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Sharan Murugan
Jun 23, 20242 min read
Ireland's HPRA: Guide to Labels and Leaflets of Human Medicines
Last Friday (09 February 2024) the Health Products Regulatory Authority (HPRA) of Ireland updated its guidance on "Labels and Leaflets of...
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Sharan Murugan
Apr 7, 20242 min read
Ireland HPRA: Submitting a Request for Ireland to Act as RMS in a Decentralised Procedure
Irelands Health Products Regulatory Authority (HPRA) released updated guidance on "Submitting a Request for Ireland to Act as RMS in a...
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Sharan Murugan
Mar 29, 20242 min read
Ireland HPRA: Guide to Renewal of Marketing Authorisations –Human Medicines
Irelands Health Products Regulatory Authority (HPRA) released guidance on "Guide to Renewal of Marketing Authorisations - Human...
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Sharan Murugan
Jul 15, 20232 min read
Ireland HPRA: Guidance on Parallel Imports of Human Medicines
Irelands Health Products Regulatory Authority (HPRA) released guidance on "Guide to Parallel Imports of Human Medicines" last week (12...
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Sharan Murugan
May 9, 20232 min read
Ireland's HPRA: Guidance on Reporting & Investigation of Quality Defects
Irelands Health Products Regulatory Authority (HPRA) released final guidance on "Reporting and Investigation of Quality Defects in...
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Sharan Murugan
Apr 17, 20232 min read
Ireland's HPRA: Guide to SAR /Event Reporting for Human Organs Intended for Transplantation
Earlier today (17-April-2023) he Health Products Regulatory Authority (HPRA) of Ireland updated its guidance on "Guide to Serious Adverse...
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Sharan Murugan
Feb 2, 20231 min read
Ireland's HPRA: Guide to Clinical Trial Applications
Recently in January, the Health Products Regulatory Authority (HPRA) of Ireland updated its guidance on "HPRA Guide to Clinical Trial...
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Sharan Murugan
Jan 8, 20231 min read
Irelands HPRA's: Guide to Fees for Human Products
On 3rd January 2023, Irelands Health Products Regulatory Authority (HPRA) released an updated Guide related to "Fees for Human Products"....
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Sharan Murugan
Nov 27, 20221 min read
Irelands HPRA's: Medical Device Guide to Clinical Investigations Carried Out in Ireland
On 18th November, 2022 Irelands Health Products Regulatory Authority (HPRA) released an updated Guide related to "Clinical Investigations...
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Sharan Murugan
Nov 16, 20221 min read
Irelands HPRA MD Guide: Performance Studies Conducted in Ireland
Irelands Health Products Regulatory Authority (HPRA) released (16- November-2022) guide on "Performance Studies Conducted in Ireland", to...
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Sharan Murugan
Jun 18, 20221 min read
Ireland's HPRA -Guide to Performance Studies Conducted in Ireland
On 15-June-22, the HPRA released a guide on how to Performance Studies Conducted in Ireland. The term ‘performance study’ (PS) is defined...
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Sharan Murugan
Jun 3, 20221 min read
HPRA Guide to Clinical Trials Conducted under the Clinical Trials Regulation (CTR) in Ireland
The Health Products Regulatory Authority published a guideline and is seeking feedback on its approach to an aspect of Clinical Trial...
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Sharan Murugan
May 8, 20221 min read
Guide to Clinical Trials conducted under the CTR in Ireland
Clinical trials contribute significantly to advances in medical treatment. A new EU Clinical Trial Regulation (Regulation No 536/2014,...
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Sharan Murugan
Apr 17, 20221 min read
HPRA Guide to Parallel Imports of Human Medicines - Ireland
The Health Products Regulatory Authority (HPRA) updated its guidance on "Parallel Imports of Human Medicine" last week. Parallel...
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Sharan Murugan
Mar 30, 20221 min read
Guide to Wholesaling & Brokering of Medicinal Products - Ireland
The Health Products Regulatory Authority (HPRA) Ireland released updated guidance on the "Guide to Wholesaling and Brokering of...
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Sharan Murugan
Feb 20, 20221 min read
Irelands HPRA Guide to Classification of a Medical Device
Throughout this guide, guidance is given on the qualification of medical devices and the application of classification rules. There is a...
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Sharan Murugan
Feb 20, 20221 min read
Ireland’s HPRA - Guidance update on Submitting Mock-ups for Labels and Leaflets
A number of important revisions and clarifications were made in the HPRA's Guide to Labels and Leaflets of Human Medicines on 9 February...
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Sharan Murugan
Feb 6, 20222 min read
Ireland's guidance on New Application & Variations, Registartion Requirements,
Irelands HPRA released a few guidances in the past week Guide to New Applications and Variations to Manufacturer's Authorisations This...
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Sharan Murugan
Dec 7, 20212 min read
Parallel Imports of Human Medicines– Ireland HPRA
Parallel importation “The importation from an EU Member State, or an EEA country, of a medicinal product which is equivalent to one...
28 views0 comments
Sharan Murugan
Sep 2, 20212 min read
Guide to Reporting and Initial Investigation of Quality Defects-Ireland HPRA
On 27th August 2021, Irelands Health Products Regulatory Authority (HPRA) released a new "Guide to Reporting and Initial Investigation of...
83 views0 comments