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Title File Type File Size Published Date  
Guide to Preparation of a Site Master File for Breeder/Supplier/Users under Scientific Animal Protection Legislation .pdf 321 KB 06/03/2019 View more information
Guide to New, Amendment and Renewal Applications for Individuals under Scientific Animal Protection Legislation .pdf 425 KB 06/03/2019 View more information
Guide to Reclassification (Switching) of Legal Supply Status for Human Medicinal Products .pdf 392 KB 26/02/2019 View more information
Guide to Retrospective Assessment Reports under Scientific Animal Protection Legislation .pdf 228 KB 14/02/2019 View more information
Guide to Ethics Committee Assessment of Project Applications under Scientific Animal Protection Legislation .pdf 516 KB 14/02/2019 View more information
Guide to Use of Animals for Educational Purposes under Scientific Animal Protection Legislation .pdf 289 KB 05/02/2019 View more information
Guide to Withdrawal of Breeder/Supplier/User Authorisations under Scientific Animal Protection Legislation .pdf 219 KB 05/02/2019 View more information
Guide to Transfers of Project Authorisations under Scientific Animal Protection Legislation .pdf 446 KB 15/01/2019 View more information
Guide to New Applications and Variations to Wholesale Distribution Authorisations .pdf 427 KB 06/12/2018 View more information
Guide to Project Applications under Scientific Animal Protection Legislation .pdf 442 KB 27/11/2018 View more information
Guide to Implementation of Packaging Changes to Authorised Veterinary Medicinal Products .pdf 251 KB 14/11/2018 View more information
Guide to Decentralised and Mutual Recognition Procedures for Veterinary Medicinal Products .pdf 2 MB 18/10/2018 View more information
Guide to Completing a Non-Technical Project Summary under Scientific Animal Protection Legislation .pdf 400 KB 17/10/2018 View more information
Guide to Traditional Herbal Medicinal Products Registration Scheme .pdf 264 KB 16/10/2018 View more information
Guide to Notification of Marketing Status of Human Medicines .pdf 131 KB 11/10/2018 View more information
Guide to Labels and Leaflets of Human Medicines .pdf 386 KB 09/10/2018 View more information
Guide to Batch-Specific Requests for Human Medicines .pdf 115 KB 28/09/2018 View more information
Medicines shortages framework .pdf 712 KB 14/09/2018 View more information
Guide to Transfers of Marketing Authorisations, Parallel Import Licences and Dual Pack Import Registrations for Human Medicines .pdf 160 KB 31/07/2018 View more information
Guide to Electronic Transmission of SUSARs associated with the use of Human Medicines .pdf 267 KB 20/07/2018 View more information