definiens: shall mean manufacture in accordance with : ( a ) Directive 911412 / EEC and Directive 2003/94IEC or any other applicable European Community legislation or regulation as amended and applicable from time to time ; ( b ) the current principles and guidelines of good manufacturing practice for medicinal products for human use and ( as such phrase is used in Section 802(f)(I ) of the Federal Food, Drug and Cosmetic Act, as such Act may be amended from time to time ) ; and ( c ) US Code of Federal Regulations, Title 21, Part 210 ( Current Food Manufacturing Practice in Manufacturing, Processing, Packaging or Holding of Drugs ), Part 21 t ( Current Food Manufacturing Practice for Finished Pharmaceuticals ) ; 4 or " DMF ' ! shall mean all filings and submissions of infonnation to the FDA pursuant to US in 21 CFR 314.420 and otherwise in connection with the filing of a drug master file with the FDA in the United States, and, in any jurisdiction outside the United States, all analogous filings and submissions of infonnation to any other regulatory body in such other jurisdiction in relation to the filing of a drug master file or analogous documentation therewith