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Title File Type File Size Published Date  
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
AUT-G0103 Guide to completing a non-technical project summary under scientific animal protection legislation pdf v3.1 .pdf 475 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
Guide to Fees for Human Products .pdf 420 KB 26/06/2018 View more information
Guide to Clinical Trial Applications .pdf 335 KB 21/06/2018 View more information
HPRA Brexit Guidance - Human and Veterinary Medicines - Update 24 October 2018 .pdf 204 KB 01/06/2018 View more information
Guide to Interchangeable Medicines .pdf 224 KB 31/05/2018 View more information
Guide to the Notification System for Exempt Medicinal Products .pdf 358 KB 23/05/2018 View more information
Guide to Appeals Under Cosmetic Product Legislation .pdf 109 KB 15/05/2018 View more information
Guide to Transfers of Veterinary Marketing Authorisations and Applications .pdf 162 KB 12/04/2018 View more information