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Title File Type File Size Published Date  
Guide to New, Amendment and Renewal Applications for Individuals under Scientific Animal Protection Legislation .pdf 197 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
Guide to Advertising Compliance .pdf 167 KB 09/06/2014 View more information
Guide to Reporting and Initial Investigation of Quality Defects in Medicinal Products for Human and Veterinary Use .pdf 310 KB 09/06/2014 View more information
Recall of Medicinal Products for Human and Veterinary Use .pdf 308 KB 09/06/2014 View more information
Quality Defect Investigation Reports .pdf 161 KB 09/06/2014 View more information
Guide to Placing System and Procedure Packs on the Market .pdf 224 KB 09/06/2014 View more information
Guide for Custom-Made Dental Device Manufacturers on Compliance with European Communities (Medical Devices) Regulations, 1994 .pdf 167 KB 09/06/2014 View more information
Guide to In-Vitro Diagnostic Medical Devices Legislation .pdf 157 KB 09/06/2014 View more information
Guide for Custom-made Medical Device Manufacturers on Compliance with European Communities (Medical Devices) Regulations 1994 .pdf 506 KB 09/06/2014 View more information
Guide for Manufacturers of General Class In-vitro Diagnostic Medical Devices .pdf 317 KB 09/06/2014 View more information
Guide for Class I Manufacturers on Compliance with European Communities (Medical Devices) Regulations 1994 .pdf 341 KB 09/06/2014 View more information
Guide to Reporting Serious Adverse Reactions (SARs) and Serious Adverse Events (SAEs) associated with Human Tissues and Cells .pdf 253 KB 09/06/2014 View more information
Guide to Incident Reporting for In-vitro Diagnostic Medical Devices .pdf 382 KB 09/06/2014 View more information
Guide to Incident Reporting for General Medical Devices and Active Implantable Medical Devices .pdf 341 KB 09/06/2014 View more information
Guide to Vigilance System for Medical Devices .pdf 249 KB 09/06/2014 View more information