HPRA Medicinal Products Newsletter - Issue Number 61

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In this issue:

(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
  • 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


  • 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

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