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Title File Type File Size Published Date  
Guide to clinical trials conducted under the CTR in Ireland .pdf 590 KB 29/04/2022 View more information
Guide to Parallel Imports - Human Medicines .pdf 541 KB 07/04/2022 View more information
Guide to Wholesaling and Brokering of Medicinal Products for Human Use in Ireland .pdf 343 KB 25/03/2022 View more information
Guide to Registration of Veterinary Medicinal Products for pets that qualify for registration under Article 5(6) of Regulation 2019/6 .pdf 383 KB 18/02/2022 View more information
Guide to Classification of a Medical Device .pdf 162 KB 16/02/2022 View more information
FAQs on Processing the Labelling and Package Leaflet for Veterinary Medicinal Products .pdf 267 KB 14/02/2022 View more information
Guide to Labels and Leaflets of Human Medicines .pdf 565 KB 09/02/2022 View more information
Guide to Electronic Submissions - Veterinary Medicines .pdf 273 KB 07/02/2022 View more information
Guide to New Applications and Variations to Wholesale Distribution Authorisations .pdf 524 KB 31/01/2022 View more information
Guide to Managing Changes to Registration for Active Substance Manufacturers, Importers and Distributors .pdf 281 KB 28/01/2022 View more information
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 680 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 1 MB 15/11/2021 View more information
Guide to Batch-Specific Requests for Human Medicines .pdf 310 KB 03/11/2021 View more information
Guide to Reporting and Initial Investigation of Quality Defects in Medicinal Products for Human and Veterinary Use .pdf 421 KB 26/08/2021 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 Applications for Certificates of Free Sale for Medical Devices .pdf 153 KB 27/05/2021 View more information
Technical guidance for completion of non-technical project summaries under scientific animal protection legislation .pdf 301 KB 14/05/2021 View more information