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Implementation of the ACVM Act: Regulatory changes

NZFSA Public Discussion Paper no 03/08

May 2008

(Online) ISSN 1177-7478

ISBN 978-0-478-32210-1

Important Disclaimer

Every effort has been made to ensure the information in this report is accurate.

NZFSA does not accept any responsibility or liability whatsoever for any error of fact, omission, interpretation or opinion that may be present, however it may have occurred.

Website

A copy of this document can be found at www.nzfsa.govt.nz.

Table of Contents

1 Introduction 3

1.1 Reform of the ACVM Act’s administration 3

1.2 Purpose of this document 3

1.3 Background 3

1.4 Next steps in the reform process 3

2 Manufacturing regulations 3

2.1 Use of terminology and definitions 3

2.2 Current regulatory regime 3

2.2.1 Regulatory control of manufacture by product class 3

2.2.2 Negative effects 3

2.2.3 International agreements 3

2.3 Proposed regulatory regime 3

2.3.1 Status of manufacturers 3

2.3.2 Overseas manufacturers 3

2.3.3 Use of operating plans 3

2.3.4 Compliance programme 3

2.3.5 Linking products to manufacturers 3

3 Labelling 3

3.1 Current regulatory regime 3

3.2 Proposed regulatory regime 3

4 Advertising and promotion regulations 3

4.1 Use of terminology and definitions 3

4.2 Current regulatory regime 3

4.2.1 Negative effects 3

4.3 Proposed regulatory regime 3

4.3.1 Warning information 3

4.3.2 Obligation to represent the product as authorised 3

4.3.3 Information transfer versus advertising/promotion 3

4.3.4 Obligations on parties with no vested interest in the products 3

4.3.5 Communication about off-label uses 3

5 Own use/off-label regulations 3

5.1 Use of terminology and definitions 3

5.2 Own use 3

5.2.1 Current regulatory regime 3

5.2.2 Proposed regulatory regime 3

5.3 Off-label use or MUMS 3

5.4 Provision of professional services 3

6 Regulatory impact statement 3

Submissions

NZFSA seeks submissions from all interested parties on any aspect of the Agricultural Compounds and Veterinary Medicines Act 1997.

The following points may be of assistance in preparing comments:

• Wherever possible, comment should be specific to a particular section of the document. All major sections are numbered and these numbers should be used to link comments to the document.

• Omissions should be clearly and separately indicated.

• Comments should be to the point and, where possible, reasons and data to support comment are requested.

• The use of examples to illustrate particular points is encouraged.

• As a number of copies may be made of your comments, please use good quality type, or make sure the comments are clearly hand-written in black or blue ink.

Please include the following information in your submission:

• The title of the discussion document

• Your name and title (if applicable)

• Your organisation’s name (if applicable)

• Your address

• The number(s) of the sections you are commenting on.

Please submit your response by 5:00pm on 11 July 2008.

Your comments should be sent to:

Policy Group

New Zealand Food Safety Authority

PO Box 2835, Wellington

Fax: 04 894 2583

Email: policy@nzfsa.govt.nz

Please note that your submission is public information and subject to the Official Information Act (OIA) 1982. The OIA states that information is to be made available unless there are grounds for withholding it. Grounds for withholding information are stated in the OIA.

If you consider that any or all information in your submission should be treated as confidential or is commercially sensitive, please state this clearly when making your submission.

NZFSA will take any such indication or request into account when determining whether or not to release information. Any decision to withhold information requested under the OIA may be reviewed by the Ombudsman.

Implementation of the ACVM Act: Regulatory changes