HPRA Medicinal Products Newsletter - Issue Number 60

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In this issue:

Human Medicines
 - Improving the management of shortages
 - Packaging

Veterinary Sciences
 - Challenges to maintaining joint labelling of veterinary medicines with the UK
 - Changes processing of New – National applications.
 - Changes to procedure for withdrawal of applications for veterinary medicines
 - Diethanolamine
 - Implementation of European Commission decisions.
 - Updates to product labelling as a result of efforts to address antimicrobial resistance (AMR)
 - Feedback on veterinary medicines information day
 - HPRA personnel changes as a result of work-planning for Brexit

Compliance
 - New expedited variation process available for IMP manufacturer’s authorisations
 - Safety Features – Key Messages
 - GDP requirements for procurement and supply of active substances for human use
 - European Commission public consultation on precursor chemicals legislation



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