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Accreditation of Independent ACVM Assessors

Under the present licensing/registration system MAF is provided a dossier of data by the applicant to determine if the product should be licensed/registered. The data is analysed with regard to certain risks and conditions are imposed along with the licence or registration to manage those risks. The analysis is done by MAF staff or experts contracted to MAF for that purpose. The applicant's responsibility is to provide all the data required to allow the product to be assessed adequately.

Under the ACVM Act 1997 there will be significant changes to this process. The ACVM Act is specific about what risks are to be managed and, consequently, what analyses are needed to assess a product adequately. In addition to the narrowed focus of relevant risks, the Act places the responsibility on the applicant to provide all the information required (including asessment of risks) at the time the application is lodged. This has been interpreted to mean that the applicant must:

• be well aware of the risks that must be analysed;
• carry out the appropriate research and testing to produce the data to analyse those risks; and
• arrange for independent risk analyses to be carried out on the product.

After 1 October 1998 a valid, complete application will need to include the appropriate data and ACVM risk assessment reports carried out by risk assessors accredited by MAF to prepare such reports. MAF is preparing standards for the information required in applications, for the accreditation of risk assessors, and for the risk assessment reports.

It is expected that the standards being developed at the moment will identify data packages similar to those required now. While it is possible that a person might be sufficiently experienced and competent to assess all the data packages, it is more likely that assessors will be accredited to analyse only those data packages that are within the scope of their expertise. This may mean that an applicant may have to contract a number of assessors and provide in their application risk assessment reports in each of the data areas.

Under the ACVM Act, MAF's function will focus on confirming that:

• all the necessary information has been provided in the application; and
• the risk assessment reports clearly identify and quantify the risks posed by the product.

MAF staff will audit the applications rather than carry out technical risk assessments themselves. However, it is expected that, for a period, there may not be sufficient accredited ACVM risk assessors. Therefore, during the transition period MAF will offer a risk assessment service. This service will be distinct from the registration process and will clearly be a temporary measure. MAF intends to encourage a regulatory environment that places the responsibility for adequate risk analysis of products firmly on the applicant.

MAF will update readers on developments in this area and will make its standards available for comment before they are promulgated.