Archive

25 Oct Communication to Industry – Implementation of RIMS – Information on eCTD 3.1 Module 1

Posted at 15:07h in

This document is intended to provide an update on the progress for the Regulatory Information Management System (RIMS) deployment.   In the development of the new eCTD specifications, attention has been given to global best practice and the frameworks and specifications from other Recognised Regulatory Authorities....

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20 Aug Sameness Declaration Form for Reliance-based Models

Posted at 16:24h in

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01 Aug Phenylephrine Lack of Effectiveness of Oral Preparations as Nasal Decongestant

Posted at 14:17h in

This document is intended to provide communication to the HCRs for orally administered phenylephrine-containing medicines.   The Advisory Clinical Committee discussed the communication from the United States Food and Drug Administration (US-FDA) regarding the efficacy of orally administered phenylephrine as a nasal decongestant. This communication emanates from...

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01 Aug Restriction on Codeine Use in Children, Pregnant and/or Breastfeeding Mothers

Posted at 14:14h in

This document is intended to provide communication to The Holder of Certificate of Registration for Codeine containing products.   The Advisory Clinical Committee (ACC) reviewed data submitted by HCRs to support the continued use of codeine in children under 12 years and concluded that there is evidence...

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23 Jul Communication to Industry – FAQs on Active Pharmaceutical Ingredient

Posted at 14:07h in

This FAQs document is intended to provide communication to the API suppliers to assist them with adequately addressing the most common queries received by SAHPRA....

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23 Jul Frequently asked questions (FAQs) and common deficiencies for the submission of PEM Post-Registration variations

Posted at 10:43h in

This communication provides guidance which represents the current thinking of the South African Health Products Regulatory Authority (SAHPRA) on this topic. It does not establish any rights for any person and is not binding on SAHPRA or the public. You can use an alternative approach...

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23 Jul CTD Checklist

Posted at 10:39h in

The checklist must be included in submissions that include variations for CTD conversions. This checklist should also be included as an annexe to the cover letter for the baseline sequence when converting from eSubmission to eCTD....

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23 Jul Z-Code Request Form

Posted at 10:37h in

Populate this information on a document that includes your company letterhead....

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16 Jul Guideline on Co-Applicancy

Posted at 12:01h in

This guideline is intended to provide guidance to applicants who intend to apply as co-applicants for the registration of a medicine. It represents the current thinking of the South African Health Products Regulatory Authority (SAHPRA) on managing applications for registration where there is more than...

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09 Jul Communication to Industry – Implementation of the Regulatory Information Management System, Version 5 Portal & Interim DVP use

Posted at 11:58h in

This document is intended to provide communication to applicants on system updates regarding the Regulatory Information Management System (RIMS) Portal and the Digital Variations Portal (DVP).   SAHPRA’s digital transformation has progressed as planned with submissions via the sFTP for new product applications, all variations, and renewals...

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