Regulatory update #189

12 June 2014

Getting ready for the changes from 1 July 2014

With less than three weeks to go until 1 July 2014 we are working hard to provide as much certainty as possible for industry. The two training events have been extremely valuable in identifying a range of issues where greater certainty is required for 1 July 2014.

The following information has been developed to address issues and questions raised. Topics covered include online applications and the decision tree, transition from EARS, holders and nominated agents and multiple applications for the same variation.

Check the website for information and frequently asked questions on a range of topics.

If you need further clarity or have other questions please email us.

How can I make applications after 1 July 2014

Applications will be made online from 1 July 2014 in the APVMA portal. This replaces the electronic application registration system (EARS) for application submissions.

If for some reason I can’t use the online portal what can I do?

In exceptional circumstances you can request a paper application form is sent to you.

What happens to my existing EARS account with the APVMA?

If you have an existing EARS account your company information will be automatically transferred to the new system.

What happens to EARS from 1 July 2014?

EARS will be available for tracking of applications submitted before 1 July 2014; however no submissions can be accepted through EARS from 1 July 2014.

When can I enter information into the online application?

The new online application will be available on 1 July 2014.

What is the decision tree and how does it help me complete an online application?

The online decision tree asks a few simple questions to help people work out the correct item number to use for their application.

For most items, answering less than five questions will identify the correct item number, and, if you are logged in, data fields will be pre-filled with your details—so you won’t have to re-type things like your company name and address.

Transitional arrangements for applications

How will the APVMA manage applications from 1 July 2014?

The APVMA will operate two streams of applications from 1 July 2014 to 30 June 2015. MORAG will continue to be available for applications submitted under the pre 1 July 2014 legislation.

On 1 July 2015 all applications in the system and reconsiderations commenced under the old legislation are transitioned in to the new legislation.

For applications already submitted, do the data requirements change from 1 July 2015?

An application which is already in the system on 1 July 2015 will be affected by changes to timelines and processes, but that will not change pre-existing data requirements.

What happens to applications that are lodged before 1 July 2014 and have a section 11A notice sent before 1 July 2014?

These applications will be assessed under the pre 1 July 2014 legislative arrangements up until 1 July 2015 when they will be transitioned to the new legislation.

What about applications that are lodged before 1 July 2014 but do not have a section 11A notice sent before 1 July 2014?

These applications would be assessed under the new legislation.

If my application is transitioned to the new legislation how will that impact my assessment period?

When an application transitions, the remaining assessment period will be calculated using a formula in the regulations which is the new assessment period (which in some cases is longer) less the old assessment period less any clock off time. This will apply from the date the application was accepted into evaluation.

Pre-application assistance

How do I get pre-application assistance?

Requests for pre-application assistance are made online in the APVMA portal. For more information.

Will I get pre-application assistance before 1 July 2014?

You won’t get assistance under the formal pre-application assistance scheme before 1 July 2014 as it will only come into effect when the new legislation begins.  However, you can make a request online now and we will contact you within 10 days to make arrangements in advance if possible.

Please contact us through normal channels if you need assistance with your applications before 1 July 2014.

What do the terms holders and nominated and authorised agents mean?

The term holder describes previous terms such as registrant, approval holder and interested person while nominated agent and authorised agent broadly replace approved persons.

A holder of an approval or registration appoints a person as a nominated agent. A nominated agent has the same rights and obligations as a holder, and is treated in the same way.

Authorised agents can be nominated by either the holder or nominated agent and are appointed only for the purpose of administering an application. When the application is complete the appointment of the authorised agent ceases.  For example, a consultant working on a product application must become an authorised agent if they want to deal with the APVMA directly about the application and their appointment finishes once the product is registered.

What does this mean for overseas holders?

Overseas holders must have a nominated agent in Australia. This ensures that there is a person in Australia with the same liabilities as the holder for a particular approved active constituent, approved label, or registered chemical product.

In effect the nominated agent holds the same responsibilities and accountabilities as the holder. Either party, holder or nominated agent may cancel the nomination in writing.

I’m an overseas holder what do I need to do?

The APVMA has written directly to overseas holders seeking their approval for current approved persons to become the nominated agent and asking them to identify which products each nominated agent can see and access in APVMA systems. About half have responded to date.

If you are an overseas holder, and you have not yet taken action please email enquiries@apvma.gov.au and put ‘Holder and nominated agent’ in the subject so we can work with you to ensure you comply with the law from 1 July 2014.

What information will nominated agents be able to access in the APVMA portal?

Nominated agents will see only those products for which the holder has nominated them as the agent. The current EARS system operates the same way where registrants identify an approved person, and those people have access only to the products identified by the registrant (now holder).

Information available to a holder in the APVMA systems about a particular product is available to the nominated agent for that product. Holders and nominated agents need to make their own arrangements regarding confidentiality of information.

How can I make the same change to multiple products from 1 July 2014?

You will be able to use the online application to apply to make the same change to multiple products if you are changing your product manufacturer or part of your product name following a change to your business.

As you complete your online application you will need to identify the products you are seeking to apply the same change to, and the resulting applications will be generated by the online system. The applications will be made under item 13A in the online system.

Help and assistance

Reminder—open for public consultation

The APVMA is currently seeking comment on:

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.

  • Econase XT P
  • Melpat Hydrocop WG Fungicide/Bactericide
  • Silirum Vaccine
  • Accensi Iprodione 365 SE Fungicide
  • Permethor Magnetic Insecticidal Dust With Magthanite
  • Bithor Dual Action Insecticide
  • Sinochem Seeker 200SC Insecticide
  • Rancona Dimension Seed Treatment
  • Tanalith E Wood Preservative Concentrate
  • Biorelease Deslorelin (BRD)
  • Turf Culture Columbus Insecticide
  • Rustler Selective Herbicide
  • Balance 750 WG Herbicide
  • Apex Thyroxine Drops
  • Vigilant II Herbicide
  • Sumitomo Samurai Systemic Insecticide

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

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