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Page 1 of 5
Date Title
09/05/2013 Guide to Fees and Fee Application Form for Human Products 2013
03/05/2013 Individual applications regulated by Directive 2010/63/EU and S.I. No. 543 of 2012
02/05/2013 Application for transfer of a blood establishment authorisation
02/05/2013 Application for transfer of a tissue establishment authorisation
02/05/2013 Application for a GDP certificate
23/04/2013 Adverse Reaction Form - Human Medicines
18/04/2013 Documents for non-routine import/export of tissues and cells
02/04/2013 Non-technical project summary under Directive 2010/63/EU and S.I. No. 543 of 2012
22/03/2013 Application for a new wholesaler’s authorisation
08/03/2013 Controlled drugs licence application form
27/02/2013 Application for a variation to a manufacturing/importation authorisation or wholesaler's authorisation
19/02/2013 Project authorisations regulated by Directive 2010/63/EU and S.I. No. 543 of 2012
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 Guide to fees and fee application form for veterinary products 2013
08/01/2013 Application for GMP certificate for API
08/01/2013 Regulatory Affairs Contact Information
04/01/2013 Application for authorisation under the European Communities (Quality and Safety of Human Organ for Transplantation) Regulations 2012 (S.I. No. 325 of 2012)
21/12/2012 Registration for brokers of finished medicinal products
20/12/2012 Serious adverse event (SAE) / Serious adverse reaction (SAR) report form - Organs
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Date Printed: 26 May 2013

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