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
How to register a medicine
Applications for registration of conventional medicines involve the submission of a completed application form, Document Submission Checklist together with a dossier of supporting documents in the Common Technical Document (CTD) format.” All applications submitted should be accompanied by the Document Submission Checklist.
Pre-registration
Step One: Application Requirements
The process of registering a conventional medicine requires the completion of the statutory application MC-8 Form . Dossiers should be completed in accordance with the Guidelines on submission of Documentation for Registration on Multisource (Generic) Finished Pharmaceutial Product_Quality Part_CTD 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 applicant completes the Quotation Confirmation form and submits to the Evaluations & Registration Division using the following email: adminEVR@mcaz.co.zw . The Division staff will complete the form and send it back to the client with appropriate fees for the service required. Local applications for registration will attract an additional 14.5% VAT on top of statutory application fees. This is to ensure that the appropriate registration fee for the application is quoted and paid to the Authority’s bank account. The application fees for human medicines are stipulated in the 2021 Fees Schedule and 2022 Fee Schedule
Step Three: Submission Procedure
New applications can be submitted physically at MCAZ from 8.00 am to 4:30 pm Monday to Friday or send via courier services. 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:
A completed and signed EVR Quotation Confirmation form .
1. An MCAZ job invoice issued by the finance division.
2. Document submission checklist
3. A fully completed and signed MC-8 Application for registration of medicine form
4. A dossier of supporting documents in the format and presentation acceptable according to the Guidelines on submission of Documentation for Registration on Multisource (Generic) Finished Pharmaceutical Product_Quality Part_CTD.
5. Appropriate samples for each application as indicated in the guidelines and submitted through the samples repository office.
Step Four: Procedure for processing applications
Screening
The Authority has committed to undertake screening for all applications within ten (10) working days of submission of an application.
Passed screening
If an application passes screening, the application will be assigned an application number, and communication will be sent to the applicant thereof. The applicant will be given 30 days to respond to any minor issues raised during the screening process. Once a response to screening has been submitted by the applicant, at the lapse of 30 days, the application proceeds to the evaluation stage.
Failed Screening
Applications that fail screening will be allocated with Quarantine numbers. A quarantine number in essence means that the application is held in abeyance pending resolution by the applicant of shortcomings noted during the screening process. It is critical to note that there is no priority afforded to quarantined applications,
Once an application is quarantined, the Authority will issue a letter to the applicant, intending to refuse to register the product, unless a complete application is submitted within 120 days. Failure by the Applicant to resubmit a complete application within the prescribed timelines will result in refusal to register the application and applicants interested in pursuing such applications will be required to resubmit new applications accompanied by payment of the full application fee.
Upon resubmission of a complete dossier and payment of the statutory resubmission fees as stipulated in item 7(a)(ix), 7(b)(v) and 7(c)(iv) of the MCAZ Fee Schedule, applications will undergo a second round of screening. Applications that fail the second round of screening will be refused registration without assessment.
Review cycles
A maximum of two review cycles will be considered during the evaluation process of applications before the Authority reaches a final regulatory decision (issuance of a registration certificate or refusal to register letter).
Deadline extensions
The Authority will not entertain any time-extension requests to respond to queries. Any such requests will result in the application being denied registration (refusal to register).
Registration Timeline
Complete applications that contain all the required technical and administration information ordinarily get registered after 1 or 2 review cycles. The Authority will use a tracker (clock start-clock stop system) to monitor and track each application. Successful applications should reach a regulatory decision within 9 months (MCAZ time).
Human Medicines Pre-Registration Guidance documents:
Quality
1. Guidelines on submission of documentation for Registration of a Multisource (Generic) Finished Pharmaceutical Product (FPP) Quality Part in the Common Technical Document (CTD) Format.
Bioequivalence, Safety and Efficacy
1. Guidelines on submission of documentation on waiver of in vivo Bioequivalence Requirements for immediate-release solid oral dosage forms .
2. Guidance on the selection of Comparator Products for Bioequivalence and Bio-pharmaceutics classification system (BCS) based biowaiver studies used to demonstrates interchangeability of pharmaceutical multisource (generic) products .
