definiens: means current Good Manufacturing Practices promul gated by the Regulatory Authorities in the jurisdictions included in Applicable Laws ( as a pplicable to TXMD and [COMPANY], respectively ) . In th e United States, this includes 21 C.F.R. Parts 210, 211 and 820, as amended from time - to - time, together with pe rtinent guidelines and guidance documents, and in the Europ ean Union, to the extent applicable to the manufact ure, handling and storage of the Product in Sweden for s hipment to, and sale in, the United States, 2003/94 /EEC Directive ( as supplemented by Volume 4 of EudraLex published by the European Commission ), as amended, Council Directive 90/385 / EEC on Active Implantable Medical Devices ( AIMDD)(1990 ) and Council Directive 93/42 / EEC on Medical Devices ( MDD ) ( 1993 ), as amend ed, supplemented and superseded from time - to - time, together with pertinent guidelines and guidance doc uments then in effect