Singapore legislation
Regulation 10
of Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021
Regulation 10
Supplying minimally manipulated CTGT products by wholesale
Subregulation 1
For the purposes of section 14(1) of the Act, a wholesaler’s licence is not required for the supply by wholesale of a CTGT product that is a result of only minimal manipulation of cell or tissue if the person supplying by wholesale —
is supplying the CTGT product not to the public but solely for —
the purpose of scientific education or research and development; or
a non‑clinical purpose; or
gives 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to a CTGT product that is a result of only minimal manipulation of cell or tissue and that notice is not refused, withdrawn or cancelled under these Regulations.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)(b) 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 be supplied by wholesale;
a statement of the supply by wholesale involved;
the premises where the CTGT product is to be stored; and
be accompanied by the relevant fee.
Subregulation 3
A licensed wholesaler of any CTGT product is not required to give notice to the Authority under paragraph (1)(b) to import or supply a CTGT product that is a result of only minimal manipulation of cell or tissue.