Archive
25 Jan Extension – Use of acknowledgement letter in lieu of a licence
Posted at 12:54h
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2020 Mar...
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This document has been archived....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This document has been archived....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This document has been archived.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
Download Version 2 (9.127)Date updated
...25 Jan BAU Variations Communication
Posted at 10:36h
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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...
25 Jan Industry Communication on Interim Measures Pending Update of Variation Addendum
Posted at 09:58h
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2020 Sep...
24 Jan Reflection document on regulatory requirements for vaccines intended to provide protection against variant strain(s) of SARS-CoV-2
Posted at 12:37h
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This document has been archived....