HPRA Newsletter Issue 49: September - December 2014
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hpra-medical-quaterly-issue-49-final.pdf
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In this Issue
General
- Herbal Medicines Information Seminar
Human Medicines
-
Proactive Approach to Reclassification (Switching)
- New EU Clinical Trials Regulation
- Reminder to submit Marketing Status Notifications for all authorisations and certificates.
Veterinary Medicines
- Certificates of suitability and retest periods
- Declaration form for the ‘Detailed Description of the Pharmacovigilance System’ relating to applications for veterinary medicinal products.
- Capacity planning
- Feedback on Veterinary Medicines Department Information Day
Compliance
- New Tools for Manufacturers to help prevent Medicines Shortages
- Amendment to the Misuse of Drugs Regulations
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