Sch 2

Schedule 2

 

 

Required Advisory Statements for Medicine Labels No. 4

 

(section 6)

 

 

Schedule 2 

Required Advisory Statements for Medicine Labels No. 4

Advisory statements

Where a medicine:

1)                  includes a substance described in Column 1 of the Table: Required Advisory Statements for Medicine Labels No. 4 (‘the table’), below; and

2)                 meets the condition(s) described in Column 2 of the table;

the statement(s) set out in Column 3 of the table must be contained on the labels of the medicine in accordance with the Labelling Order, in a manner that is compliant with any applicable presentation requirement(s) set out below  (the requirements are indicated in the table by the presence of the applicable alphabetical in square brackets, next to the statement or, in the case of a requirement to use upper case and/or bold face, by use of upper case and/or bold face letters in the statement itself).

Unless otherwise specified, the requirements apply only if the substance is included in the medicine as an active ingredient.

Permitted variation and combination of statements

The wording of the statements specified in this document may be varied provided that the intent is not changed.

Where more than one statement is required, they may be combined to form simple sentences where appropriate, provided that the intent is not changed and that any additional requirements are also met.

Additional presentation requirements for some advisory statements

In some cases, additional requirements apply to advisory statements, such as font, letter size etc.   Where such additional requirements apply, they are indicated in Column 3 of the table either by a letter in square brackets (e.g. [c]) or, in the case of a requirement to use upper case and/or bold face, by use of  upper case and/or bold face letters in the statement itself.  The meaning of the letters is set out below:

 [c]: Statement(s) must be included at the beginning of the directions for use on the label.

 [f]:  Statement(s) must be included on the label written:

(i) on a separate line or lines immediately below the cautionary statement “KEEP OUT OF REACH OF CHILDREN”; and

(ii)  in bold-face sanserif capital letters of uniform thickness; and

(iii) in letters as least four tenths the height of the letters used for the signal heading; and

(iv) with nothing else besides the statement written on the same line.

[g]: Statement(s), written in sanserif capital letters, must be included on the main label or as part of the directions for use.