06.06.2024
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Iris V5.8.3-Y2024S1
Iris V5.8.3-Y2024S1
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02.02.2024
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Joint Advice through the BfArM and the Federal Joint Committee (G-BA)
As part of the exemption of reserve antibiotics from the benefit assessment according to section 35a SGB V, the list of criteria and pathogens for classification as a reserve antibiotic was updated.
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03.04.2024
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Kick-off meeting with structural building partner countries
At the end of July 2023, the kick-off meeting for the structural development activities of the LabTrain project took place, which is part of the Global Health Protection Programme (GHPP) of the Federal Ministry of Health, based at BfArM.
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19.01.2024
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List of supply-critical apis according to section 52b sub-section 3c AMG
List of supply-critical apis according to section 52b sub-section 3c AMG
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19.01.2024
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List of supply-relevant apis according to section 52b sub-section 3c AMG
List of supply-relevant apis according to section 52b sub-section 3c AMG
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29.01.2024
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Manual for reporting shortages of human vaccines (PDF, 2.1 MB)
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25.03.2024
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Manuals
Manuals
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03.05.2024
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Manuals
Various nanuals are available for the PharmNet applications.
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19.06.2024
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Marketable Medicinal Products in the Responsibility of the BfArM
On the following page you will find the figures of marketable medicinal products in the responsibility of the BfArM, broken down according to type of authorisation procedure as well as details of the authorisation status. The figures are updated on a monthly basis.
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02.07.2024
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Medicinal products containing hydroxyprogesterone: safety review
Active substance: hydroxyprogesterone
Hydroxyprogesterone caproate medicines to be suspended from the EU market.
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14.06.2024
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Metamizole-containing medicinal products: risk of agranulocytosis - referral
Active substance: metamizole
EMA has started a review of medicines containing the painkiller metamizole following concerns that the measures in place to minimise the known risk of agranulocytosis may not be effective enough.
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02.05.2024
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Monthly Iris webinar - May 2024
The next Iris webinar will take place on May 29th, 2024 (1:00pm to 2:30pm CEST).
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12.01.2024
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MSSQL settings
MSSQL settings
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20.02.2024
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New information regarding allocation of DCP slots
Update on allocation of DCP slots
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02.02.2024
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Non-exhaustive list of multidrug-resistant bacteria and criteria for classification of an antibiotic as a reserve antibiotic according to § 35a para. 1 SGB V (dated 01.02.2024)
Exemption of reserve antibiotics from benefit assessment according to § 35a SGB V - Non-exhaustive list of multidrug-resistant bacteria and criteria for classification of an antibiotic as a reserve antibiotic according to § 35a para. 1 SGB V
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23.05.2024
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Non-interventional studies („Anwendungsbeobachtungen“, post-authorisation safety studies)
Non-interventional studies („Anwendungsbeobachtungen“, post-authorisation safety studies)
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05.04.2024
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Notification of the graduated plan officer
According to Section 63a, sub-section 3 of the German Medicines Act (AMG), the graduated plan officer and any change must be notified to the competent higher federal authorities.
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13.03.2024
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Pharmaceutical brokers
The list of Pharmaceutical Brokers is currently only accessible in German language on our German website.
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14.03.2024
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Pharmaceutical wholesaler
Pharmaceutical wholesalers are legally bound by § 52a German Drug Law to purchase medicinal products from a manufacturer or a holder of a wholesale distribution authorisation only.
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14.02.2024
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Pharmacoepidemiology
Pharmacoepidemiology
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