Regulatory News


Winter 2018 Newsletter

Our Winter Newsletter edition looks at the importance of a 5 Batch analysis report and ways to avoid the common pitfalls. Also discussed are the proposed application fee increases for applications to the New Zealand Environmental Protection Authority. Our TGA segment looks at the need for Good Manufacturing Practice (GMP) clearance even for low risk complementary products. Plus we highlight the personal side of our consultant, Eunice Wong.

Autumn 2018 Newsletter

The Autumn 2018 De Groot Technical Services Newsletter contains articles on Duty of Care, Improving APVMA Assesment Performance, Reporting Adverse Experiences and GHS Labelling update.

Autumn 2018 Newsletter

Our Autumn issue looks at Duty of Care. The recent poisoning of a person who accidently ingested a Schedule 7 dangerous poison from an unreliable drink bottle highlights the importance of understanding Duty of Care obligations.

Also discussed are some of the outcomes from an external review of the APVMA assessment performance. The message is clear. Good quality submissions mostly from frequent applicants and/ or via use of consultants make up the majority of applications that are assessed within time.

What constitutes an Adverse Experience and their reporting requirements together with a reminder about GHS compliance are also discussed in this edition.



External APVMA Review Outcomes

The outcomes of an external review identifying causes for delays in approvals and registrations by the APVMA has been released.

The report highlights that a key factor influencing assessment performance is how the APVMA responds to and handles submissions of varying quality standards. For the time period under review (just over 3 years) some interesting statistics emerge:

- A total of 11,000 applications from 887 applicants.
- The top 38 applicants (frequent and good quality submissions) account for over 50% of the assessments.
- Item 7, 8 and 12 applications make up the largest group not meeting the timeframe targets.

Not surprisingly good quality submissions from frequent applicants (either from company applicants or via use of consultants) make up the majority of applications that are within timeframes.

The review makes a range of recommendations which the APVMA have announced they have accepted and will prioritise for implementation.

 Of particular interest is the attention in future on quality applications through:

- More effective use of refusals and requests for information, with poorer quality submissions.
- Encouragement for low frequency applicants to utilise the services of a consultant.
- Encouragement of Pre Application Assistance (PAA) for modular items to reduce re-categorisations.

The consultant team at De Groot Technical Services has always has a 'right first time' focus.

We aim to achieve this through a combination of:

- Disciplined project management.
- Highly qualified and experienced team.
- Quality processes and templates.
- Team input from different expertise areas.
- Back up resources.

 At De Groot Technical Services we take pride that most of our submissions are successfully assessed by the APVMA first time.





National Food Waste Strategy

 Following a Summit held in November 17 more details are available on the National Food Waste Strategy which provides a framework towards halving Australia's food waste by 2030.

Read more: National Food Waste Strategy


Updated List of Exempt Actives

The APVMA has published an updated list of "Active constituents exempt from the requirements of APVMA approval for use in agricultural or veterinary chemical products".

The list is available on the APVMA website. Approval by the APVMA of active constituents in this list is not required.

However be aware that the APVMA has established standards for some exempt actives which must be complied with.



Summer 2017 Newsletter

The Summer 2017 De Groot Technical Services Newsletter contains articles on ensuring compliance with registered details held by the APVMA, the ongoing debate around the herbicide glyphosate, the current review of gene technology regulations and some changes with New Zealand EPA.

Use this link to access the Summer 2017 Newsletter


More on a Good News Story

In the Spring 17 edition of the De Groot Technical Services Newsletter is an article under the heading of 'A Good News Story" relating to the dramatic increase in food production and the impressive trend in improving world health. 

Read more: More on a Good News Story


Introducing De Groot Technical Services

Looking for a short overview on De Groot Technical Services?

This PDF brochure provides an outline of who we are, the services we provide and why we believe you should choose our team for your product development and regulatory work.

Introducing De Groot Technical Services


Spring 2017 Newsletter

The Spring 2017 edition of the De Groot Technical Services Newsletter is now available. This edition discusses the increasing importance of "Getting It Right First Time" when submitting applications for approval and registrations to the APVMA. This is particularly so considering the delays currently being experienced in assessment times due to the relocation of the APVMA from Canberra to Armadale. The Spring edition also introduces Yasser Sokeirik with his broad ranging expertise with a focus on chemistry.

Spring 2017 Newsletter





Fines for Contaminated Hervbicide

The APVMA has fined a national chemical manufacturer / formulator a total of $100,000 for the supply of contaminated herbicides. The herbicides contained additional chemical actives other than those listed in the registered formulation.

Read more: Fines for Contaminated Hervbicide


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