Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.

 

Correction of an Error on AICS

The National Industrial Chemical Notification Scheme (NICNAS) has corrected a listing error on the Australian Inventory ofChemical Substances (AICS), after an entry that was nominated (without assessment) and listed on AICS in error.    Source: AICS amendment  See also: Recent addition of chemicals to AICS: AICS update

 

The Seismic Shifts in Marketing’s Role in Direct Selling

“Marketing doesn’t matter for a direct selling company.” Have you ever heard this one before? If you’ve been working in direct selling for more than ten years, there’s a good chance you’ve heard someone say this outright, or at least imply it. In fact, that person may have even been you. For example, it was a popular rebuttal to any marketer with a consumer packaged goods background prior to coming on board, as they began their journey in the mysterious waters of direct selling. You’d hear this sentiment when a creative director was asking for packaging that would take away a few extra pennies from the bottom line. You’d even hear it when it felt like corporate was over-stepping their bounds, relying on the field to come up with their own tools, their own campaigns and their own messaging on how to share the products. I always loved the simplicity of that statement, and the loaded implications behind it. Unfortunately, I think there’s a little more to it than that now, though”.    Source: Brett Duncan, World of Direct Selling Direct selling & marketing

 

Quote for the month:

 “You don’t have to be great to start, but you have to start to be great”.    Zig Ziglar

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As per our usual practice, this year we are donating to Nordoff-Robbins Music Therapy (www.nordoff-robbins.com.au) in lieu of sending Christmas cards to clients. Nordoff-Robbins Music Therapy uses music to transform lives and bring the benefits of music therapy to those in need. You can also donate http://www.noro.org.au/support-us/donate-now. RFA Regulatory Affairs is a long-time supporter of Nordoff-Robbins Music Therapy Australia.  http://www.noro.org.au/about/our-supporters  You can be too!

Nordhoff Robbins

Are you new to the Australian market? Are you unsure about how to comply with recent changes to TGA regulations such as the new TGA Order 92? Do you have a new member of your regulatory or marketing team and would like them to be trained on food classifications and labelling in Australia? Do you want to supply cosmetics but aren’t quite sure what the label is required to look like?

RFA Regulatory Affairs offers Skype training so that you can train at home or from your office at a time that suits, or you and your team can come to our office in Glebe for a group-training session. Our courses cover complementary medicines, cosmetics and food products and a range of topics from labelling to GMP requirements.

All courses are presented in a modular format of either two or three hour’s duration. Training resources are provided and certificates are presented to each participant at the successful conclusion of each module.

You can find more information at RFA Training Courses or email us This email address is being protected from spambots. You need JavaScript enabled to view it.  to discuss your requirements.

     BREAKING NEWS!

Pharmacovigilance Obligations Training

NEW COURSE NOW AVAILABLE

In September this year, the TGA released guidance on the pharmacovigilance responsibilities of sponsors.  Newly developed, this training course is for sponsors and their nominated pharmacovigilance staff with complementary medicines included on the Australian Register of Therapeutic Goods. We cover TGA pharmacovigilance obligations and mandatory reporting requirements, the what, how and when you MUST report.  All required documents including SOPs and reporting templates will be provided for your future use.

This one hour training course is available via Skype or in person in our office in Glebe, Sydney. You will receive full course notes, document templates, SOPs and a certificate of attendance.  This is all included in the price.

For more information or to schedule a training time, please email us at This email address is being protected from spambots. You need JavaScript enabled to view it.

 

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