In this issue:
Brexit
(Human and Veterinary Medicines)
- Potential withdrawals arising due to Brexit
- Packaging
- Request for PA/VPA numbers in advance of an application
- Brexit and Clinical Trials for Human Medicines
- Type IA Annual reporting of variations
- Brexit related changes to authorisations
- Queries to Receipt and Validation section
- HPRA contact details
- MAH contact details
Safety Features
- Safety features: Batch-specific requests
update
- Safety Features and Articles 23:Update for Wholesale Distributors
- Safety features Update for manufacturers and Marketing Authorisation Holders
Human Medicines
- Notification of marketing status for traditional herbal medicinal products (THMPs)
- Appropriate use of the Common Technical
- Document format for herbal medicinal products
- HPRA decision to classify and regulate
- Faecal Microbiota Transplant products as medicinal products
Veterinary Sciences
- New veterinary regulation
- Booking slots as Reference Member State
- Periodic Safety Update Reports for veterinary medicines
- Personnel changes in Veterinary Department
Compliance
- Certificate of a Pharmaceutical Product (CPP) - notice regarding discontinuation of the Product Specific Details (PSD) for a marketing authorisation
- Introduction of new variation process for investigational medicinal product manufacturer’s / importer’s authorisation (IMP MIA)
- Upcoming revision of guide to new applications and variations to manufacturer’s/ importer’s authorisation (MIA)
- Sampling and Analysis Programme Dealing with out-of-specification test results – A message for marketing authorisation holders