outside of the EU under the terms specified in an Importing Tissue Establishment Licence certificate.
EU coding platform
The EU Coding Platform contains two compendia:
- the EU Tissue Establishment (TE) Compendium - this contains information on all tissue establishments authorised in the EU; and
- the EU Tissue and Cell Product Compendium – this contains categories of tissue and cell product codes.
All establishments that hold an HTA human application licence are listed in the TE compendium. This platform includes information on:
- the activities that an establishment is licensed to undertake; and
- the tissue and cell types that an establishment is authorised to undertake these activities for.
It is the HTA’s responsibility to keep the TE compendium up to date and to make any updates as required. Establishments should check that their information as listed on the TE compendium is accurate and notify the HTA if any of the information appears to be incorrect.
The coding Directive brought in measures to implement a SEC, which is a standardised coding system for facilitating the traceability of tissues and cells for human application. The SEC includes a specific tissue and cell product number that establishments need to apply and can be found in the EU Tissue and Cell Product Compendium. If you cannot find an applicable code listed in the compendium for your tissue or cell type, you should contact the HTA for further guidance. Where necessary, the HTA can request that a new product category is added to the EU Tissue and Cell Product Compendium.
Changes to import licensing
The import of tissues and cells for use in patient treatment (human application) can only be undertaken by establishments who hold an HTA import licence, and can now no longer be undertaken via a third party agreement.
If you no longer wish to import from third countries and would like to revoke this activity from your licence, please contact the HTA Licensing Team: firstname.lastname@example.org