Published 5 February 2021
In this issue
Human Medicines
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Brexit Updates (pages 1–4)
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Non-Compliant Marketing Authorisations following the Brexit Transition Period
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Marketing Authorisation Holder Transfer
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Multilingual Labelling and Joint Labelling with the UK
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Article 41 of the Withdrawal Agreement
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Registration of New Sites of Batch Release and/or Quality Control Testing Sites
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European Commission Permitted Flexibilities to Facilitate Supply of Medicines to the Irish Market
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Use of Stock Sourced from Great Britain to Mitigate Medicine Shortages to the Irish Market Where the Product is Authorised in Both Markets
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Parallel Product Authorisations
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Clinical Trials
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Useful Links
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Worksharing Variations (with National and/or MR products) for which Ireland is the Reference Authority
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Product Information Update (PIU)
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Registered Product Information
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Shortened Renewal Procedure – CMDh Best Practice Guide on the Processing of Renewals in the Mutual Recognition and Decentralised Procedures
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Article 57 Database: Updates to Qualified Person Responsible for Pharmacovigilance (QPPV) and the Pharmacovigilance System Master File (PSMF)
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Compliance with the QRD Template
Veterinary Medicines
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Brexit Implications for Veterinary Medicinal Products
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Time-limited Conditional Exemptions to Facilitate Supply of Medicines to the Irish market after Brexit
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Communicating with the Veterinary Sciences Department on General Matters
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Compliance of Veterinary Medicines for Exotic Pets with New Regulatory Requirements
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HPRA has Commenced Implementation of Regulation 2019/6 – How to Keep Track of Developments
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Update on Irish Language Case
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Update on Stakeholder Survey in September 2020
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HPRA Veterinary Information Day 2021
Compliance
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Annex 2 of the Wholesale Distribution Authorisation (WDA) – Contract Storage Site(s) in the United Kingdom
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Mutual Recognition Agreements with Third-country Authorities and Supporting Documentation Required for Addition of Sites Located in these Territories to Annex 3 and Annex 4 of Manufacturing Importation Authorisations (MIAs)
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Updated Details for Reporting of Quality Defects
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A Review of Deficiencies Cited during Good Distribution Practice (GDP) inspections in 2018 and 2019
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Requirements in Relation to Third-country Qualifications of Safety Assessors of Cosmetic Products