Archive
14 Oct Submission Form Template
Posted at 17:04h
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The template of submission form is populated by the API supplier and subitted to SAHPRA during submission of the APIMF record....
21 Sep Bioequivalence Trial Information for Veterinary Medicines
Posted at 09:14h
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This document should be completed by the applicant to ensure the inclusion of all necessary Bioequivalence Trial information....
20 Sep Veterinary Medicines Biowaiver Application Form for Parenterals
Posted at 17:50h
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The formulation and API characteristics, including the route of administration and species, are factors which may affect requirements to waive bioequivalence studies (i.e., to compare the rate and extent of absorption between two formulations containing same active substances). Applicants must submit the following relevant information...
07 Sep Medicines Application Form Module 1.2.1
Posted at 14:08h
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This application form should be included in the South African Common Technical Document – Module 1 Administrative Information. The application form is to be used for an application for registration, variation or renewal of a medicinal product for Human or Veterinary use submitted to the South...
01 Sep Owner Consent Form (Use of an Unregistered Veterinary Product)
Posted at 11:03h
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Owner Consent Form - Use of an Unregistered Veterinary Product...
01 Sep Veterinary Clinical Trial Application Template
Posted at 11:01h
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This template is intended to provide recommendations to applicants wishing to submit veterinary clinical trial applications. The template should be completed in conjunction with the attached guideline document. ...
01 Sep Veterinary Medicines Section 21 Application Form
Posted at 10:58h
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Request For Use of an Unregistered Product In Terms Of Section 21 Of Act 101 of 1965...