Accessibility

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class="col-9"> <p class="title">Find a Medicine</p> </div> </div> <div class="row"> <div class="col-sm-4 cta"> <span class="h2">Find a medicine</span> <p>This area includes safety and quality updates for patients and healthcare professionals, and regulatory news for industry.</p> <a href="https://www.hpra.ie/find-a-medicine" class="btn btn-primary">Find out more</a> </div> <div class="col-sm-3 sub-menu "> <ul aria-label="second level menu"> <li class="d-sm-none"> <a data-url="/find-a-medicine" href="https://www.hpra.ie/find-a-medicine" aria-haspopup="false">Find out more</a> </li> <li class="sub 0"> <a tabindex="0" data-url="/find-a-medicine/for-human-use" href="#" aria-expanded="false" aria-haspopup="true">For human use</a>  <ul aria-label="third level menu"> <li> <a data-url="/find-a-medicine/for-human-use" href="https://www.hpra.ie/find-a-medicine/for-human-use">Overview</a> </li> <li > <a tabindex="0" data-url="/find-a-medicine/for-human-use/authorised-medicines" href="https://www.hpra.ie/find-a-medicine/for-human-use/authorised-medicines" aria-haspopup="false">Authorised medicines</a> </li> <li > <a tabindex="0" data-url="/find-a-medicine/for-human-use/withdrawn-medicines" href="https://www.hpra.ie/find-a-medicine/for-human-use/withdrawn-medicines" aria-haspopup="false">Withdrawn medicines</a> </li> <li > <a tabindex="0" data-url="/find-a-medicine/for-human-use/interchangeable-medicines" href="https://www.hpra.ie/find-a-medicine/for-human-use/interchangeable-medicines" aria-haspopup="false">Interchangeable Medicines </a> </li> <li > <a tabindex="0" data-url="/find-a-medicine/for-human-use/medicine-shortages" href="https://www.hpra.ie/find-a-medicine/for-human-use/medicine-shortages" aria-haspopup="false">Medicine shortages </a> </li> <li > <a tabindex="0" data-url="/find-a-medicine/for-human-use/herbal-and-homeopathic-medicines" href="https://www.hpra.ie/find-a-medicine/for-human-use/herbal-and-homeopathic-medicines" aria-haspopup="false">Herbal and homeopathic medicines | Find a medicine</a> </li> <li > <a tabindex="0" data-url="/find-a-medicine/for-human-use/general-sales-and-pharmacy-only-sales" href="https://www.hpra.ie/find-a-medicine/for-human-use/general-sales-and-pharmacy-only-sales" aria-haspopup="false">General sales and pharmacy-only sales</a> </li> <li > <a tabindex="0" data-url="/find-a-medicine/for-human-use/xml-product-listings" href="https://www.hpra.ie/find-a-medicine/for-human-use/xml-product-listings" aria-haspopup="false">XML product lists</a> </li> <li class="sub 1"> <a tabindex="0" data-url="/find-a-medicine/for-human-use/using-the-medicines-list" href="https://www.hpra.ie/find-a-medicine/for-human-use/using-the-medicines-list" aria-expanded="false" aria-haspopup="true">Using the medicines list</a> </li> </ul> </li> <li class="sub 0"> <a tabindex="0" data-url="/find-a-medicine/for-animal-use" href="#" aria-expanded="false" aria-haspopup="true">For animal use</a>  <ul aria-label="third level menu"> <li> <a data-url="/find-a-medicine/for-animal-use" href="https://www.hpra.ie/find-a-medicine/for-animal-use">Overview</a> </li> <li > <a tabindex="0" data-url="/find-a-medicine/for-animal-use/authorised-medicines" href="https://www.hpra.ie/find-a-medicine/for-animal-use/authorised-medicines" aria-haspopup="false">Authorised medicines – HPRA</a> </li> <li > <a tabindex="0" data-url="/find-a-medicine/for-animal-use/authorised-medicines---all-eu-eea" href="https://www.hpra.ie/find-a-medicine/for-animal-use/authorised-medicines---all-eu-eea" aria-haspopup="false">Authorised medicines – all EU/EEA</a> </li> <li > <a tabindex="0" data-url="/find-a-medicine/for-animal-use/withdrawn-medicines" href="https://www.hpra.ie/find-a-medicine/for-animal-use/withdrawn-medicines" aria-haspopup="false">Withdrawn medicines</a> </li> <li > <a tabindex="0" data-url="/find-a-medicine/for-animal-use/suspended-medicines" href="https://www.hpra.ie/find-a-medicine/for-animal-use/suspended-medicines" aria-haspopup="false">Suspended medicines</a> </li> <li > <a tabindex="0" data-url="/find-a-medicine/for-animal-use/veterinary-medicines-information" href="https://www.hpra.ie/find-a-medicine/for-animal-use/veterinary-medicines-information" aria-haspopup="false">Medicines for animal use information </a> </li> <li class="sub 1"> <a tabindex="0" data-url="/find-a-medicine/for-animal-use/shortages-of-veterinary-medicines" href="https://www.hpra.ie/find-a-medicine/for-animal-use/shortages-of-veterinary-medicines" aria-expanded="false" aria-haspopup="true">Shortages of medicines for animal use</a> </li> <li > <a tabindex="0" data-url="/find-a-medicine/for-animal-use/xml-product-list" href="https://www.hpra.ie/find-a-medicine/for-animal-use/xml-product-list" aria-haspopup="false">XML product list</a> </li> </ul> </li> </ul> </div> <div class="col-sm-5 spotlight-col"> </div> </div> </div> </div> </li> <li class="" > <a id="dd-item1" class="a" data-url="/safety-information" href="#/" aria-expanded="false" aria-haspopup="true"> <span>Safety Information</span> </a> <div class="grey-box" aria-hidden="true"> <div class="container"> <div class="navbtn row d-sm-none"> <div class="col-3"> <a href="#/" class="btn btn-link-dark-secondary back-btn btn-dark-blue "> Back </a> </div> <div class="col-9"> <p class="title">Safety Information</p> </div> </div> <div class="row"> <div class="col-sm-4 cta"> <span class="h2">Safety Information</span> <p>Find out how we monitor safety. See Safety Notices for important updates on products we regulate. </p> <a href="https://www.hpra.ie/safety-information" class="btn btn-primary">Find out more</a> </div> <div class="col-sm-3 sub-menu "> <ul aria-label="second level menu"> <li class="d-sm-none"> <a