Biologics
1. Screening checklist for biological medicines
Special dosage Forms
1. Guidance on Data Requirements for applications for Registration of Inhalation and Nasal Medicines.
SADC Guidelines
1. SADC Guidance on submission of applications for Registration in CTD format: Quality .
2. SADC Guidelines on Bioavailability / Bioequivalence
3. SADC Guideline on Product Information and Labelling and Excipients labeling
2. Post-registration
How to submit a variation to an approved medicine or a re-instatement to previously registered medicine
An application for variation(s) to registered medicines can be made by the principal (owner) of the medicine (or an applicant acting on behalf of the principal) through following the steps described below. The same process is also applicable when an applicant or principal intends to re-instate the registration of a medicine that was previously cancelled for non-payment of retention fees.
Step One: Application Requirements
The process of applying for a variation to a registered medicine requires the completion of the respective variation(s) application form EVRF55 Annual notifications Form or EVRF56 Immediate notifications, minor variations and major variations Form. Applications should be compiled in accordance with the SADC Guideline for submitting applications for variations to registered medicines which provides guidance on classification of the different types of variations, supporting information required and presentation format of the application. This guidance document is essential for first time and seasoned applicants to ensure good quality applications are submitted. Some variation(s) application(s) may require the submission of a bioequivalence study, and additional Guidelines are available for use by the applicant.
Step Two: Payment Procedure
The applicant completes section 2.2 of the EVR Quotation Confirmation Form and submits to the Evaluations & Registration Division using the following email adminEVR@mcaz.co.zw. The division staff will complete the form and send it back to the client with appropriate fee (service charge plus 14.5% VAT). This is to ensure that the appropriate fee and VAT for the application is quoted and paid to the Authority. When evidence of payment presented has been received and the funds are reflecting in the Medicines Control Authority of Zimbabwe (MCAZ) account i.e., a receipt is issued. The application fees for variations to registered medicines are stipulated in the Statutory Fee Schedule.
Step Three: Submission Process
New variation/reinstatement 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 a variation/reinstatement 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 EVRF55 Annual notifications Form or EVRF56 Immediate notifications, minor variations and major variations Form
4. A dossier of supporting documents in the format and presentation acceptable according to the SADC Guideline for submitting applications for variations to registered medicines
5. The completed, signed and dated MC8 forms and Quality Information summary (for those variations affecting the MC8 form or QIS)
6. Appropriate samples for each application as indicated in the guidelines and submitted through the samples repository office (where applicable).
Reporting Type | Change implementation | Initial review by MCAZ |
Annual notifications (ANs) | Prior acceptance not required. To be notified within 12 months of implementation | NA |
Immediate Notification (INs) | Prior acceptance not required. Change should be notified immediately after implementation | If no objection raised within 60 days of date of acknowledgement of receipt, the variation can be considered accepted |
Minor Variations (Vmins) | Prior acceptance required. | Within 90 days of date of acknowledgement of receipt |
Major variations (Vmajs) | Prior acceptance required. | Within 120 days of date of acknowledgement of receipt |
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:
- 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
- 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.
- 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 an EVR Quotation Confirmation Form and submits to the Evaluations & Registration Division using the following email adminevr@mcaz.co.zw. 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:
- A completed and signed EVR Quotation Confirmation Form.
- An MCAZ job invoice issued by the finance division.
- A fully completed and signed MC-8 form.
- A dossier of supporting documents in the format and presentation acceptable according to the guidelines.
- 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.
Step Four: Procedure for processing applications
Screening
The Authority has committed to undertake screening for all applications within ten (10) working days of submission of an application.
Passed screening
If an application passes screening, the application will be assigned an application number, and communication will be sent to the applicant thereof. The applicant will be given 30 days to respond to any minor issues raised during the screening process. Once a response to screening has been submitted by the applicant, at the lapse of 30 days, the application proceeds to the evaluation stage.
Failed Screening
Applications that fail screening will be allocated with Quarantine numbers. A quarantine number in essence means that the application is held in abeyance pending resolution by the applicant of shortcomings noted during the screening process. It is critical to note that there is no priority afforded to quarantined applications,
Once an application is quarantined, the Authority will issue a letter to the applicant, intending to refuse to register the product, unless a complete application is submitted within 120 days. Failure by the Applicant to resubmit a complete application within the prescribed timelines will result in refusal to register the application and applicants interested in pursuing such applications will be required to resubmit new applications accompanied by payment of the full application fee.
