Zimbabwe Drug Product Registration

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: adminEVR@mcaz.co.zw
• 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.

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 Medicines should 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 fills out EVR Quotation Confirmation Form and sends it to the Evaluations & Registration Division via email at adminEVR@mcaz.co.zw 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.