data-url="/safety-information" href="https://www.hpra.ie/safety-information" aria-haspopup="false">Find out more</a> </li> <li class="sub 0"> <a tabindex="0" data-url="/safety-information/safety-notices" href="#" aria-expanded="false" aria-haspopup="true">Safety Notices</a>  <ul aria-label="third level menu"> <li> <a data-url="/safety-information/safety-notices" href="https://www.hpra.ie/safety-information/safety-notices">Overview</a> </li> <li > <a tabindex="0" data-url="/safety-information/safety-notices/sign-up-for-alerts" href="https://www.hpra.ie/safety-information/safety-notices/sign-up-for-alerts" aria-haspopup="false">Sign up for alerts </a> </li> </ul> </li> <li class="sub 0"> <a tabindex="0" data-url="/safety-information/how-we-monitor-safety" href="#" aria-expanded="false" aria-haspopup="true">How we monitor safety</a>  <ul aria-label="third level menu"> <li> <a data-url="/safety-information/how-we-monitor-safety" href="https://www.hpra.ie/safety-information/how-we-monitor-safety">Overview</a> </li> <li class="sub 1"> <a tabindex="0" data-url="/safety-information/how-we-monitor-safety/medicines" href="https://www.hpra.ie/safety-information/how-we-monitor-safety/medicines" aria-expanded="false" aria-haspopup="true">Medicines for human use</a> </li> <li class="sub 1"> <a tabindex="0" data-url="/safety-information/how-we-monitor-safety/veterinary-medicines" href="https://www.hpra.ie/safety-information/how-we-monitor-safety/veterinary-medicines" aria-expanded="false" aria-haspopup="true">Medicines for animal use</a> </li> <li class="sub 1"> <a tabindex="0" data-url="/safety-information/how-we-monitor-safety/medical-devices" href="https://www.hpra.ie/safety-information/how-we-monitor-safety/medical-devices" aria-expanded="false" aria-haspopup="true">Medical devices </a> </li> <li class="sub 1"> <a tabindex="0" data-url="/safety-information/how-we-monitor-safety/cosmetics" href="https://www.hpra.ie/safety-information/how-we-monitor-safety/cosmetics" aria-expanded="false" aria-haspopup="true">Cosmetics </a> </li> <li class="sub 1"> <a tabindex="0" data-url="/safety-information/how-we-monitor-safety/blood" href="https://www.hpra.ie/safety-information/how-we-monitor-safety/blood" aria-expanded="false" aria-haspopup="true">Blood </a> </li> <li class="sub 1"> <a tabindex="0" data-url="/safety-information/how-we-monitor-safety/tissues-and-cells" href="https://www.hpra.ie/safety-information/how-we-monitor-safety/tissues-and-cells" aria-expanded="false" aria-haspopup="true">Tissues and cells </a> </li> <li class="sub 1"> <a tabindex="0" data-url="/safety-information/how-we-monitor-safety/organs" href="https://www.hpra.ie/safety-information/how-we-monitor-safety/organs" aria-expanded="false" aria-haspopup="true">Organs </a> </li> </ul> </li> </ul> </div> <div class="col-sm-5 spotlight-col"> </div> </div> </div> </div> </li> <li class="" > <a id="dd-item2" class="a" data-url="/regulation" href="#/" aria-expanded="false" aria-haspopup="true"> <span>Regulation</span> </a> <div class="grey-box" aria-hidden="true"> <div class="container"> <div class="navbtn row d-sm-none"> <div class="col-3"> <a href="#/" class="btn btn-link-dark-secondary back-btn btn-dark-blue "> Back </a> </div> <div class="col-9"> <p class="title">Regulation</p> </div> </div> <div class="row"> <div class="col-sm-4 cta"> <span class="h2">Regulation</span> <p>Find out how we regulate and view resources to help you comply. View resources for sponsors, manufacturers, distributors, importers and retailers. </p> <a href="https://www.hpra.ie/regulation" class="btn btn-primary">Find out more</a> </div> <div class="col-sm-3 sub-menu "> <ul aria-label="second level menu"> <li class="d-sm-none"> <a data-url="/regulation" href="https://www.hpra.ie/regulation" aria-haspopup="false">Find out more</a> </li> <li class="sub 0"> <a tabindex="0" data-url="/regulation/human-medicine" href="#" aria-expanded="false" aria-haspopup="true">Medicines for human use</a>  <ul aria-label="third level menu"> <li> <a data-url="/regulation/human-medicine" href="https://www.hpra.ie/regulation/human-medicine">Overview</a> </li> <li class="sub 1"> <a tabindex="0" data-url="/regulation/human-medicine/marketing-authorisation-holders" href="https://www.hpra.ie/regulation/human-medicine/marketing-authorisation-holders" aria-expanded="false" aria-haspopup="true">Marketing authorisation holders</a> </li> <li class="sub 1"> <a tabindex="0" data-url="/regulation/human-medicine/manufacturers" href="https://www.hpra.ie/regulation/human-medicine/manufacturers" aria-expanded="false" aria-haspopup="true">Manufacturers</a> </li> <li class="sub 1"> <a tabindex="0" data-url="/regulation/human-medicine/wholesalers-and-retailers" href="https://www.hpra.ie/regulation/human-medicine/wholesalers-and-retailers" aria-expanded="false" aria-haspopup="true">Wholesalers and retailers</a> </li> <li class="sub 1"> <a tabindex="0" data-url="/regulation/human-medicine/clinical-trials" href="https://www.hpra.ie/regulation/human-medicine/clinical-trials" aria-expanded="false" aria-haspopup="true">Clinical trial sponsors</a> </li> <li class="sub 1"> <a tabindex="0" data-url="/regulation/human-medicine/patients-and-healthcare-professionals" href="https://www.hpra.ie/regulation/human-medicine/patients-and-healthcare-professionals" aria-expanded="false" aria-haspopup="true">Patients and healthcare professionals</a> </li> </ul> </li> <li class="sub 0"> <a tabindex="0" data-url="/regulation/veterinary-medicines" href="#" aria-expanded="false" aria-haspopup="true">Medicines for animal use</a>  <ul aria-label="third level menu"> <li> <a data-url="/regulation/veterinary-medicines" href="https://www.hpra.ie/regulation/veterinary-medicines">Overview</a> </li> <li class="sub 1"> <a