Regulatory update #201

Legislation changes commencing 1 January 2015

A range of legislative changes take effect on 1 January 2015. These include label particulars, prescribed relevant particulars and the notification scheme. More information will be available over coming weeks to help people get ready.

Tips for submitting applications

• Include all information: when you get to the ‘information’ tab of the online application please complete a ‘data item box’ for all information that makes up your application package. This means all the pieces of information in your application must be listed—not just data in the sense of trials or toxicity—but everything. This includes documents such as GMP information, declarations, MSDSs, your executive summary, any arguments for not providing information, and any information that might be coming separately from a third party—obviously you won’t be able to attach those files but you still need to complete a data item box.
• Please use the eLabel template: label particulars must be entered into the eLabel template (available to registered users of our online services). Using the old text or MPL format or attaching Word or PDF documents may result in the application being refused.

Data guidelines

New data guidelines, or changes to existing ones, will now be listed in the regulatory update and from now on you will see a ‘last updated’, and ‘last reviewed’ date at the end of each guideline and a version history where appropriate.

Amended data guidelines (since July 2014)
 
The following data guidelines were reviewed by the APVMA and changes made:

• Pesticides efficacy and crop safety general guideline (Part 8) – added reference to the fact that efficacy data, argument or use of a reference product might not be needed for some products, including a link to the legislative instrument for efficacy criteria
• Registration of an agricultural chemical product – added references to confidential commercial information in relation to reference products
• Approval of a new source of an active constituent – deleted references to stability studies and GPS coordinates for manufacturing sites.

New data guidelines

The following data guideline was added:
Guideline for registering generic veterinary chemical products.

Chief Scientist appointment

Dr Phil Reeves has been appointed to the new role of APVMA Chief Scientist. Dr Reeves will be working on a number of initiatives, including a focus on the continuous enhancement of scientific capability at the APVMA. Dr Les Davies remains Principal Scientist (Pesticides) in the Office of Chief Scientist and will be a driving force for promoting scientific capacity at the APVMA.

Website improvements

We’ve made some improvements to our home page and added some fly-out menus to improve navigation.

Updated list of licensed manufacturers of veterinary chemical products

We have updated the list of licenced veterinary chemical product manufacturers (current as of 22 September 2014). Amendments to the list are published in the APVMA gazette each month.
 
Please note: any special conditions which may apply to the licences do NOT appear in this document. These conditions may limit or exclude particular types of products or steps of manufacture—always check with the manufacturer.

First-principles review of the APVMA's cost recovery arrangements

The Department of Agriculture has published submissions on the final report into first-principles review of the APVMA's cost recovery arrangements.

Help and assistance

Visit: www.apvma.gov.au
Telephone: +61 2 6210 4701
Email: enquiries@apvma.gov.au

Reminder—open for public consultation

• Imepitoin in the products Pexion 400 mg Tablets for Dogs and Pexion 100 mg Tablets for Dogs – until 16 December 2014
• Oclacitinib in the products Apoquel 16 mg, Apoquel 5.4 mg and Apoquel 3.6 mg – until 16 December 2014
• Proposed approval of the new active constituent, fluralaner, and registration of Bravecto Fluralaner Chewable Tablets for Dogs – until 30 December 2014
• Proposal to Amend Standard 1.4.2 of the Australia New Zealand Food Standards Code – until 12 January 2015

Applications

Advice Summaries published since last issue are listed below. For a complete list and further information, please refer to the Advice Summaries content on our website.

• Vivus Max Helicoverpa Biocontrol
• Crop Culture Armoury Herbicide
• Dupont Benevia Insecticide
• Porcilis PCV Vaccine
• Vetmedin 10mg Chewable Tablets For Dogs
• Emblem Fungicide
• Whitestar Flutriafol 500 SC Fungicide
• Barmac Thiram DG Fungicide
• Ridomil Gold 25G Systemic Granular Fungicide
• Medallion Turf Fungicide
• Poncho Plus Insecticidal Seed Treatment
• Valor 500 WG Herbicide
• Wetcit Spray Adjuvant
• Vaxsafe IB Vaccine (Living)
• Pyrinex Super Insecticide/Miticide
• Dupont Vydate L Insecticide/Nematicide
• Mosquito-Patch Insect Repellent
• Mozziegear Anti-Mosquito Wipes
• Vaxsafe MS Vaccine (Living)
• AC Emporium 500 Seed Treatment
• Loveland Products Liberate Adjuvant
• Terminade Residual Termiticide
• Nufarm Weedmaster Dst Dual Salt Technology Herbicide
• Nufarm Champ Flowable 350sc Fungicide
• Biotrap Ddvp Cubes
• Bay-O-Pet Tick Collar for Dogs Over 8 KG
• Bay-O-Pet Tick Collar for Dogs and Puppies Less Than 8 KG
• Nexgard Chewables for Dogs 2-4 KG
• Nexgard Chewables for Dogs 4.1-10 KG
• Nexgard Chewables for Dogs 10.1-25 KG
• Nexgard Chewables for Dogs 25.1-50 KG
• Fel-O-Vax FIV Vaccine (Inactivated)
• Nufarm Champ 500 WG Fungicide
• Crop care Captan 900WG Fungicide
• Slimax Broadacre Slug and Snail Bait
• Imtrade Haloxyfop 900 EC Herbicide
• Yates Zero Rapid 1-hr Action Weedkiller
• Nail 600EC Herbicide
• Dormex Plant Growth Regulator
• Carbonyl Sulfide
• Dupont Mankocide DF Fungicide

Application summaries are updated weekly. For a complete list, please refer to the application summaries content on our website.