HPRA preparedness for Brexit 13 June 2018 Paul McNeill, HPRA

“By failing to prepare, you are preparing to fail.” Benjamin Franklin 09/04/2019

Update on preparations for Brexit As a National Competent Authority As part of the EU Regulatory Network

Preparations as National Competent Authority

Preparations aimed at maintaining the HPRA Strategic goals Protecting the availability of medicines and the integrity of our market. Reflected in our Strategic Plan 2016-2020 Optimising our role within the European regulatory network. Commitment to supporting stakeholders. Maintaining our strong working relationships with UK colleagues.

Brexit ahead. Get in Lane Preparations to date Established an internal working group under the direction of the HPRA’s Deputy Chief Executive. planning for all possible eventualities and outcomes Brexit ahead. Get in Lane Hard Brexit Soft Brexit

Preparations to date Ongoing provision of information on the Brexit-dedicated section of our website to keep stakeholders informed of developments.

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Preparations to date Consulted with marketing authorisation holders by means of a survey in May 2017 to allow the HPRA to prepare in terms of resources and opportunities to better meet stakeholders’ needs. Poor response (<10% response rate) Too early/inadequate information available

Preparations to date Hosted a stakeholder seminar on the topic of Brexit on 31st August 2017. Joint human/veterinary seminar Attended by approximately 300 stakeholders Discussed the concerns of various groups Focused on potential impact on product availability in Ireland Much valuable feedback received to help steer our planning

Preparations to date Published a ‘Brexit Guidance for Stakeholders - human and veterinary medicines’ document on the HPRA website. One of the first agencies to do this Being updated on an on-going basis as more clarity from the European Commission and within the regulatory network becomes available

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Preparations to date Communicated our willingness to act as RMS for products for which we are an existing CMS with UK as RMS wrote to individual MAHs in July 2017 published articles in the HPRA Newsletter since mid-2017 Requested MAHs to advise the HPRA by 31st March 2018 if they wish to change RMS to IE for existing products and offered to meet to discuss. Offer a no-fee & simple administrative procedure to change RMS to IE.

Preparations to date Over 100 letters issued to MAHs. 425 procedures identified where UK is RMS and IE is one of the CMSs. 37 procedures identified where IE is the only CMS and automatically becomes RMS. Responses received from 24 MAHs to date indicating their intention to change RMS to IE concerning 120 products. So far there have been 69 requests for change of RMS from UK to IE relating to Brexit.

Preparations to date Exploring all possible means to maintain existing and explore new opportunities for joint labelling with other Member States. Successfully operated official and unofficial joint labelling with the VMD for many years and very much wish this to continue More than half of all veterinary medicinal products currently authorised in Ireland enjoy joint labels with the UK Have held bilateral meetings with the VMD and more are planned Encourage MAH’s to develop multilingual packs, combining several languages (including English) on a single pack, where possible

Preparations to date Held a number of meetings with companies (at their request) at the HPRA offices to provide advice/guidance on implications of Brexit. Free of charge Benefit for both the HPRA and the MAHs in exchanging information Published a booking calendar on the HPRA website to indicate current availability of HPRA for RMS work.

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Preparations to date Ongoing discussions on resource/staffing to ensure available capacity. Requires approval from the Dept. of Health. Dependent upon volume of work (tangible not notional). Lead in time required in terms of recruitment and training of new staff. Recently recruited an additional pharmaceutical assessor and an additional veterinary assessor in April 2018

Preparations as part of the EU Regulatory Network

Preparations to date Participation in the CMDv Brexit Working Group. Participation in the HMA’s Task Force on Brexit. Participation in EMA Working Group on committees’ operational preparedness for veterinary medicines. HPRA has committed to take over a number of (Co-) Rapporteur-ships as part of the redistribution of the UK portfolio

Preparations to date HMA survey on NCA’s preparations. HPRA has indicated its readiness to increase staffing and to proactively participate in the sharing of workload within the regulatory network as a result of Brexit Preparations to increase involvement in EMA procedural work (Rapporteur; Co- Rapporteur; Peer reviewer; Co-ordinator etc.) Participation in and contribution to the EU NTC – knowledge sharing/training opportunities

Preparations to date CMDv survey on MAHs’ plans for change of RMS. 2,146 products registered via MR/DC procedures shared across 21 RMSs. CMDv identified 722 products from 80 companies where the UK is the RMS Received a response from 70 companies, covering 558 of the products IE was the most frequently selected MS for proposed change of RMS-ship (accounting for just over 25% of first preferences). Approximately 190 products (28%) have already undergone change of RMS from UK to another MS.

Preparations to date To date, 190 products have undergone change of RMS from the UK.

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Latest information EC/EMA due to publish a 3rd iteration of the Q&A document on Brexit-related implications on VMPs within the framework of the centralised procedure. CMDv likely to publish an update to the related Q&A published on the CMDv pages of the HMA website in due course. HPRA closely monitoring developments and will provide updates as necessary.

Where will this take us? 09/04/2019

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