tabindex="0" data-url="/regulation/veterinary-medicines/regulation-2019-6" href="https://www.hpra.ie/regulation/veterinary-medicines/regulation-2019-6" aria-expanded="false" aria-haspopup="true">Regulation 2019/6</a> </li> <li class="sub 1"> <a tabindex="0" data-url="/regulation/veterinary-medicines/medicines-authorisation" href="https://www.hpra.ie/regulation/veterinary-medicines/medicines-authorisation" aria-expanded="false" aria-haspopup="true">Medicines authorisation </a> </li> <li class="sub 1"> <a tabindex="0" data-url="/regulation/veterinary-medicines/labelling-and-veterinary-medicinal-product-distribution" href="https://www.hpra.ie/regulation/veterinary-medicines/labelling-and-veterinary-medicinal-product-distribution" aria-expanded="false" aria-haspopup="true">Labelling and distribution</a> </li> <li class="sub 1"> <a tabindex="0" data-url="/regulation/veterinary-medicines/availability-of-veterinary-medicines-in-ireland" href="https://www.hpra.ie/regulation/veterinary-medicines/availability-of-veterinary-medicines-in-ireland" aria-expanded="false" aria-haspopup="true">Availability of medicines for animal use </a> </li> <li > <a tabindex="0" data-url="/regulation/veterinary-medicines/veterinary-clinical-field-trials" href="https://www.hpra.ie/regulation/veterinary-medicines/veterinary-clinical-field-trials" aria-haspopup="false">Clinical field trials </a> </li> <li class="sub 1"> <a tabindex="0" data-url="/regulation/veterinary-medicines/care-in-use-of-veterinary-medicines" href="https://www.hpra.ie/regulation/veterinary-medicines/care-in-use-of-veterinary-medicines" aria-expanded="false" aria-haspopup="true">Care in use </a> </li> <li class="sub 1"> <a tabindex="0" data-url="/regulation/veterinary-medicines/manufacture-of-veterinary-medicines-in-ireland" href="https://www.hpra.ie/regulation/veterinary-medicines/manufacture-of-veterinary-medicines-in-ireland" aria-expanded="false" aria-haspopup="true">Manufacturing</a> </li> <li > <a tabindex="0" data-url="/regulation/veterinary-medicines/active-substance-registration-for-veterinary-medicines" href="https://www.hpra.ie/regulation/veterinary-medicines/active-substance-registration-for-veterinary-medicines" aria-haspopup="false">Active substance registration</a> </li> <li > <a tabindex="0" data-url="/regulation/veterinary-medicines/export-certification-(veterinary-medicines)" href="https://www.hpra.ie/regulation/veterinary-medicines/export-certification-(veterinary-medicines)" aria-haspopup="false">Export certification</a> </li> <li class="sub 1"> <a tabindex="0" data-url="/regulation/veterinary-medicines/market-compliance-and-surveillance-of-veterinary-medicines" href="https://www.hpra.ie/regulation/veterinary-medicines/market-compliance-and-surveillance-of-veterinary-medicines" aria-expanded="false" aria-haspopup="true">Market compliance and surveillance</a> </li> <li > <a tabindex="0" data-url="/regulation/veterinary-medicines/guidance-documents" href="https://www.hpra.ie/regulation/veterinary-medicines/guidance-documents" aria-haspopup="false">Guidance documents</a> </li> <li > <a tabindex="0" data-url="/regulation/veterinary-medicines/fees-for-medicines-for-animal-use" href="https://www.hpra.ie/regulation/veterinary-medicines/fees-for-medicines-for-animal-use" aria-haspopup="false">Fees – medicines for animal use</a> </li> <li > <a tabindex="0" data-url="/regulation/veterinary-medicines/legislation-for-medicines-for-animal-use" href="https://www.hpra.ie/regulation/veterinary-medicines/legislation-for-medicines-for-animal-use" aria-haspopup="false">Legislation </a> </li> </ul> </li> <li class="sub 0"> <a tabindex="0" data-url="/regulation/scientific-animal-protection" href="#" aria-expanded="false" aria-haspopup="true">Scientific animal protection </a>  <ul aria-label="third level menu"> <li> <a data-url="/regulation/scientific-animal-protection" href="https://www.hpra.ie/regulation/scientific-animal-protection">Overview</a> </li> <li class="sub 1"> <a tabindex="0" data-url="/regulation/scientific-animal-protection/the-3rs" href="https://www.hpra.ie/regulation/scientific-animal-protection/the-3rs" aria-expanded="false" aria-haspopup="true">The 3Rs</a> </li> <li > <a tabindex="0" data-url="/regulation/scientific-animal-protection/guidance-documents" href="https://www.hpra.ie/regulation/scientific-animal-protection/guidance-documents" aria-haspopup="false">Guidance documents</a> </li> <li > <a tabindex="0" data-url="/regulation/scientific-animal-protection/animal-welfare-body" href="https://www.hpra.ie/regulation/scientific-animal-protection/animal-welfare-body" aria-haspopup="false">Animal Welfare Body</a> </li> <li > <a tabindex="0" data-url="/regulation/scientific-animal-protection/alternative-approaches" href="https://www.hpra.ie/regulation/scientific-animal-protection/alternative-approaches" aria-haspopup="false">Alternative approaches </a> </li> <li class="sub 1"> <a tabindex="0" data-url="/regulation/scientific-animal-protection/authorisations" href="https://www.hpra.ie/regulation/scientific-animal-protection/authorisations" aria-expanded="false" aria-haspopup="true">Authorisations </a> </li> <li class="sub 1"> <a tabindex="0" data-url="/regulation/scientific-animal-protection/non-technical-project-summaries" href="https://www.hpra.ie/regulation/scientific-animal-protection/non-technical-project-summaries" aria-expanded="false" aria-haspopup="true">Non-technical project summaries </a> </li> <li > <a tabindex="0" data-url="/regulation/scientific-animal-protection/statistical-reporting" href="https://www.hpra.ie/regulation/scientific-animal-protection/statistical-reporting" aria-haspopup="false">Statistical reporting </a> </li> <li > <a tabindex="0" data-url="/regulation/scientific-animal-protection/compliance-monitoring" href="https://www.hpra.ie/regulation/scientific-animal-protection/compliance-monitoring" aria-haspopup="false">Compliance