Amendments to the Rules of Procedure – Part 3: Extension of deadline for the new AMNOG dossier

Mon, 2019 / 07 / 01
More than four months after the last information from the G-BA, further modifications to Annex II of Chapter 5 have been presented with the recently published resolution of June 20th, 2019.

Part 3: Extension of deadline for the new AMNOG dossier until March 31st, 2020

It should be anticipated that we still have to be patient waiting for the updated module templates for the dossier entering into force. So far, the templates of 18th April 2013 were valid with the transitional period until December 31st, 2019. Although the Federal Joint Committee has complied with the latest requests of the Federal Ministry of Health regarding the decision on patient data listings, the final decision on the modules is still to be taken.

In the recently published decision of June 20th, 2019 by the G-BA, the previously planned transitional period is extended and Annex II in the version of the decision of 18th April 2013 can continue to be used for submission of dossiers for the benefit assessment. During this period, pharmaceutical companies are free to submit not only the module version of 18th April 2013, but also of March 16th, 2018, taking into account the resolutions of February 21st and June 20th, 2019.

SKC consulting has been successfully supporting pharmaceutical companies in the initial conception and final compilation of the value dossier for several years.

Gather further information about the amendments to the Rules of Procedure in our blog serious: 

Part 1: Executive summary of the history of amendments by the G-BA

Part 2: Overview of the most important changes

Source: G-BA: Verfahrensordnung: Änderung der Anlage II zum 5. Kapitel (German only)

BY Prof. Matthias P. Schönermark, M.D., Ph.D. and Dr. Alexandra Lipus

About the author

Ihr Ansprechpartner Prof. Matthias P. Schönermark, M.D., Ph.D.
Prof. Matthias P. Schönermark, M.D., Ph.D.
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