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Title
File Type
File Size
Published Date
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 Reporting Serious Adverse Reactions (SARs) and Serious Adverse Events (SAEs) associated with Human Tissues and Cells
.pdf
247 KB
29/06/2023
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Guide to clinical trials conducted under the CTR in Ireland
.pdf
394 KB
28/06/2023
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Joint HPRA-VMD guide to acceptable texts for joint labelling for veterinary medicinal products for use in IE and the UK
.pdf
233 KB
13/06/2023
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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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Guide to Fees for Human Products
.pdf
289 KB
19/04/2023
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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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Guide to Fees for Veterinary Products
.pdf
203 KB
31/01/2023
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Guide to Clinical Trial Applications
.pdf
255 KB
26/01/2023
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Guide to Interchangeable Medicines
.pdf
188 KB
23/01/2023
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Guide to Fees for Scientific Animal Protection
.pdf
82 KB
03/01/2023
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Guide to Import and Export Licences and LONOs for Controlled Drugs (including the import of cannabis products)
.pdf
208 KB
20/12/2022
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Guide to Applications for Certificates of Free Sale for Medical Devices
.pdf
221 KB
20/12/2022
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Guide to Reclassification (Switching) of Legal Supply Status for Human Medicinal Products
.pdf
222 KB
15/12/2022
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Guide to Clinical Investigations carried out in Ireland
.pdf
145 KB
18/11/2022
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Guide to Performance Studies Conducted in Ireland
.pdf
175 KB
16/11/2022
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Date Printed: 28/09/2023