Messages in brief
Medical devices: Information on consultation procedures, registration of guideline products and registration deadlines published
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24/04/2019
Article 54 of the MDR regulates the consultation procedure related to the clinical evaluation of certain class III and class IIb devices. Regarding…
Revision of the EMA “Guideline on the non-clinical requirements for radiopharmaceuticals”
messages in brief
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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…
Revision of the EMA “Guideline on the non-clinical requirements for radiopharmaceuticals”
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Information on the introduction of safety features in the form of individual identification marks on each individual drug package. (Update)
messages in brief
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21/02/2019
For more information on this topic, follow the link to the security features.
Valsartan / Sartan-containing drugs: Pharmaceutical companies to review manufacturing processes to avoid occurrence of nitrosamine-containing impurities
Safety warnings
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messages in brief
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14/02/2019
During the transitional phase, strict limits are already in place for these impurities.
Valsartan / Sartan-containing drugs: Pharmaceutical companies to review manufacturing processes to avoid occurrence of nitrosamine-containing impurities
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Revision of the EMA “Guideline on the environmental risk assessment (ERA) of human medicines”
messages in brief
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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…
Revision of the EMA “Guideline on the environmental risk assessment (ERA) of human medicines”
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New guideline on assessment and control of mutagenic impurities in veterinary medicinal products
messages in brief
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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…
New guideline on assessment and control of mutagenic impurities in veterinary medicinal products
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National Immunization Schedule 2019
messages in brief
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04/02/2019
The National Immunization Schedule 2019 ("Österreichischer Impfplan") is now available.
link: https://www.sozialministerium.at/site/Gesundheit/Kran…
National Immunization Schedule 2019
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link: https://www.sozialministerium.at/site/Gesundheit/Kran…
German and Austrian drug agencies intensify cooperation on regulation of allergen products
messages in brief
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22/01/2019
A team from the Austrian Federal Office for Safety in Health Care (BASG) was a guest at the Paul Ehrlich Institute (PEI) on Jan. 14, 2019. The aim was…
Falsification suspicion of parallel-imported "ALIMTA 500 mg powder for the preparation of a concentrate for infusion solution".
Safety warnings
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messages in brief
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21/12/2018
Situation in Austria The Federal Office for Safety in Health Care (BASG) has received information that several packages of the drug "ALIMTA 500 mg…
Changes in the declaration procedure for the medical device levy 2018
messages in brief
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19/12/2018
The procedure for declaring duties for the year 2018 will change fundamentally as of 01.01.2019. As of this date, the self-declaration must be…
