26.01.2024
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Reporting obligations
Within the scope of Section 52b sub-section 3c Medicinal Products Act, BfArM is obliged to create lists for supply-relevant and supply-critical active substances.
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19.01.2024
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Reports LabTrain Project
Reports LabTrain Project
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19.01.2024
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Reports PharmTrain projects
Reports PharmTrain project
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30.04.2024
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Request for classification and/or qualification decision
Request for classification and/or qualification decision
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11.06.2024
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Result reports of clinical trials
Result reports of clinical trials
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18.06.2024
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SAE and DD reporting for clinical investigations
SAE and DD reporting for clinical investigations
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14.05.2024
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Service
Various manuals and FAQs on the PharmNet applications are available in the service area.
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29.01.2024
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Short manual "Notifications for Sunset Clause"
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08.03.2024
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Short Manual for the application Product Information Texts (PIT)
Short Manual for the application Product Information Texts
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07.05.2024
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spec-ICD11-V2023S147 PDF
spec-ICD11-V2023S147 PDF
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07.05.2024
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specV2021SR40 PDF
specV2021SR40 PDF
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21.06.2024
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Spotlight on pharmacokinetics - Workshop at BfArM conveys the principles of clinical assessment
In April 2024, the fellows of the clinical fellowship programme met for a workshop in Bonn.
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15.07.2024
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Start of a review concerning the conduct of studies at Synapse Labs Pvt. Ltd., India
Active substance: various
The Federal Institute for Drugs and Medical Devices (BfArM) implements the decision of the European Commission of 24 May 2024 for the German marketing authorisations with its decision of 17 June 2024.
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14.06.2024
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Statistical requirements for applications for authorisation of a clinical trial with medical devices
The BfArM has summarised the requirements for statistics in clinical trials with medical devices in a guideline.
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05.07.2024
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Statistics "Complementary and Alternative Medicines (CAM) and Traditional Medicinal Products (TMP)"
The following table gives an overview of the herbal, homeopathic and anthroposophic medicinal products with completed marketing authorisation or registration procedure which are available on the German market.
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14.05.2024
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Statistics related to advice procedures
The statistics related to advice procedures have been updated.
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25.03.2024
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Structure Development
Structure Development
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09.07.2024
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Structure of the BfArM
Structure
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23.04.2024
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Sunset Clause
The BfArM informs about the start of the electronic application portal for exemptions and suspensions to the sunset clause
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25.04.2024
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Sunset Clause
Notifications for Sunset Clause and Sunset Clause - Exceptions
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