HPRA Medicinal Products Newsletter - Issue Number 55

Download: hpra-medicinal-products-newsletter---issue-number-55.pdf 1 MB

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


• PIC/S: Data integrity: Draft guidance published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

« Back