Upon resubmission of a complete dossier and payment of the statutory resubmission fees as stipulated in item 7(a)(ix), 7(b)(v) and 7(c)(iv) of the MCAZ Fee Schedule, applications will undergo a second round of screening. Applications that fail the second round of screening will be refused registration without assessment.
Review cycles
A maximum of two review cycles will be considered during the evaluation process of applications before the Authority reaches a final regulatory decision (issuance of a registration certificate or refusal to register letter).
Deadline extensions
The Authority will not entertain any time-extension requests to respond to queries. Any such requests will result in the application being denied registration (refusal to register).
Registration Timeline
Complete applications that contain all the required technical and administration information ordinarily get registered after 1 or 2 review cycles. The Authority will use a tracker (clock start-clock stop system) to monitor and track each application. Successful applications should reach a regulatory decision within 9 months (MCAZ time).
Pre-registration
How to register a complementary medicine
Complementary medicines are usually used in conjunction with conventional therapy in humans or animals with the aim of improving the disease condition or general well being of the person or animal. Applications for approval of complementary medicines involve the submission of a completed application CM-1 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 CM-1 Form. Dossiers should be completed in accordance with the Guidelines on submission of documentation for Registration of Complementary Medicines which provide 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 applicant completes an EVR Quotation Confirmation Form and submits it together with a schedule of ingredients (qualitative and quantitative) to the Evaluations & Registration Division using the following email adminevr@mcaz.co.zw . The division staff will confirm if the product qualifies as a complementary medicine; and complete the form 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.
The application fees for complementary medicines are stipulated in the Medicines and Allied Substances Control (Complementary Medicines) Regulations, 2015 (S.I. 97 of 2015) .
Step Three: Submission Procedure
New applications can be submitted physically at MCAZ from 8.00 am to 4:30 pm Monday to Friday or send via courier services. The receiving officer will only accept a submission if evidence payment for the application has been submitted. 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 format and presentation acceptable according to the Guidelines on submission of Documentation for Registration on Multisource (Generic) Finished Pharmaceutical Product_Quality Part_CTD.
4. Appropriate samples for each application as indicated in the guidelines and submitted through the samples repository office.
5.Complete the sample submission form.
Step Four: Procedure for processing applications
Screening
The Authority has committed to undertake screening for all applications within ten (10) working days of submission of an application.
Passed screening
If an application passes screening, the application will be assigned an application number, and communication will be sent to the applicant thereof. The applicant will be given 30 days to respond to any minor issues raised during the screening process. Once a response to screening has been submitted by the applicant, at the lapse of 30 days, the application proceeds to the evaluation stage.
Failed Screening
Applications that fail screening will be allocated with Quarantine numbers. A quarantine number in essence means that the application is held in abeyance pending resolution by the applicant of shortcomings noted during the screening process. It is critical to note that there is no priority afforded to quarantined applications,
Once an application is quarantined, the Authority will issue a letter to the applicant, intending to refuse to register the product, unless a complete application is submitted within 120 days. Failure by the Applicant to resubmit a complete application within the prescribed timelines will result in refusal to register the application and applicants interested in pursuing such applications will be required to resubmit new applications accompanied by payment of the full application fee.
Upon resubmission of a complete dossier and payment of the statutory resubmission fees as stipulated in item 7(a)(ix), 7(b)(v) and 7(c)(iv) of the MCAZ Fee Schedule, applications will undergo a second round of screening. Applications that fail the second round of screening will be refused registration without assessment.
Review cycles
A maximum of two review cycles will be considered during the evaluation process of applications before the Authority reaches a final regulatory decision (issuance of a registration certificate or refusal to register letter).
Deadline extensions
The Authority will not entertain any time-extension requests to respond to queries. Any such requests will result in the application being denied registration (refusal to register).
Registration Timeline
Complete applications that contain all the required technical and administration information ordinarily get registered after 1 or 2 review cycles. The Authority will use a tracker (clock start-clock stop system) to monitor and track each application. Successful applications should reach a regulatory decision within 9 months (MCAZ time).
Complementary Medicines Pre-Registration Guidance documents:
Guidelines on submission of documentation for Registration of Complementary Medicines. Click here to download .