HPRA Medicinal Products Newsletter - Issue Number 65
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Published 29 May 2020
In this issue
Human Medicines
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COVID-19: Queries and Updates
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COVID-19 Related Human Research – Expedited Regulatory and Ethical Review
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Guidance on the Management of Clinical Trials during COVID-19
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Variation Implementation Times for Labelling and Leaflet Updates to Human Medicines: Update on Regulatory Flexibility during the COVID-19 Pandemic
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Exceptional Change Management Process
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Excipients in the Labelling and Packaging Leaflet of Medicinal Products for Human Use
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Pharmacovigilance: Prioritisation of ICSRs during the COVID-19 Pandemic
Veterinary Medicines
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Revision of National Legislation on Veterinary Medicinal Products
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Strategic and Operational Planning for Veterinary Medicines
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Update on Implementation of the Report of the Task Force on the Method of Supply of Antiparasitic Veterinary Medicinal Products that are Intended for Use in Food-producing Species
Compliance
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Automatic Extension of Periods of Validity of GMP and GDP Certificates due to Restrictions Linked to the COVID-19 Pandemic
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Remote GxP Inspections
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Provision for Remote Qualified Person (QP) Certification during the COVID-19 Pandemic
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Variations to a Manufacturer’s Authorisation (MIA)
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Manufacturing/Importation Arrangements during the Post-Brexit Transition Period
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Reminder for Distributors of Teeth Whitening Products containing Hydrogen Peroxide
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