Schedule 2

Every investigational product and every auxiliary product used on or after 1 November 2017 in a clinical trial must be labelled with information for all of the following purposes:

to ensure protection of the subject and product tracking;[S 107/2021 wef 01/03/2021](b)to enable identification of the product and the trial;

to facilitate proper use and storage of the product;

to ensure the reliability and robustness of data generated in the trial.[S 107/2021 wef 01/03/2021](2) Without limiting the generality of sub‑paragraph (1), every unregistered investigational product, every registered investigational product which does not satisfy the requirements in sub‑paragraph (5), and every unregistered auxiliary product, must be labelled with all of the following information:

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

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

the trial 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 product;

information on the trial; and

emergency unblinding;

in the case of a therapeutic product, the name of the substance used in the product and its strength or potency, as well as, in the case of blinded trials, the name of the comparator or placebo;[S 107/2021 wef 01/03/2021](ea)in the case of an applicable 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 107/2021 wef 01/03/2021](f)the pharmaceutical form, route of administration and quantity of dosage units of the product;

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

the batch or code number identifying the contents and packaging operation of the product;

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 107/2021 wef 01/03/2021](k)in the case of an autologous applicable CTGT product, the unique patient identifier and the words “for autologous use only” or similar wordings;[S 107/2021 wef 01/03/2021](l)in the case of an applicable CTGT product, the list of excipients, including preservative systems (if applicable), for the CTGT product;[S 107/2021 wef 01/03/2021](m)in the case of an applicable CTGT product, any warning that is necessary for the CTGT product;[S 107/2021 wef 01/03/2021](n)in the case of an applicable 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 107/2021 wef 01/03/2021](3) Without limiting the generality of sub‑paragraph (1), every registered investigational product which satisfies the requirements of sub‑paragraph (5) must be labelled with all of the following information:

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

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

the name of the person to whom the product is to be administered or the trial subject identification number;

where the product is supplied or dispensed —

at a licensed retail pharmacy or a trial site that is not an approved permanent premises, a 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 803/2023 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 identification number or logo of the healthcare service licensee;[S 431/2023 wef 26/06/2023](e)the name of the product, being the proprietary name or the appropriate non‑proprietary name of the active ingredient in the product;[S 107/2021 wef 01/03/2021](f)in the case of a therapeutic product, where the appropriate non‑proprietary name is included on the label of the product, the appropriate quantitative particulars of any active ingredient of the product;[S 107/2021 wef 01/03/2021](fa)in the case of an applicable CTGT product, the name of the CTGT product and a description, expressed qualitatively and quantitatively, of any active substance in the CTGT product;[S 107/2021 wef 01/03/2021](g)the directions for use of the product;

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

the expiry date of the product;

the date that the product is dispensed;

where the product is registered, the registration number assigned to the product by the Authority;[S 107/2021 wef 01/03/2021](l)the conditions under which the product must be stored;[S 107/2021 wef 01/03/2021](m)in the case of an autologous applicable CTGT product, the unique patient identifier and the words “for autologous use only” or similar wordings;[S 107/2021 wef 01/03/2021](n)in the case of an applicable CTGT product, the list of excipients, including preservative systems (if applicable), for the CTGT product;[S 107/2021 wef 01/03/2021](o)in the case of an applicable CTGT product, any warning that is necessary for the CTGT product;[S 107/2021 wef 01/03/2021](p)in the case of an applicable 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 107/2021 wef 01/03/2021](4) Without limiting the generality of sub‑paragraph (1), every registered auxiliary product must be labelled with all of the following information:

the name of the person to whom the product is to be administered or the trial subject identification number;

where the registered auxiliary product is supplied or dispensed —

at a licensed retail pharmacy or a trial site that is not an approved permanent premises, a 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 803/2023 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 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 approved 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 identification number or logo of the healthcare service licensee;[S 431/2023 wef 26/06/2023](c)the name of the product, being the proprietary name or the appropriate non‑proprietary name of the active ingredient in the product;[S 107/2021 wef 01/03/2021](d)in the case of a therapeutic product, where the appropriate non‑proprietary name is included on the label of the product, the appropriate quantitative particulars of any active ingredient of the product;[S 107/2021 wef 01/03/2021](da)in the case of an applicable CTGT product, the name of the CTGT product and a description, expressed qualitatively and quantitatively, of any active substance in the CTGT product;[S 107/2021 wef 01/03/2021](e)the directions for use of the product;

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

the expiry date of the product;

the date that the product is dispensed;

where the product is registered, the registration number assigned to the product by the Authority;[S 107/2021 wef 01/03/2021](j)the conditions under which the product must be stored;[S 107/2021 wef 01/03/2021](k)in the case of an autologous applicable CTGT product, the unique patient identifier and the words “for autologous use only” or similar wordings;[S 107/2021 wef 01/03/2021](l)in the case of an applicable CTGT product, the list of excipients, including preservative systems (if applicable), for the CTGT product;[S 107/2021 wef 01/03/2021](m)in the case of an applicable CTGT product, any warning that is necessary for the CTGT product;[S 107/2021 wef 01/03/2021](n)in the case of an applicable 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 107/2021 wef 01/03/2021](5) The requirements for the purpose of sub‑paragraphs (2) and (3) in relation to any investigational product are all of the following:

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

the product is not repackaged for use in the trial;

the product is used in accordance with the terms of its product registration.[S 107/2021 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), (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 107/2021 wef 01/03/2021](9) In this paragraph, “autologous”, in relation to an applicable 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.[S 107/2021 wef 01/03/2021]2. [Deleted by S 107/2021 wef 01/03/2021]