Schedule 2

Labelling requirements

of Medicines (Clinical Trials) Regulations 2016

Subsidiary LegislationIn forceProvision 31 of 31

SECOND SCHEDULERegulation 26Labelling requirements1.—

(1)

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

(a)

to ensure protection of the subject and traceability;

(b)

to enable identification of the product and the trial;

(c)

to facilitate proper use and storage of the product;

(d)

to ensure the reliability and robustness of data generated in the trial.

(2)

Without limiting the generality of sub‑paragraph (1), every investigational medicinal product that is not licensed, every licensed investigational medicinal product that does not satisfy the requirements of sub‑paragraph (5), and every auxiliary medicinal product that is not licensed, must be labelled with all of the following information:

(a)

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

(b)

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

(c)

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

(d)

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

(i)

information on the product;

(ii)

information on the trial; and

(iii)

emergency unblinding;

(e)

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;

(f)

the pharmaceutical form, route of administration and quantity of dosage units of the product;

(g)

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);

(h)

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

(i)

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;

(j)

the storage conditions.

(3)

Without limiting the generality of sub‑paragraph (1), every licensed investigational medicinal product which satisfies the requirements of sub‑paragraph (5) must be labelled with all of the following information:

(a)

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

(b)

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

(c)

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

(d)

where the licensed investigational medicinal product is supplied or dispensed —

(i)

at 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 trial site; [S 812/2023 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;

(iii)

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

(A)

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

(B)

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

(iv)

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

(A)

(B)

in any other case — the business name, address and any identification number or logo of the healthcare service licensee;[S 440/2023 wef 26/06/2023](e)the name of the product, being the proprietary name and the appropriate non‑proprietary name of the active ingredient in the product;

(f)

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;

(g)

the directions for use of the product;

(h)

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

(i)

the expiry date of the product;

(j)

the date that the product is dispensed;

(k)

where the product is licensed, the product licence number assigned to the product by the Authority.

(4)

Without limiting the generality of sub‑paragraph (1), every licensed auxiliary medicinal product must be labelled with all of the following information:

(a)

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

(b)

where the licensed auxiliary medicinal product is supplied or dispensed —

(i)

(iii)

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

(A)

(B)

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

(iv)

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

(A)

(B)

in any other case — the business name, address and any identification number or logo of the healthcare service licensee;[S 440/2023 wef 26/06/2023](c)the name of the product, being the proprietary name and the appropriate non‑proprietary name of the active ingredient in the product;

(d)

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;

(e)

the directions for use of the product;

(f)

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

(g)

the expiry date of the product;

(h)

the date that the product is dispensed;

(i)

where the product is licensed, the product licence number assigned to the product by the Authority.

(5)

The requirements for the purpose of sub‑paragraphs (2) and (3) in relation to medicinal products, and auxiliary medicinal products that are not licensed, are all of the following:

(a)

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

(b)

the product is not repackaged for use in the trial;

(c)

the product is used in accordance with the terms of its product licence.

(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‑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 —

(a)

sub‑paragraph (1) is complied with; and

(b)

the reasons for the omission are set out in the protocol or such other document as the Authority may allow.

2. Every investigational medicinal product and every auxiliary medicinal product used before 1 November 2017 in a clinical trial must —

(a)

be labelled in accordance with paragraph 1; or

(b)

have the following particulars written on its container:

(i)

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

(ii)

the name and address of the manufacturer;

(iii)

the production batch number of the product;

(iv)

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

(v)

the date of manufacture and the expiry date of the product;

(vi)

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

(vii)

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.

Read in full context — Medicines (Clinical Trials) Regulations 2016 →

Schedule 2

Labelling requirements

of Medicines (Clinical Trials) Regulations 2016

Subsidiary LegislationIn forceProvision 31 of 31

SECOND SCHEDULERegulation 26Labelling requirements1.—

(1)

(a)

to ensure protection of the subject and traceability;

(b)

to enable identification of the product and the trial;

(c)

to facilitate proper use and storage of the product;

(d)

to ensure the reliability and robustness of data generated in the trial.

(2)

(a)

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

(b)

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

(c)

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

(d)

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

(i)

information on the product;

(ii)

information on the trial; and

(iii)

emergency unblinding;

(e)

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;

(f)

the pharmaceutical form, route of administration and quantity of dosage units of the product;

(g)

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);

(h)

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

(i)

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;

(j)

the storage conditions.

(3)

(a)

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

(b)

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

(c)

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

(d)

where the licensed investigational medicinal product is supplied or dispensed —

(i)

(iii)

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

(A)

(B)

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

(iv)

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

(A)

(B)

(f)

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;

(g)

the directions for use of the product;

(h)

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

(i)

the expiry date of the product;

(j)

the date that the product is dispensed;

(k)

where the product is licensed, the product licence number assigned to the product by the Authority.

(4)

Without limiting the generality of sub‑paragraph (1), every licensed auxiliary medicinal product must be labelled with all of the following information:

(a)

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

(b)

where the licensed auxiliary medicinal product is supplied or dispensed —

(i)

(iii)

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

(A)

(B)

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

(iv)

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

(A)

(B)

(d)

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;

(e)

the directions for use of the product;

(f)

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

(g)

the expiry date of the product;

(h)

the date that the product is dispensed;

(i)

where the product is licensed, the product licence number assigned to the product by the Authority.

(5)

The requirements for the purpose of sub‑paragraphs (2) and (3) in relation to medicinal products, and auxiliary medicinal products that are not licensed, are all of the following:

(a)

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

(b)

the product is not repackaged for use in the trial;

(c)

the product is used in accordance with the terms of its product licence.

(6)

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

(7)

(8)

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 —

(a)

sub‑paragraph (1) is complied with; and

(b)

the reasons for the omission are set out in the protocol or such other document as the Authority may allow.

2. Every investigational medicinal product and every auxiliary medicinal product used before 1 November 2017 in a clinical trial must —

(a)

be labelled in accordance with paragraph 1; or

(b)

have the following particulars written on its container:

(i)

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

(ii)

the name and address of the manufacturer;

(iii)

the production batch number of the product;

(iv)

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

(v)

the date of manufacture and the expiry date of the product;

(vi)

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

(vii)

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.

Read in full context — Medicines (Clinical Trials) Regulations 2016 →