monitoring</a> </li> <li > <a tabindex="0" data-url="/regulation/scientific-animal-protection/training-requirements-and-courses" href="https://www.hpra.ie/regulation/scientific-animal-protection/training-requirements-and-courses" aria-haspopup="false">Training requirements and courses</a> </li> <li > <a tabindex="0" data-url="/regulation/scientific-animal-protection/fees-for-scientific-animal-protection" href="https://www.hpra.ie/regulation/scientific-animal-protection/fees-for-scientific-animal-protection" aria-haspopup="false">Fees </a> </li> <li > <a tabindex="0" data-url="/regulation/scientific-animal-protection/useful-links" href="https://www.hpra.ie/regulation/scientific-animal-protection/useful-links" aria-haspopup="false">Useful links </a> </li> <li class="sub 1"> <a tabindex="0" data-url="/regulation/scientific-animal-protection/legislation" href="https://www.hpra.ie/regulation/scientific-animal-protection/legislation" aria-expanded="false" aria-haspopup="true">Legislation </a> </li> <li class="sub 1"> <a tabindex="0" data-url="/regulation/scientific-animal-protection/national-committee" href="https://www.hpra.ie/regulation/scientific-animal-protection/national-committee" aria-expanded="false" aria-haspopup="true">National Committee</a> </li> </ul> </li> <li class="sub 0"> <a tabindex="0" data-url="/regulation/medical-devices" href="#" aria-expanded="false" aria-haspopup="true">Medical devices </a>  <ul aria-label="third level menu"> <li> <a data-url="/regulation/medical-devices" href="https://www.hpra.ie/regulation/medical-devices">Overview</a> </li> <li > <a tabindex="0" data-url="/regulation/medical-devices/registration" href="https://www.hpra.ie/regulation/medical-devices/registration" aria-haspopup="false">Registration</a> </li> <li class="sub 1"> <a tabindex="0" data-url="/regulation/medical-devices/common-aspects-of-the-regulations" href="https://www.hpra.ie/regulation/medical-devices/common-aspects-of-the-regulations" aria-expanded="false" aria-haspopup="true">Common aspects of the regulations</a> </li> <li class="sub 1"> <a tabindex="0" data-url="/regulation/medical-devices/medical-devices-regulation" href="https://www.hpra.ie/regulation/medical-devices/medical-devices-regulation" aria-expanded="false" aria-haspopup="true">Medical Devices Regulation</a> </li> <li class="sub 1"> <a tabindex="0" data-url="/regulation/medical-devices/in-vitro-diagnostic-medical-devices-regulation" href="https://www.hpra.ie/regulation/medical-devices/in-vitro-diagnostic-medical-devices-regulation" aria-expanded="false" aria-haspopup="true">In Vitro Diagnostics Regulation</a> </li> <li class="sub 1"> <a tabindex="0" data-url="/regulation/medical-devices/documents-and-guidance" href="https://www.hpra.ie/regulation/medical-devices/documents-and-guidance" aria-expanded="false" aria-haspopup="true">Documents and guidance</a> </li> <li > <a tabindex="0" data-url="/regulation/medical-devices/fees-for-medical-devices" href="https://www.hpra.ie/regulation/medical-devices/fees-for-medical-devices" aria-haspopup="false">Fees</a> </li> <li > <a tabindex="0" data-url="/regulation/medical-devices/legislation-for-medical-devices" href="https://www.hpra.ie/regulation/medical-devices/legislation-for-medical-devices" aria-haspopup="false">Legislation</a> </li> </ul> </li> <li class="sub 0"> <a tabindex="0" data-url="/regulation/cosmetics" href="#" aria-expanded="false" aria-haspopup="true">Cosmetics </a>  <ul aria-label="third level menu"> <li> <a data-url="/regulation/cosmetics" href="https://www.hpra.ie/regulation/cosmetics">Overview</a> </li> <li class="sub 1"> <a tabindex="0" data-url="/regulation/cosmetics/cosmetics-regulation" href="https://www.hpra.ie/regulation/cosmetics/cosmetics-regulation" aria-expanded="false" aria-haspopup="true">Cosmetics regulation</a> </li> <li class="sub 1"> <a tabindex="0" data-url="/regulation/cosmetics/obligations-of-responsible-persons" href="https://www.hpra.ie/regulation/cosmetics/obligations-of-responsible-persons" aria-expanded="false" aria-haspopup="true">Obligations of responsible persons</a> </li> <li class="sub 1"> <a tabindex="0" data-url="/regulation/cosmetics/labelling-and-claims" href="https://www.hpra.ie/regulation/cosmetics/labelling-and-claims" aria-expanded="false" aria-haspopup="true">Labelling and claims</a> </li> <li > <a tabindex="0" data-url="/regulation/cosmetics/guidance-documents" href="https://www.hpra.ie/regulation/cosmetics/guidance-documents" aria-haspopup="false">Guidance documents</a> </li> <li > <a tabindex="0" data-url="/regulation/cosmetics/fees-for-cosmetic-products" href="https://www.hpra.ie/regulation/cosmetics/fees-for-cosmetic-products" aria-haspopup="false">Fees </a> </li> </ul> </li> <li class="sub 0"> <a tabindex="0" data-url="/regulation/blood" href="#" aria-expanded="false" aria-haspopup="true">Blood </a>  <ul aria-label="third level menu"> <li> <a data-url="/regulation/blood" href="https://www.hpra.ie/regulation/blood">Overview</a> </li> <li > <a tabindex="0" data-url="/regulation/blood/our-role-in-regulating-blood-and-blood-components" href="https://www.hpra.ie/regulation/blood/our-role-in-regulating-blood-and-blood-components" aria-haspopup="false">Our role</a> </li> <li > <a tabindex="0" data-url="/regulation/blood/legislation-for-blood-and-blood-components" href="https://www.hpra.ie/regulation/blood/legislation-for-blood-and-blood-components" aria-haspopup="false">Legislation</a> </li> <li class="sub 1"> <a tabindex="0" data-url="/regulation/blood/blood-establishments" href="https://www.hpra.ie/regulation/blood/blood-establishments" aria-expanded="false" aria-haspopup="true">Blood establishments</a> </li> <li > <a tabindex="0" data-url="/regulation/blood/hospital-blood-banks" href="https://www.hpra.ie/regulation/blood/hospital-blood-banks" aria-haspopup="false">Hospital