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AgVetLink December 2002

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Data Assessment Service workshops

The ACVM Group ran a series of workshops in early November to facilitate the changes proposed in future data assessment. Workshops, which were held in Auckland, Christchurch and Wellington, were generally well attended with around 75 people in total.

These workshops were run in response to concerns that were expressed in the ACVM Amendment Act discussion document covering the time-frames for approvals under the ACVM Act. While the ACVM Act, like the HSNO Act, has regulated time-frames for the assessments of applications, there is no regulatory agency worldwide that can complete a full data assessment in the 40 to 75 days allowed in the Act. The ACVM Group had envisaged the use of accredited people in this role, but there is insufficient work at present to make this effective.

Now that the ACVM Group and registrants have been working with the standards and guidelines for some time, it was felt that there was the opportunity for companies to undertake their own assessments, or to contract individual assessors to do this. This is consistent with the method used by ERMA New Zealand for HSNO applications.

We intend to survey attendees to find out if the workshops provided the information they required and to seek suggestions for future sessions. It was mentioned at the workshops, for example, that it could be useful to cover the area of residues in more detail.

A number of suggestions/questions from the workshops are being followed up. These include:

• Provide (on the website) a list of commonly used proprietary formulants that the ACVM Group has assessed.
• Supply sample copies of completed chemistry and manufacturing data assessment reports on the website.
• Check with the ACVM Group experts who are currently contracted to see if they agree to having their names published on the ACVM website for others to use.
• Check terminology in ACVM forms and documents - veterinary ter-minology appears in some plant compound forms.
• There may be duplication between the product data sheet and the data assessment reports - is this really needed? 
• Is the data package review still needed?
• Can a list of ACVM-approved manufacturers be put on the website (along with the categories for which they are approved) or, alternatively, can we provide the criteria we use for the approval of overseas manufacturers?

PRESCRIPTION MEDICINES: UK COMPETITION COMMISSION REPORT

The United Kingdom's Competition Commission is investigating allegations that the supply of prescription only animal remedies in the UK may constitute a monopoly. The ACVM Group is studying the provisional conclusions of the investigation, especially in light of the comments from the equivalent body in New Zealand. The report and background information can be found at: http://www.competition-commission.org.uk/inquiries/vetmed.htm.

The report information covers a range of ideas that could be of interest in New Zealand. One of the recommendations of interest concerns the separation of dispensing and administration from consulting/prescribing. It appears that most of the recommendations in the report have been covered in previous proposals from the ACVM Group.

Responding to email requests

The ACVM Group has found that the use of electronic means of communication by companies has increased two-fold. In the past we treated emails (as well as phone calls to some extent) as 'quick' queries - setting them a shorter response time than letters.

In fact, many of the queries we are getting, especially via the email system, are quite complex and take considerable time (and often technical input) to answer.

In light of this, we advise that if your query is specifically product related, requires some research, or is about regis-tration of products etc., it will be treated as if it were hard copy, written communication. This means that it will be recorded as inward mail, date stamped, and will be placed in the relative recipient's queue.

If the queries relate to a specific application, or request advice from ACVM staff, there may be a charge associated for the time taken to respond. We will also be attempting to make sure that complex telephone enquiries are treated in the same manner.

We do not want to deter companies from communi-cating by email or by phone, but with the high workloads, and the need to work to regulated time-frames in the registration process we will be using a single response period for email and written queries.