Schedule 2

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 traceability;

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.

Without limiting the generality of sub‑paragraph (1), every investigational CRM that is not licensed, every licensed investigational CRM which does not satisfy the requirements in sub‑paragraph (5), and every auxiliary CRM that is not licensed 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;

the name of the substance used in the clinical research material and its strength or potency, as well as, in the case of blinded trials, the name of the comparator or placebo;

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.

Without limiting the generality of sub‑paragraph (1), every licensed 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, 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 806/2023 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 439/2023 wef 26/06/2023](e)the name of the clinical research material, being the proprietary name and the appropriate non‑proprietary name of the active ingredient in the clinical research material;

where the appropriate non‑proprietary name is included on the label of the product, the appropriate quantitative particulars of any active ingredient of the clinical research material;

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.

Without limiting the generality of sub‑paragraph (1), every licensed 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, 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 806/2023 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 439/2023 wef 26/06/2023](c)the name of the clinical research material, being the proprietary name and the appropriate non‑proprietary name of the active ingredient in the clinical research material;

where the appropriate non‑proprietary name is included on the label of the product, the appropriate quantitative particulars of any active ingredient of the clinical research material;

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.

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).

The information referred to in sub‑paragraphs (2), (3) and (4) must be in English, and must be clearly legible and unambiguous.

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.

The information referred to in sub‑paragraph (2)(b), (c), (d) and (f) to (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.

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.

be labelled in accordance with paragraph 1; or

have the following particulars written on its container:

the proprietary name, reference number or other identification mark of each item of such material;

the name and address of the manufacturer;

the production batch number of the material;

the name or other identification mark of the subject for whom the material is intended;

the date of manufacture and the expiry date of the material;

the storage conditions appropriate for each item of material as may be indicated by the manufacturer; and

the words “This product shall only be used under strict medical surveillance” or “This product shall only be used under strict dental surveillance”, as the case may be.