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Title
File Type
File Size
Published Date
Guide to Attainment of Qualified Person Status in Ireland
.pdf
111 KB
15/04/2024
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Guide to Submitting a Request for Ireland to Act as RMS in a DCP for Human Medicines
.pdf
77 KB
03/04/2024
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Guide to Submitting a Request for a New National Application Procedure for a Human Medicinal Product
.pdf
74 KB
03/04/2024
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Guide to Renewal of Marketing Authorisations - Human Medicines
.pdf
121 KB
14/03/2024
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Guide to Reporting Serious Adverse Reactions (SARs) and Serious Adverse Events (SAEs) associated with Human Tissues and Cells
.pdf
251 KB
09/02/2024
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Guide to Fees for Human Products
.pdf
256 KB
02/01/2024
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Guide to Fees for Veterinary Products
.pdf
203 KB
02/01/2024
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Guide to Fees for Scientific Animal Protection
.pdf
82 KB
02/01/2024
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Guide to Invented Names of Veterinary Medicines
.pdf
92 KB
01/12/2023
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Technical guidance for completion of non-technical project summaries under scientific animal protection legislation
.pdf
128 KB
02/11/2023
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Joint HPRA-VMD guide to acceptable texts for joint labelling for veterinary medicinal products for use in IE and the UK
.pdf
212 KB
20/10/2023
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Guide to Refusals and Appeals under Scientific Animal Protection Legislation
.pdf
168 KB
05/10/2023
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Guide for National Scientific and Regulatory Advice
.pdf
134 KB
20/09/2023
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Guide to Parallel Imports - Human Medicines
.pdf
303 KB
12/07/2023
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Guide to clinical trials conducted under the CTR in Ireland
.pdf
394 KB
28/06/2023
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Guide to Serious Adverse Reaction/Event Reporting for Human Organs Intended for Transplantation
.pdf
179 KB
19/05/2023
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Guide to Clinical Field Trial Licence Applications under National Veterinary Legislation
.pdf
208 KB
16/05/2023
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Guide to Reporting and Investigation of Quality Defects in Medicinal Products for Human and Veterinary Use
.pdf
245 KB
04/05/2023
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Endorsed document on Non-technical Project Summaries
.pdf
1 MB
06/03/2023
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Guide to Registration of Processes Exempted under Article 61(5) of the Clinical Trial Regulation
.pdf
124 KB
02/02/2023
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Date Printed: 20/04/2024