Schedule 3

Clinical research materials supplied on or after 1 November 2017 must be labelled with information for all of the following purposes:

to ensure protection of the subject and product tracking;[S 108/2021 wef 01/03/2021](b)to enable identification of the material and the trial;

to facilitate proper use and storage of the material;

to ensure the reliability and robustness of data generated in the trial.(2) Without limiting the generality of sub‑paragraph (1), every unregistered investigational CRM, every registered investigational CRM which does not satisfy the requirements in sub‑paragraph (5), and every unregistered auxiliary CRM must be labelled with all of the following information:

the words “For clinical research use only” or similar wordings;

a clinical research reference allowing identification of the trial, site, investigator and sponsor;

the research subject identification number or treatment number and, where relevant, visit number;

the name, address and telephone number of the main contact for —

information on the clinical research material;

information on the research; and

emergency unblinding;

in the case of clinical research material that is a therapeutic product, the name of the substance used in the therapeutic product and its strength or potency, as well as, in the case of blinded trials, the name of the comparator or placebo;[S 108/2021 wef 01/03/2021](ea)in the case of clinical research material that is a CTGT product, the name of the CTGT product and a description, expressed qualitatively and quantitatively, of any active substance in the CTGT product, as well as, in the case of blinded trials, the name of the comparator or placebo;[S 108/2021 wef 01/03/2021](f)the pharmaceutical form, route of administration and quantity of dosage units of the clinical research material;

the directions for use of the clinical research material (which may be a reference to a leaflet or other explanatory document intended for use by the subject or person administering the material);

the batch or code number identifying the contents and packaging operation of the clinical research material;

the period of use (which may be an expiry date or a retest date), in month and year format and in a manner that avoids any confusion as to which is the month and which is the year;

the storage conditions;[S 108/2021 wef 01/03/2021](k)in the case of clinical research material that is an autologous CTGT product, the unique patient identifier and the words “for autologous use only” or similar wordings;[S 108/2021 wef 01/03/2021](l)in the case of clinical research material that is a CTGT product, the list of excipients, including preservative systems (if applicable), for the CTGT product;[S 108/2021 wef 01/03/2021](m)in the case of clinical research material that is a CTGT product, any warning that is necessary for the CTGT product;[S 108/2021 wef 01/03/2021](n)in the case of clinical research material that is a 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.[S 108/2021 wef 01/03/2021](3) Without limiting the generality of sub‑paragraph (1), every registered investigational CRM which satisfies the requirements of sub‑paragraph (5) must be labelled with all of the following information:

the words “For clinical research use only” or similar wordings;

a clinical research reference allowing identification of the trial, site, investigator and sponsor;

the name of the person to whom the clinical research material is to be administered or the research subject identification number;

where the clinical research material is supplied or dispensed —

at a licensed retail pharmacy or a trial site that is not an approved permanent premises, temporary premises or an approved conveyance of a healthcare service licensee — the name, address and any identification number or logo of the licensed retail pharmacy or trial site; [S 802/2023 wef 18/12/2023](ii)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;[S 430/2023 wef 26/06/2023](e)the name of the clinical research material, being the proprietary name or the appropriate non‑proprietary name of the active ingredient in the clinical research material;[S 108/2021 wef 01/03/2021](f)in the case of clinical research material that is a therapeutic product, where the appropriate non-proprietary name is included on the name of the label of the product, the appropriate quantitative particulars of any active ingredient of the product;[S 108/2021 wef 01/03/2021](fa)in the case of clinical research material that is a CTGT product, the name of the CTGT product and a description, expressed qualitatively and quantitatively, of any active substance in the CTGT product;[S 108/2021 wef 01/03/2021](g)the directions for use of the clinical research material;

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

the expiry date of the clinical research material;

the date that the clinical research material is dispensed;

where the clinical research material is registered, the registration number assigned to the product by the Authority;[S 108/2021 wef 01/03/2021](l)the conditions under which the clinical research material must be stored;[S 108/2021 wef 01/03/2021](m)in the case of clinical research material that is an autologous CTGT product, the unique patient identifier and the words “for autologous use only” or similar wordings;[S 108/2021 wef 01/03/2021](n)in the case of clinical research material that is a CTGT product, the list of excipients, including preservative systems (if applicable), for the CTGT product;[S 108/2021 wef 01/03/2021](o)in the case of clinical research material that is a CTGT product, any warning that is necessary for the CTGT product;[S 108/2021 wef 01/03/2021](p)in the case of clinical research material that is a 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.[S 108/2021 wef 01/03/2021](4) Without limiting the generality of sub‑paragraph (1), every registered auxiliary CRM must be labelled with all of the following information:

