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Page 2 of 4
Date Title
04/10/2011 Guide to Control and Monitoring of Storage and Transportation Temperature Conditions for Medicinal Products and Active Substances
29/09/2011 Guide to wholesaling of medicinal products for human use in Ireland
21/09/2011 Guide to Renewal of Marketing Authorisations - Human Medicines
02/09/2011 Guide to the attainment of Qualified Person status in Ireland
20/07/2011 Frequently asked questions on advertising compliance
27/06/2011 Frequently asked questions on export certificates
17/06/2011 Guide to the quality system for grocery wholesale distributors
07/04/2011 Notification for invalidation fee
10/03/2011 Guide to Submitting a Request for Ireland to act as RMS in a Decentralised Procedure for a Human Medicinal Product
09/02/2011 Guide to withdrawal of authorisations or certificates for human medicines
15/11/2010 Guidance on the recall of medicinal products for human and veterinary use
14/10/2010 Guide to Reclassification (Switching) of Legal Supply Status of Human Medicinal Products
09/07/2010 Changes to IMB processes for variation applications for human and veterinary medicines from 1st August 2010 - updated December 2010
24/06/2010 Statement of licensing status of pharmaceutical product
23/04/2010 Guidance for Marketing Authorisation Holders on Direct Healthcare Professional Communication Drafting
18/12/2009 New Variations Regulation - key points to note
06/11/2009 Checklist for Dossier Requirements
12/08/2009 Advice for Healthcare Professionals on Reporting of Adverse Drug Reactions
08/06/2009 Quality defect investigation reports
03/04/2009 Certificate of Pharmaceutical Product Explanatory Notes in Spanish
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Date Printed: 23 May 2013

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