blood banks</a> </li> <li > <a tabindex="0" data-url="/regulation/blood/blood--tissues-and-organs-fees" href="https://www.hpra.ie/regulation/blood/blood--tissues-and-organs-fees" aria-haspopup="false">Fees </a> </li> <li > <a tabindex="0" data-url="/regulation/blood/new-regulation-on-substances-of-human-origin-(soho)" href="https://www.hpra.ie/regulation/blood/new-regulation-on-substances-of-human-origin-(soho)" aria-haspopup="false">SoHO Regulation </a> </li> <li > <a tabindex="0" data-url="/regulation/blood/guidance-documents" href="https://www.hpra.ie/regulation/blood/guidance-documents" aria-haspopup="false">Guidance documents</a> </li> </ul> </li> <li class="sub 0"> <a tabindex="0" data-url="/regulation/tissues-and-cells" href="#" aria-expanded="false" aria-haspopup="true">Tissues and cells </a>  <ul aria-label="third level menu"> <li> <a data-url="/regulation/tissues-and-cells" href="https://www.hpra.ie/regulation/tissues-and-cells">Overview</a> </li> <li > <a tabindex="0" data-url="/regulation/tissues-and-cells/tissues-and-cells-and-the-hpra's-role" href="https://www.hpra.ie/regulation/tissues-and-cells/tissues-and-cells-and-the-hpra's-role" aria-haspopup="false">Our role </a> </li> <li > <a tabindex="0" data-url="/regulation/tissues-and-cells/tissues-and-cells-legislation" href="https://www.hpra.ie/regulation/tissues-and-cells/tissues-and-cells-legislation" aria-haspopup="false">Legislation</a> </li> <li class="sub 1"> <a tabindex="0" data-url="/regulation/tissues-and-cells/tissue-establishments" href="https://www.hpra.ie/regulation/tissues-and-cells/tissue-establishments" aria-expanded="false" aria-haspopup="true">Tissue establishments </a> </li> <li > <a tabindex="0" data-url="/regulation/tissues-and-cells/blood--tissues-and-organs-fees" href="https://www.hpra.ie/regulation/tissues-and-cells/blood--tissues-and-organs-fees" aria-haspopup="false">Fees </a> </li> <li > <a tabindex="0" data-url="/regulation/tissues-and-cells/new-regulation-on-substances-of-human-origin-(soho)" href="https://www.hpra.ie/regulation/tissues-and-cells/new-regulation-on-substances-of-human-origin-(soho)" aria-haspopup="false">SoHO Regulation</a> </li> <li > <a tabindex="0" data-url="/regulation/tissues-and-cells/guidance-documents" href="https://www.hpra.ie/regulation/tissues-and-cells/guidance-documents" aria-haspopup="false">Guidance documents</a> </li> </ul> </li> <li class="sub 0"> <a tabindex="0" data-url="/regulation/organs" href="#" aria-expanded="false" aria-haspopup="true">Organs </a>  <ul aria-label="third level menu"> <li> <a data-url="/regulation/organs" href="https://www.hpra.ie/regulation/organs">Overview</a> </li> <li > <a tabindex="0" data-url="/regulation/organs/organs-for-transplantation-and-the-hpra's-role" href="https://www.hpra.ie/regulation/organs/organs-for-transplantation-and-the-hpra's-role" aria-haspopup="false">Our role </a> </li> <li > <a tabindex="0" data-url="/regulation/organs/regulatory-information-relating-to-organs" href="https://www.hpra.ie/regulation/organs/regulatory-information-relating-to-organs" aria-haspopup="false">Authorisations </a> </li> <li > <a tabindex="0" data-url="/regulation/organs/legislation-for-human-organs-intended-for-transplantation" href="https://www.hpra.ie/regulation/organs/legislation-for-human-organs-intended-for-transplantation" aria-haspopup="false">Legislation </a> </li> <li > <a tabindex="0" data-url="/regulation/organs/the-inspection-process-(blood--tissues--organs)" href="https://www.hpra.ie/regulation/organs/the-inspection-process-(blood--tissues--organs)" aria-haspopup="false">Inspections </a> </li> <li > <a tabindex="0" data-url="/regulation/organs/blood--tissues-and-organs-fees" href="https://www.hpra.ie/regulation/organs/blood--tissues-and-organs-fees" aria-haspopup="false">Fees </a> </li> <li > <a tabindex="0" data-url="/regulation/organs/organs-establishment-list" href="https://www.hpra.ie/regulation/organs/organs-establishment-list" aria-haspopup="false">Organs establishment list</a> </li> <li > <a tabindex="0" data-url="/regulation/organs/guidance-documents---organs" href="https://www.hpra.ie/regulation/organs/guidance-documents---organs" aria-haspopup="false">Guidance documents</a> </li> </ul> </li> <li class="sub 0"> <a tabindex="0" data-url="/regulation/controlled-drugs" href="#" aria-expanded="false" aria-haspopup="true">Controlled drugs </a>  <ul aria-label="third level menu"> <li> <a data-url="/regulation/controlled-drugs" href="https://www.hpra.ie/regulation/controlled-drugs">Overview</a> </li> <li > <a tabindex="0" data-url="/regulation/controlled-drugs/our-role-in-regulating-controlled-drugs" href="https://www.hpra.ie/regulation/controlled-drugs/our-role-in-regulating-controlled-drugs" aria-haspopup="false">Our role</a> </li> <li class="sub 1"> <a tabindex="0" data-url="/regulation/controlled-drugs/controlled-drugs-legislation" href="https://www.hpra.ie/regulation/controlled-drugs/controlled-drugs-legislation" aria-expanded="false" aria-haspopup="true">Legislation</a> </li> <li class="sub 1"> <a tabindex="0" data-url="/regulation/controlled-drugs/requirements" href="https://www.hpra.ie/regulation/controlled-drugs/requirements" aria-expanded="false" aria-haspopup="true">Requirements</a> </li> <li > <a tabindex="0" data-url="/regulation/controlled-drugs/medical-cannabis-access-programme" href="https://www.hpra.ie/regulation/controlled-drugs/medical-cannabis-access-programme" aria-haspopup="false">Medical cannabis access programme </a> </li> <li > <a tabindex="0" data-url="/regulation/controlled-drugs/guidance-documents" href="https://www.hpra.ie/regulation/controlled-drugs/guidance-documents" aria-haspopup="false">Guidance documents</a> </li> </ul> </li> <li class="sub 0"> <a