the name of the person to whom the clinical research material is to be administered or the research subject identification number;

where the clinical research material is supplied or dispensed —

at a licensed retail pharmacy or a trial site that is not an approved permanent premises, temporary premises or an approved conveyance of a healthcare service licensee — the name, address and any identification number or logo of the licensed retail pharmacy or trial site; [S 802/2023 wef 18/12/2023](ii)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 of 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;[S 430/2023 wef 26/06/2023](c)the name of the clinical research material, being the proprietary name or the appropriate non‑proprietary name of the active ingredient in the clinical research material;[S 108/2021 wef 01/03/2021](d)in the case of clinical research material that is a therapeutic product, where the appropriate non-proprietary name is included on the name of the label of the product, the appropriate quantitative particulars of any active ingredient of the product;[S 108/2021 wef 01/03/2021](da)in the case of clinical research material that is a CTGT product, the name of the CTGT product and a description, expressed qualitatively and quantitatively, of any active substance in the CTGT product;[S 108/2021 wef 01/03/2021](e)the directions for use of the clinical research material;

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

the expiry date of the clinical research material;

the date that the clinical research material is dispensed;

where the clinical research material is registered, the registration number assigned to the product by the Authority;[S 108/2021 wef 01/03/2021](j)the conditions under which the clinical research material must be stored;[S 108/2021 wef 01/03/2021](k)in the case of clinical research material that is an autologous CTGT product, the unique patient identifier and the words “for autologous use only” or similar wordings;[S 108/2021 wef 01/03/2021](l)in the case of clinical research material that is a CTGT product, the list of excipients, including preservative systems (if applicable), for the CTGT product;[S 108/2021 wef 01/03/2021](m)in the case of clinical research material that is a CTGT product, any warning that is necessary for the CTGT product;[S 108/2021 wef 01/03/2021](n)in the case of clinical research material that is a 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.[S 108/2021 wef 01/03/2021](5) The requirements for the purpose of sub‑paragraphs (2) and (3) in relation to any investigational CRM are all of the following:

the material is not used in the clinical trial in a blinded fashion;

the material is not repackaged for use in the trial;

the material is used in accordance with the terms of its registration (if registered) or in accordance with the notice submitted to the Authority under regulation 16 of the CTGTP Regulations.[S 108/2021 wef 01/03/2021](6) The information referred to in sub‑paragraphs (2), (3) and (4) must be in English, and must be clearly legible and unambiguous.(7) The address and telephone number referred to in sub‑paragraph (2)(d) need not appear on the label if the subjects are given a leaflet or card providing such information and instructed to keep the leaflet or card in their possession at all times.(8) The information referred to in sub‑paragraphs (2)(b), (c), (d) and (f) to (i), (3)(a), (b), (d), (g), (j) and (k) and (4)(b), (e), (h) and (i) need not appear on the label if they are available by any other means, so long as —

sub‑paragraph (1) is complied with; and

the reasons for the omission are set out in the protocol or such other document as the Authority may allow.[S 108/2021 wef 01/03/2021](9) Sub‑paragraphs (1)(d), (2)(a) to (d) and (g), (3)(a) to (d), (g) and (j) and (4)(a), (b), (e) and (h) do not apply where the supply is by wholesale.(10) In this paragraph —“autologous”, in relation to a CTGT product, means a CTGT product that contains cells or tissue that are obtained only from the individual to whom the CTGT product is to be administered;“registered auxiliary CRM” and “registered investigational CRM” include auxiliary clinical research material or investigational clinical research material (as the case may be) that is treated as a Class 1 CTGT product under the CTGTP Regulations and for which a notice under regulation 16 of the CTGTP Regulations has been submitted to the Authority;“unregistered auxiliary CRM” and “unregistered investigational CRM” include auxiliary clinical research material or investigational clinical research material (as the case may be) that is treated as a Class 1 CTGT product under the CTGTP Regulations and for which a notice under regulation 16 of the CTGTP Regulations has not been submitted to the Authority.[S 108/2021 wef 01/03/2021]2. [Deleted by S 108/2021 wef 01/03/2021 wef 01/03/2021]