RMS NEWS

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

NEWSTICKER 30.09.2021

  • RECENT COMMITTEE NEWS

Day 0 Repeat Use Procedure. The CMDh reminds marketing authorisation holders of the possibility to include additional member states by means of a purely administrative Day 0 Repeat Use procedure, e.g. to avoid potential supply shortages (see press release). In this case, both the RMS and the new CMS must agree prior to submission that the procedure can be carried out purely administratively and that the time table will be drastically shortened.

Please submit such requests with AT as RMS to rms@basg.gv.at. Information about the respective fee can be found in the currently valid regulation of fees. For more details and requirements, see the BASG website.

ASMF Worksharing. CMDh would like to remind applicants and ASMF Holders when submitting an ASMF to use the ASMF Worksharing procedure, if possible. This saves resources and facilitates a harmonised review. Details of the ASMF Worksharing Procedure are published at this link on the CMDh website.

Product Information Update - Safety Reviews. The CMDh would like to remind marketing authorisation holders that an update of the product information due to a Safety Review of the MHRA should not be submitted by means of a Type IB Variation (C.I.3), as the Safety Review was not conducted by an EU/EEA agency (see press release). If desired, such changes must be submitted via a Type II Variation (C.I.4) including supporting data. It should also be noted that any deviations from an EU harmonised wording (following a recently finalised PSUSA procedure) must be duly justified by means of a Type II Variation.

  • IMPORTANT EVENT

BASG dialogue: Meet the Case Manager

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

Take the chance and register!

More information about the exciting program can be found on the AGES Academy website, where you can also register for the event.

Please note that the talks will be in German.

When: 12.10.2021, 13:00-17:00

Where: Online via Zoom

Program/registration: Link

  • 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 30.06.2021

  • AUSTRIA AS YOUR RMS

New RMS Flyer. Current figures and statistics on Austria as your RMS can be found in our new RMS flyer!

  • RECENT COMMITTEE NEWS

Multilingual packing pilot. The CMDh would like to remind applicants of the Multilingual packaging pilot. The wish to participate in the pilot should be articulated in the cover letter of new submissions indicating the respective member state cluster(s). Further details on the pilot can be found in the May 2021 CMDh Press releases or the corresponding CMDh Best Practice Guide on Multilingual Packaging.

Statistics on MRPs, DCPs, Variations and Renewals. As of June 2021, the information published in the press releases on the procedures started or finalised will be changed. In the future, only the frequency of participation in started MRPs or DCPs of each member state will be published; the full information on started and finalised procedures will continue to be published every 6 months by the CMDh at this link.

Document Update. The CMDh, together with the EMA and EC, has revised the EMA/CMDh Q&As on the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations and also added new Q&As. The revised version will be published on the CMDh website at this link. The template for requests for RMS in a DCP for medicinal products for human use has also been revised, in which applicants should in future also specify the intended indication(s) of the product and information on whether the ASMF is to be assessed in a worksharing procedure, if applicable. The revised version will be published on the CMDh website at this link.

  • 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!

More information about the exciting program can be found on the AGES Academy website, where you can also register for the event. If you have any questions on one of the topics, we would ask you to send them in advance - please by 30.09.2021 at the latest - to lcm@ages.at. We will answer them anonymously in the presentations!

Please note that the talks will be in German.

When: 12.10.2021, 13:00-17:00

Where: Online via Zoom

Program/registration: Link

  • 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 30.04.2021

  • RECENT COMMITTEE NEWS

MRP/DCP Statistics 2020. The CMDh presented its annual statistics on DC/MR procedures for 2020 according to the CTS database. In 2020, Austria ranked 7th as RMS for finalised procedures for human medicinal products and 6th for started procedures. Thank you very much for your trust - we are very pleased to be able to continue to be your competent and reliable partner in marketing authorisation procedures at the European level! We would like to take this opportunity to remind you that slot requests can also be submitted via our eService portal. This information can now also be found in the corresponding CMDh document on slot requests!

