Published 17 February 2023
Contents in this issue:
Human Medicines
- HPRA identifier for DHPCs and educational materials
- Clinical trials – deadlines, training, and supports
- Brexit update
- Nitrosamines
- Swift scientific advice (quality sections of dossier)
Veterinary Medicines
- HPRA welcomes extension to Brexit exemptions for veterinary medicines
- Change in fee system for veterinary medicines in the EU
- Changes to the processing of the Summary of Product Characteristics by the HPRA
- Update on antiparasitic veterinary medicinal products for food-producing animals
- Recent updates to the pharmacovigilance section of the HPRA website
- Publication of information on newly authorised centralised veterinary medicines and updating of national product data in the Union Product Database
- Veterinary medicinal products containing zinc oxide to be administered orally to food-producing species
- Mock up requirements following G.I.18 variations
Compliance
- Requirements for HPRA access to manufacturing sites where batch certification only takes place
- Adjusting our compliance management approach
- Registration of processes exempted under Article 61(5) of the Clinical Trials Regulation
- Common deficiencies issued to wholesale distributors