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

is in writing and signed by a qualified practitioner; and

contains all the following particulars:

the date of the prescription;

the name and address of the qualified practitioner giving the prescription;

the name, identity card or other identification document number, and contact details, of the patient to whom the prescription relates;

the name and total amount of the prescribed CTGT product to be supplied to, and the dose to be taken by, the patient;

where the qualified practitioner giving the prescription intends for the prescription to be repeated, an indication of the number of times, and the time period between which, the prescribed CTGT product may be supplied;

where the prescription is given by a registered dentist, a declaration by the registered dentist that the prescription is for dental treatment only.

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to a CTGT product that is a result of only minimal manipulation of cell or tissue and that notice is not refused, withdrawn or cancelled under these Regulations.

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.

is not manufactured for any supply to the public; and

is manufactured solely for —

the purpose of scientific education or research and development; or

a non‑clinical purpose.

who is the holder of an importer’s licence or a manufacturer’s licence for any CTGT product;

who is the holder of a wholesaler’s licence for any CTGT product; 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to a CTGT product that is a result of only minimal manipulation of cell or tissue and that notice is not refused, withdrawn or cancelled under these Regulations.

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;

a description of the CTGT product to which the notice relates;

a statement of the import involved;

the premises where the CTGT product is to be stored; and

be accompanied by the relevant fee.

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.

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.

[Deleted by S 801/2023 wef 18/12/2023](b)the transfer of the unregistered Class 2 CTGT product by a healthcare service licensee from any approved permanent premises, temporary premises or approved conveyance of the healthcare service licensee to —

[Deleted by S 801/2023 wef 18/12/2023](ii)another approved permanent premises, temporary premises or approved conveyance of the healthcare service licensee; or

any approved permanent premises, temporary premises or approved conveyance of another healthcare service licensee.

the unregistered Class 2 CTGT product is —

imported under regulation 7(1)(c) or 9(a)(i) or (ii) for a qualified practitioner to administer it to a patient; or

manufactured for administration to a patient; and

the unregistered Class 2 CTGT product is intended for administration to a patient at the approved permanent premises, temporary premises or approved conveyance to which the unregistered Class 2 CTGT product is transferred.

the supply of a CTGT product that —

is imported in accordance with regulation 9(a)(i) by a licensed importer; and

is supplied by the licensed importer to a healthcare service licensee;

the supply of a CTGT product that —

is imported in accordance with regulation 7(1)(c) by a known importer that is also a healthcare service licensee; and

is pursuant to the written instructions of a qualified practitioner who is a personnel of the healthcare service licensee, and is for administration to a patient of the healthcare service licensee;

the supply by a healthcare service licensee of a CTGT product that is imported in accordance with regulation 7(1)(c) or 9(a)(ii), to a patient of the healthcare service licensee;

the supply of a CTGT product that is imported in accordance with regulation 7(1)(c) or 9(a)(i) or (ii), and is supplied —

[Deleted by S 801/2023 wef 18/12/2023](ii)by a healthcare service licensee from any approved permanent premises, temporary premises or approved conveyance of the healthcare service licensee to —

[Deleted by S 801/2023 wef 18/12/2023](B)another approved permanent premises, temporary premises or approved conveyance of the healthcare service licensee; or

any approved permanent premises, temporary premises or approved conveyance of another healthcare service licensee;

is manufactured by a healthcare service licensee; and

is for the administration to a patient of the healthcare service licensee, or another healthcare service licensee;

[Deleted by S 801/2023 wef 18/12/2023](ii)any approved permanent premises, temporary premises or approved conveyance of the healthcare service licensee or another healthcare service licensee;

the supply in accordance with regulation 16 of a Class 1 CTGT product that is —

manufactured by a licensed manufacturer, or a known manufacturer who has given a notice to manufacture under regulation 4 that has not been refused, cancelled or withdrawn;

imported by a licensed importer, or a known importer who has given a notice to import under regulation 7 that has not been refused, cancelled or withdrawn; or

supplied by a licensed wholesaler, or a known wholesaler who has given notice to the Authority under regulation 10 to supply the CTGT product by wholesale and the notice has not been refused, cancelled or withdrawn;

the supply of a CTGT product for —

the purpose of scientific education or research and development; or

a non‑clinical purpose,but only if there is no supply of the CTGT product to the public;

the supply by wholesale of a CTGT product that is —

manufactured solely for export; or

imported solely for re‑export.

give notice to the Authority in the form and manner specified on the Authority’s website of the supply of that CTGT product, and receive the Authority’s written acceptance of the notification;

provide the information to the Authority about that CTGT product that the Authority requires in the form and manner specified on the Authority’s website;

ensure, in relation to a CTGT product that is imported or obtained from a facility outside Singapore, that the facility is approved or licensed by the regulatory agency of the foreign jurisdiction, or accredited by an international accreditation body as specified by the Authority, to supply that CTGT product in that jurisdiction; and

ensure that the CTGT product is free from infectious agents.

that the CTGT product to be supplied to the patient is not registered with or approved by the Authority;

that the safety, efficacy and quality of the CTGT product to be supplied to the patient has not been evaluated by the Authority.

