HPRA Medicinal Products Newsletter - Issue Number 68

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Published 31 May 2021

In this issue

Human Medicines

  • Approval Dates for Package Leaflets

  • Nitrosamine Impurities

  • Article 31 Referral for Sartan Medicines – Reminder

  • Preparation of Labelling for Joint IE/UK (NI) Packs

  • Audits of Type IA Notifications: 2019/2020 Review

  • Reference Medicinal Products – Updated CMDh Brexit Guidance

  • Clinical Trial Regulation Progress


Veterinary Medicines 

  • HPRA Appearance before Oireachtas Committee on Agriculture and the Marine

  • HPRA Veterinary Medicines Information Day 2021

  • Submission of Variations to Change MAH’s Local Representative for MR Products

  • Veterinary Medicinal Products and Labelling-related Revisions

  • Update on Implementation of HPRA Report on the Method of Supply of Antiparasitic Veterinary Medicinal Products Intended for use in Food-producing Animals

  • Update on Implementation of Regulation 2019/6 and New National Legislation to Replace SI No 786 of 2007

  • Pharmacovigilance Changes Arising from the New Veterinary Regulation (EU) 2019/6

  • QPPV Data Requirement for the Union Product Database

  • Uploading of Product Data to the EMA’s Union Product Database

  • Change to VPO and VPO-1 Category of Supply

  • Revision of National Legislation on Veterinary Clinical Field Trials

  • Update on Irish Language Case



  • Authenticity Verification of Authorisations and Certificates issued by the HPRA

  • Certificates of Free Sale for Devices Approved under the New Medical Devices Regulation 2017/745

  • EU And UK Trade and Cooperation Agreement Summary of Annex on Technical Barriers to Trade (TBT) 2 - Medicinal Products

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