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Title File Type File Size Published Date  
Guide to clinical trials conducted under the CTR in Ireland .pdf 394 KB 28/06/2023 View more information
Guide to Serious Adverse Reaction/Event Reporting for Human Organs Intended for Transplantation .pdf 179 KB 19/05/2023 View more information
Guide to Clinical Field Trial Licence Applications under National Veterinary Legislation .pdf 208 KB 16/05/2023 View more information
Guide to Reporting and Investigation of Quality Defects in Medicinal Products for Human and Veterinary Use .pdf 245 KB 04/05/2023 View more information
Endorsed document on Non-technical Project Summaries .pdf 1 MB 06/03/2023 View more information
Guide to Registration of Processes Exempted under Article 61(5) of the Clinical Trial Regulation .pdf 124 KB 02/02/2023 View more information
Guide to Clinical Trial Applications .pdf 255 KB 26/01/2023 View more information
Guide to Interchangeable Medicines .pdf 188 KB 23/01/2023 View more information
Guide to Import and Export Licences and LONOs for Controlled Drugs (including the import of cannabis products) .pdf 208 KB 20/12/2022 View more information
Guide to Applications for Certificates of Free Sale for Medical Devices .pdf 221 KB 20/12/2022 View more information
Guide to Reclassification (Switching) of Legal Supply Status for Human Medicinal Products .pdf 222 KB 15/12/2022 View more information
Guide to Performance Studies Conducted in Ireland .pdf 175 KB 16/11/2022 View more information
Guide to Product Literature Standard (PLS) for Veterinary Medicinal Products .pdf 120 KB 14/11/2022 View more information
Guide to appeals under cosmetic product legislation .pdf 90 KB 04/11/2022 View more information
Guide to Use of Animals for Educational Purposes under Scientific Animal Protection Legislation .pdf 129 KB 17/10/2022 View more information
Guide to Batch-Specific Requests for Human Medicines .pdf 118 KB 13/10/2022 View more information
HPRA note for non-pharmacy retail advertising of medicines .pdf 77 KB 29/07/2022 View more information
Guide to definition of a veterinary medicinal product and the classification process .pdf 193 KB 15/06/2022 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
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