[Deleted by S 801/2023 wef 18/12/2023](b)by a licensed manufacturer or known manufacturer to a healthcare service licensee for the use of the CTGT product by a patient of the healthcare service licensee;

[Deleted by S 801/2023 wef 18/12/2023](d)by a healthcare service licensee for the use of the CTGT product on a patient of the healthcare service licensee.

under an agreement between a licensed manufacturer and the healthcare service licensee mentioned in paragraph (1)(b) or (d);

in accordance with its formulation and specifications, and the written instructions of a qualified practitioner, who is a personnel of the healthcare service licensee mentioned in paragraph (1)(b) or (d), and for the use solely by or in connection with the patient mentioned in that paragraph;

in specified premises or any other premises that the Authority approves; and

in accordance with the terms and conditions specified in the manufacturer’s licence held by the licensed manufacturer.

there is a written order, signed by the recipient —

stating the recipient’s name and address, trade, business or profession, and the name and total quantity of the Class 2 CTGT product required for supply to the recipient; and

that is not cancelled before the supply is carried out;

before each supply is carried out, the person must be satisfied that the recipient carries on the trade, business or profession stated in the order in sub‑paragraph (a) and that the trade, business or profession is one in which the Class 2 CTGT product is used; (c)after each supply is carried out, the person must insert in the appropriate entry in the record of supply prescribed by regulation 33(2)(b), a reference number by which the order can be identified.

the date of supply;

the name, identity card or other identification document number, and contact details, of the person to whom the CTGT product is supplied;

the name of the CTGT product, being either the proprietary name or the appropriate non‑proprietary name, and the total amount supplied;

if the CTGT product is supplied by a qualified pharmacist or a person acting under the supervision of a qualified pharmacist, or at or from a licensed retail pharmacy, the name and address of the qualified practitioner who signed the prescription.

be made on the day on which the CTGT product is supplied or, if that is not reasonably practicable, within the next day even if a public holiday; and

be kept for a period of 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.

a trade description which is false or misleading must not be applied to the CTGT product;

a trade description which explicitly or implicitly suggests that the supply or use of the CTGT product is promoted or endorsed by the Authority, the Ministry of Health or the Health Promotion Board must not be applied to the CTGT product.

it contains any false statement or information concerning the CTGT product; or

it is likely to create an erroneous impression regarding the formulation, specifications, quality, safety, efficacy or uses of the CTGT product.

affixes or annexes the trade description to, or in any manner marks it on or incorporates it in —

the CTGT product; or

any thing in or on the CTGT product or with which the CTGT product is supplied;

places the CTGT product in, on or with any thing which the trade description has been affixed or annexed to, marked on or incorporated in; or

makes any oral or written statement of the trade description, or uses the trade description in any other manner, which is likely to be understood as referring to the CTGT product.

the CTGT product is supplied pursuant to a request in which the trade description is used; and

it is reasonable in the circumstances to infer that any CTGT product so supplied will correspond to that trade description.

the name of the CTGT product, being the proprietary name and the appropriate non‑proprietary name;

the qualitative and quantitative description of any active substance in the CTGT product;

an appropriate control number, such as a serial number, batch number or lot number;

the expiry date of the CTGT product in day (if applicable), month and year format that is stated in a manner that avoids any confusion as to which is the day (if applicable), which is the month and which is the year;

where the CTGT product is registered, the registration number assigned to the registered CTGT product by the Authority;

the conditions under which the CTGT product must be stored;

in relation to an autologous CTGT product, the unique patient identifier and the words “for autologous use only” or similar wordings;

the list of excipients, including preservative systems, for the CTGT product;

any warning that is necessary for the CTGT product;

any precaution relating to the disposal of any unused CTGT product or any waste derived from the CTGT product (where appropriate) and any available collection system for the unused CTGT product or waste;

the name and address of the registrant or the manufacturer, as the case may be.

