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.
Department of Health's consultation
From 17 March-7 April 2017, the Department of Health (DH) consulted 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 DH consultation document provided a summary of the amendment Regulations and the two Directives. The summaries include a brief explanation of how DH expect they will be implemented, followed by a series of questions that aim to help DH better understand the practical implications of the amendment Regulations. The HTA also welcomed any feedback or comments regarding our draft guidance document aimed at establishments in the human application sector as part of the consultation.
HTA's draft guidance on the coding and import of tissues and cells for human application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.
During the consultation period, we hosted webinar sessions that focussed on how the Directives affect those working in the human application sector. You can view a recording of the webinar presentation below:
If you have any questions about the Directives,or the HTA guidance document please contact us either by email or by phone on 020 7269 1900.
We are working with DH to analyse the consultation 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 when further information is available.