Document ID: chunk:federal_register_of_legislation:F2023C00456:schedule:3:p18
Version: federal_register_of_legislation:F2023C00456
Segment Type: schedule
Provision Reference: sch 3 (pt 18/27)
Character Range: 48748–51535

use - a statement to the effect that 'the medicine should not be used more than four weeks', or such shorter period as specified in the approved product details in relation to the medicine, after the container is first opened;

           (d) if the medicine consists of a solid ophthalmic medicine for preparing eye drops for multidose use - a statement to the effect that 'the medicine when prepared should not be used more than four weeks', or such shorter period as specified in the approved product details in relation to the medicine, after the container is first opened.

           (e) if the medicine consists of a solid ophthalmic medicine for preparing eye drops for multidose use - the words 'for eye drops'.

       (2) Preparations for use on skin and/or mucous membranes or by inhalation, and metered nasal sprays

       The label on a container and on a primary pack (if any) of a medicine which is a preparation for use on skin and/or mucous membranes or is for inhalation or is a metered nasal spray must, in addition to the requirements referred to in sections 8 and 9 above, include the name of any antimicrobial preservative in the medicine.

       (3) Homoeopathic medicines

       Where all the active ingredients in a medicine are homoeopathic preparations, the main label on the container and the main label on the primary pack (if any) must, in addition to the requirements referred to in sections 8 and 9 above, include a statement to the effect that the medicine is a homoeopathic medicine in text size that is not less than 50% of the text size of the name of the medicine and (in any event) not less than 2 millimetres.

       (4) Formulations containing both homoeopathic preparations and non-homoeopathic ingredients

       Where a medicine contains active ingredients that are homoeopathic preparations, and other active ingredients that are not homoeopathic preparations, then, in addition to the requirements referred to in sections 8 and 9 above:

           (a) the main label on the container and the main label on the primary pack (if any) must include a statement to the effect that the medicine contains homoeopathic preparations in text size that is not less than 50% of the text size of the name of the medicine and (in any event) not less than 2 millimetres; and

           (b) the label on the container and the label on the primary pack (if any) must differentiate ingredients that are homoeopathic preparations from those that are not, such as by including the statement 'contains homoeopathic preparations of' adjacent to the list of homoeopathic ingredients, or by prefacing the name of the homoeopathic active ingredient with the term 'homoeopathic'.

       (5) Sunscreen preparations

       If:

           (a) the medicine is a