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Implementation of More Stringent Pre-screening Requirements

Pre-screen Process: Deficient Applications

Introduction of the pre-screen service in January 1998 was a successful mechanism for referring incomplete or deficient applications back to the applicant. The principal advantage of this mechanism was that it freed up ACVM Group staff to progress applications that met the required specifications. The system has also helped to ensure that applicants have an appropriate understanding of the agricultural compounds and veterinary medicines they wish to sell or use in New Zealand.

We believe that the implementation of this process has allowed us to provide a more equitable service for all applicants. As the ACVM Group is funded predominantly from application and registration fees, it has also permitted us to reduce the subsidisation of deficient applications (through advice, time and resources spent assisting these applicants) by applicants who adhere to time frames, and supply the information required with their applications.

In general, since introduction of this process, the quality of applications received has greatly improved, allowing faster and more efficient registration/licensing. Nevertheless, the ACVM Group continues to receive large numbers of deficient  applications that ‘clog up’ the system. Our experience indicates that the majority of such applications are submitted by applicants who do not have a good understanding of the products they wish to register or who are unfamiliar with the required process.

On 1 July 1999, the ACVM Group produced a series of documents setting out the requirements for the registration of agricultural compounds in New Zealand. At that time our stated policy was to turn down:

(a) applications that require more than one attempt to amend deficiencies noted at pre-screen; or

(b) incomplete applications that have remained in pre-screening for more than two months.

In practice, though, we have tried to assist applicants as far as possible and have allowed some applications more than one attempt to amend pre-screening deficiencies without being turned down.

As discussed above, however, this practice does raise issues of unfair subsidisation and inconsistent service to our clients. For this reason, from 1 April 2001 we intend to enforce our stated policy. If an application does not provide the required information within the required time frame, or if the deficiencies are not sufficiently addressed as per the deficiency letter, the application will be considered to be incomplete and returned, and a new application will be required to register/ license the product. Essentially, applicants will have ‘one shot’ at addressing deficient applications.

Should the applicant wish to resubmit the application at a later date, address-ing previous deficiencies, the resubmission will be treated as a new application and a new pre-screen fee will be required.

The onus is on the applicant to ensure adherence to the appropriate standards and guidelines, so that the application is complete and valid upon arrival at the ACVM Group.

It should be noted that approved creditors will still be invoiced for the pre-screen fee, which is a non-refundable fee that pays for work done during the pre-screen process for the application.

Data Package Review Forms/ Overall Application Summary

Every data package received by the ACVM Group should contain:

• a Data Package Review
• an Overall Application Summary.

The Data Package Review (DPR) is an index supplied with each individual data package (Residues, Efficacy, Toxicology, etc.) that points the technical assessors to the critical data in those packages as itemised in the pre-screen process. DPRs are intended to assist applicants to indicate where data in individual packages might be deficient and to explain why this is so. This easy means of referring back to specific information in previous applications is also intended to improve the processing of queries from applicants and variations to the licence. Templates for the individual DPRs can be obtained at:  http://www.maf.govt.nz/acvm/publications/forms/dpr.htm  

The Overall Application Summary summarises the complete application and contains any discussion or argu-ment relating to the application. One copy must be supplied with the application form and one copy with the first part of any accompanying data package. This summary should provide information on formulation, details of pharmacology and other essential details. It must also address each of the data packages submitted.

In the August 2000 issue of AgVetLink readers were informed that the lack of DPRs with submitted data packages was causing significant delays [ continued... ]