Maintaining joint packaging and labelling into the future Rhona McHugh HPRA Veterinary Medicines Information Day Wednesday, 13 June 2018

Overview of presentation Why is maintaining joint packaging of such importance? History of the HPRA/VMD working collaboration on joint packaging The impact of Brexit Multilingual labelling New veterinary legislation HPRA take-home message 18/11/2018

Why is maintaining joint labelling and packaging of such importance? 18/11/2018

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HPRA strategic objective: To optimise the use of the current regulatory system to maintain authorised products on the market in Ireland 18/11/2018

Will it be possible to have joint labelling with Ireland? What can we do to minimise the impact of Brexit on packaging requirements post Brexit. Currently up to 73 % of VM packs are dual labelled in Ireland. Many of these would not support a business case for separate packs in the Irish market, so if labelling requirements diverge; the availability of VMPs on the Irish market will be curtailed. Will it be possible to have joint labelling with Ireland? What would be the impact of Brexit on joint labelling for UK-IE markets for already approved products? Will the EMA still allow for the UK blue box to be included on multilingual packaging? Will the EMA permit dual labelling within the UK/EEA for approved products? Will the Vm number be allowed within the blue box? 18/11/2018 6

History of the HPRA/VMD working collaboration on joint packaging 18/11/2018

Unofficial Dual Labelling Pre-2000 MAHs were permitted to use dual labels/leaflets for product authorised in the UK and IE No formal communication mechanism between IE, UK and the MAH MAHs still permitted to use dual labelling Difficulties in keeping the labelling/leaflets aligned following regulatory activity Sole responsibility of the MAH to keep the labels/leaflets harmonised

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For MRPs as stand-alone procedure Joint Labelling Post-MRP or DCP For MRPs as stand-alone procedure (Type IB variation) For nationally authorised products as stand-alone procedure (Type IB harmonisation variation) Joint labelled products include agreed QRD text along with national specific information 18/11/2018

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The impact of Brexit 18/11/2018

As of 30th March the UK will become a “third country” so what will happen this well established HPRA/VMD collaboration with respect to maintaining joint labels? 18/11/2018

Current activities and possibilities Informal discussions are ongoing with the VMD. Is it feasible to maintain joint-labelling should the SPCs remain harmonised? Is it feasible to maintain joint-labelling if UK-specific information could still appear in the blue-box? Review annexes of the product literature standard in an effort to standardise IE and UK-specific requirements. Work closely with EU competent authorities to enable the use of common packs. Explore further opportunities to expand our existing bilateral agreement with the UK’s VMD. Await official confirmation from the EC on this matter. 18/11/2018

Multilingual labels 18/11/2018

Multilingual labels Multilingual labels should have a clear separation between the different languages. All the information provided in each language should be kept together. All labels and packaging must be in English. They may also contain other languages provided that the: - requirements of the VMD and HPRA are respected legibility of the English text is not compromised information given is identical in all languages* *The VMD or HPRA will only assess the English text on the label See the Product Literature Standard on the HPRA website. 18/11/2018

How do we facilitate multilingual labelling? Review of the QRD requirements. Can current compulsory information be reduced in order to provide additional space those essential criteria? Replacement of text with standardised pictograms. QRD guidance on the use of approved pictograms on the packaging of veterinary medicinal products authorised via the centralised (CP), mutual recognition (MRP) and decentralised procedures (DCP) published in December 2017. Use abbreviations which have been standardised across the Union (guideline on stylistics matters). AHE have proposed additional new species pictograms to CMDv (camel, fox, pheasant, guinea fowl, canary, bee, pigeon, reindeer) – currently being discussed. Would the use of functional pictograms allow for additional space? Allow for different languages on different pack sizes (or components of the packaging). 18/11/2018

New veterinary legislation 18/11/2018

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HPRA strategic objective (2016 – 2020) Seek to influence European discussions to ensure legal frameworks promote medicines’ availability and does not restrict supply. 18/11/2018

Packaging and labelling changes – draft legislation Goal is to simplify packaging requirements, but to include all information on the package leaflet. Problem is that most Member States want to retain requirement for marketing authorisation number. How to cater for method of supply categorisation in each Member State. Consideration for leaflets to be accessed electronically in the future. If new regulations are accepted by the UK before they leave the EU both nations will be more or less aligned. 18/11/2018 23

HPRA take-home message 18/11/2018

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HPRA and VMD have a long history of co-operation in this area HPRA and VMD have a long history of co-operation in this area.  We will therefore continue to endeavour to facilitate joint labelling wherever possible

vetinfo@hpra.ie www.hpra.ie Thank you vetinfo@hpra.ie www.hpra.ie www.hma.eu https://ec.europa.eu/health/veterinary-use_en