Ministry of Health and Childcare of Zimbabwe
http://www.mohcw.gov.zw/
Medicines Control Authority of Zimbabwe (MCAZ)
https://www.mcaz.co.zw/
Yes
1 000 US$
5 years
At least 6 months before the expiry date.
The Common Technical Document (CTD) format dossier of supporting documents and a completed application form is required for applications for the registration of conventional medicines. The Document Submission Checklist must be submitted with every application.
When the application is received, it will be screened for completeness using the appropriate screening checklist depending on whether the product is biological or small.
Applications that are incomplete or lack sufficient information typically require 2 or more review cycles, which includes time for representations. As a result, the overall registration time for these applications is longer.
Reporting Type |
Change implementation |
Initial review by MCAZ |
Annual notifications (ANs) |
No need to receive approval in advance. to be informed within a year following implementation. |
NA |
Immediate Notification (INs) |
No need to receive approval in advance. Notification of changes should be made as soon as they are implemented. |
The modification might be deemed accepted if no objection is voiced within 2 months after the date of the acknowledgement of receipt. |
Minor Variations (Vmins) |
Prior acceptance is required. |
Within 3 months of date of acknowledgement of receipt |
Major variations (Vmajs) |
Prior acceptance is required. |
Within 4 months of date of acknowledgement of receipt |
Applications for the approval of complementary medicines must be submitted with a dossier of supporting documents in a CTD format, together with a completed application CM-1 Form .
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Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
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