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messages in brief | 30/06/2020

 

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

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