definiens: or means, in addition to the provisions under the Pharmacovigilance Agreement, all applicable good ph armacovigilance practices promulgated and published by the FDA, EMA or any other applicable R egulatory Authority including, as applicable, major pharmacovigilance process and product and/or popula tion specific considerations as defined in ( a ) European Commission Regulation code relating to med icinal products for human use, Directives 2010/84 / EU and 2012/26 / EU, as well as by the Commis sion Implementing Regulation ( EU ) No 520/2012 on the Performance of Pharmacovigilance Activities pro vided for in Regulation ( EC ) No 726/2004 and Directive 2001/83 / EC, Title IX and Article 108a(a ) and principles detailed in the ICH guidelines for pharmacovigilance as well as ( b ) principles detaile d in the United States 21 CFR and Guidance for Industry Good Pharmacovigilance Practices and Pharm acoepidemiological Assessment