Official announcements
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06/10/2021
The aim of this event is to help future CTIS users prepare for submitting and evaluating clinical trial applications in CTIS after its go-live on 31 January 2022.
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30/09/2021
This issue of RMS NEWS again contains current and relevant news for our applicants for marketing authorisations with Austria as RMS.
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Medicines
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20/09/2021
The Product Information has been updated with the new shelf-life for the frozen vial, that has been extended from 6 months to 9 months. The storage conditions remain unchanged (-90 °C to -60 °C).
CHMP Monthly News
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04/08/2021
Up-to-date information from the 19.07.-22.07.2021 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.
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19/07/2021
The registry lists in a new form - with search and filter options - those SARS-CoV-2 rapid antigen tests that can be placed on the Austrian market for self-testing.
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CHMP Monthly News
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07/07/2021
Up-to-date information from the 21.06.-24.06.2021 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.
messages in brief
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30/06/2021
This issue of RMS NEWS again contains current and relevant news for our applicants for marketing authorisations with Austria as RMS.
messages in brief
CHMP Monthly News
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17/06/2021
Up-to-date information from the 17.05.-20.05.2021 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.
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02/06/2021
On May 28, 2021, the use "for active immunization of individuals 12 years of age and older" was extended by the EMA.
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25/05/2021
As of 22.5.2021, the function "Withdrawal according to §23 AMG" will be available in the area "Overview Medicinal Products".