HPRA Medicinal Products Newsletter – Issue Number 70 – February 2022

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Published 23 February 2022

Contents in this issue: 


Clinical Trials Regulation

  • Overview of the Clinical Trials Regulation, including information on implementation in Ireland.


Human Medicines

  • Fees for variations – FAQs


Veterinary Medicines

  • Implementation of Regulation 2019(6) – general update

  • Pharmacovigilance changes

  • Changes to HPRA requirements for mock-ups

  • Changes to product listings on the HPRA website

  • Transition to new labelling requirements

  • Submission of the Mutual Recognition and Subsequent Recognition Applications

  • Processing of the Summary of Product Characteristics

  • Brexit and supply of veterinary medicines

  • Irish language packaging



  • Safety Features – end of ‘use and learn’ phase

  • Integration of EudraGMP and OMS

  • Remote QP certification

  • Supporting documents required when applying to include a QP on an MIA

  • Registrations for active substances used in veterinary medicines

  • Risk-based cross-contamination control

  • Responses to deficiencies cited in GMP inspection reports


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