BfArM - Federal Institute for Drugs and Medical Devices

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Processing Statistics of the BfArM 2020 PDF, 288KB, File does not meet accessibility standards Date: 17. February 2021 Topics: Licensing Type: Download

State: February 2021

Information about the AMIS overall replacement Date: 09. February 2021 Topics: Licensing Type: Article

AMIS overall replacement

Notification obligations of the marketing authorisation holder in accordance with Section 29 sub-section 1g AMG as of 28 October 2013 Date: 17. December 2020 Topics: Licensing Type: Article

Section 29 sub-section 1g AMG which came into force on 28 October 2013 in accordance with Article 5 sub-section 2 of the Third Act to Amend Provisions under the Law Concerning Medicinal Products and Other Provisions of 7 August 2013 (BGBl. I …

Opinion No. 02/2020 of the Joint Expert Committee on Classification of Substances PDF, 963KB, File does not meet accessibility standards Date: 16. December 2020 Topics: Licensing Type: Download

Classification of products containing curcumin with improved bioavailability

Processing Statistics of the BfArM 2019 PDF, 289KB, File does not meet accessibility standards Date: 04. August 2020 Topics: Licensing Type: Download

State: February 2020

Opinion No. 01/2020 of the Joint Expert Committee on Classification of Substances PDF, 1MB, File is accessible Date: 23. July 2020 Topics: Licensing Type: Download

Classification of products of the Ayurvedic tradition

Costs Date: 22. May 2020 Topics: Licensing Type: Article

Costs and special statutory regulations

COVID-19: beware of falsified medicines from unregistered websites Date: 26. March 2020 Topics: Licensing Type: Risk information

Active substance: diverse

The BfArM and the EMA advise the public not to purchase medicines from unauthorised websites or other vendors trying to take advantage of the fears and concerns of the public.

eSubmission Date: 13. March 2020 Topics: Licensing Type: Article

Implementation of the HMA eSubmission Roadmap in Germany - eCTD format mandatory in purely national procedures for all submission types as of 1 January 2019.

Medicinal Products Date: 26. November 2019 Topics: Licensing Arzneimittelsicherheit Type: Article

Medicinal products are substances that are used to treat diseases, to relieve complaints, or to prevent such diseases or complaints in the first place. This definition applies regardless of whether the medicinal product is administered to humans or …