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 View tracked changes Guide to Invented Names of Human Medicines PDF : 207 KB | 07/12/2015 View tracked changes Guide to Registration of Homeopathic Medicinal Products PDF : 390 KB | 12/11/2014 View tracked changes 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 Prev 1 2 3 Next
