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Title File Type File Size Published Date  
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 330 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 330 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
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 171 KB 09/06/2014 View more information
Guide for Manufacturers of General Class In-vitro Diagnostic Medical Devices .pdf 279 KB 09/06/2014 View more information
Guide for Class I Manufacturers on Compliance with European Communities (Medical Devices) Regulations 1994 .pdf 282 KB 09/06/2014 View more information
Guide to Incident Reporting for In-vitro Diagnostic Medical Devices .pdf 240 KB 09/06/2014 View more information
Guide to Incident Reporting for General Medical Devices and Active Implantable Medical Devices .pdf 236 KB 09/06/2014 View more information
Guide to Vigilance System for Medical Devices .pdf 144 KB 09/06/2014 View more information
Guide to Field Safety Corrective Actions for Medical Devices and In-vitro Diagnostic Medical Devices .pdf 147 KB 09/06/2014 View more information
Guide to Completion of the Blood Establishment Annual Report .pdf 107 KB 09/06/2014 View more information
Guide to One-Off (Non-routine) Import/Export of Tissues and Cells for Human Application Involving Countries Outside the European Union .pdf 128 KB 09/06/2014 View more information
Guide to Completion of the Hospital Blood Bank Annual Report .pdf 157 KB 09/06/2014 View more information
Guide to Applying for a Variation to a Tissue / Importing Tissue Establishment Authorisation .pdf 102 KB 09/06/2014 View more information
Guide to Applying for a Variation to a Blood Establishment Authorisation .pdf 101 KB 09/06/2014 View more information
Guide to Regulatory Requirements for the Procurement of Human Tissues and Cells .pdf 98 KB 09/06/2014 View more information
Guide to Hospital-Based Advanced Therapy Medicinal Products .pdf 131 KB 09/06/2014 View more information
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