must be provided in English; and

must be legible and indelible.

the name of the person to whom the CTGT product is to be administered;

where the CTGT product is supplied or dispensed —

at a licensed retail pharmacy — the name, address and any identification number or logo of the licensed retail pharmacy;

at any approved permanent premises by a healthcare service licensee under a business name — the business name, address of the approved permanent premises and any identification number or logo of the healthcare service licensee;

at any temporary premises or approved conveyance by a healthcare service licensee under a business name —

if the healthcare service licensee is also approved under the Healthcare Services Act 2020 to provide the licensable healthcare service at any permanent premises under that business name — the business name, address of the approved permanent premises and any identification number or logo of the healthcare service licensee; or

in any other case — the business name, address and any identification number or logo of the healthcare service licensee; or

by a healthcare service licensee using a remote service kiosk or by delivery under a business name —

if the healthcare service licensee is also approved under the Healthcare Services Act 2020 to provide the licensable healthcare service at any permanent premises under that business name — the business name, address of the approved permanent premises and any identification number or logo of the healthcare service licensee; or

in any other case — the business name, address and any identification number or logo of the healthcare service licensee;

the date that the CTGT product is dispensed;

the directions for the use of the CTGT product;

the name of the CTGT product, being either the proprietary name or the appropriate non‑proprietary name;

the qualitative and quantitative description of any active substance in the CTGT product;

the conditions under which the CTGT product is to be stored;

the appropriate control number, such as a serial number, batch number or lot number;

the expiry date of the CTGT product in day (if applicable), month and year format that is stated in a manner that avoids any confusion as to which is the day (if applicable), which is the month and which is the year;

in relation to an autologous CTGT product, the unique patient identifier and the words “for autologous use only” or similar wordings;

the list of excipients, including preservative systems, for the CTGT product;

any warning that is necessary for the CTGT product;

any precaution relating to the disposal of any unused CTGT product or any waste derived from the CTGT product (where appropriate) and any available collection system for the unused CTGT product or waste.

where the qualified practitioner giving the prescription does not specify that the prescription is to be repeated, the relevant person dispensing the CTGT product must —

when dispensing, mark the prescription in a manner so as to permanently attach the person’s name and address and the dispensing date to the prescription; and

retain the prescription for a period of at least 2 years after dispensing the CTGT product;

where the qualified practitioner giving the prescription specifies that the prescription may be repeated, the relevant person dispensing the CTGT product —

must not dispense more than the total number of times specified on the prescription;

when dispensing, must mark the prescription in such a manner as to permanently attach the person’s name and address and the dispensing date to the prescription; and

must retain the prescription for a period of at least 2 years after dispensing the CTGT product for the last time.

stop disseminating, publishing or using the trade description with immediate effect;

stop applying the trade description to the CTGT product, or stop supplying the CTGT product applied with the trade description, with immediate effect;

take any measures that may be reasonable and necessary in the circumstances to discontinue or remove any trade description that may already have been applied, disseminated, published or used;

apply, disseminate or publish a corrective trade description in the manner and containing the information that the Authority requires.

stop supplying the CTGT product with immediate effect;

take any measures that may be reasonable and necessary in the circumstances to ensure that the CTGT product is only supplied with the required information.

any premises that are used for the manufacture, supply or storage of CTGT products; and

any conveyance that is being used for the transport of CTGT products.

require any person having possession or control of any CTGT product that is found during the inspection to provide, without charge, a sample of that CTGT product for the Authority’s examination; and

take or cause to be taken any photograph of —

the premises or conveyance mentioned in paragraph (1); or

any property or material found on the premises or in the conveyance.

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.

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.

a manufacturer, an importer, a wholesaler or a registrant of a CTGT product; or

the supplier of a CTGT product in accordance with regulation 12 or 15(1)(a), (b), (c), (ea) or (ec).

if P is not the manufacturer of the CTGT product, maintain a record of every receipt by P of the CTGT product;

maintain a record of every supply by P of the CTGT product; and

produce for inspection by the Authority or an enforcement officer the record of every receipt or supply as and when required by the Authority or enforcement officer.

