definiens: shall mean any applicable Legal Requir ement of any Governmental Authority ( including multi - country organizations ) the purpose of which is to ensure the quality, identity, stren gth, purity, potency, safety, efficacy and use of medicinal or p harmaceutical products, devices or methods of treat ment by regulating the research, development, manufacturing, advertising, distribution or sale of such product s, devices or methods, including applicable Legal Requirement rel ating to good laboratory practices, good clinical p ractices, investigational use, product marketing authorizatio n, manufacturing facilities compliance and approval, good manufacturing practices, labeling, advertising, pro motional practices, safety surveillance, record kee ping and filing of required reports, including the U.S. Food, Drug and Cosmetic Act of 1938, the Public Health Service Act, the associated rules and regulations promulgated and gu idance issued thereunder and all of their foreign e quivalents