HPRA Medicinal Products Newsletter – Issue Number 77 – June 2024

Published 21 June 2024

Contents in this issue:

Human Medicines

• Environmental risk assessment for human medicines
• Implementation period for product information updates
• Clinical trials – Important information and updates
• Applying for a national product or DCP authorisation in Ireland – Slot booking
• Product information changes
• Mutual Recognition and repeat use procedure – Proof of payment

Veterinary Medicines

• G.I.18 VRAs – Guidance on submissions
• Implementation deadline for G.I.18 VRAs also applicable to products already in the distribution chain
• Introduction of ‘Umbrella’ type variations
• Introduction of super grouping and widened scope of technical grouping of VNRAs
• Update on the joint labelling initiative
• Provision of labelling mock-ups for joint assessment
• SPC harmonisation – Action for generic/ hybrid MAHs of Domosedan solution for injection
• HPRA Information Day on implementation of Regulation 2019/6 in Ireland
• Publication of veterinary medicines shortages on the HPRA website

Compliance

• Importation of exempt medicinal products by the holder of a Wholesale Distribution Authorisation (WDA)
• GMP records for receipt of materials