definiens: or means, in addition to the provisions under the Pharmacovigilance Agreement, all applicable good ph armacovigilance practices promulgated and published by FDA, EMA or any other Regulatory Autho rities having jurisdiction over the Development, Manufacture or Commercialization of the Product, a s applicable, pursuant to its regulations, guidelin es or otherwise, including as applicable, major pharma covigilance process and product and/or population specific considerations as defined in ( a ) European Commission Regulation code relating to medicinal products for human use, Directives 2010/84 / EU and 2 012/26 / EU respectively, as well as by the Commission Implementing Regulation ( EU ) No 520/2012 on the Performance of Pharmacovigilance Activities Provided for in Regulation ( EC ) No 726/2 004 and Directive 2001/83 / EC, Title IX of the Directive, Article 108a ( a ) of Directive 2001/83 / EC, 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