Current issue of “RMS NEWS”

messages in brief | 29/01/2021

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 1200^th 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.