The process of submitting an application for registration of a medicine is described below in detail. All guidelines used in the division are available under downloads
Applications for registration of conventional medicines involve the submission of a completed application form together with a dossier of supporting documents in the Common Technical Document (CTD) format. The process has been summarised in the steps below.
Step One: Application Requirements
The process of registering a conventional medicine requires the completion of the statutory application form MC-8. Dossiers should be completed in accordance with the MCAZ CTD Guidelines which provide guidance on supporting information required and presentation format of the application dossiers. This guidance document is essential for first time and seasoned applicants to ensure good quality applications are submitted. Applications for generic solid dosage forms (tablets, capsules, suspension etc) medicines may require the submission of a bioequivalence study, and additional guidelines are available for use by the applicant.
Step Two: Payment Procedure
The application fees for conventional medicines are stipulated in the statutory fee schedule. There are three main types of medicine applications that attract different application fees. These are:
Step Three: Submission Process
New applications can be submitted from 8.00 am to 4:30 pm Monday to Friday. The receiving officer will only accept a submission if payment for the application has been made. The applicant is required to provide the following when submitting an application for registration:
The application will then be screened for completeness using the appropriate screening checklist depending on whether the product is a small molecule or biological and a response of the outcome of the screening will be sent to the client within 90 days of receipt.
Applications that pass screening will progress to the evaluation stage. Communication to this effect will be sent within the stipulated 90 day period.
In the event that an application is incomplete and fails the screening stage, the applicant can re-submit a complete application at a later date. This re-submission will incur a $600 excl. VAT resubmission fee. The quotation form will be sent together with the communication that the product has failed screening.
Complete applications that contain all the required technical and administration information ordinarily get registered after 1 or 2 review cycles. Incomplete applications with deficient information are the ones that usually need 2 or more review cycles including time for representations thus the total time to registration is longer for such applications.