Singapore legislation
Regulation 32
of Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021
Regulation 32
Duty to maintain records of manufacture
Subregulation 1
Subject to paragraph (5), a manufacturer of a CTGT product must maintain records of —
any information relating to the CTGT product and its manufacture that the Authority specifies on the Authority’s website or, if the manufacturer is the holder of a manufacturer’s licence, in the manufacturer’s licence; and
the manufacture of each batch of the CTGT product and of the tests carried out on each batch, in the manner specified on the Authority’s website or in the relevant licence issued by the Authority, if applicable.
Subregulation 2
The manufacturer must maintain for any CTGT product the records mentioned in paragraph (1) —
where the records do not relate to traceability, for the longer of the following periods:
one year after the expiry date of the CTGT product;
5 years after the date of manufacture of the CTGT product; and
where the records relate to traceability, at least 30 years after the expiry date of the CTGT product or any other shorter period that the Authority allows in a particular case.
Subregulation 3
A manufacturer of a CTGT product who fails to comply with paragraph (1) or (2) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $10,000 or to imprisonment for a term not exceeding 6 months or to both.
Subregulation 4
A person who, in compliance or purported compliance with paragraph (1), provides the Authority or an enforcement officer with any record which the person knows is false or misleading in a material particular shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both.
Subregulation 5
This regulation does not apply to a manufacturer of a CTGT product who is excepted from the requirement to have a manufacturer’s licence because of regulation 4(1)(b) or 5.