contains, in relation to each receipt by P of the CTGT product, all the following information:

the proprietary name or appropriate non‑proprietary name of the CTGT product, if the CTGT product is supplied by a manufacturer, an importer, a wholesaler or a registrant of a CTGT product, as the case may be;

the date on which the CTGT product is received;

the name and address of the person from whom the CTGT product is received;

the quantity of the CTGT product received;

the identification number (including the control number, lot number, batch number or serial number) of the CTGT product received;

contains, in relation to each supply by P of the CTGT product, all the following information:

the proprietary name or appropriate non‑proprietary name of the CTGT product;

the date on which the CTGT product is supplied;

the name and address of the person to whom the CTGT product is supplied;

the quantity of the CTGT product supplied;

the identification number (including the control number, lot number, batch number or serial number) of the CTGT product supplied; and

is retained for 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.

sourcing;

procurement;

processing;

testing;

packaging;

storage;

transport;

delivery to the licensed retail pharmacy or the approved permanent premises, temporary premises, approved conveyance or remote service kiosk of a healthcare service licensee (as the case may be), where the CTGT product is used, administered, supplied or disposed of, as the case may be.

maintain a record of every event or other occurrence that reveals any defect in the CTGT product or that concerns any adverse effect arising from the administration of the CTGT product; and

produce that record for inspection by the Authority or an enforcement officer as and when required by the Authority or enforcement officer.

contains all the following information:

the proprietary name or appropriate non‑proprietary name of the CTGT product which is defective or of which an adverse effect has arisen from its administration;

the date on which the person first became aware of the event or occurrence;

the identification number or mark (including the control number, lot number, batch number or serial number) of the CTGT product;

the nature of the defect or adverse effect;

any other information that the Authority specifies in writing; and

is retained for at least 2 years after the expiry date of the CTGT product.

if the defect represents a serious threat to persons or public health — within 48 hours;

in all other cases — within 15 days.

may result in a person’s death;

may threaten a person’s life;

results in a person being hospitalised or prolongs a person’s existing stay in hospital;

results in a person’s persistent or significant disability or incapacity;

results in a congenital anomaly or birth defect; or

is judged to be medically important even though the effect might not be immediately life‑threatening or result in death or hospitalisation, but may jeopardise the person’s health or may require intervention to prevent the person’s death or one of the other outcomes mentioned in sub‑paragraphs (c), (d) and (e).

investigate the matter occasioning the recall of the CTGT product and provide a report of the findings of the investigation to the Authority;

take any other measures that the Authority thinks necessary.

must ensure, and maintain objective evidence to establish, that the manufacture of the CTGT product complies with the following standards:

in the case of a known manufacturer — Good Tissue Practice;

in the case of a licensed manufacturer — Good Manufacturing Practice Standard;

must provide and maintain, or ensure the provision and maintenance of, the staff, premises, equipment and facilities that are necessary for carrying out those stages of the manufacture of the CTGT product that are undertaken by the manufacturer;

must not carry out any stages of manufacture of the CTGT product in any premises that are not specified premises;

must provide and maintain, or ensure the provision and maintenance of, the staff, premises, equipment and facilities for the handling, storage and distribution of the CTGT product that are necessary to prevent the deterioration of the CTGT product while it is in the manufacturer’s ownership, possession or control;

must only use the specified premises, or any other premises that the Authority approves, for handling or storing the CTGT product;

must carry out, or arrange for a testing laboratory to carry out, tests on the strength, quality and purity of the CTGT product to ensure that the standards of the CTGT product comply with any applicable standard set by the Authority for the CTGT product;

must conduct all manufacturing operations in such a way as to ensure that the CTGT product is of the correct identity and conforms with the applicable standards of strength, quality and purity; and

must ensure that any tests for determining conformity with the applicable standards and specifications applying to the CTGT product are, unless otherwise provided in the licence, applied to samples taken after all manufacturing processes have been completed, or at any earlier stage in the manufacture that the Authority approves.

in the case of a known manufacturer — a testing laboratory determined by the known manufacturer; or

in the case of a licensed manufacturer — the testing laboratory specified in the licence.

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.

any change or proposed change to any particulars provided by the licensee to the Authority in relation to the application for the licensee’s licence; and

any change or proposed change that significantly affects the activities of the licensee that are authorised by that licence.

be made in the form and manner specified on the Authority’s website;

be submitted within the time that the Authority specifies in the conditions of the licence;

be accompanied by the particulars, information, documents and samples that the Authority requires;

be accompanied by the relevant fee; and

if required by the Authority, be accompanied by a statutory declaration by the licensee verifying any information contained in or relating to the notice.

the premises where the licensee operates;

the operations and processes carried out by the licensee;

the responsible person mentioned in regulation 43.

in compliance or purported compliance with paragraph (1), provides the Authority with any notice which the licensee knows is false or misleading; or