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GENERAL, ECTD & HUMAN MEDICINES COMMUNICATION TO INDUSTRY

Document NumberTitleCategoriesDate UpdatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
HPA13Digital Variations Portal (DVP) User Changes11/07/20231pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
HPA-08FAQs on Medicine Registration Renewals22/08/20235, pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
PEM03-2022/23Implementation of the QOS and QIS23/05/20231, , pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines pem-pre-reg pharmaceutical-evaluation-management
HPA-11Communication on Hard Copy Registration Certificates17/02/20231, pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
HPA-10Communication to Industry – Pilot Application Process through the SAHPRA Service Desk01/02/20231, pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
HPA01-2022Medicines Registration Renewals Implementation Framework22/08/20236pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
HPA09Pre-registration veterinary medicines tracker guide08/12/20221, pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines veterinary-medicines
Certification Variation Screening – Type II Proprietary Name Change Applications and TOAs14/12/20222pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
Expression of Interest-WHO Pre-Qualification Collaborative Registration Procedure17/11/20221pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
HPA07Certification Variation Screening – Type II Proprietary name change applications and TOA’s20/10/20221pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
Position Paper – Proposal to Applicants for Dossier Processing Fee (ZaZiBoNa)13/10/20221docxDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
Over-arching: Good Review Practice Guide, 24/06/20221, pdfDownloadcommunication-to-industry guidecorporate general-ectd-human-medicines-guidelines
Extension on commentary period for Borderline Products Guideline15/09/20221, pdfDownloadcommunication-to-industrycorporate general-ectd-human-medicines-guidelines
Missing Applications – Call to Industry18/08/20221, , pdfDownloadcommunication-to-industrycorporate general-ectd-human-medicines-guidelines information-technology
Expression Of Interest: SADC Medicines Regulatory Worksharing, Zazibona Collaborative Process, 24/10/20191pdfDownloadcommunication-to-industry expression-of-interestgeneral-ectd-human-medicines-guidelines
Communication to Industry on Nitrosamine Review for New Applications and Registered Products including Biologicals16/06/20221pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
Communication on Medicines Registration Renewals Implementation Framework24/11/20222, , , pdfDownloadcommunication-to-industrybiological-medicines-evaluation-and-research general-ectd-human-medicines-guidelines quality veterinary-medicines
Retention Fee Notification – 9 June 202224/06/20221, , , pdfDownloadcommunication-to-industrybiological-medicines-evaluation-and-research general-ectd-human-medicines-guidelines inspectorate-and-good-manufacturing-practices medical-devices
Payment of annual retention fees for registered products25/05/20221pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
HPA03Priority Review Requests Communication11/12/20233pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
Communication to industry on Clones and Replicas26/11/20201pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
2.19Communication to industry on metformin-containing medicines22/10/20201pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
2.18Communication to industry on ranitidine-containing medicines21/10/20201pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
2.17Communication to industry on the sartans-containing medicines22/10/20202pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
SAHPRA INVOLVEMENT IN THE SWISSMEDIC MARKETING AUTHORISATION FOR GLOBAL HEALTH PRODUCTS (MAGHP) PROCEDURE23/11/20211pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
9.129Re-submission of BAU New Medicines Applications from 2018 and 201920/10/20212Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
9.128Pilot: BAU new medicine applications for registration21/07/20212Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
9.127eCTD Implementation roadmap communication27/10/20212Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
SAHPGL-HPA-05BAU Variations Communication07/09/20224, pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines hpa
Industry Communication on Interim Measures Pending Update of Variation Addendum, 10/09/20201pdfDownloadcommunication-to-industry guidelinegeneral-ectd-human-medicines-guidelines