tabindex="0" data-url="/regulation/precursor-chemicals" href="#" aria-expanded="false" aria-haspopup="true">Precursor chemicals </a>  <ul aria-label="third level menu"> <li> <a data-url="/regulation/precursor-chemicals" href="https://www.hpra.ie/regulation/precursor-chemicals">Overview</a> </li> <li > <a tabindex="0" data-url="/regulation/precursor-chemicals/our-role-in-regulating-precursor-chemicals" href="https://www.hpra.ie/regulation/precursor-chemicals/our-role-in-regulating-precursor-chemicals" aria-haspopup="false">Our role</a> </li> <li class="sub 1"> <a tabindex="0" data-url="/regulation/precursor-chemicals/precursor-chemicals-legislation" href="https://www.hpra.ie/regulation/precursor-chemicals/precursor-chemicals-legislation" aria-expanded="false" aria-haspopup="true">Legislation</a> </li> <li > <a tabindex="0" data-url="/regulation/precursor-chemicals/requirements-for-operators-and-end-users" href="https://www.hpra.ie/regulation/precursor-chemicals/requirements-for-operators-and-end-users" aria-haspopup="false">Operators and end users </a> </li> <li class="sub 1"> <a tabindex="0" data-url="/regulation/precursor-chemicals/licensing-and-registration" href="https://www.hpra.ie/regulation/precursor-chemicals/licensing-and-registration" aria-expanded="false" aria-haspopup="true">Licensing and registration</a> </li> <li > <a tabindex="0" data-url="/regulation/precursor-chemicals/guidance-documents" href="https://www.hpra.ie/regulation/precursor-chemicals/guidance-documents" aria-haspopup="false">Guidance documents</a> </li> </ul> </li> <li class="sub 0"> <a tabindex="0" data-url="/regulation/classification-and-innovation-services" href="#" aria-expanded="false" aria-haspopup="true">Classification and innovation services</a>  <ul aria-label="third level menu"> <li> <a data-url="/regulation/classification-and-innovation-services" href="https://www.hpra.ie/regulation/classification-and-innovation-services">Overview</a> </li> <li > <a tabindex="0" data-url="/regulation/classification-and-innovation-services/classification-of-products" href="https://www.hpra.ie/regulation/classification-and-innovation-services/classification-of-products" aria-haspopup="false">Classification of human health products</a> </li> <li > <a tabindex="0" data-url="/regulation/classification-and-innovation-services/hpra-innovation-office" href="https://www.hpra.ie/regulation/classification-and-innovation-services/hpra-innovation-office" aria-haspopup="false">Innovation Office</a> </li> </ul> </li> <li > <a tabindex="0" data-url="/regulation/guidance-documents" href="https://www.hpra.ie/regulation/guidance-documents" aria-haspopup="false">Guidance documents</a> </li> </ul> </div> <div class="col-sm-5 spotlight-col"> </div> </div> </div> </div> </li> <li class="" > <a id="dd-item3" class="a no-popup" data-url="/news-events" href="https://www.hpra.ie/news-events" aria-haspopup="false"> <span>News & Events</span> </a> </li> <li class="" > <a id="dd-item4" class="a" data-url="/about-us" href="#/" aria-expanded="false" aria-haspopup="true"> <span>About Us</span> </a> <div class="grey-box" aria-hidden="true"> <div class="container"> <div class="navbtn row d-sm-none"> <div class="col-3"> <a href="#/" class="btn btn-link-dark-secondary back-btn btn-dark-blue "> Back </a> </div> <div class="col-9"> <p class="title">About Us</p> </div> </div> <div class="row"> <div class="col-sm-4 cta"> <span class="h2">About Us</span> <p>Find out more about our organisation, the products we regulate and how we regulate them. </p> <a href="https://www.hpra.ie/about-us" class="btn btn-primary">Find out more</a> </div> <div class="col-sm-3 sub-menu "> <ul aria-label="second level menu"> <li class="d-sm-none"> <a data-url="/about-us" href="https://www.hpra.ie/about-us" aria-haspopup="false">Find out more</a> </li> <li class="sub 0"> <a tabindex="0" data-url="/about-us/our-role" href="#" aria-expanded="false" aria-haspopup="true">Our role </a>  <ul aria-label="third level menu"> <li> <a data-url="/about-us/our-role" href="https://www.hpra.ie/about-us/our-role">Overview</a> </li> <li > <a tabindex="0" data-url="/about-us/our-role/what-and-how-we-regulate" href="https://www.hpra.ie/about-us/our-role/what-and-how-we-regulate" aria-haspopup="false">What and how we regulate </a> </li> <li > <a tabindex="0" data-url="/about-us/our-role/mission--vision-and-values" href="https://www.hpra.ie/about-us/our-role/mission--vision-and-values" aria-haspopup="false">Mission, vision and values</a> </li> <li > <a tabindex="0" data-url="/about-us/our-role/strategic-plan" href="https://www.hpra.ie/about-us/our-role/strategic-plan" aria-haspopup="false">Strategic plan</a> </li> </ul> </li> <li class="sub 0"> <a tabindex="0" data-url="/about-us/our-structure" href="#" aria-expanded="false" aria-haspopup="true">Our structure </a>  <ul aria-label="third level menu"> <li> <a data-url="/about-us/our-structure" href="https://www.hpra.ie/about-us/our-structure">Overview</a> </li> <li > <a tabindex="0" data-url="/about-us/our-structure/leadership-team" href="https://www.hpra.ie/about-us/our-structure/leadership-team" aria-haspopup="false">HPRA Leadership Team</a> </li> <li > <a tabindex="0" data-url="/about-us/our-structure/hpra-authority-members" href="https://www.hpra.ie/about-us/our-structure/hpra-authority-members" aria-haspopup="false">HPRA Authority Members</a> </li> <li > <a tabindex="0" data-url="/about-us/our-structure/advisory-committees" href="https://www.hpra.ie/about-us/our-structure/advisory-committees" aria-haspopup="false">Advisory Committees</a> </li> </ul> </li> <li class="sub 0"> <a tabindex="0" data-url="/about-us/patient-forum" href="#" aria-expanded="false" aria-haspopup="true">Patient Forum </a>  <ul aria-label="third level menu"> <li> <a data-url="/about-us/patient-forum" href="https://www.hpra.ie/about-us/patient-forum">Overview</a> </li> <li > <a tabindex="0" data-url="/about-us/patient-forum/about-the-patient-forum" href="https://www.hpra.ie/about-us/patient-forum/about-the-patient-forum" aria-haspopup="false">About the Patient Forum </a> </li> <li > <a tabindex="0" data-url="/about-us/patient-forum/terms-of-reference" href="https://www.hpra.ie/about-us/patient-forum/terms-of-reference" aria-haspopup="false">Terms of Reference</a> </li> <li > <a tabindex="0" data-url="/about-us/patient-forum/consideration-of-potential-conflicts-of-interest" href="https://www.hpra.ie/about-us/patient-forum/consideration-of-potential-conflicts-of-interest" aria-haspopup="false">Conflicts of interest</a> </li> <li > <a tabindex="0" data-url="/about-us/patient-forum/rolling-work-plan-2023" href="https://www.hpra.ie/about-us/patient-forum/rolling-work-plan-2023" aria-haspopup="false">Rolling Work Plan</a> </li> <li > <a tabindex="0" data-url="/about-us/patient-forum/meeting-reports" href="https://www.hpra.ie/about-us/patient-forum/meeting-reports" aria-haspopup="false">Meeting reports</a> </li> <li > <a tabindex="0" data-url="/about-us/patient-forum/patient-forum-resources" href="https://www.hpra.ie/about-us/patient-forum/patient-forum-resources" aria-haspopup="false">Resources</a> </li> </ul> </li> <li class="sub 0"> <a tabindex="0" data-url="/about-us/our-standards" href="#" aria-expanded="false" aria-haspopup="true">Our standards</a>  <ul aria-label="third level menu"> <li> <a data-url="/about-us/our-standards" href="https://www.hpra.ie/about-us/our-standards">Overview</a> </li> <li > <a tabindex="0" data-url="/about-us/our-standards/standard-of-service" href="https://www.hpra.ie/about-us/our-standards/standard-of-service" aria-haspopup="false">Standards of service</a> </li> <li > <a tabindex="0" data-url="/about-us/our-standards/quality-management" href="https://www.hpra.ie/about-us/our-standards/quality-management" aria-haspopup="false">Quality Management and Benchmarking</a> </li> </ul> </li> <li class="sub 0"> <a tabindex="0" data-url="/about-us/consultations" href="#" aria-expanded="false" aria-haspopup="true">Consultations </a>  <ul aria-label="third level menu"> <li> <a data-url="/about-us/consultations" href="https://www.hpra.ie/about-us/consultations">Overview</a> </li> <li > <a tabindex="0" data-url="/about-us/consultations/previous-consultations" href="https://www.hpra.ie/about-us/consultations/previous-consultations" aria-haspopup="false">Previous consultations </a> </li> </ul> </li> <li > <a tabindex="0" data-url="/about-us/corporate-publications" href="https://www.hpra.ie/about-us/corporate-publications" aria-haspopup="false">Corporate publications</a> </li> </ul> </div> <div class="col-sm-5 spotlight-col"> </div> </div> </div> </div> </li> </ul> <div id="tns-mobile-menu"> <ul class="right-menu"> <li ><a href="/make-a-submission">Make a Submission</a></li> <li ><a href="/report-an-issue">Report an Issue</a></li> </ul> <nav id="tns" aria-label="Top Navigation"> <ul aria-label="Top Navigation"> <li><a href="/ga/eolas-fuinn">Gaeilge</a></li> <li><a href="/careers">Careers</a></li> <li><a href="/contact-us">Contact us</a></li> <li><a href="/my-alerts">My Alerts</a></li> </ul> </nav> </div> </nav> </div> <div class="col-sm-4"> <ul class="right-menu"> <li ><a href="/make-a-submission">Make a Submission</a></li> <li ><a href="/report-an-issue">Report an Issue</a></li> </ul> </div> </div> </div> </div> </header><span id="main-content"></span> <main id="Contentplaceholder1_T08CCD4C1039_Col00" class="sf_colsIn" data-sf-element="Main" data-placeholder-label="Main Content"><div id="Contentplaceholder1_TC5AC4AA2007_Col00" class="sf_colsIn container" data-sf-element="Container" data-placeholder-label="Area Breadcrumb"><nav aria-label="breadcrumb"> <ol class="breadcrumb"> <li class="breadcrumb-item"><a href="/">Home</a></li> <li class="breadcrumb-item active" aria-current="page">Accessibility</li> </ol> </nav> </div> <section id="Contentplaceholder1_T9B25936E005_Col00" class="sf_colsIn" data-sf-element="Section" data-placeholder-label="Section"><div id="Contentplaceholder1_T9B25936E006_Col00" class="sf_colsIn container" data-sf-element="Container" data-placeholder-label="Container"><div class="row" data-sf-element="Row"> <div id="Contentplaceholder1_T9B25936E003_Col00" class="sf_colsIn col-sm-4" data-sf-element="Column 1" data-placeholder-label="Area: Left Navigation Area"> <nav aria-labelledby="leftSidebarNavigation" class="left-nav-wrapper"> <span id="leftSidebarNavigation" class="sidebar-title"> Accessibility </span> </nav> </div> <div id="Contentplaceholder1_T9B25936E003_Col01" class="sf_colsIn col-sm-8" data-sf-element="Column 2" data-placeholder-label="Column 2"><article id="Contentplaceholder1_T9B25936E008_Col00" class="sf_colsIn standard-content" data-sf-element="Article" data-placeholder-label="Area: Main Content"> <h1>HPRA Accessibility Statement</h1><p>At the HPRA, we are committed to making our website accessible so that as many people as possible can use this site regardless of technology or ability. This in accordance with European Union (Accessibility of Websites and Mobile Applications of Public Sector Bodies) Regulations 2020. .</p><h2>Measures to support accessibility</h2><p>Some measures we have taken when building this site include: </p><ul><li>All front-end development work ensures compatibility with multiple devices and screen readers. </li><li>Clear and intuitive site navigation is provided, including a breadcrumb trail for improved user experience. </li><li>Users can navigate the website using a keyboard only, with interactive elements fully accessible via tabbing and focus states.  </li><li>Good colour contrast is maintained throughout the site to support users with visual impairments.  </li><li>HTML tags are structured to assist navigation, including <h1> for page headers, <h2> for subheadings, and <p> for paragraphs.</li><li>Alt text field on CMS is included in image settings to describe their content, unless the content is decorative. </li><li>No flashing elements have been used to avoid triggering seizures or other health concerns. </li><li>Peer reviews, keyboard testing, and automated audits were conducted to validate compliance with accessibility best practices. </li><li><p>Training has been provided to staff working on website content to ensure future updates maintain compliance with accessibility standards. </p></li></ul><h2>Compliance status</h2><p>The HPRA is partially compliant with WCAG 2.1 level AA. Some content does not yet fully comply with this accessibility standard. This is outlined below. <br></p><h2>Non accessible content</h2><p>Despite our best efforts to ensure accessibility of the HPRA website, there are some limitations in some areas of the site content</p><p>Below is a description of these known limitations however please contact our accessibility officer using our <a data-sf-ec-immutable="" rel="noreferrer noopener" target="_blank" href="https://www.hpra.ie/contact-us/online-contact-form">online contact form</a> and selecting ‘Other’ > ‘General query’ from the drop-down menus if you notice an issue not listed below.</p><ul><li>Some PDF documents: Some HPRA documents produced prior to 2025 do not adhere to accessibility guidelines. It will not be possible for all documents to be made accessible, due to the disproportionate cost burden. We intend to have all future documentation online fully accessible. If you require any pdf documentation provided in an alternative format, please contact our access officer using our <a data-sf-ec-immutable="" rel="noreferrer noopener" target="_blank" href="https://www.hpra.ie/contact-us/online-contact-form">online form</a> and selecting ‘Other’ > ‘Accessibility query’ from the drop-down menus. </li><li>Safety Notices: The HPRA publishes third party notices relating to the safety and/or quality of health products. These are shared with us by external organisations and may not always be fully accessible </li><li>Package Leaflets: Package leaflets for human medicinal products on the HPRA website are currently published in pdf format. The marketing authorisation holder (normally, a pharmaceutical company) has an obligation to provide package leaflets in formats appropriate for the blind and partially sighted on request from patients. We can assist you in making a request to the marketing authorisation holder for a more accessible alternative; </li><li>All videos created from 2025 onwards will include a transcript to download.  We host our video content on Youtube and embed them into the site using iframes. Closed captions may be available through the Youtube platform. tThere are some accessibility issues with these iframes that we do not have control over on the Youtube platform. </li></ul><h2>Website settings</h2><p>The browser being used will have its own accessibility options or free downloads to increase accessibility options and improve browsing experience. </p><p>Some of the content on this site, may also require plugins to work on your browser. This and other helpful guides on how to better your online experience can be found on <a data-sf-ec-immutable="" rel="noreferrer noopener" target="_blank" href="https://www.w3.org/WAI/users/browsing">Better Web Browsing: Tips for Customising your Computer.</a></p><h2>Assessment approach </h2><p>Accessibility was validated through peer reviews, keyboard testing and automated audits. We benchmarked the results based on the WCAG Level AA standards. </p><h2>Feedback</h2><p>We welcome your feedback on the accessibility of our site. Please let us know if you encounter accessibility barriers by contacting our Access Officer by phone at 01 676 4971 or contact our access officer using our <a data-sf-ec-immutable="" rel="noreferrer noopener" target="_blank" href="https://www.hpra.ie/contact-us/online-contact-form">online form</a> and selecting ‘Other’ > ‘General query’ from the drop-down menus. </p><p>You can also send your feedback by post to: </p><p>Access Officer, HPRA, Kevin O'Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2, Ireland, D02 XP77 </p><h2>Formal complaints </h2>You can make a complaint about the accessibility of this website under the Disability Act 2005 (No. 14 of 2005) by emailing our accessibility officer through our contact us form selecting the ‘Other’ category and choosing ‘Accessibility query’. <br> <br>If you are not happy about our response to your complaint, you can contact the Ombudsman to look into your complaint:.<p> </p><p>The Office of the Ombudsman<br>6 Earlsfort Terrace,<br>Dublin 2,<br>D02 W773.</p><p>Phone: +353 1 639 5600<br>Email: <a data-sf-ec-immutable="" href="http://mailto:complaints@ombudsman.ie">complaints@ombudsman.ie</a></p> </article> </div> </div> </div> </section> </main><footer id="Contentplaceholder1_T08CCD4C1047_Col00" class="sf_colsIn footer" data-sf-element="Footer" data-placeholder-label="Non-Searchable Footer"><div id="Contentplaceholder1_T08CCD4C1021_Col00" class="sf_colsIn container" data-sf-element="Container" data-placeholder-label="Kieran"><div class="row" data-sf-element="Row"> <div id="Contentplaceholder1_T08CCD4C1022_Col00" class="sf_colsIn col-sm-7" data-sf-element="Column 1" data-placeholder-label="Area: Footer Logo"> <p><span class="visually-hidden">Homepage link</span> </p><img src="/images/default-source/banners/hpra_footer_logo.svg?sfvrsn=c526468d_1" alt=""> </div> <div id="Contentplaceholder1_T08CCD4C1022_Col01" class="sf_colsIn col-sm-5" data-sf-element="Column 2" data-placeholder-label="Area: My Alert 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