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Publications for the page Human Medicines

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Date	Title
21/05/2013	Guide to electronic submissions - human medicines
17/05/2013	Pharmacovigilance Risk Assessment Committee (PRAC) Meeting Highlights
15/05/2013	The European Commission published revision 10 of the application form for a marketing authorisation of a medicinal product for human use in April 2013.
09/05/2013	Guide to Fees and Fee Application Form for Human Products 2013
02/05/2013	Application for a GDP certificate
22/03/2013	Application for a new wholesaler’s authorisation
08/03/2013	Controlled drugs licence application form
05/03/2013	Guide to Parallel Imports - Human Medicines
28/02/2013	Drug Safety Newsletter 52nd Edition
28/02/2013	Guide to hospital-based advanced therapy medicinal products
27/02/2013	Application for a variation to a manufacturing/importation authorisation or wholesaler's authorisation
14/02/2013	Registration for active substance manufacturers, importers and distributors
28/01/2013	Application for a renewal to a registration certificate for a homeopathic medicinal product
15/01/2013	Clinical Trial Subcommittee Meeting Dates and Application Cut-off Dates for 2013
14/01/2013	Guide to Clinical Trial Applications
11/01/2013	Tredaptive (nicotinic acid/laropiprant) - Important Safety Information from Irish Medicines Board
08/01/2013	Application for GMP certificate for API
08/01/2013	Regulatory Affairs Contact Information
21/12/2012	Registration for brokers of finished medicinal products
21/12/2012	Drug Safety Newsletter 51st Edition