HPRA Medicinal Products Newsletter - Issue Number 67

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Published 5 February 2021

In this issue

Human Medicines

  • Brexit Updates (pages 1–4)

    • Non-Compliant Marketing Authorisations following the Brexit Transition Period

    • Marketing Authorisation Holder Transfer

    • Multilingual Labelling and Joint Labelling with the UK

    • Article 41 of the Withdrawal Agreement

    • Registration of New Sites of Batch Release and/or Quality Control Testing Sites

    • European Commission Permitted Flexibilities to Facilitate Supply of Medicines to the Irish Market

    • Use of Stock Sourced from Great Britain to Mitigate Medicine Shortages to the Irish Market Where the Product is Authorised in Both Markets

    • Parallel Product Authorisations

    • Clinical Trials

    • Useful Links

  • Worksharing Variations (with National and/or MR products) for which Ireland is the Reference Authority

  • Product Information Update (PIU)

  • Registered Product Information

  • Shortened Renewal Procedure – CMDh Best Practice Guide on the Processing of Renewals in the Mutual Recognition and Decentralised Procedures

  • Article 57 Database: Updates to Qualified Person Responsible for Pharmacovigilance (QPPV) and the Pharmacovigilance System Master File (PSMF)

  • Compliance with the QRD Template 

Veterinary Medicines

  • Brexit Implications for Veterinary Medicinal Products

  • Time-limited Conditional Exemptions to Facilitate Supply of Medicines to the Irish market after Brexit

  • Communicating with the Veterinary Sciences Department on General Matters

  • Compliance of Veterinary Medicines for Exotic Pets with New Regulatory Requirements

  • HPRA has Commenced Implementation of Regulation 2019/6 – How to Keep Track of Developments

  • Update on Irish Language Case

  • Update on Stakeholder Survey in September 2020

  • HPRA Veterinary Information Day 2021 

Compliance

  • Annex 2 of the Wholesale Distribution Authorisation (WDA) – Contract Storage Site(s) in the United Kingdom

  • 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)

  • Updated Details for Reporting of Quality Defects

  • A Review of Deficiencies Cited during Good Distribution Practice (GDP) inspections in 2018 and 2019

  • Requirements in Relation to Third-country Qualifications of Safety Assessors of Cosmetic Products



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