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EudraCT-Version 10.5.0.0 Date: 17. June 2021 Topics: Licensing Type: News

The EudraCT PUBLIC applications for creating the Clinical Trial Application Form (Annex 1 pdf and xml) have been upgraded to v10.5.0.0. The upgraded version should allow a more user friendly completion of the form.

List of Reference Prices for Medicinal Products Date: 11. June 2021 Topics: Licensing Type: Article

The reference price of a medicinal product is the maximum amount, which is reimbursed by the statutory health insurance fund.

SNOMED CT for Project Managers PDF, 4MB, File does not meet accessibility standards Date: 31. May 2021 Topics: Licensing Type: Download

Ian Green – Customer Relations Lead, Europe and Global Clinical Engagement Lead
Charles Gutteridge – Clinical Engagement Lead, EMEA
Jane Millar – Collaborations Lead

CHMP Meeting Highlights May 2021 Date: 31. May 2021 Topics: Licensing Type: Article

CHMP Meeting Highlights May 2021

Points to consider in line with ICSR reporting (ICH E2B compliant XML-file) via EudraVigilance? Date: 10. May 2021 Topics: Licensing Type: FAQ

It is in the sponsor’s responsibility to submit E2B compliant ICSRs in accordance with the EU ICSR Implementation Guide provisions.

There is no particular testing with BfArM necessary, given that registration with EudraVigilance had been completed …

How can the product information of a generic or hybrid marketing authorisation be kept up-to-date if the marketing authorisation of the reference medicinal product has expired? Date: 09. March 2021 Topics: Licensing Type: FAQ

A change of the reference medicinal product of the initial marketing authorisation is generally not possible. Please refer to the CMDh Questions & Answers on Variations No. 3.13 (cf. https://www.hma.eu/20.html).

However, in order to update the …

In which language should the dossier and the product information texts in MR-/DC variations and renewals be submitted if only German-speaking member countries (DE/AT or only DE) are involved? Date: 09. March 2021 Topics: Licensing Type: FAQ

All CMDh guidance documents refer to the use of English language dossiers and English language product information texts. At the end of the procedures, the RMS should provide the final English texts for SmPC, PL and labelling. This is also required …

Expert Committees of the Homoeopathic Pharmacopoeia Commission Date: 24. February 2021 Topics: Licensing Type: Article

Expert Committees of the Homoeopathic Pharmacopoeia Commission

Processing Statistics of the BfArM 2021 PDF, 167KB, File does not meet accessibility standards Date: 21. February 2021 Topics: Licensing Type: Download

State: February 2022

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 …

FAQ "Variations" Date: 26. November 2019 Topics: Licensing Type: Article

FAQ "Variations"

FAQ "Sunset clause" Date: 26. November 2019 Topics: Licensing Type: Article

FAQ "Sunset clause"

FAQ Licensing Date: 26. November 2019 Topics: Licensing Type: Article

FAQ Licensing

New information in the topic licensing Date: 11. October 2019 Topics: Licensing Type: Article

New information in the topic licensing

New information in the topic medicinal products Date: 11. October 2019 Topics: Licensing Type: Article

New information in the topic medicinal products

Recommendations of the Jour Fixe on Delivery and Supply Shortages for drafting contracts between operators of hospital pharmacies / pharmacies supplying hospitals and pharmaceutical companies with the aim of improving the delivery excellence of relevant medicinal products in hospitals PDF, 228KB, File is accessible Date: 08. October 2019 Topics: Licensing Type: Download

Recommendations of the Jour Fixe on Delivery and Supply Shortages for drafting contracts between operators of hospital pharmacies / pharmacies supplying hospitals and pharmaceutical companies with the aim of improving the delivery excellence …

Liste der in EudraCT enthaltenen Felder, die für nicht-pädiatrische klinische Prüfungen veröffentlicht werden PDF, 107KB, File does not meet accessibility standards Date: 03. July 2019 Topics: Licensing Type: Download

Liste der in EudraCT enthaltenen Felder, die für nicht-pädiatrische klinische Prüfungen veröffentlicht werden

Liste der in EudraCT enthaltenen Felder, die für pädiatrische klinische Prüfungen veröffentlicht werden PDF, 93KB, File does not meet accessibility standards Date: 03. July 2019 Topics: Licensing Type: Download

Liste der in EudraCT enthaltenen Felder, die für pädiatrische klinische Prüfungen veröffentlicht werden

Technische Anleitung zum Format der Datenfelder ergebnisbezogener Informationen klinischer Prüfungen PDF, 277KB, File does not meet accessibility standards Date: 03. July 2019 Topics: Licensing Type: Download

Technische Anleitung zum Format der Datenfelder ergebnisbezogener Informationen klinischer Prüfungen