CMDv and Brexit

Mag. Beate Gasser AGES MEA/LCM/REGA

Vienna, 13.09.2017

CMDv Website

• Brexit Subpage

CMDv Website

• Brexit Subpage

Brexit Working Group

Info about necessary variations/transfers

CMDv position

• Mandate: “Although it is not possible to prejudge the

outcomes of the negotiations, for business continuity and resource planning the CMDv needs to plan for the UK not being part of the European Medicines Network.” without prejudice of any negotiations, preparation for

“worst case” Q&As taking into account “worst case”

Questions and Answers

• Transfers: • MA transfer • RMS transfer

• Variations: • QPPV • DDPS • Importer in the EEA • Batch control in the EEA • Batch releaser in the EEA

Will be updated further

UK: RMS for 1/3 of New MAA

• 10 year review: 6 Member States 87% of RMSships

• UK 33% • IE 17% • FR 13% • ES 10% • NL 7% • DE 7%

Brexit impact on RMSships more severe than on Human side

CMDv-Letter to MAHs

• Goal: To better understand the possible impact on

National Competent Authorities in matching expectations with capacity

• Answers until end of September

• Preferred RMS and timing and reasons for choice

Information on RMS transfers

CMDv Brexit related activities

• Ensure business continuity • Liaise closely with HMA ( MAWP), CMDh, Veterinary

Pharmacovigilance WP, Inspections WP, EMA’s WG on committees’ operational preparedness for VMPs

• Liaise with MAHs about timing and preference of RMS transfers

• Letter to MAHs

• Propose cut-off dates for UK RMSship • Publish guidance (Q&As, Report for Release, IP meeting) • Initiatives to free and save resources

• Tight clock stop management • Overview of open procedures

First areas identified

EMA’s WG on committees’ operational preparedness for VMPs

• Mandate: http://www.ema.europa.eu/docs/en_GB/document_library/Other/2017/06/WC500229507.pdf

• Ongoing analysis of mapping survey circulated to the MS regarding planned increased involvement and expertise within the Network.

CMDv Chair/Vice Chair involved

UK position paper

• https://www.gov.uk/government/publications/continuity-in-the-availability-of-goods-for-the-eu-and-the-uk-position-paper

• “Outlines the United Kingdom’s (UK) position and

principles in ensuring a smooth and orderly withdrawal from the European Union (EU) in regard to the availability of goods, in a way that supports the move to the freest possible future economic relationship.”

Relocation of EMA

• http://www.consilium.europa.eu/en/press/press-releases/2017/08/01-uk-based-eu-agencies/

• Offers to host the European Medicines Agency (EMA) • http://www.consilium.europa.eu/en/policies/relocation-

uk-based-agencies/ema/

• More info on relocation • http://www.consilium.europa.eu/en/policies/relocation-

london-agencies-brexit/

• The procedure is enclosed, and available on • http://www.consilium.europa.eu/en/meetings/european-

council/2017/06/22-euco-procedure-agencies_pdf/

Information available on offers, criteria and next steps

EMA/EBA candidates

• Source: http://www.consilium.europa.eu/en/press/press-

releases/2017/08/01-uk-based-eu-agencies

Bundesamt für Sicherheit im Gesundheitswesen www.basg.gv.at

BASG - Austrian Federal Office for Safety in Health Care

www.basg.gv.at

Traisengasse 5 1200 Vienna

Deputy Head of Department Regulatory Affairs

T +43 (0) 50 555-36612 | M +43 (0) 664 88692096

beate.gasser@ages.at

Mag. Beate Gasser