definiens: means any Law of any Governmental Entity(including multi - country organizations ) the purpose of which is to ensure the safety, efficacy and quality ofmedicinal and pharmaceutical products by regulating the research, development, manufacturing and distribution ofthese products, including Laws relating to good laboratory practices, good clinical practices, investigational use, product marketing authorization, manufacturing facilities compliance and approval, good manufacturing practices, labeling, advertising, promotional practices, safety surveillance, record keeping and filing of required reports suchas the U.S. Food, Drug and Cosmetic Act of 1938, as amended, the Public Health Service Act, as amended, theassociated rules and regulations promulgated thereunder and all of their foreign equivalents, ( y ) the term means the Governmental Entities which administer Health Laws including the FDA, the EuropeanMedicines Agency and other equivalent agencies, and ( z ) the term means all medicinal orpharmaceutical products regulated by Health Authorities with respect to which an Investigational New Drugapplication, New Drug Application, or Biologics License Application ( or the foreign equivalent thereof ) forauthorization to commence human clinical trials has been filed with the FDA ( or foreign equivalent thereof ) and theCovered Products