PROTECTING YOUR RIGHT TO MEDICINES AND MEDICAL DEVICES
Thursday, 14 December 2017
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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

                                                    

Conventional Medicines

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:

  1. Generic Medicines ($2 500 [foreign], $900 [local] excluding 15% value added tax (VAT) per product application)
    •  Alternative products to a brand name product (innovator) that are considered pharmaceutical and therapeutic equivalents to the brand name product.
  2. New Chemical Entities ($3 000 excluding VAT per product application)
    • Generally the pharmaceutical product that was first authorised for marketing in Zimbabwe (normally as a patented product) on the basis of documentation of efficacy, safety and quality.
    • Biological and biosimilar medicines are included under this group.
  3. Line extensions ($1 500 excluding VAT per product application)
    • A lower or higher strength of a product that has been submitted to the Authority for registration (e.g. submission of Metformin 1000mg when Metformin 500mg in same dosage form from same manufacturer is already submitted or registered)

The applicant completes the EVR Quotation Confirmation Form and submits to the Evaluations & Registration Division using the following email This email address is being protected from spambots. You need JavaScript enabled to view it.. The division staff will complete the form and send it back to the client with appropriate fees for the service required. This is to ensure that the appropriate payment for the application is quoted and paid to the Authority. When payment has been received successfully by the Medicines Control Authority of Zimbabwe (MCAZ) i.e evidence of payment presented, an MCAZ receipt is issued. A specific job invoice will then be generated by the MCAZ Finance division using a completed and signed EVR Quotation Confirmation Form and only then can an application for registration of a medicine be submitted.

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:

  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 form.
  4. A dossier of supporting documents in the format and presentation acceptable according to the guidelines.
  5. Appropriate samples for each application as indicated in the guidelines and submitted through the samples repository office.
    • Click here to complete the online sample submission form.

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.

Passed Screening

Applications that pass screening will progress to the evaluation stage. Communication to this effect will be sent within the stipulated 90 day period.

Failed Screening

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.

Registration Timeline

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.

Veterinary Medicines

Applications for registration of veterinary medicines involve the submission of a completed application form, together with a dossier of supporting documents in the CTD format. The process has been summarised in the steps below.

Step One: Application Requirements

The process of registering a veterinary medicine requires the completion of the statutory application form MC-8. Dossiers should be completed in accordance with the veterinary medicines 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. Veterinary vaccine guidelines must be consulted when preparing applications for registration of veterinary medicines.

Step Two: Payment Procedure

The application fees for veterinary medicines are stipulated in the statutory fee schedule. There are three main types of medicine applications that attract different application fees. These are:

  1. Veterinary Generic Medicines ($1 500 [foreign], $600 [local] excl. VAT per product application)
    •  Alternative products to a brand name product (innovator) that are considered equivalent to the brand name product.
    • Veterinary vaccines also pay the same amount as generic medicines
  2. Veterinary New Chemical Entities ($2 000 excl. VAT per product application)
    • Generally the pharmaceutical product that was first authorised for marketing in Zimbabwe (normally as a patented product) on the basis of documentation of efficacy, safety and quality.
  3. Line extensions ($1 000 excl. VAT per product application)
    • A lower or higher strength of a product that has been submitted to the authority for registration.

The applicant completes a EVR Quotation Confirmation Form and submits to the Evaluations & Registration Division using the following email This email address is being protected from spambots. You need JavaScript enabled to view it.. The division staff will complete the form and send it back to the client with the appropriate fees for the service required.  This is to ensure that the appropriate payment for the application is quoted and paid to the Authority. When payment has successfully been received by the Medicines Control Authority of Zimbabwe (MCAZ), an MCAZ receipt is issued. A specific job invoice will then be generated using the EVR Quotation Confirmation Form and only then can an application be submitted.

Step Three: Submission Process

Application submission is open Monday to Friday from 8am to 4:30 pm. The receiving officer will only accept a submission if payment for the application has been submitted. The applicant is required to provide the following when submitting an application for registration:

  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 form.
  4. A dossier of supporting documents in the format and presentation acceptable according to the guidelines.
  5. Appropriate samples for each application as indicated in the guidelines and submitted through the samples repository office.
    • Click here to complete the online sample submission form.

The application will then be screened for completeness using the screening checklist and a response of the outcome of the screening will be sent to the client within 90 days of receipt.

Passed Screening

Applications that pass screening will progress to the evaluation stage. Communication to this effect will be sent within the stipulated 90 day period.

Failed Pre-Screening

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.

Registration Timeline

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 products.

Complementary Medicines

In September 2015 a statutory instrument S.I. 97 of 2015 was enacted mandating the approval of complementary medicines. Complementary medicines are usually used in conjunction with conventional therapy in humans with the aim of improving the disease condition or general wellbeing of the person or animal. Applications for approval of complementary medicines involve the submission of a completed application form together with a dossier of supporting documents in an acceptable format. The process has been summarised in the steps below.

Step One: Application Requirements

The process for approval of a complementary medicine requires the completion of the statutory application form CM-1. Dossiers should be completed in accordance with the Complementary Medicines Guidelines which provides guidance on supporting information required and the presentation format of application dossiers. This guidance document is essential for first time and seasoned applicants to ensure good quality applications are submitted.

Step Two: Payment Procedure

The application fees for complementary medicines are stipulated in the statutory fee schedule. The cost per complementary medicine application is $600 excl. VAT.

The applicant completes a EVR Quotation Confirmation Form and submits to the Evaluations & Registration Division using the following email This email address is being protected from spambots. You need JavaScript enabled to view it.. The division staff will complete the form and send it back to the client with the appropriate fees for the service required.  This is to ensure that the appropriate payment for the application is quoted and paid to the Authority. When payment has successfully been received by the Medicines Control Authority of Zimbabwe (MCAZ), an MCAZ receipt is issued. A specific job invoice will then be generated using the EVR Quotation Confirmation Form and only then can an application be submitted.

Step Three: Submission Process

Application submission is open Monday to Friday from 8am to 4:30 pm. The receiving officer will only accept a submission if payment for the application has been submitted. The applicant is required to provide:

  1. An MCAZ job invoice issued by the finance department.
  2. A fully completed and signed CM-1 form.
  3. A dossier of supporting documents in the format and presentation acceptable according to the guidelines.
  4. Appropriate samples for each application as indicated in the guidelines and submitted through the samples repository office.
  • Click here to complete the online sample submission form.

Approval Timeline

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 products.

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