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04.04.2025
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Complementary and Alternative Medicines (CAM) and Traditional Medicinal Products (TMP)
Complementary and Alternative Medicines (CAM) and Traditional Medicinal Products (TMP)
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01.04.2025
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Variations
On the occasion of the new Variation Regulation (EC) No 1234/2008 which applies since 1 January 2010 a new web page "Variations" has been created and should be considered.
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20.03.2025
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New validation criteria for eCTD submissions - mandatory since 1st March 2025
As of 1st March 2025 new validation criteria for eCTD submissions are mandatory.
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10.02.2025
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Joint Commission of Experts on the Classification of Substances
The opinion on the classification of dehydroepiandrosterone is available.
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03.02.2025
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AMIce - Public Part - Module Batch Release
AMIce - Öffentlicher Teil (AMIce-Public Part) contains parts of the Federal Drug Application Database (AmAnDa), which is maintained and updated by the German drug regulatory authorities BfArM, BVL, and PEI.
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03.02.2025
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AMIce - Public Part - Module Substances
AMIce - Öffentlicher Teil (AMIce-Public Part) contains parts of the Federal Drug Application Database (AmAnDa), which is maintained and updated by the German drug regulatory authorities BfArM, BVL, and PEI.
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03.02.2025
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AMIce - Public Part - Module Terms for Substances
AMIce - Öffentlicher Teil (AMIce-Public Part) contains parts of the Federal Drug Application Database (AmAnDa), which is maintained and updated by the German drug regulatory authorities BfArM, BVL, and PEI.
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03.02.2025
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AMIce - Public Part - Module Medicinal Products
AMIce - Öffentlicher Teil (AMIce-Public Part) contains parts of the comprehensive medicinal products information system AMIce, managed and updated by the German drug regulatory authorities BfArM, BVL, and PEI.
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03.02.2025
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Medicinal Products Information System AMIce
AMIce contains the authorisation data of the German drug regulatory authorities BfArM (Federal Institute for Drugs and Medical Devices), PEI ( Paul-Ehrlich-Institut - Federal Institute for Vaccines and Biomedicines) and BVL (Federal Agency for Consumer Protection and Food Safety).
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27.01.2025
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Advisory Council for Delivery and Supply Shortages
According to section 52b subsection 3b of the Medicinal Products Act, the Federal Institute for Drugs and Medical Devices is empowered to set up an Advisory Council to continuously monitor and evaluate the overall supply situation in Germany.
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17.12.2024
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New information regarding allocation of DCP slots
Update on allocation of DCP slots
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12.12.2024
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Written renouncement
As of 12.12.2024 online procedures für „Renouncement declarations in accordance with Section 31 sub-section 1 sentence 1 number 2 AMG in conjunction with Section 29 sub-section 1g AMG (Medicinal Products Act)“ and „Declarations of the reasons for the non-submission of an application for renewal in accordance with Section 29 sub-section 1g AMG (Medicines Products Act)“ are availabe via the portal PharmNet.Bund.
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12.12.2024
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Notification obligations of the marketing authorisation holder in accordance with Section 29 sub-section 1g AMG as of 28 October 2013
As of 12.12.2024 online procedures für „Renouncement declarations in accordance with Section 31 sub-section 1 sentence 1 number 2 AMG in conjunction with Section 29 sub-section 1g AMG (Medicinal Products Act)“ and „Declarations of the reasons for the non-submission of an application for renewal in accordance with Section 29 sub-section 1g AMG (Medicines Products Act)“ are availabe via the portal PharmNet.Bund.
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30.10.2024
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Clinical Trials Information System – CTIS
Clinical trials data publication now more transparent in the EU - Article in EUobserver, July 19, 2024
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