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Title File Type File Size Published Date  
Technical Guidance for Completion of Statistical Returns form under Scientific Animal Protection Legislation .pdf 313 KB 17/06/2021 View more information
Guide to Labels and Leaflets of Human Medicines .pdf 511 KB 16/06/2021 View more information
Guide to Applications for Certificates of Free Sale for Medical Devices .pdf 447 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
Guide to Notification of Marketing Status of Human Medicines .pdf 225 KB 15/04/2021 View more information
Guide to Withdrawal of Authorisations or Certificates for Human Medicines .pdf 250 KB 15/04/2021 View more information
Guide to Clinical Trials Regulation-National Collaboration Project .pdf 645 KB 29/03/2021 View more information
Guide to product literature standard (PLS) for veterinary medicinal products .pdf 272 KB 26/03/2021 View more information
Guide to joint-labelling of veterinary medicinal products for use in Ireland and the UK .pdf 265 KB 26/03/2021 View more information
Guide to Transfers of Marketing Authorisations, Parallel Import Licences and Dual Pack Import Registrations for Human Medicines .pdf 273 KB 19/03/2021 View more information
Guide to New Applications and Variations to Wholesale Distribution Authorisations .pdf 439 KB 08/03/2021 View more information
Guide to Good Distribution Practice of Medicinal Products for Human Use .pdf 457 KB 08/03/2021 View more information
Working document on Non-technical Project Summaries .pdf 613 KB 19/02/2021 View more information
Guide to Renewal of Marketing Authorisations - Human Medicines .pdf 301 KB 08/01/2021 View more information
Guide for Distributors of Medical Devices .pdf 1 MB 18/12/2020 View more information
Guide to the Notification System for Exempt Medicinal Products .pdf 508 KB 04/12/2020 View more information
Brexit Guide for Stakeholders - Organisations Responsible for Human Application for Tissues and Cells - Dentists .pdf 240 KB 20/11/2020 View more information
Brexit Guide for Stakeholders - Tissue Establishments .pdf 235 KB 20/11/2020 View more information
Brexit Guide for Stakeholders - Organisations Responsible for Human Application of Tissues and Cells - Hospitals .pdf 240 KB 20/11/2020 View more information
Guide to Routine Import/Export of Tissues and Cells for Human Application Involving Countries Outside the European Union .pdf 291 KB 13/11/2020 View more information
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