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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23/03/2022
The product called "Maxviril" is marketed as a purely herbal food supplement especially for men. However, it is to be classified as an illegal medicinal product.
CHMP Monthly News
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17/03/2022
Up-to-date information from the 21.02-24.02.2022 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.
CHMP Monthly News
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17/03/2022
Up-to-date information from the 24.01.-27.01.2022 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.
messages in brief
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14/02/2022
With the AMG amendment of 14.02.2022, § 21(2) was changed to the effect that the BASG must now be notified four months (instead of the previous two months) in advance of a temporary or permanent discontinuation of the marketing of medicinal products.
messages in brief
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07/02/2022
The new Veterinary Medicinal Products Regulation is to be applied as of 28.01.2022.
Safety warnings
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Blood & Tissue
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20/01/2022
The Federal Office for Safety in Health Care has been informed by the Danish authority that it has been informed by the Danish tissue bank Cryos International (DK257551) that the donor HANDY has been diagnosed with sclerosis.
Safety warnings
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Blood & Tissue
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20/01/2022
The Federal Office for Safety in Health Care has been informed by the Danish authority that it has been informed by the Danish tissue bank European Sperm Bank (DK257572) that a child has developed congenital dilated cardiomyopathy in connection with the use of semen from sperm donor 27012-ROLAND.
CHMP Monthly News
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13/01/2022
Up-to-date information from the 13.12.-16.12.2021 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.
Safety warnings
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Blood & Tissue
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21/12/2021
The Federal Office for Safety in Health Care has been informed by the Danish authority that it has been informed by the Danish tissue bank European Sperm Bank (DK257572) that a POLG-associated disease of a child has occurred in connection with the use of semen from the sperm donor 8948-ERHAN.
messages in brief
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16/12/2021
An overview of information by BASG to the novel Corona virus SARS-CoV-2 and the COVID-19 disease as well as links to websites with further information.