definiens: or means, in addition to the provisions under the anypharmacovigilance agreement between the Parties, all applicable good pharmacovigilance practices promulgated andpublished by FDA, EMA or any other Regulatory Health Authorities having jurisdiction over the Development, Manufacture or commercialization of the CD39 Option Products pursuant to its regulations, guidelines or otherwise, including as applicable, major pharmacovigilance process and product or population specific considerations as definedin ( a ) European Commission Regulation code relating to medicinal products for human use, Directives 2010/84 / EUand 2012/26 / EU respectively, as well as by the Commission Implementing Regulation ( EU ) No 520/2012 on thePerformance of Pharmacovigilance Activities Provided for in Regulation ( EC ) No 726/2004 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 forpharmacovigilance as well as ( b ) principles detailed in the United States 21 CFR and Guidance for Industry GoodPharmacovigilance Practices and Pharmacoepidemiological Assessment