BfArM - Federal Institute for Drugs and Medical Devices

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D.4. Is a (renewed) notification of marketing required for a medicinal product for which post-marketing authorisation was granted after 6 September 2005 and which was marketed previously? Date: 09. September 2008 Topics: Licensing Type: FAQ

No new notification is necessary if the granting of the marketing authorisation does not entail changes of the marketing status. This means that such a notification can be dispensed with if the medicinal product was marketed continuously.

Medicinal Products for Human Use, VOLUME 2B Module 1: Administrative Information application form, May 2008 doc, 387KB, File does not meet accessibility standards Date: 22. May 2008 Topics: Licensing Type: Form

(Formularsatz für den Antrag auf Zulassung eines Arzneimittels beim Bundesinstitut für Arzneimittel und Medizinprodukte und beim Paul-Ehrlich-Institut/Bundesamt für Sera und Impfstoffe (Stand 22.05.2008))

Processing Statistics of the BfArM 2007 PDF, 357KB, File does not meet accessibility standards Date: 26. February 2008 Topics: Licensing Type: Download

State: January 2008

Criteria for Scientific Material in Support of Clinical Indications in Homeopathy PDF, 56KB, File does not meet accessibility standards Date: 12. February 2008 Topics: Licensing Type: Download

Criteria for Scientific Material in Support of Clinical Indications in Homeopathy

Processing Statistics of the BfArM 2006 PDF, 382KB, File does not meet accessibility standards Date: 20. February 2007 Topics: Licensing Type: Download

State: February 2007

Guide to Submission of Applications for Marketing Authorisations of the Decentralised Procedure (DCP) (according to Art. 28(3) of Directive 2001/83/EC) Date: 19. December 2006 Topics: Licensing Type: Article

In order to speed up the processing of the applications at validation the following current requirements for submission should be taken into account.

For multiple applications of the same medicinal product rtf, 22KB, File does not meet accessibility standards Date: 18. May 2005 Topics: Licensing Type: Form

(Parallelanträge für das betreffende Arzneimittel)