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Manufacturing minimally manipulated CTGT products

Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021

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—(1) For the purposes of section 12(1) of the Act, a manufacturer’s licence is not required for the manufacture of a CTGT product that is a result of only minimal manipulation of cell or tissue if carried out by a person —(a)who is the holder of a manufacturer’s licence for any CTGT product;(b)who is manufacturing the CTGT product not for any supply to the public but solely for —(i)the purpose of scientific education or research and development; or(ii)a non‑clinical purpose; or(c)who gives or has given notice to the Authority in accordance with paragraph (2) in relation to a CTGT product that is a result of only minimal manipulation of cell or tissue and that notice is not refused, withdrawn or cancelled under these Regulations.(2) The notice required by paragraph (1)(c) for a CTGT product that is a result of only minimal manipulation of cell or tissue must —(a)be in the form and manner specified on the Authority’s website;(b)be accompanied by the following information in writing:(i)the particulars of the person giving the notice as required by the Authority; (ii)a description of the CTGT product to which the notice relates;(iii)a statement of the manufacture involved;(iv)the premises where the manufacture is to be carried out; and(c)be accompanied by the relevant fee.

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