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Zimbabwe: MCAZ Finalised Guidelines for Submitting Applications for Variations to Registered Medicines

Monday, December 18, 2017: The Medicines Control Authority of Zimbabwe (MCAZ) has finalised 'guideline for submitting applications for variations to registered medicines'. This guideline provides the necessary information that must be submitted by all applicants to the MCAZ. Please note that this guideline also refers to changes or variations to a registered medicine.

The better part of this guideline was derived from the EU "Guideline on dossier requirements for type IA and IB notifications", the World Health Organisation (WHO) "Guidance on variations in a dossier submitted within the prequalification program", FDA "Guidance for Industry: Changes to an approved NDA or ANDA', and Scale-Up and Post-approval Changes (SUPAC) guidelines.

References to compendial monographs (British Pharmacopoeia (BP), International Pharmacopoeia (Ph. Int.), Japanese Pharmacopoeia (JP), European Pharmacopoeia (Ph. Eur) or United States Pharmacopoeia (USP) or to guidelines (WHO, ICH-region and associated countries) are inserted to assist applicants on compiling their applications for submission. However, it remains the applicant's responsibility to ensure that all relevant legislation and guidelines, as revised or maintained, are taken into account in the preparation of each part of their dossier.

MCAZ adopted the Common Technical Document (CTD) guidelines for submissions of applications for registration of medicines in March 2013. Applicants are encouraged to refer to the MCAZ Guideline on Submission of Documentation for Registration of a Multi-source (Generic) Finished Pharmaceutical Product (FPP): Quality Part of the (CTD) Format”. Applicants are urged to note the requirements for submission of applications in this guideline as failure to comply fully will lead to rejection of the application. As per MCAZ regulations, applicants are required to submit the application for variation and the applicant should be representative of the principal.

No requests for refunds to rejected applications will be entertained. Any failure to submit additional information requested on evaluation of the variation within the stipulated period (usually not more than 30 days) will lead to rejection of the application. The MCAZ will not accept any responsibility for the safekeeping of incomplete applications. Any documents accompanying applications received by the Authority, whether accepted or rejected, will become the property of the Authority and their storage will fall under the applicable legislative control and confidentiality clauses.

This guidance document is applicable only to Active Pharmaceutical Ingredients (APIs) and excipients manufactured by chemical synthesis or semisynthetic processes and Finished Pharmaceutical Products (FPPs) containing such APIs and excipients. Variations to a biological API and/or biological excipient, or biological finished products are assessed as major changes. In this case the applicant should refer to guidance documents that specifically address biological APIs, excipients and finished products (e.g. ICH Q5A (R1), QSB, Q5C, Q5D, Q5E, Q6B).

This guideline applies to all variations whether from the applicant's initiative or requested by the Authority. This guideline does not apply to medicines whose application for registration is still under consideration by the MCAZ.

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