{"id":136,"date":"2019-05-22T17:38:07","date_gmt":"2019-05-22T17:38:07","guid":{"rendered":"https:\/\/www.libertymanagement.us\/fda-news\/?p=136"},"modified":"2019-05-22T17:38:07","modified_gmt":"2019-05-22T17:38:07","slug":"self-identification-an-overview","status":"publish","type":"post","link":"https:\/\/www.libertymanagement.us\/fda-news\/2019\/05\/22\/self-identification-an-overview\/","title":{"rendered":"SELF IDENTIFICATION – AN OVERVIEW"},"content":{"rendered":"\n

The Generic Drug User Fee Amendments of 2012 (GDUFA)\nrequires that the manufacturers of human generic drugs, active pharmaceutical\ningredients manufacturers (API) and the organizations which support the\nmanufacture or approval of generic drugs to identify themselves electronically  and update the  information annually to FDA.<\/p>\n\n\n\n

Self-identification<\/a> is a vital requirement to help global supply chain transparency and provide assistance in building an accurate inventory of facilities and organizations involved in the manufacture of generic drugs and also simplifies inspections and compliance.<\/p>\n\n\n\n

Who requires\nSelf-Identification?<\/strong><\/p>\n\n\n\n

  1. Facilities that manufacture human generic drug API<\/a>s or Finished dosage form of drugs (FDF) or both.<\/li>
  2. Packager and labeler of generic drugs.<\/li>
  3. Facilities identified in generic drug submission where the applicant remove the drug from a primary container and subdivide in to different primary containers.<\/li>
  4. Labs that are performing Bioequivalence (BE)\/bioavailability (BA) tests.<\/li>
  5. Facilities identified in a generic drug submission where the testing is performed to check the characteristics of the FDF or the API pursuant to a contract with the applicant to satisfy a cGMP testing requirement<\/li><\/ol>\n\n\n\n

    Who requires to\npay the fees?<\/strong><\/p>\n\n\n\n

    1. Facilities manufacturing, or intending to\nmanufacture, API of human generic drugs and\/or finished dosage form (FDF) human\ngeneric drugs.<\/li>
    2. Facilities that engage in generic drug packaging\nand labeling (FDA consider these as manufacturing facilities)<\/li><\/ol>\n\n\n\n

      Who does not\nrequire to pay the fees?<\/strong><\/p>\n\n\n\n

      1. Firms that engages in testing, repackaging or\nrelabeling are not required to pay the fees.<\/li><\/ol>\n\n\n\n

        Penalty for not\nsubmitting Self\u2013 Identification<\/strong><\/p>\n\n\n\n

        1. Under GDUFA, all FDF or API products\nmanufactured at the facility will be considered as misbranded.  <\/li>
        2. Products manufactured in foreign facilities are\nconsidered misbranded and it is a violation of federal law to market misbranded\nproducts in interstate commerce or to import the products into the United States.<\/li><\/ol>\n\n\n\n

          Drug manufacturers\u2019 needs to submit their Self \u2013\nIdentification information to FDA through Electronic Submission Gateway (ESG)\nby creating Structured Product Labeling (SPL) files.<\/p>\n\n\n\n

          For FY 2019, the Self-Identification period starts from May\n1st<\/sup> 2019 to June 1st<\/sup> 2019.<\/p>\n\n\n\n

          Liberty Management Group<\/a>, a leading FDA consulting firm provides assistance with SPL preparation and submission of Self-Identification to FDA.<\/p>\n\n\n\n

          Sudhs S<\/p>\n\n\n\n

          Regulatory Consultant<\/p>\n\n\n\n

          Mail: office@libertymanagement.us<\/p>\n\n\n\n

          http:\/\/www.fdahelp.us<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

          The Generic Drug User Fee Amendments of 2012 (GDUFA) requires that the manufacturers of human generic drugs, active pharmaceutical ingredients manufacturers (API) and the organizations which support the manufacture or approval of generic drugs to identify themselves electronically  and update the  information annually to FDA. Self-identification is a vital requirement to help global supply chain … Continue reading “SELF IDENTIFICATION – AN OVERVIEW”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[26],"tags":[17,30],"class_list":["post-136","post","type-post","status-publish","format-standard","hentry","category-fda-registration-drug","tag-drug-establishment-registration","tag-self-identification"],"_links":{"self":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts\/136","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/comments?post=136"}],"version-history":[{"count":2,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts\/136\/revisions"}],"predecessor-version":[{"id":138,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts\/136\/revisions\/138"}],"wp:attachment":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/media?parent=136"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/categories?post=136"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/tags?post=136"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}