Guidance on using the Required Advisory Statements for Medicine Labels (RASML)
To find out which statements (if any) are required by the RASML for a particular over-the-counter or complementary medicine, follow the following stepwise explanation.
Check Column 1 of the table (headed "Substances").
Medicines are arranged alphabetically in rows ('entries') in the table, by substance. Substances may be designated in a number of ways including:
- by use of its Australian Approved Name (AAN, ABN, AHN etc)
- by designation of its pharmaceutical class (eg antihistamines).
It is possible that a medicine may require advisory statements from any or all of these entries. It is the sponsor's responsibility to ensure that all relevant advisory statements are included on the label.
For example, a medicine containing paracetamol and an antihistamine would be required to include advisory statements for both "paracetamol" and "antihistamines".
If the medicine includes a substance referred to in Column 1, go to Step 2. If not, no advisory statements are required by the RASML.
For each relevant substance in Column 1, check the conditions stated in Column 2 "Conditions".
Where the medicine contains a substance referred to in Column 1 and meets the condition(s) shown in Column 2, the advisory statements referred to in Column 3 "Required Statement(s)" must be included on the label. If additional presentation requirements apply to a particular statement, these are shown as letters in square brackets in Column 3. These letters correspond to the additional requirements included under the heading "Additional presentation requirements for some advisory statements" on page 1 of the RASML.
If the conditions in Column 2 do NOT apply to the medicine, no advisory statements are required by this RASML entry.
For example, for medicines containing tramazoline 'Entry 1' in RASML No. 2 shows the condition "in nasal decongestant preparations for topical use" in Column 2. If the medicine containing tramazoline is for topical use as a nasal decongestant the statement "If congestion persists, consult your doctor or pharmacist" is required. If the medicine is not a nasal decongestant, or is not for topical use, this statement is not required. However, other statement(s) may be required by one or more of the other entries for this substance.
Permitted variation of statement wording
The wording shown in Column 3 of the table is the wording that should be used in most cases. The wording of the statements may be varied provided that the intent is not changed.
For example, "lactating" is acceptable on existing labels instead of the synonym "breastfeeding" (although "breastfeeding" is preferred). However, it is not acceptable to use broad terminology such as "health professional" instead of specific words such as "doctor", "dentist" and/or "pharmacist" where these are used in the entry.
In some cases, presentation requirements apply to advisory statements; such as a particular font, letter size etc. Where such additional requirements exist, they are indicated by a letter in square brackets, adjacent to the required statement(s).
(Entry 1 of 2)
|In nasal decongestant preparations for topical use||If congestion persists, consult your doctor or pharmacist. [j]|
Presentation requirement '[j]' states that:
"The statement(s) must:
- be grouped with any other statements marked with this additional requirement; and
- if the heading "SAFETY DIRECTIONS" is required on the label, be included immediately after that heading; or
- if the heading "SAFETY DIRECTIONS" is not required on the label, be included immediately preceding the directions for use."
In the case of tramazoline, the heading "SAFETY DIRECTIONS" is not required, so the presentation requirement '[j]' only means that the required statement must be located immediately preceding the directions for use.
In many cases more than one advisory statement is required. If required statements are shown as a list of dot points, all the indicated statements are required.
In some cases alternative statements are allowed. In this case, the alternative statements are prefaced by "either" and "or".
For example, in the case of 'Antihistamines' the requirements are:
This medication may cause drowsiness. If affected do not drive a vehicle or operate machinery. Avoid alcohol.[j]
This medication may cause drowsiness and may increase the effects of alcohol. If affected do not drive a motor vehicle or operate machinery. [j]"
Where more than one statement is required, they may be combined to form simple sentences where appropriate, provided that the intent of each of the statements is not changed and any additional presentation requirements are also met.