Two new EU Directives are being put in place for the coding and import of tissues and cells for human application. These Directives are due to come into force throughout the EU. When implemented, all establishments licensed in the human application sector will need to meet the requirements laid out in these Directives.
For more information regarding each of these Directives, please follow this link.
The Department of Health (DH) is consulting on the draft Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2017. The draft Regulations are due to come into force during Summer 2017 and will transpose the EU Directives on Coding and Import into UK law.
The consultation will run for a four-week period from 10 March to 7 April 2017.
The DH consultation document provides a summary of the amendment Regulations and the two Directives. These summaries include a brief explanation of how DH expect they will be implemented. Each section is followed by a series of questions which aim to help DH better understand the practical implications of the amendment Regulations. The HTA also welcomes any feedback or comments regarding our draft guidance document aimed at establishments in the human application sector as part of this consultation.
How to respond
Before you respond to the consultation, we recommend that you read:
- The Department of Health consultation document, which includes:
- Directive 2015/565/EC – the Coding Directive;
- Directive 2015/566/EC – the Import Directive;
- The draft Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2017
- HTA's draft guidance on the Coding and Import of tissues and cells for human application
To respond to the consultation, please follow this link.
HTA's draft guidance on the coding and import of tissues and cells for human application
The HTA has prepared guidance which should be read by establishments in the human application sector, alongside the DH consultation document on The Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2017. The guidance contains key information on how the Directives will affect particular groups of establishments, such as:
- private tissue banks;
- commercial importers and distributors;
- registries and hematopoietic stem cell (HSC) transplant centres;
- tissue banks; and
- establishments procuring for advanced therapy medicinal product (ATMP) manufacture.
The guidance is currently in draft format, pending the feedback we receive from the consultation. If you have any comments on its content, you can include them as part of your response at the end of the DH consultation.
Alternatively, you are welcome to email us with any feedback you may have.
We will host two webinar sessions throughout the consultation period. The webinars will focus on how the Directives will affect those in the human application sector, as well as provide an opportunity for establishments to ask us any questions regarding our draft guidance.
The dates of the webinars are as follows:
- Wednesday 22 March: 3-4pm GMT
- Friday 31 March: 10:30-11:30am GMT
You can register for the sessions via the HTA webinar home page.
If you have any questions about the Directives, the consultation or the HTA guidance document please contact us either by email or by phone on 020 7269 1900.
You can also visit the DH consultation page for further information.
The HTA and DH would very much like to hear your views on the draft Regulations and our guidance. Once the consultation closes, we will work with DH to analyse your responses and review the draft Regulations. DH will make the final decision on the drafting of the amendment Regulations to be considered by Parliament.
Following the review, DH will submit the Regulations for Parliamentary approval. We will keep you updated on the timetable for approval on our website.