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Inside the Spray Tank: Updated Product Datasheets

September 2009

Welcome back to Inside the Spray Tank – an informal ‘slice of life’ view of ACVM operations.

This is the continuation of a series of blogs by Andrew Pearson, who is currently our MRL advisor but also has experience with most of the application types we receive. Andrew provides an internal perspective on procedures/issues to give you some background to our decision making. (photo: Andrew Pearson)

New PDS forms

Anyone who has submitted an application to us in the last few months will have undoubtedly noticed the ACVM registration and product data sheet (PDS) has changed dramatically. Gone is the need to repeat the general use claim from the label, the requirement to search back through the records to find the date of first registration and, of course, the ever tedious initialling and dating of every page (although if you still wish to do this, we won’t discourage you).

The new form requires the completion of a small number of new fields but most of the changes are in the layout and format. I’ll try and shed some light on what we expect to be provided and why this information is relevant.

Standardised forms

Firstly, some background on the forms. The formatting changes are the result of the harmonisation of all ACVM documentation towards a standardised format. Internally this has a number of benefits, such as aiding training and allowing faster completion of appraisal and administrative documentation.

It is also hoped that this will benefit you in completing forms – once you are familiar with any one form, it should be easier for you to complete other ACVM forms, such as smart tracks, class determinations or, when I get around to updating them, the GRAS register application forms.

Guidance documents

I was here shortly after the last PDS form was introduced, so I have had experience with the common problems that applicants had in the transfer of product details from the previous incarnations under the Animal Remedies and Pesticide Boards. That change in form produced a much clearer document but there were still a number of issues and grey areas that caused problems.

This time round the development team has supplemented the new forms by generating guidance documents (available on the website) to help you complete the new datasheets. I don’t intend to repeat any of the guidelines but I’ll briefly review the significant additions to the PDS forms.

A2 – Application type

This is present to allow us to keep track of PDS forms submitted with each different application for a product, especially for situations where we may look back on a file to see when certain changes were implemented. Relating this to the advice in my first article (surviving the screen), this section doesn’t provide any further detail on the application other than the general change and thus isn’t the substitute for a good covering letter.

A5-A7 NZ contact, agent and consultant

Although these sections could all be interpreted to mean a similar thing, there are important differences that affect the way we communicate with a registrant.

NZ Contact – This is the New Zealand contact for an overseas company who will accept service of documents on their behalf. We still expect to undertake most communication regarding the product registration with the overseas company.

NZ Agent – This is the New Zealand-based individual or company authorised to undertake applications for this product on behalf of the parent company. This contact is listed on the ACVM public register,

NZ Consultant – This is solely for noting the registration consultant involved in any aspect of preparation of the application. If the consultant is to remain as primary contact after submitting the application form, then this authorisation needs to be provided. Authorisation will also be needed again for the consultant to act on behalf of the parent company for any further dealings after the product is registered.

A9 - Responsible manufacturer of the formulated product

Of the changes to the PDS this is likely the most significant and also the change most likely to be misinterpreted.

The reason why we’ve added this section is simple – we are legally required under the ACVM Act to hold and publish the responsible manufacturer on the public register (section 24 (2)(J)).

The intent of adding the section is so the registrant can nominate the manufacturer who will ensure the product is in compliance with its registration and authorise the product for release to the market. We expect that this nominated site will actually perform this function and hold the records, so it may not always be the registrant’s address. For veterinary medicines and vertebrate toxic agents, we also expect the site to hold the appropriate GMP status of ‘releasing from manufacture for supply or sale’.

This requirement will be phased in over the next year with information about our expectations of the responsible manufacturer. To facilitate asking for this data we have updated our internal database so that the responsible manufacturer(s) can be logged. We will, however, only be logging this data from the submission of the new PDS and will not display a responsible manufacturer without confirmation from the registrant that it is correct.

B1-B3 – Manufacturers

The first point to note is that all of the manufacturing sites except for the responsible manufacture now sit within the confidential data section. We do not plan to list these on the public register. Changes to this section are primarily to differentiate better between the various roles different sites may have in the production, packaging and quality control of the final product. In completing these sections, ensure the check boxes are correctly filled as all sites will need GMP approval (except for agricultural chemicals) or the product may be declined at application screening. In addition, under B2 the answer to the question will ensure that an import approval can be granted if necessary to import foreign labelled product for relabelling/packaging.

B8 – HSNO status

This section needs to be completed accurately as incorrect data can delay the progress of an application until the correct HSNO status can be confirmed. In particular, you need to note if an ERMA approval was submitted under a code name. During screening ERMA is notified of any change to an application we believe may impact on its HSNO status.

None of the remaining information requirements for section B have changed, but more guidance has been presented to aid accurate completion of the sections.

Superseded forms no longer accepted

The new PDS forms have been rolled out over the last year and applicants were encouraged to comment. The useful feedback we received was considered in the final releases of the forms. As such, the forms now on the web are the finalised versions of the PDS and all products should update to this version. We will no longer accept submissions on the old application forms.