HPRA Medicinal Products Newsletter - Issue Number 57
Download:
hpra-medicinal-products---issue-number-57.pdf
673 KB
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.
« Back