Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021 · As enacted · Part 2 · Ctgt Product Manufacture — Licensing and Exceptions
4. Manufacturing minimally manipulated CTGT products
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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 —
who is the holder of a manufacturer’s licence for any CTGT product;
who is manufacturing the CTGT product not for any supply to the public but solely for —
the purpose of scientific education or research and development; or
a non‑clinical purpose; or
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to a CTGT product that is a result of only minimal manipulation of cell or tissue and that notice is not refused, withdrawn or cancelled under these Regulations.
The notice required by paragraph (1)(c) for a CTGT product that is a result of only minimal manipulation of cell or tissue must —
be in the form and manner specified on the Authority’s website;
be accompanied by the following information in writing:
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;
a statement of the manufacture involved;
the premises where the manufacture is to be carried out; and
be accompanied by the relevant fee.
Subregulation 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 —
who is the holder of a manufacturer’s licence for any CTGT product;
who is manufacturing the CTGT product not for any supply to the public but solely for —
the purpose of scientific education or research and development; or
a non‑clinical purpose; or
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to a CTGT product that is a result of only minimal manipulation of cell or tissue and that notice is not refused, withdrawn or cancelled under these Regulations.
Subregulation 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 —
be in the form and manner specified on the Authority’s website;
be accompanied by the following information in writing:
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;
a statement of the manufacture involved;
the premises where the manufacture is to be carried out; and
be accompanied by the relevant fee.