RMS NEWS

Here you will find interesting news and links to current RMS-relevant topics.

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 rmsbasg.gvat.

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!

  • IMPORTANT LINKS

CMDh (Press releases)

CHMP (Committee meeting highlights)

PRAC (Meeting highlights)

List of committees and working parties

RMS flyer

Allocation scheme

Current slot matrix

NEWSTICKER 30.06.2020

  • RECENT COMMITTEE NEWS

COVID-19 pandemic. The outbreak of the COVID-19 pandemic has a major impact on regulatory activities in Europe. Many pharmaceutical companies are directly or indirectly affected by it and therefore had to adapt their regulatory activities accordingly; this also applies to the national authorities.

The European Commission, the European Medicines Agency (EMA) and Network of Heads of European Medicines Authorities (HMA) are continuously evaluating the situation and have agreed on a variety of measures to ensure the best possible supply of critical medicines even during the pandemic.

An overview of the measures taken and helpful documents on regulatory flexibility can be found on the CMDh and EMA websites and in the latest press releases of the CMDh meetings. Information on national requirements/exemptions during the COVID-19 pandemic can be found here on the website of the BASG.

BREXIT. The CMDh has published an updated version of the "Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP" document, which addresses the implications of the withdrawal agreement and the transition period. Marketing authorisation holders are still requested to take all necessary measures at the latest by the end of the transitional period.

Update Templates/Guidance documents. Various CMDh documents have been revised and updated versions have been published in the last months. For example there is a new version of the RMS validation checklist for DC procedures and an updated Best Practice Guide on the use of eCTD in MRP/DCP.

 

  • IMPORTANT INFORMATION

AT-RMS Presubmission Phase in eServices. The BASG is breaking new ground during the AT-RMS presubmission phase: For many years, transparency and the rapid processing of requests have been important criteria in this phase and are well established in Austria. In 2020, the service for applicants has now been further optimised.

As one of the first agencies EU-wide, the BASG developed and published a slot availability matrix on its website as early as 2010 in order to transparently display the availability of the individual assessor groups. Since then, it has been possible for applicants to specifically book slots (submission dates) for procedures with Austria as RMS and plan them in the best possible way.

BASG is now going one step further with the implementation of the presubmission phase in the eServices. Since the beginning of 2020, slot bookings are listed for applicants in the current applications in the eServices. In addition to the product name and the national procedure number, the European procedure number and the agreed submission date are also displayed. With the function "Voluntary Response" further documents (e.g. Presubmission Meeting Minutes) can be uploaded to the procedure.

Furthermore, applicants can submit slot requests directly in the eServices under the item "New Application". After filling in the mandatory fields and uploading the slot request form, the request is submitted and appears in the current applications. After the BASG has checked the request, a submission date is set and the presubmission procedure is handed over to a Case Manager. The Case Manager, who is the concrete contact person, carries out the further preparation of the procedure with the applicant and then also guides through the European procedure competently and reliably.

These new presubmission eService functions are intended to provide and guarantee a better overview in this phase in terms of transparency and service orientation.

Of course, the Case Manager team can still be contacted via the e-mail address rmsbasg.gvat. We are at your disposal as your reliable RMS!

 

  • IMPORTANT EVENT

***Save the date: BASG dialogue: Meet the Case Manager***

During this BASG meeting you will have the opportunity to meet your case managers for AT=RMS procedures personally and to ask questions.

Take the chance and register!

When: 13.10.2020, 13:00-17:00 (date may still change due to the current corona pandemic)

Where: to be announced

Program/registration: here

 

  • IMPORTANT LINKS

CMDh (Press releases)

CHMP (Committee meeting highlights)

PRAC (Meeting highlights)

List of committees and working parties

RMS flyer

Allocation scheme

Current slot matrix

keyboard_arrow_up to top