Guidance documents – medicines for human use
Guide to scientific and regulatory advice for GXP activities
PDF : 218 KB | 06/10/2017
Guide to electronic submissions - human medicines
PDF : 189 KB | 14/07/2016
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Guide to Invented Names of Human Medicines
PDF : 207 KB | 07/12/2015
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Guide to Registration of Homeopathic Medicinal Products
PDF : 390 KB | 12/11/2014
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Guide to submission of educational tools and materials
PDF : 78 KB | 17/06/2014
Guide to additional monitoring requirements and statements encouraging reporting of adverse reactions
PDF : 237 KB | 31/01/2014
Guide to hospital-based advanced therapy medicinal products
PDF : 130 KB | 01/03/2013
Guide to National Rules Scheme for Homeopathic Medicinal Products for human use
PDF : 148 KB | 10/05/2010