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Consultation on Registration Applications Policy

176 ACVM 07/06

Approval

Author: Chris Boland	Signature:	Date:
PM (ACVM and Non-Food Products): Maree Zinzley	Signature:	Date:
Asst Director Approvals: John Bongiovanni	Signature:	Date:
Director Approvals: Debbie Morris	Signature:	Date:

1 INTRODUCTION

This policy provides a policy basis for carrying out consultation on registration applications. It covers:

• consulting in regard to novel active ingredients or uses not considered by the public before;

• applying power to waive notification;

• handling of public submissions; and

• responding to submissions.

The policy does not cover consultation on the making of regulations under sections 75 or 81.

2 PURPOSE OF POLICY

This policy provides guidance to the ACVM Group when carrying out consultation on registration applications to ensure that:

• the public has an opportunity to address new risks;

• all parties are clear what principles must be applied to consultation on registration applications; and

• due care is taken.

Ref:

Agricultural Compounds and Veterinary Medicines Act 1997

ACVM Group Policy on Consultation, ACVMGP/S – 02p

3 BACKGROUND

3.1 Statutory basis for consultation on registration applications

3.1.1 Notification

Under section 13 of the Agricultural Compounds and Veterinary Medicines Act 1997 the ACVM Group, under delegated authority, must notify:

• the Minister;

• Environmental Risk Management Authority; and

• any Department that has expressed a desire to be notified

of an application to register a trade name product.

Under section 14 of the Agricultural Compounds and Veterinary Medicines Act 1997 the ACVM Group, under delegated authority, must publish a notice in the NZ Gazette and give any further notice that the ACVM Group considers is appropriate given the nature of the application and the persons likely to have an interest in the application. Section 14 also specifies what must be in a notification.

The obligation to notify is qualified in section 15, allowing the ACVM Group (also under delegated authority) to waive the requirement to notify an application if the Group considers it:

• refers to a similar product that has already been considered; or

• relates to a minor variation in an existing registration; or

• is needed for a biosecurity or forest disease emergency.

3.1.2 Submissions

Any person may make a written submission on any notified application. The submission must state in full the reasons for making the submission and may state any decision sought. A period of 30 working days must be provided to allow parties to submit comments on an application that has been notified under section 14. The end of the submission period must be specified because consideration of the application must be completed within 25 working days from the end of the submission period.

Section 18 places an obligation on the ACVM Group to forward submissions to the applicant as soon as reasonably practical.

3.1.3 Notification of outcome of consideration

Under subsection 21(3) the ACVM Group must give the application decision in writing to the applicant and to every person who made a submission.

3.2 Limitations of the ACVM Act

While the Act places an obligation on the ACVM Group to allow people to participate via submissions on notified registration applications and to notify the decision to submitters, it does not provide any guidance as to how requests for information about notified applications and subsequent submissions should be processed. Consequently, this policy and the ACVM Group Policy on Consultation should be used to guide the Group’s procedures.

The Act does not provide any guidance as to how to make a judgement that it is not necessary to publicly notify an application.

4 POLICY

4.1 Public notification

The ACVM Act requires all applications for registration (and variations to existing registrations) to be notified to the public, unless it is considered unnecessary to do so, given the criteria in section 15 of the Act. The intent of subsection 15(1)(a) is to be interpreted to mean that public notification is not necessary, if it is considered that the public has already had an opportunity to consider the issues in the context of assessments of other similar products. It should be presumed in the first instance that products registered under the ACVM Act have had adequate public consideration of the risks. Therefore, it is not necessary to publicly notify ACVM applications concerning a similar product. However, if it is suspected that the product in the application in question poses new or significantly altered risks from those previously considered, then the application must be publicly notified even though they may strictly conform to criteria specified in subsection 15(1)(a). If in doubt, the judgement should be made by either the DMC or the senior management team.

If the registered products that are similar also pose the new (or significantly altered) risk(s) posed by the product in the application in question, a decision should be made by the DMC or senior management team in regard to their reassessment under section 29 to ensure comparable risk management.

The intent of subsection 15(1)(b) is to be interpreted to mean that public notification is not necessary for any variation of a registration if the nature of the variation is such that the change is not likely to pose any new or significantly altered risks that the public should have the opportunity to consider.

Subsection 15(2) should be applied exactly as it is written.

4.2 Notifying applications

Applications should be notified in accordance with the procedure for Gazette notice (Gazetting and notification 109ACVM04/05).

Section 15 presumes that the notification would provide sufficient information about the product to facilitate informed public comment. ACVM information requirements and advice from the ACVM Group should make it clear to applicants that certain general information on their applications will be made available to the public as part of the notification process. The information will be either:

• included in the Gazette notice; or

• provided to an inquirer.

If the ACVM Group chooses not to provide a summary of the public information in the Gazette notice then it must provide that information free of charge to an inquirer.

Applicants should be given the opportunity to prepare information for the public, being guided by the kinds of information in Part A of the product data sheet. If the applicant does not want to prepare a public summary of their application, the ACVM Group should provide, without charge, Part A of the product data sheet to anyone who inquires about a publicly notified application.

If the ACVM Group receives a request for information (held by the Group) about an application, where that information was not included in the relevant public notification and is not commercially sensitive or under data protection, then the information should be provided. It should be provided free of charge if there are no material costs incurred. If significant work must be carried out to supply the information, the person requesting the information must be advised of the actual and reasonable cost that must be met before the information is prepared and provided. A request for information about an application that has been publicly notified does not constitute a submission and would not prompt the following required actions in regard to handling submissions and responding to submitters.

4.3 Handling submissions

The public notification will include information on:

• how to make a submission;

• what must be and what can be included in a submission; and

• when submissions must be received.

Every submission received must be copied to the applicant as soon as reasonably practicable after receipt of the submission. The applicant should be given an opportunity to address issues in submissions. However, if the applicant indicates that it would take time to respond and that delay would prevent the processing of the application within the statutory time limits set in section 16, then a decision must be made whether or not the timeframe should be extended. Extending the timeframe is acceptable only if:

• all the parties agree to the delay; or

• it is judged that the parties who have not consented to the delay will not be unduly prejudiced.

All submissions and applicant responses received before or on the deadline for submissions must be attached to the application when it is sent for review and evaluation. The applicant’s response should be considered, along with the original submissions, when evaluating the application.

A list of submitters must be kept with a direction to send a copy of the decision on the application and the rationale to each submitter.

4.4 Responding to submitters

Receipt of a submission should be acknowledged, in writing, in the most appropriate manner (i.e. letter, email etc.).

It is not the role of the ACVM Group to, on behalf of the applicant, investigate or resolve issues raised in submissions. The Group must not act as an advocate for the product in question. The Group must maintain a neutral position in regard to the application. However, issues raised by submitters may prompt the Group to investigate on its own behalf matters that are pertinent to the review and evaluation of the application.

While the Group should facilitate dialogue in any reasonable manner, the Group should not act as mediator between submitters and an applicant.