Gazette APVMA 12, 5 Decmeber 2005 page 33

LABELS FOR A RANGE OF PACK SIZES

The APVMA has amended the Label Approval Process so that applicants now have the opportunity to provide a single marketed product label (MPL) that can be approved and used for a range of pack sizes.

A label for a range of pack sizes means that a label which is attached to a container for each pack size within and including the smallest and largest pack size in that range, is identical, apart from the net contents statement, in:

wording and instructions;
format and layout including components, colours and graphics; and
dimensions, i.e. size.

Example:

An applicant intends to market a product (no. 34567) in the following 12 different pack sizes:

1, 2, 5, 10, 15, 20, 25, 40, 50, 60, 100 and 200L.

Rather than providing labels and gaining label approval for the 12 different pack sizes, the applicant indicates that three labels can be provided to cover the following sizes:

i.          the 5L label representing labels for pack sizes 1 to 10L;
ii.         the 20L label representing labels for pack sizes 15 to 60L; and
iii.       the 100L label representing labels for pack sizes 100 to 200L.

In this example, the 20L label differs to the 5L label in dimension, i.e. it is larger. The 100L label is identical in dimensions to the 20L label, but contains different disposal instructions.

Permit PER9523

The APVMA has issued permit PER9523 that allows applicants to supply a product with a label that is not identical to the approved label, but only in relation to the net contents statement.

This permit means that registrants need not make an application to the APVMA to vary the approved label, if the only variation is to include a net contents that is within the range specified in the notice of registration or label approval.

Indicating on the Application Form

If an applicant wishes to have a label approved that can be used for a range of pack sizes in accordance with permit PER9523, the applicant must indicate this on the application form.

In the appropriate section on the application form where proposed pack size(s) are indicated, rather than listing individual pack sizes, applicants should specify the range of pack sizes to which the approved label will apply. In the above example, the applicant would specify 1 to 10L, 15 to 60L; and 100 to 200L.

The applicant must provide the three draft labels for these three ranges with the application.

Note again, that the label for each range of pack sizes must be identical in wording, instructions, format and size, and may only differ in the net contents statement.

Changes to the Label Approval Number

The Label Approval Number (or LAN) is included on the components of all approved labels. The LAN has the format: product number / pack size identifier (or PSI) / version control and is preceded by ‘APVMA Approval No.’ or just ‘APVMA’.

Currently, the Pack Size Identifier (PSI) within the Label Approval Number (LAN) contains the specific pack size of the label or some other character as determined by the applicant.

If an applicant wishes to use a label for a range of pack sizes, the LAN must be amended so that where a single label is to be approved for a range of pack sizes, its PSI incorporates the range of pack sizes for which that label will be used.

Example:

For the product (number 34567 - previous example) the respective LANs would become:

5L label: 34567 / 1-10L / 1006
20L label: 34567 / 15-60L / 1006
100L label: 34567 / 100-200L / 1006

Supply of Unapproved Labels under PER9523

For the example product (number 34567), the permit PER9523 will allow the label approval holder to supply the product with the following unapproved labels:

a label with LAN 34567 / 1-10L / 1006 and a net contents statement within the range 1L to 10L inclusive, provided that the label is identical to the approved 5L label apart from the net contents statement;
a label with LAN 34567 / 15-60L / 1006 and a net contents statement within the range 15L to 60L inclusive, provided that the label is identical to the approved 20L label apart from the net contents statement;
a label with LAN 34567 / 100-200L / 1006 and a net contents statement within the range 100L to 200L inclusive, provided that the label is identical to the approved 100L label apart from the net contents statement.

Labels outside the specified pack size range

If a registrant wishes to supply an unapproved label with a net contents statement that sits outside the specified pack size range, the registrant must submit a Category 12 application to either approve a new label with the new pack size, or to vary the existing representative label to extend the pack size range.

Example:

For product number 34567, the following labels are approved:

5L label: 34567 / 1-10L / 1006
20L label: 34567 / 15-60L / 1006
100L label: 34567 / 100-200L / 1006

The registrant now wishes to market a label with a net contents of 80L.

The registrant may take one of two actions:

Submit a Category 12 application to approve a separate 80L label (with LAN 34567/80L/1106); or
Submit a Category 12 application to vary either the 20L or 100L labels by amending the PSI within the LAN to include the additional pack size, i.e. 34567 / 15-80L / 1106 or 34567 / 80-200L / 1106 depending on which of the representative labels is best suited for the container.

For enquiries please contact:

Peter Prammer
Team Manager, Application Management & Enquiries
Australian Pesticides and Veterinary Medicines Authority
PO Box E240
KINGSTON ACT 2604

Phone: (02) 6210 4703
Fax: (02) 6210 4721
email: peter.prammer@apvma.gov.au

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