Experts from the AMS agreed that the following registration steps would be logical and 45 agreeable to regulators: Figure 2: Typical registration steps for BCA The pre-registration meeting was included as a new element, which most of the AMS found useful because it could provide orientation for the applicant as well as the regulator. However, no consensus was reached as to what exactly should be discussed in that meeting and whether or not a binding agreement, for instance, on data waivers or procedural changes was acceptable. The above steps largely mirror the FAO guidelines on harmonisation of biopesticides regulation, which elaborate on the administrative aspects of the registration process (48), starting with the submission of a registration dossier. The process continues with evaluation by the regulatory authority, and is usually terminated by a decision of the regulatory body on whether or not registration (and permission to sell) is granted. Registration can be unconditional or conditional, whereby in the latter case, additional data, studies, or action by the registrant may be required. The process is concluded by issuance of a registration certificate along with the approved label bearing a unique identification number. It would be helpful also to assign unique numbers to exempted products for which there has been a process of notification. Without such numbers, growers get offered products and they cannot judge if they are really exempt. Technical evaluation of the registration dossier would include verification of the data provided, waiver of data in certain instances, and verification of specifications by analytical methods and test protocols on test samples provided by the registrant and evaluation of the applicants conclusions. It can further include inspection of the manufacturing process. There must be a mechanism for the applicant to notify if they change production method, source material or formulation, and a mechanism to determine how much of a change is allowed before a new application is needed. Producers regularly change/optimise their methods and significant difference to the registered product may occur.
Implementing Biological Control Agents in the ASEAN Region
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