Archive
27 Jan Communication to industry on Clones and Replicas
Posted at 08:18h
in
A clone is defined as an application submitted by the Innovator as a copy of its own product under a different proprietary name at any stage during the product life cycle. A replica is defined as a copy of an already registered generic product,...
27 Jan Communication to industry on metformin-containing medicines
Posted at 08:17h
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The South African Health Products Regulatory Authority (SAHPRA), in collaboration with other regulatory agencies, are reviewing the final pharmaceutical products for immediate and extended release dosage forms containing metformin hydrochloride as an active substance. This review was triggered because of the detection of an impurity,...
27 Jan Communication to industry on ranitidine-containing medicines
Posted at 08:16h
in
The South African Health Products Regulatory Authority (SAHPRA), in collaboration with other regulatory agencies, are reviewing all ranitidine-containing medicines with the following Active Pharmaceutical Ingredient; ranitidine. SAHPRA previously issued a media release regarding the recall and quarantine of ranitidine containing medicines (29 October 2019 and...
27 Jan Communication to industry on the sartans-containing medicines
Posted at 08:14h
in
The notice of concern for the above registered products refers. The South African Health Products Regulatory Authority (SAHPRA), in collaboration with other regulatory agencies, are reviewing all sartan-containing medicines with the following Active Pharmaceutical Ingredients; azilsartan, candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan and...
27 Jan SAHPRA INVOLVEMENT IN THE SWISSMEDIC MARKETING AUTHORISATION FOR GLOBAL HEALTH PRODUCTS (MAGHP) PROCEDURE
Posted at 08:09h
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The Marketing Authorisation for Global Health Products (hereinafter referred to as MAGHP) procedure is a Swissmedic project in the area of regulatory systems strengthening. The aim of...
25 Jan Re-submission of BAU New Medicines Applications from 2018 and 2019
Posted at 10:42h
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This document has been archived....
25 Jan Pilot: BAU new medicine applications for registration
Posted at 10:40h
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This document has been archived....
25 Jan eCTD Implementation roadmap communication
Posted at 10:38h
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This document has been archived.
Archives
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...25 Jan BAU Variations Communication
Posted at 10:36h
in
This document is intended to provide communication to applicants wishing to submit variations to existing registrations. This will be a “living document” and will be updated. Kindly note that this is an interim document and that the information will be incorporated into a General Information...