BREXIT Update Q&A. The CMDh agreed an update of its Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP to provide clarification on MRP/RUPs for IE, CY, MT and/or UK(NI) from procedures finalised in 2020 and containing both EEA/UK(NI) and UK(GB) batch release sites/batch control sites in their dossiers. The updated document will be published on the CMDh website under “Brexit”.

Summary of CMDh activities in 2020. In the spirit of transparency, the CMDh has prepared a summary of the main activities carried out in 2020 by the CMDh and its working groups. A list of all new or revised CMDh documents published by the CMDh in 2020 is attached to this report as an annex and can be found at this link on the CMDh website.

Update Guidance document Applicant's response document in MRP and DCP. The CMDh has clarified in the revised version of the Guidance document on the Applicant's response document in MRP and DCP for MAAs that an updated version of the electronic application form must be submitted with the responses each time there are changes in Module 3 and 1.2. The current revision of the document is published at this link on the CMDh website.

  • 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 29.01.2021

AUSTRIA ALLOCATES PROCEDURE NUMBER “AT/H/1200”!

2020 has been a very extraordinary and challenging year for each of us, which has strongly influenced many areas of what used to be "normal" life. Therefore, we are even more pleased that so many applicants continue to choose us as their Reference Member State (RMS) and that we have now been able to allocate the 1200th procedure number in decentralised procedures at the beginning of 2021. It confirms the confidence and reliance that applicants have in the Austrian agency - even in times of crisis. AT as RMS was able to continue its procedures in the past year in the usual quality and we have adapted to the new situation in the best possible and flexible way.

Please contact rms@basg.gv.at in case you have any questions regarding AT as RMS. If you would like to book a slot with us as RMS for a submission you are planning, please see the BASG website for our current slot matrix and detailed information on how to proceed.

Slot requests/bookings can be submitted directly through our eServices portal since the beginning of last year, and are thus visible for applicants in their current applications.

We would like to express our sincere thanks - especially in these challenging times - for the trust you have placed in us and for the constructive way in which we have together conducted our work over the past year. We look forward to continuing to support you in the future as your competent and experienced partner as RMS in European procedures!

  • RECENT COMMITTEE NEWS

BREXIT. The United Kingdom (UK) formally left the EU on 31.01.2020 and became a third country with a transition period. This transition period ended on 31.12.2020 and thus also the application of pharmaceutical legislation according to the "Acquis Communautaire" in the UK. The CMDh has therefore published an update of the "Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP", which addresses the changes applicable after 31.12.2020. Since 01.01.2021 the so-called Ireland/Northern Ireland Protocol ("IE/NI Protocol") is in force, which regulates the applicability of pharmaceutical legislation according to the "Acquis Communautaire" in Northern Ireland. The rules currently in force in relation to MR/DC procedures are described in the newly published guidance document "CMDh Practical Guidance on the implementation of the Protocol on Ireland/Northern Ireland for medicinal products for human use approved via MRP/DCP".

All Brexit-related guidance documents can be found on the CMDh website under "BREXIT".

Marketing Authorisation Holders are reminded to fulfill their obligations and to adapt their marketing authorisation dossiers according to EU legislation if relevant activities are still localised in the UK. For details, see the BASG website.

Update Templates/Guidance documents. Various CMDh documents have been revised and updated versions have been published in the last months (f.i. updated Q&A – Pharmacovigilance Legislation, Renewal Assessment Report/End of Renewal Template, Best Practice Guides (BPGs) for the Submission and Processing of Variations in the Mutual Recognition Procedure).

COVID-19 Pandemic - Measures. An overview of regulatory measures taken at the European level to address the pandemic and helpful documents on the regulatory flexibility currently granted can be found on the websites of the CMDh and EMA. Information on national requirements/exemptions during the COVID-19 pandemic can be found here on the BASG website.

  • 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 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!

  • 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 rms@basg.gv.at. 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

Email

Further inquiry note