Current issue of "RMS NEWS"

messages in brief | 29/09/2020

NEWSTICKER 29.09.2020

RECENT COMMITTEE NEWS

BREXIT. Marketing authorisation holders are again reminded to make all necessary changes by 31.12.2020 to ensure that their products comply with EU legislation even after the end of the transition period. Therefore, marketing authorisation holders, batch control/release sites, QPPV and PSMF may no longer be located in the UK. The CMDh also refers to the regulations applicable in Northern Ireland under the so-called "Protocol on Ireland/Northern Ireland"; details can be found in the "Notice to stakeholders - withdrawal of the United Kingdom and EU rules for medicinal products for human use and veterinary medicinal products" under part C.

Update templates/guidance documents. Various CMDh documents have been revised and updated versions have been published in the last months (updated Q&A – QP declarations, Examples for acceptable/non acceptable groupings). Information on the assessment of similarity with authorised orphan medicinal product(s) has been included in the RMS Day 70 and Day 120 overview AR templates and a separate RMS similarity assessment report template has been created and agreed. The new templates can be found under this link on the CMDh website. In addition, the corresponding guidance documents for DC, MR and RUP procedures have been updated and the role of the RMS has been further highlighted. These documents will be published here on the website of the CMDh.

IMPORTANT INFORMATION

Cancellation BASG dialogue: AT as RMS - Meet the Case Manager. We had been looking forward to meeting you personally at our BASG dialogue: AT as RMS - Meet the Case Manager scheduled for 13.10.2020. In addition to the professional exchange in the form of keynote speeches on current regulatory-relevant topics or changes and innovations, the personal face-to-face discussions with you and the introduction of our new colleagues are a very central and valuable part of our Meet the Case Manager series.

"We" - these are the regulatory experts for new marketing authorisations, renewal procedures and all other lifecycle changes of medicinal products with AT as RMS and we are part of the Institute for Marketing Authorisation of Medicinal Products & Lifecycle Management. In the past months we have been strengthened by several new colleagues who are currently undergoing internal training and are supported by the experienced colleagues with many years of professional expertise.

As a direct contact person and hub for all information relevant to the respective procedure, we are particularly concerned with active communication with our Applicants in addition to competent support for the procedures.

Due to the Corona pandemic, it has now been decided to cancel the planned live meeting for the time being. Unfortunately, the current situation does not allow us to satisfactorily fulfill the high standards we aim for with this event, because personal discussions with so many baby elephants in the room and in compliance with all distance and hygiene measures would be rather difficult.

As far as the professional exchange is concerned, you can of course rely on us even in these personally distanced times! We will continue to keep you up to date with the latest regulatory information and innovations with the RMS NEWS. If you have any procedure-related questions, the respective case manager will be available to you as usual. If you have any questions on general RMS-relevant topics, please feel free to send them to rms@basg.gv.at.

We very much enjoyed our first BASG dialogue: Meet the Case Manager in 2017 and therefore we hope that this opportunity will come up again soon. Until then we wish you all the best and good health!