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
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Implementation of Regulation 2019(6) – general update
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Pharmacovigilance changes
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Changes to HPRA requirements for mock-ups
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Changes to product listings on the HPRA website
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Transition to new labelling requirements
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Submission of the Mutual Recognition and Subsequent Recognition Applications
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Processing of the Summary of Product Characteristics
-
Brexit and supply of veterinary medicines
-
Irish language packaging
Compliance
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Safety Features – end of ‘use and learn’ phase
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Integration of EudraGMP and OMS
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Remote QP certification
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Supporting documents required when applying to include a QP on an MIA
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Registrations for active substances used in veterinary medicines
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Risk-based cross-contamination control
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Responses to deficiencies cited in GMP inspection reports