Part 9Substitution of Part 7 (Labelling of Investigational Medicinal Products)

Substitution of Part 7

32.  For Part 7 (labelling of investigational medicinal products) substitute—

“Part 7LABELLING

Labelling of investigational medicinal products

46.—(1) Subject to paragraph (4), where the investigational medicinal product is not an authorised medicinal product, it must be labelled with the following information—

(a)the words “for clinical trial use only”;

(b)a warning that the product must be stored out of the reach and sight of children (unless the product is to be exclusively administered in a hospital or health centre taking part in the clinical trial);

(c)information to identify the sponsor and contact persons involved in the clinical trial;

(d)information to allow identification of the clinical trial, for example the clinical trial reference code;

(e)information linking the product to the participant, for example, the participant identification number;

(f)information to allow identification of the medicinal product, including—

(i)the common name of the active substance,

(ii)the strength and pharmaceutical form,

(iii)the contents by weight, volume or number of doses, and

(iv)the batch or code number;

(g)information related to the use of the medicinal product, including—

(i)instructions for use (which may be by reference to a patient information leaflet),

(ii)method or route of administration,

(iii)expiry date, and

(iv)any special storage precautions; and

(h)in the case of trials in which blinding occurs, the name of any comparator or placebo product used alongside the investigational medicinal product.

(2) Subject to paragraph (4), where the investigational medicinal product is an authorised medicinal product, it must be labelled either—

(a)in accordance with paragraph (1); or

(b)in accordance with Part 13 of the 2012 Regulations.

(3) Paragraph (4) applies to an investigational medicinal product which is—

(a)an authorised medicinal product to be exclusively administered in a hospital or health centre taking part in the clinical trial; or

(b)a radiopharmaceutical used for diagnostic purposes.

(4) Where paragraph (3) applies, the investigational medicinal product must be labelled with at least the following information—

(a)the words “for clinical trial use only”, or equivalent wording;

(b)information linking the product to the participant, for example, the participant identification number;

(c)information to allow identification of the medicinal product, including—

(i)the common name of the active substance,

(ii)the strength and pharmaceutical form,

(iii)the contents by weight, by volume or by number of doses, and

(iv)the batch or code number;

(d)information related to the use of the medicinal product (which may be by reference to a patient information leaflet);

(e)the expiry date; and

(f)any other information relating to the clinical trial or the product that the authorities, as defined in regulation 11 (interpretation of Part 3), may require by guidelines published under paragraph (8).

(5) The sponsor may request to disapply or vary any of the requirements of this regulation at the time of the application under regulation 16.

(6) If a request under paragraph (5) is agreed—

(a)the licensing authority must inform the sponsor by a notice in writing at the time of approval under regulation 18 or 18B; and

(b)the sponsor must record that decision and any conditions in the investigational medicinal product dossier.

(7) Where—

(a)the trial is a notifiable trial; and

(b)the request concerns an authorised medicinal product which is to be exclusively administered in a hospital or health centre taking part in the trial,

the request is to be treated as agreed if no notice is given in accordance with paragraph (6)(a).

(8) The licensing authority may publish guidance on labelling of investigational medicinal products, which may include guidance on how the labelling requirements are to be met in relation to products that are—

(a)radiopharmaceuticals used for diagnostic purposes;

(b)used exclusively in a hospital or health centre;

(c)provided in differently sized or differently assembled packs, for example blister packs and small packages.

(9) For the purposes of this regulation, a medicinal product is authorised if there is a UK marketing authorisation or Article 126a authorisation, each as defined in regulation 8(1) of the 2012 Regulations, in force for the product.

(10) This regulation is subject to regulation 46B (labelling of certain POC investigational medicinal products).

Labelling of non-investigational medicinal products

46A.—(1) Subject to paragraph (2), a non-investigational medicinal product must be labelled in accordance with the requirements set out in regulation 46, and any reference in that regulation to “investigational medicinal product” is to be construed as a reference to “non-investigational medicinal product” accordingly.

(2) Regulation 46(4) does not apply to a non-investigational medicinal product which falls within sub-paragraph (a) of regulation 46(3).

Labelling of certain POC investigational medicinal products

46B.  Regulation 46 does not apply to a POC investigational medicinal product that is to be administered in its entirety immediately after manufacture.”.