In this Issue
Human Medicines
• Contamination of herbal products with pyrrolizidine alkaloids
• Improved Access to Educational Materials on the HPRA website
• Article 57 database
• EudraVigilance updates and the move to E2B(R3) and centralised reporting
Veterinary Sciences
• Brexit and availability of veterinary medicines in Ireland
• Guide to which variation categories require the submission of updated mock ups
• Changes to mock-ups: when is a notified change acceptable?
• Changes to Veterinary Sciences Department
• Reminder of mandatory use of eSubmission Gateway for veterinary submissions to EMA as of 1 January 2017
Compliance
• PIC/S: Data integrity: Draft guidance published
• Submission of annual returns for Controlled Drugs & Precursor Chemicals
• Notice regarding a fee increase for applications for medical device certificates of free sale
• Misuse of Drugs legislative amendments
• Preventing falsified medicines from entering the supply chain: Have you played your part as an authorised wholesaler?
• Launch of the public consultations on the draft Commission acts on GMP