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The authorisation status of allergen products

messages in brief | 10/05/2019
The authorisation status of allergen products, both for diagnosis and therapy, in the European Union is heterogeneous.
In order to facilitate…
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Update Community Referral Sartans

messages in brief | 07/05/2019
The Commission Implementing Decision is published. Further information can be found under:  https://www.basg.gv.at/de/news-center/news/news-detai…
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Revision of the EMA “Guideline on the non-clinical requirements for radiopharmaceuticals”

messages in brief | 23/04/2019
The purpose of the ‚Draft guideline on the non-clinical requirements for radiopharmaceuticals‘ (EMA/CHMP/SWP/686140/2018) is to provide guidance on…
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Revision of the EMA “Guideline on the environmental risk assessment (ERA) of human medicines”

messages in brief | 04/02/2019
The EMA published a revision of the “Guideline on the environmental risk assessment (ERA) of human medicines” on 30 November 2018. The guideline is…
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New guideline on assessment and control of mutagenic impurities in veterinary medicinal products

messages in brief | 04/02/2019
In December 2018 the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a guideline on the assessment and control of DNA reactive…
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National Immunization Schedule 2019

messages in brief | 04/02/2019
The National Immunization Schedule 2019 ("Österreichischer Impfplan") is now available.
link: https://www.sozialministerium.at/site/Gesundheit/Kran…
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Round table on "Availability of medicines in Austria" (1)

messages in brief | 28/11/2018

On November 27, 2018 a big "round table" took place on the topic of availability of medicines in Austria. At the top-class event, which was organised…

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BASG OMCL plans to join the WHO-National Control Laboratory Network for Biologicals

messages in brief | 26/11/2018
The WHO-National Control Laboratory Network for Biologicals was established to facilitate the availability of WHO pre-qualified vaccines. The WHO…
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Mock-Up-Guidance Document

messages in brief | 19/11/2018

To summarize legal provisions, requirements regarding content as well as information how to submit and handle Mock-Ups a new Guidance Document was set…

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Save the date - "Pharmacovigilance update"

messages in brief | 29/05/2018
During this event PHV experts of the BASG will provide  an overview on ICSR-Reporting, Signal-Management, the implementation of PHV-issues, as well as…
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