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Title File Type File Size Published Date  
Guide to Registration Requirements for Active Substances Manufacturers Importers and Distributors in Ireland .pdf 2 MB 28/01/2022 View more information
Guide to New Applications and Variations to Manufacturer's Authorisations .pdf 413 KB 27/01/2022 View more information
Guide to Completion of Tissue Establishment Annual Report .pdf 237 KB 01/12/2021 View more information
Guide to Completion of Tissue Establishment Annual Report for Reproductive Tissues and Cells .pdf 231 KB 01/12/2021 View more information
Guide to NDSWeb extranet .pdf 811 KB 15/11/2021 View more information
Technical Guidance for Completion of Statistical Returns form under Scientific Animal Protection Legislation .pdf 313 KB 17/06/2021 View more information
Guide to Notification of Marketing Status of Human Medicines .pdf 225 KB 15/04/2021 View more information
Guide to Withdrawal of Authorisations or Certificates for Human Medicines .pdf 250 KB 15/04/2021 View more information
Guide to joint-labelling of veterinary medicinal products for use in Ireland and the UK .pdf 267 KB 26/03/2021 View more information
Guide to Transfers of Marketing Authorisations, Parallel Import Licences and Dual Pack Import Registrations for Human Medicines .pdf 273 KB 19/03/2021 View more information
Guide to Good Distribution Practice of Medicinal Products for Human Use .pdf 322 KB 08/03/2021 View more information
Guide for Distributors of Medical Devices .pdf 1 MB 18/12/2020 View more information
Guide to the Notification System for Exempt Medicinal Products .pdf 508 KB 04/12/2020 View more information
Brexit Guide for Stakeholders - Organisations Responsible for Human Application for Tissues and Cells - Dentists .pdf 240 KB 20/11/2020 View more information
Brexit Guide for Stakeholders - Tissue Establishments .pdf 235 KB 20/11/2020 View more information
Brexit Guide for Stakeholders - Organisations Responsible for Human Application of Tissues and Cells - Hospitals .pdf 240 KB 20/11/2020 View more information
Guide to Routine Import/Export of Tissues and Cells for Human Application Involving Countries Outside the European Union .pdf 291 KB 13/11/2020 View more information
Public consultation on veterinary medicines fees 2021 .pdf 506 KB 09/10/2020 View more information
HPRA Brexit Guidance - Human and Veterinary Medicines - Update October 2020 .pdf 415 KB 07/10/2020 View more information
Guide to Quality System for General Sale Wholesale Distributors .pdf 739 KB 01/10/2020 View more information
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