HPRA Medicinal Products Newsletter - Issue Number 57

In this issue:

Human Medicines

• New EudraVigilance System: Changes to Reporting Requirements - Go-Live Planning
• Use of the rabbit pyrogen test

Veterinary Sciences

• Best Practice Guide on Measures Improving Predictability of Submissions/Responses and Adherence to Communicated Submission/Responses Deadlines.
• Brexit Preparations
• Outcome of Brexit Survey – Industry Desire to Maintain Joint Labelling
• Introduction of ‘Value’ or Promotional Packs of Veterinary Medicines
• Obligations Regarding the Withdrawal of Marketing Authorisations in Ireland
• Veterinary Medicinal Products containing Zinc Oxide to be Administered Orally to Food - Producing Species.
• Number 1 in Europe

Compliance

• HPRA Regional Information Evenings - Cosmetic Products
• Responding to a Data Integrity Failure
• European Commission Delegated Regulation for Safety Features on Medicinal Products for Human Use
• Updated Quality Defect Reporting Guidance Note and New Reporting Form.