In this issue

Human Medicines

• COVID-19: Queries and Updates

• COVID-19 Related Human Research – Expedited Regulatory and Ethical Review

• Guidance on the Management of Clinical Trials during COVID-19

• Variation Implementation Times for Labelling and Leaflet Updates to Human Medicines: Update on Regulatory Flexibility during the COVID-19 Pandemic

• Exceptional Change Management Process

• Excipients in the Labelling and Packaging Leaflet of Medicinal Products for Human Use

• Pharmacovigilance: Prioritisation of ICSRs during the COVID-19 Pandemic

Veterinary Medicines

• Revision of National Legislation on Veterinary Medicinal Products

• Strategic and Operational Planning for Veterinary Medicines

• 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

• Automatic Extension of Periods of Validity of GMP and GDP Certificates due to Restrictions Linked to the COVID-19 Pandemic

• Remote GxP Inspections

• Provision for Remote Qualified Person (QP) Certification during the COVID-19 Pandemic

• Variations to a Manufacturer’s Authorisation (MIA)

• Manufacturing/Importation Arrangements during the Post-Brexit Transition Period

• Reminder for Distributors of Teeth Whitening Products containing Hydrogen Peroxide