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Title File Type File Size Published Date  
Guide to Clinical Field Trial Licence Applications under Animal Remedies Legislation .pdf 309 KB 11/09/2014 View more information
Guide for Manufacturers and Sponsors on Clinical Investigations carried out in Ireland .pdf 280 KB 14/08/2014 View more information
Guide to Withdrawal of Breeder/Supplier/User Authorisations under Scientific Animal Protection Legislation .pdf 162 KB 14/08/2014 View more information
Guide to Transfers of Project Authorisations under Scientific Animal Protection Legislation .pdf 260 KB 22/07/2014 View more information
Guide to Managing Changes to Registration for Active Substance Manufacturers, Importers and Distributors .pdf 99 KB 15/07/2014 View more information
Guide to Retrospective Assessment Reports under Scientific Animal Protection Legislation .pdf 203 KB 11/07/2014 View more information
Guide to the Notification System for Exempt Medicinal Products .pdf 246 KB 10/07/2014 View more information
Guide to Cosmetics .pdf 132 KB 02/07/2014 View more information
Guide to Cosmetic Products for Responsible Persons .pdf 331 KB 02/07/2014 View more information
Guide to Batch-Specific Requests for Human Medicines .pdf 150 KB 25/06/2014 View more information
Guide to Withdrawal of Authorisations or Certificates for Human Medicines .pdf 201 KB 24/06/2014 View more information
Guide to Project Applications under Scientific Animal Protection Legislation .pdf 769 KB 19/06/2014 View more information
Guide to Amendment and Renewal Applications for Projects under Scientific Animal Protection .pdf 217 KB 19/06/2014 View more information
Guide to Completing a Non-Technical Project Summary under Scientific Animal Protection Legislation .pdf 224 KB 19/06/2014 View more information
Guide to New and Amendment Applications for Individuals under Scientific Animal Protection Legislation .pdf 608 KB 19/06/2014 View more information
Guide to Refusals and Appeals under Scientific Animal Protection Legislation .pdf 296 KB 19/06/2014 View more information
Guide to Submission of Educational Tools and Materials .pdf 79 KB 19/06/2014 View more information
Guide to Additional Monitoring Requirements and Statements Encouraging Reporting of Adverse Reactions .pdf 119 KB 09/06/2014 View more information
Guide for Marketing Authorisation Holders on Direct Healthcare Professional Communications .pdf 145 KB 09/06/2014 View more information
Guide to Compliance with Scientific Animal Protection Legislation .pdf 205 KB 09/06/2014 View more information