PROTECTING YOUR RIGHT TO MEDICINES AND MEDICAL DEVICES
Friday, 24 November 2017
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There are various other avenues which allow for review of applications for registration to be concluded faster as well as allow for marketing of products in the whole region. These include the Expedited review procedure, WHO Prequalification Collaborative registration procedure, and ZAZIBONA.

  1. Expedited or “Fast-track” Registration Procedure

***Applicants should note that the expedited review process is currently suspended and applicants will be informed once this route is activated***

The Authority developed a separate channel for expedited reviews, which should not affect timely review of other applications. Finalisation of the application within 6 months of MCAZ time is guaranteed with this pathway.

More resources are outlaid towards processing applications submitted through the expedited review pathway thus higher fees are prescribed in the current fee schedule.

The following fees are applicable for applications using this pathway:
$4 500 excl. VAT per product for New Chemical Entities

$4 000 excl. VAT per product for generic products

$3 000 excl. VAT per product for line extensions

When submitting applications for registration under the expedited review pathway, applicants should follow steps 1 to 3 described under ‘How to register Conventional medicines’, taking note to indicate the registration pathway as ‘expedited’ in the EVR Quotation Confirmation Form.

  1. WHO Collaborative Registration Procedure

Since June 2012, MCAZ has been participating in the WHO Collaborative Registration Procedure for prequalified products. This collaborative procedure serves to facilitate and accelerate registration of products which have already been assessed and prequalified by WHO Prequalification Team-Medicines (WHO/PQTm). All applicants with WHO prequalified products are encouraged to use this route. With this pathway, finalisation of the application within 90 days of MCAZ time is guaranteed.

A fee of $4 000 excl. VAT per product is charged for applications considered under this procedure.

In the event that an applicant wishes to have an application which is already pending with the MCAZ considered under the WHO collaborative procedure, the applicant should pay a top up fee of $ 1 500 excl. VAT and submit an updated dossier which is in line with that submitted and approved by WHO/PQTm

Applicants wishing to use this route should:

  1. Notify WHO PQ of their intention to use this procedure for registration of a particular product as outlined on the WHO PQ website (Click here)
  2. Follow steps 1 to 3 described under ‘How to register Conventional medicines’, taking note to indicate the registration pathway as ‘WHO Collaborative Procedure’ in the EVR Quotation Confirmation Form.

It is important to note that the approval of the product using this route is based on the WHO prequalification status of the product, therefore, the technical contents of the dossier submitted to Zimbabwe should be exactly similar to that submitted and approved by WHO/PQTm; in addition to Zimbabwe specific requirements on the application form, samples and labelling.

  1. ZAZIBONA

ZAZIBONA is a SADC collaborative registration initiative among the five actively participating national medicines regulatory authorities (NMRAs) in Botswana, Namibia, Zambia, Zimbabwe and South Africa. Active participation in joint review process will be extended to the remaining nine SADC Member States. The objective is to facilitate access to good quality medicines through work-sharing in assessment of applications for registration and inspection of manufacturing and testing facilities. Products that meet the assessment criteria are then granted registration in the participating countries. Where countries agree that it is necessary, variations to the products which have been registered under this collaboration may be handled through the same process.

The ZAZIBONA collaboration does not replace the need to submit applications for registration in participating countries in line with national requirements, and final national registration decisions are the responsibility of individual participating authorities. Both new applications and applications in the pipeline are eligible for consideration under the procedure provided that the product application has been submitted to at least two of the participating countries and in the CTD format.

Applicants interested in having their products assessed under the ZAZIBONA initiative should follow steps 1 to 3 described under ‘How to register Conventional medicines’, taking note to indicate the registration pathway as ‘ZAZIBONA’ in the EVR Quotation Confirmation Form. More information on the ZaZiBoNa procedure can be requested from the following email, This email address is being protected from spambots. You need JavaScript enabled to view it..

 

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