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Zimbabwe Drug Product Registration

Safeguarding Public Health Through Comprehensive Regulation

MoH: Ministry of Health and Childcare of Zimbabwe

MoH Website: http://www.mohcw.gov.zw/

Regulatory Agency: Medicines Control Authority of Zimbabwe (MCAZ)

Regulatory Agency Website: https://www.mcaz.co.zw/

Local Authorised Representative: Yes

Fees: 1 000 US$

License Validity: 5 years

License Renewal: Atleast 6 months before the expiry date.

Registration of Human / conventional medicine

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.

Pre- Registration

Step 1: Application Requirements

Step 2: Payment Procedure

  • Quotation Confirmation form is filled out by the applicant and sent to the Evaluations & Registration Division via email at [email protected].
  • After filling out the form, the Division staff will send it back to the customer together with the necessary payments for the service provided.
  • In addition to the mandatory application fees, local applications for registration will be subject to an extra 14.5% VAT.
  • The 2021 Fees Schedule and 2022 Fee Schedule  contain the application fees for human medications.

Step 3: Submission Procedures

  • New applications can be sent by courier or physically presented at MCAZ, Monday to Friday, from 8:00 am to 4:30 pm.
  • Submissions will only be accepted by the receiving officer if the application fee has been paid.
  • When filing an application for registration, the applicant must include the following information:
  1. A completed and signed EVR Quotation Confirmation form .
  2. An MCAZ job invoice issued by the finance division.
  3. A fully completed and signed MC-8 Application for registration of medicine form
  4. A dossier of supporting documents in the CTD format and presentation acceptable according to the Guidelines .
  5. Appropriate samples for each application as indicated in the guidelines and submitted through the sample repository office.

Step 4: Procedure for processing applications:

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.

Failed Screening

  • The applicant has 60 days to resubmit a complete application if their incomplete application is rejected during the screening process.
  • A re-submission fee of $600 excl. VAT will be charged for this submission.

Registration timeline:

  • After 1 or 2 review rounds, Complete applications that contain all the required technical and administrative information often get registered.

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.

Post- Registration

  • The drug’s principle, or owner, or an applicant acting on the principal’s behalf, may apply for variations to registered medicines by following the procedures outlined below.
  • When a principal or applicant wants to reinstate the registration of a medication that was previously canceled due to nonpayment of retention costs, the same procedure applies.

Step 1: Application Requirements

  • Filling out the appropriate variation(s) application form (EVRF55 Annual notifications Form or EVRF56 Immediate notifications,  minor variations, and significant variations Form) is necessary to apply for a modification to a registered medication.
  • The SADC Guideline for submitting applications for variations to licensed medications should be followed when compiling the application.
  • This guideline offers instructions on how to classify the various types of variants, what supporting documentation is needed, and how to present the application.

Step 2: Payment Procedure

  • The applicant sends EVR Quotation Confirmation Form to the Evaluations & Registration Division using the mail ID: [email protected]
  • The form will be filled up by division employees and sent to the customer together with the necessary payment (service charge plus 14.5% VAT).
  • When a receipt is produced, indicating that evidence of payment has been received and the funds are showing up in the Medicines Control Authority of Zimbabwe (MCAZ) account.
  • The Statutory Fee Schedule outlines the application costs for modifications to registered medications.

Step 3: Submission Procedures

  • Applications for new variations and reinstatements may be submitted on Monday to Friday from 8:00 am to 4:30 pm.
  • Submissions will only be accepted by the receiving officer if the application fee has been paid.
  • When filing an application for registration for a variation or reinstatement, the applicant must provide the following information:
  1. A completed and signed EVR Quotation Confirmation Form.
  2. An MCAZ job invoice issued by the finance division.
  3. A fully completed EVRF55 Annual notifications Form or EVRF56 Immediate notifications, minor variations and major variations Form
  4. A dossier of supporting documentation in the manner and format permitted by the SADC Guidelines must be submitted with an application for a variant on a registered medicine.
  5. The completed, signed and dated MC8 forms and Quality Information summary (for those variations affecting the MC8 form or QIS)
  6. Appropriate samples, as specified in the guidelines and provided via the sample’s repository office (where relevant), for every application.

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

Registration of complementary medicine

Pre- Registration

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 .

Step 1: Application Requirements

  • The statutory application, CM-1 Form., must be completed in order for a complementary medication to be approved.
  • The Guidelines on submission of documentation for Registration of Complementary Medicinesshould be followed while completing application dossiers, since they include instructions on the necessary supporting documents and the format in which the dossiers should be submitted.

Step 2: Payment Procedure

  • The applicant fiils out EVR Quotation Confirmation Form and sends it to the Evaluations & Registration Division via email at [email protected] along with a schedule of ingredients, both qualitative and quantitative.
  • The division staff will verify if the product meets the criteria for complementary medicine, fill out the form, and return it to the customer together with the necessary payment for the rendered service.
  • An MCAZ receipt is sent after the Medicines Control Authority of Zimbabwe (MCAZ) has successfully received payment.
  • The EVR Quotation Confirmation Form will then be used to create a specific task invoice, and only then may an application be filed.
  • Medicines and Allied Substances Control (Complementary Medicines) Regulations, 2015 (S.I. 97 of 2015) specify the application costs for complementary medicines.

Step 3: Submission Procedures

  • New applications can be sent by courier or physically presented at MCAZ, Monday to Friday, from 8:00 am to 4:30 pm.
  • Submissions will only be accepted by the receiving officer if the application fee has been paid.
  • The applicant is required to provide:
  1. An MCAZ job invoice issued by the Finance Unit.
  2. A fully completed and signed CM-1 Form
  3. A dossier of supporting documents in the CTD format and presentation acceptable according to the Guidelines .
  4. Appropriate samples for each application as indicated in the guidelines and submitted through the sample repository office.
  5. Complete the sample submission form.

Approval Timeline

  • After 1 or 2 review rounds, complete applications with all necessary technical and administrative data are often registered.
  • Applications that are incomplete or have missing information typically require 2 or more review cycles, which adds time for representations.

As a result, the overall registration time for these goods is longer.