Singapore legislation
Regulation 43
of Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021
Regulation 43
Responsible person
Subregulation 1
A holder of a licence in relation to a CTGT product must appoint one or more persons as a responsible person to be named as such in the licence.
Subregulation 2
The holder of a licence must ensure that —
the responsible person has adequate knowledge of the activities to be carried out and of the procedures to be performed under the licence;
the responsible person has relevant working experience relating to those activities and procedures;
in the case of a manufacturer’s licence, the responsible person named in the licence has practical experience in production supervision or in testing and checking to ensure the quality of CTGT products or any other health products that are related to the CTGT products;
in the case of an importer’s licence or wholesaler’s licence for the import or supply of any CTGT product, the responsible person named in the licence has practical experience in the handling, storage and distribution of CTGT products to ensure their quality or any other practical experience that the Authority approves; and
at any time, there is at least one responsible person who is contactable by the Authority by way of a mobile telephone number or an email address.
Subregulation 3
The holder of a licence must ensure that the responsible person discharges the duties imposed on the responsible person by the terms of the licence.
Subregulation 4
The holder of a licence must ensure that no person other than the person named as the responsible person in the licence may act as the responsible person.