Before an application for registration of an ACVM trade name product (TNP) can be accepted as complete for processing, it must meet a number of criteria via pre-screening processes. Prescreening ensures that the application contains all the required information, as detailed in our Registration Information Requirements, and that this information is correct for the application type. This is a two-step process. A deficient application can be rejected at either step.
On arrival, applicants will be advised that the application has been received and will be processed by the Operations Team of the Approvals and ACVM Group. The applications are checked for completeness in terms of the supporting documents that must be included. Whether complete or not, a number is assigned to the application, a product file is created to hold the documents and relevant information is entered into an internal database. If not complete, the Adviser-Operations (AO) contacts the applicant. If complete, the application progresses to the next step, the technical pre-screen. AOs normally have a set of pre-assigned clients with whom they communicate regularly.
At this pre-screen, the Technical Appraisers (TAs) make a preliminary appraisal to confirm whether or not the data supplied with an application are sufficient to be appraised to support registration. If information provided is considered to be inadequate, the application is not accepted for technical appraisal and risk assessment. With a note of the identified deficiencies, the application is returned to the relevant AO, who then contacts the applicant with a request to address the deficiencies. (NB: This additional step incurs an additional technical prescreen fee.)
If adequate information is provided, the application is accepted into the system, which signals the start of the 40-working days regulatory timeframe for completing the registration, provided that the application does not require prior public notification (see below). The application is allocated to one of the TAs for the next step of the registration process: technical appraisal and risk assessment. (Unlike the AOs, TAs do not have pre-assigned clients.) The relevant AO is advised of the application’s acceptance at technical pre-screen, who then communicates this to the applicant.
Section 14 of the ACVM Act requires all applications for registration (and variations to existing registrations) to publish a notice in the NZ Gazette. However, section 15 of the Act grants MPI the ability to waive the notification if:
• there is a registered TNP with the same active ingredients and an equivalent formulation as the TNP being submitted for registration
• the variation to an existing registration does not affect the evaluation of risks relevant to the TNP.
Typically, new active ingredient(A1) and registered active ingredient with new risk profile (A2) applications require public notification. The decision whether or not to waive the requirement to publicly notify is made at technical pre-screen. If public notification is not waived, the applicant is informed of this decision. The notification period is 30 working days and precedes the technical appraisal and risk assessment of the application.
TAs carry out the technical appraisal and risk assessment of the applications, determining whether or not the product meets the criteria for registration and what conditions should be placed on the registration to manage any risks identified. This phase can take 25 working days. The TAs' recommendations on applications are made within the context of existing policies, which are set via a process that is separate from the registration process.
During the technical appraisal and risk assessment, the TA or the AO may contact the applicant for additional information or clarification. If the applicant is unable to provide the information within a reasonable period of time (normally 5 working days), the applicant should ask MPI for a Waiver of Time (WOT) for a given period (normally not exceeding 20 working days). If the WOT request is accepted, the regulatory clock for the appraisal of the application is stopped until the additional information is received. If the WOT request is not made, or if the request is made but MPI declines to accept it (the reason will be communicated to the applicant), the TA will complete the appraisal based on the available information and is likely to recommend that the application be declined.
With certain applications MPI may require time that is likely to exceed the regulatory timeframe for completing the technical appraisal and risk assessment part of the registration process. In addition to staff resourcing issues, the reasons for this could be one or more of the following:
• TA's occasionally need to take their recommendations on applications to MPI Technical Consultative Committee (TCC) or an external expert for scientific and technical support in the registration decision process (note that the TCC is not a decision-making body). Organising the TCC and/or obtaining expert opinion takes time.
• TNPs that contain prescription medicines as defined under the Medicines Act require consent from Medsafe before they can be registered under the ACVM Act. The time period for obtaining such consent is outside the control of MPI. Likewise, we may have to consult with another directorate within MPI or with other governmental agencies before a decision on registration can be made. Such consultations add time to the appraisal of a registration application.
• Some applications may require new MPI policy to be drafted, or an existing policy amended, or in-house legal opinion obtained for the registration to occur.
If for the reasons stated above MPI requires more time to complete the technical appraisal and risk assessment, we will ask the applicant for an Extension of Time (EOT). If the EOT request is accepted, the regulatory clock for the appraisal of the application will be stopped for this time. If a reasonable EOT timeframe could not be agreed upon with the applicant, then the assessor will process the application based on available information. In such a case, the assessor is likely to recommend that the application be declined.
After the technical appraisal and risk assessment, the TA makes a recommendation either to approve the registration of the product or decline the application (a split recommendation may also occur) to the delegate (under delegation from the Director-General of MPI) who decides whether the application should be approved or declined. As required by the ACVM Act, the decision must be made within 15 working days.
If the recommendation is for approval and the TA also advises changes to the original product data sheet (PDS) and/or label content, the AO contacts the applicant for submission of an amended PDS and/or label content. The delegate’s decision will be made before the registrant supplies the updated PDS and/or label, but the actual registration will not be issued until all outstanding issues have been addressed. (This means that the product won’t be able to be imported, manufactured or sold.)
When an application is approved, the appropriate registration documentation is issued to the applicant. This includes:
• the certificate of registration, which contains a unique registration number and any conditions applied
• the approved PDS, which details all the relevant information about the product, such as, manufacturer, formulation, use
• the approved label content.
Registrations are always conditional. If a registrant fails to comply with the relevant conditions, MPI may place a prohibition on the importation, manufacture and sale of the product. Therefore, it is important registrants read the list of conditions of registration on the certificate of registration so they are fully aware of their legal obligations under the ACVM Act.
Registrations are normally issued for three years. After this period, they must be renewed.