Do I need a licence to import/export starting material for an ATMP from/to the EU?
The HTA regulates establishments that undertake the procurement, testing, processing, storage, distribution, import and export of tissues and cells for human use. This includes any steps involved in the handling of tissues and cells prior to them being manufactured into medicines.
Under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended) (the Q&S Regs), export of tissues and cells from a tissue establishment to a third country is a licensable activity, and therefore all exports of tissues and cells to such countries can only be undertaken by establishments licensed for export by the HTA.
The HTA considers the licensable activity of export as ensuring tissues and cells leaving the UK meet the required legislative standards. This licensing requirement applies to the export of all tissues and cells intended for use in human application, including those that will be used in the manufacture of an advanced therapy medicinal product (ATMP) where the tissues and cells are referred to as starting materials. In the UK, MHRA regulates the manufacture of ATMPs and confirms that GMP does not apply to the donation, procurement, testing and export of starting materials. The quality of the starting materials is key to the quality of the finished medicinal products and compliance with the Tissues and Cells legislation is an important element in providing assurance of quality.
Do I need a licence to import/export biosamples used for donor testing?
Under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended) biological samples may required from the donor to demonstrate the quality and safety of any tissues and cells used in human application. These samples need to meet any relevant quality and safety standards set out in the HTA’s Guide to Quality and Safety Assurance for Human Tissues and Cells for Patient Treatment, but can transported into, or out of, the UK without an import or export licence.
Do I need a licence to import/export biosamples collected for analysis (not for human application) as part of a clinical trial from/to the EU?
Biosamples may be obtained for analysis purposes to provide data for a clinical trial. These types of samples are considered relevant material under the Human Tissue Act 2004 (HT Act). For the purposes of the HT Act, import and export is considered as into and out of England, Wales or Northern Ireland. This definition will be unchanged following the UK’s withdrawal from the EU. Where import and export are taking place, these are not licensable activities under the HT Act. However, the storage of the material once it is imported may be licensable if this is for a scheduled purpose, such as research within the scope of the HT Act.