Published 19 February 2024
Contents in this issue:
Human Medicines
- Clinical trials – Important dates and information
- Swift written scientific advice – Quality and regulatory queries
- Brexit and the Windsor Framework deadline of 31 December 2024
- Multilingual packaging pilot
Veterinary Medicines
- Alignment of product information with version 9.0 of the QRD templates
- HPRA Information Day on the implementation of Regulation 2019/6 in Ireland
- Implementation of Article 107 of Regulation 2019/6
- implementation of fee increases for veterinary medicines
- National legislation on veterinary medicines
- Review of impact of Regulation 2019/6 on the HPRA’s Veterinary Sciences Department
- Updating the adverse events section of the product information
- Deadlines for the submission of sales data on veterinary medicinal products to the Union Products Database
Compliance
- Chemicals now scheduled as Category 1 Precursor Chemicals