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License Applicants and Pharmaceutical Industry

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This section provides information for License Applicants and Pharmaceutical Industry. Topics are Marketing Authorisation, Batch Release, Fees and others. The information is provided for both human and veterinary Medicine.

Information on specific medicinal products (Latest 5)

The table below shows the latest 5 articels with information on specific medicinal products. Please note that most articles are available in German only.

Publications in the German Federal Gazette

The legally binding source for publishing information from the Paul-Ehrlich-Institut is the "Bundesanzeiger" (Federal Law Gazette). The table below shows the latest publications. This Information is only available in German.

Overview Publications in the Bundesanzeiger (Link to the German Section)

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Additional Information

Next Meeting

17.10.2017
XXV Anniversary Congress of the European Society of Gene and Cell Therapy (ESGCT)

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New Articles

30.01.2015: PEI-C Rebuild - electronic submission of applications for batch release applications

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25.09.2017: Paul Ehrlich Institut's scientific advice on oncology products provided to the German Cancer Consortium

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28.03.2017: DZIF Office for Scientific and Regulatory Advice (DZIF-OSRA)

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03.03.2014: Changes in electronic submissions of regulatory documents to the Paul-Ehrlich-Institut

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Further Information

EudraLex

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Latest Press Release

27.09.2017: Safe blood products – PEI develops WHO-reference materials for platelet concentrates

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05.09.2017: Mode of action of the vaccine adjuvant flagellin in fusion proteins has been clarified

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