HPRA Newsletter - Issue 52 - January 2016

In this Issue

General 

• New Chief Executive Appointment

Human Medicines

• Emergency Medicines - The Medicinal Products (Prescription and Control of Supply)
  (Amendment) (No.2) Regulations 2015, SI No 449 of 2015#
• Introduction of Educational Materials for medicines on HPRA.ie

Veterinary Sciences

• Change to mock up submission to the HPRA
• Clarification of changes to mock ups
• Personnel changes in Veterinary department
• Fee update
• Update on legislative proposal for new EU Regulation
• Update to the product literature standard
• Use of animal test methods for regulatory testing of human

Compliance

• Change to requirements regarding Applications for Certificates of
  Pharmaceutical Product and Certificates of Free Sale for medicines
  authorised by the HPRA.
• Importation of Controlled Drugs
• Exporting Controlled Drugs
• European Commission Delegated Regulation for Safety Features on
  Medicinal Products for Human Use
• Sale or supply of traditional herbal medicinal products (THMPs) that are
  the subject of transitional protection
• Revision to Annex 16 of the EU GMP Guide: Certification by a Qualified
  Person and Batch Release
• Quality Defect Investigations – Guidance in relation to Reporting
  and Information Gathering