IMB Newsletter-Issue No. 47 January-April 2014

Download: imb-newsletter-issue-no-47-january-april-2014.pdf 159 KB

Contents

Irish Medicines Board (IMB) to become The Health Products Regulatory Authority (HPRA) on 1 July 2014

 

General

Veterinary Information Day - 26 September 2014

GMP Information Day - 12 November 2014

Wholesale Distribution Information Day - 11 November 2014

Pharmacovigilance Information Day – 21 November 2014

 

Human Medicines 

Electronic Reporting of ICSRs to Marketing Authorisation Holders

 

Veterinary Medicines

Report on veterinary antimicrobial consumption in 2012 and update on collection of the 2013 data

Authorisation of products in accordance with Article 6(3) of Directive 2001/82/EC

Switching applications – A new fee code for changes to the legal supply classification

 

Compliance

Delegated Act on Safety Features for Medicinal Products for Human Use

Cosmetics Certificates of Free Sale – Update



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