- Print Friendly - Help

Previous page  | Contents |  Next page

Pack size approval

The ACVM Group has introduced a policy to modify the method of pack size approval. The new methodology provides an adequate level of product quality assurance to the ACVM Group at a greatly reduced expense to registrants.

The current system requires that all new pack sizes be the subject of a formal application (C3), with variable data requirements and expense to the applicant. Under the new policy, provided the appropriate data and information are supplied, the ACVM Group will approve a range of pack sizes at initial registration. From that point, all pack sizes with a risk profile that fall within the assessed range (such as the same packaging material) will be considered approved.

For existing products applications can be made to approve a range of pack sizes as a normal C3, with referencing to data already on file, or via the provision of additional information.

In either case, the ACVM Group will require notification of the actual pack sizes being marketed in the form of an official letter, which must be provided each time a new pack in the approved range is introduced to the market.

In addition, any subsequent applications requiring a product data sheet to be submitted must state the marketed pack sizes as well as the approved range. Labels for additional packs will not require approval provided the content does not differ from that approved. For new packs falling outside of the approved risk profiles, new data and a C3 application will still be required.

A fee of $364.50 is applicable. This is in addition to the prescreen fee of $364.50.

Annual fees

It is that time of the year again when information is collected for charging of fees for the 2002/2003 financial year. By now you should have received a letter and product list explaining what is required of each company this year.

If you have not received the letter and product list, or if you have any ques-tions, please contact:

Sarah Smyth
04 460 8753 or
smyths@maf.govt.nz

RLC meeting

The ACVM Group was represented at the 22 nd Registration Liaison Committee Meeting at the Australian National Registration Authority (NRA) by Brian Pidford and Maree Zinzley. Six-monthly updates of current issues and initiatives are provided by the NRA, the regulatory authorities in the States and Territories, and by MAF at the meeting. Key points noted included the following:

• There is a continuing difficulty of setting and implementing controls on the use of agricultural chemicals on a national basis in Australia because compliance is undertaken by States and Territories under their local legislation.
• The NRA proposes to reform the labelling requirements of agricultural chemical products so that all mandated information and voluntary information is provided in seven panels. Label information in this context includes user information leaflets. A discussion paper will be provided for comment.
• The NRA is submitting proposals to the EMEA in Europe for its own GMP approval process to be accepted as equivalent to the European process under their mutual recognition agreement. Australian manufacturers who export to the EC are currently approved by the TGA.
• Notice of the proposed NRA review of 1080 has drawn large public interest (250 submissions were made on the scope of the review). The review scope document and agricultural evaluation should be available in June. The NRA is not expecting 1080 will need to be withdrawn, but the review will be contentious.
• Concerns exist for an apparent lack of scrutiny in regard to the statistical validity of trials involving animals. There is no requirement by the NRA for biometric input into proposed trials to ensure consistency and validity. This might result in too many animals being used, or invalidate studies because of too few test subjects. Priority was assigned to dealing with this issue at the next meeting.