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The European Commission has launched the web-based EU Coding Platform. The platform is free to access and is designed to help build the Single European Code (SEC) to be allocated and applied to tissues and cells.The EU Coding Platform contains two compendia:
We have prepared draft guidance on the requirements of the two new EU Directives that are being put in place for the coding and import of tissues and cells for human applica
We have created separate documents that provide additional guidance for our licensing Standards for Codes B, C, D and E.
There are four primary roles under HTA licences. The list below gives a short definition of each role. You can find more details on the responsibilities that come with each role under the sector-specific information.
Designated Individuals (DIs)
Introduction to the Regulations
Under the Q&S Regulations, the HTA licences and inspects establishments that undertake the following activities using tissues and cells intended for human application:
Two new EU Directives are being put in place for the coding and import of tissues and cells for human application. These Directives are in force throughout the EU but have not been transposed into the UK law. When implemented, all establishments licensed in the human application sector will need...
You can find information about how to meet the requirements of the Regulations in our documentary framework.
Codes of Practice