Anne Hayes, Inspection Manager Brexit Compliance Issues Anne Hayes, Inspection Manager HPRA Veterinary Medicines Information Day Wednesday 13 June 2018, Dublin

Continuity of supply of medicines Priorities Continuity of supply of medicines Increased engagement to facilitate trade Assist companies by reviewing plans for changes Participation in EU Brexit working groups Patients & animals - committed to ensuring continuity of supply of medicines Increased engagement with industry, associations, Government departments, customs & IDA to facilitate trade Participation in EU Brexit working groups to collaborate on guidance, Q&As etc. Work with individual companies, as requested, to discuss their plans for changes 07/04/2019

Requirements For Products Coming From the UK After Brexit Usual 3rd country requirements in EEA Importation by authorised manufacturer Testing in EEA QP certification in EEA Wholesalers are not authorised to import from 3rd countries 07/04/2019

Requirements For Products Coming From UK After Brexit Transport through the UK using the ‘transit protocol’ does not invoke export / import requirements Negotiations on an MRA/ACAA will not start before Brexit Continuity of supply strategies should be implemented 07/04/2019

Relocation of batch certification activities to Ireland Significant no. transferring New companies establishing New Manufacturer’s Authorisation Variation to add importation Inclusion of products and 3rd country sites on the annexes Added to existing authorisation 07/04/2019

Relocation of batch certification activities to Ireland Contact us inspect@hpra.ie Intending applicants At least 6 months before authorisation is required Timeline 07/04/2019

Frequently Asked Questions regarding new QPs Will a QP named on a UK licence be accepted in IE? Does the QP need to be resident in Ireland? Can the QP work from another jurisdiction? Yes No No 07/04/2019

Marketing Authorisation Transfer Due to Brexit Day Zero When an MA is transferred QP certification of product in old livery should cease Companies can request a date when transfers are processed Complex Complex supply chain with typical forecasts in 18 month cycles Difficulty planning for zero day implementation highlighted by various companies Impacts significant proportion of the industry with stock outs resulting Flexibility MAHs preparing for Brexit allowed up to 6 months to make packaging changes Removal of reference to stock rundown or recall of product bearing previous details Currently following transfer of an MA from one MAH to another, the HPRA requires immediate cessation of QP certification of medicinal products bearing the current MA number once the transferred authorisation has been granted Difficulties highlighted by MAH’s include:   The supply chain is complex and global. With forecasts in a typical 18 month planning cycle, and the complexity of multiple stock keeping units with variable forecasts, supply chain experts advise that it is impossible to plan with a fixed zero day implementation date without incurring periods of stock-out. The issue impacts a significant proportion of the industry and stock-outs across multiple products around the uncertain period of ‘Brexit’ in 2019/2020 are likely. Even with careful forecasting, demand by customers has the potential to skew forecast product availability in the marketplace, as uncertainty around Brexit may lead to customers ordering extra stock. 07/04/2019

Points for QPs to Consider in Managing Transition Pack changes Plan to manage the transitions at site level are strongly recommended New Products Request data e.g. report quality defects, PQRs Contracts Covering onward reporting of complaints and adverse drug reactions 07/04/2019

Thank You