What's new
Newsletters "UptoDate" of BASG/AGES MEA are published monthly and contain the latest articles from the last month (link to subscription page).
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Enforcement
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18/08/2020
Alleged natural product contains undeclared synthetic active pharmaceutical ingredient.
Recall
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Medicines
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13/07/2020
Low volumes of the nasal sprays has been observed, possibly due to evaporation from the bottles.
Recall
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Medicines
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13/07/2020
Low volumes of the nasal sprays has been observed, possibly due to evaporation from the bottles.
messages in brief
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09/07/2020
The EC has published a useful summary of applicable EU rules after the end of the transition period. You can find the link here on the website of the BASG.
messages in brief
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30/06/2020
Also in the future, we want to continue to inform our applicants of marketing authorisation procedures with Austria as RMS with relevant news from the committees or exciting innovations such as the slot application via our eServices!
Recall
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Medicines
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25/05/2020
Dissolution of an active substance may be slowed down.
messages in brief
Medicines
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20/04/2020
Central contact points in each federal state survey needs and coordinate distribution
messages in brief
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26/03/2020
Based on the current situation it has been agreed between the EMA and NCAs to extent the deadline for submission to complete Step 1 for the evaluation of the risk of the presence of nitrosamine impurities in human medicinal products containing chemically synthesised active pharmaceutical ingredients, from 26. March 2020 to 1. October 2020.
Recall
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Medicines
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26/02/2020
Recall due to reduced active ingredient content
Safety warnings
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Medicines
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11/02/2020
The all-clear can be given, because samples of the active substance noscapine from manufacturer and affected pharmacies have been examined in the meantime.