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The Regulation Directorate carries out investigations into alleged breaches. An alleged breach could be:
If we receive information that licensable activities are being carried out without a licence, we will undertake an investigation. If necessary, we will also issue both advice and warnings. If licensable activities are being carried out without a licence, we will normally require the...
For information on reproductive cells, please refer to the Human Embryology and Fertilisation Authority’s website.
We anticipate that all importing tissue establishments will need to renew their import licence to comply with the new Directive. Our aim is to ensure continuity of licensing, and to minimise the burden of renewing your licence. In order to renew your licence, we expect that you will have to...
Once licensed, importing tissue establishments cannot undertake any substantial changes to their import activities without our prior written approval.
Substantial changes include any changes to the:
The EU Tissue Establishment and Tissue and Product Compendia is available online.
Once the consultation closes we will analyse all the responses received. A summary of the consultation responses will be published on our website. Responses will inform our final fee structure proposals.