Messages in brief
Project Monitoring of advertising material for medicinal products in 2020
messages in brief
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09/12/2020
In order to monitor the advertising regulations according to the regulations of the Austrian Medicines Act, advertising is always checked to ensure that it complies with the legal requirements.
Project Monitoring of advertising material for medicinal products in 2020
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Warnung vor Chlordioxidlösungen (MMS, CDS, CDL)
messages in brief
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10/11/2020
Keine Wirkung gegen COVID-19 und begründeter Verdacht auf schädliche Wirkungen.
Warnung vor Chlordioxidlösungen (MMS, CDS, CDL)
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#MedSafetyWeek 2020 - Every report counts. An appeal to patients and health professionals to report suspected adverse reactions from 2-8 November 2020
messages in brief
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30/10/2020
The BASG participates in the worldwide social media campaign called #MedSafetyWeek to raise public awareness of the importance of adverse drug reaction reporting.
#MedSafetyWeek 2020 - Every report counts. An appeal to patients and health professionals to report suspected adverse reactions from 2-8 November 2020
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Information on excipients in homeopathic medicinal products
messages in brief
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22/10/2020
Excipients used in the manufacture of active ingredients (such as lactose, whey, sucrose, honey, ethanol, glycerol) that may be present in trace amounts in the finished product have been re-evaluated according to the Excipients guideline and no longer need to be mentioned in the product information if they are less than or equal to a certain threshold. Above this threshold, a listing in FI and GI is required and the corresponding warnings must be mentioned in the product information.
Information on excipients in homeopathic medicinal products
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Position Paper Distribution Restrictions
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05/10/2020
The new position paper focuses on managing supply bottlenecks by improving processes and transparency and serves to clarify the role of players in the distribution chain.
Position Paper Distribution Restrictions
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Current issue of "RMS NEWS"
messages in brief
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29/09/2020
This issue of RMS NEWS again contains current and relevant news for our applicants for marketing authorisations with Austria as RMS.
Current issue of "RMS NEWS"
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BREXIT – current challenges for Marketing Authorisation Holders
messages in brief
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29/09/2020
In the following cases Marketing Authorisation Holders/Holders of a Registration need to act, these tasks have to be finalised until 31.12.2020.
BREXIT – current challenges for Marketing Authorisation Holders
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Creating Accessible Documents
messages in brief
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29/09/2020
Please note that all package leaflets have to be published in an accessible format on Arzneispezialitätenregister at latest at 31.12.2020.
Creating Accessible Documents
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COVID-19 Tests - Delimitation and Responsibilities
messages in brief
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24/09/2020
Three different test methods for the detection of COVID-19 are currently in use in Austria: PCR (polymerase chain reaction) tests, antibody tests and antigen tests.
COVID-19 Tests - Delimitation and Responsibilities
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Creating Accessible Package Leaflets – FAQ Update
messages in brief
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10/09/2020
Since July, it has been possible request conversion to accessible product information texts, even for several products together, if this cannot be done within ongoing regulatory procedures. Based on previous experience, the corresponding FAQ No. 2 has now been updated and supplemented regarding this approach.
Creating Accessible Package Leaflets – FAQ Update
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