Structured Product Labeling

The Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product and facility information.

SPL documents contain both the content of labeling (all text, tables and figures) for a product along with additional machine readable information (drug listing data elements). Drug listing data elements include information about the product (product and generic names, ingredients, ingredient strengths, dosage forms, routes of administration, appearance, DEA schedule) and the packaging (package quantity and type).

Mabh Regulatory Labeling qualified expertise team has specialization in conversion of package insert / medication guide in xml format.

We use Pragmatic Validator Lite™ to validate SPL for any critical error. We do lifecycle management of SPL (version and set id management).

Other Regulatory Services

MABH qualified and experienced Regulatory professionals who provide one stop solution, support and services for Other Regulatory Affairs Related Services

MABH offers following Other Regulatory Affairs services to Pharmaceuticals (Finished Product and API), Biopharmaceutical, to Healthcare, CMO and Medical Devices industry.

  • Druglisting & De-listing
  • Blanket no change certification
  • Self-identification
  • Current establishment registration

  • Druglisting:

    For Listing of data, the Extensible Markup Language (XML) files are use in the Structured Product Labeling (SPL) format. The listing must happen within 14 days from date of original ANDA approval. Any change in the approved labeling must be list again.

    Mabh Regulatory Labeling professionals list all of the products produce by registered establishments for commercial distribution under their own labeler code. This includes API manufacturers, other bulk manufacturers, contract manufacturers, re-packers, and re-labelers.

    Blanket No Change Certification

    Within the new regulations adopted in 2016, there is now an annual requirement to update your listings or certify that no changes have occurred for products that were not initially listed or updated during the current calendar year. The period for Product Listing Certification using the Product Listing Certification SPL submission is October 1st through December 31st.

    Any product listing that is required to be certified but not certified, may be considered inactive and removed from the NDC Directory and other publications of Listing data. Outside this three month window an update of the Listing SPL submission for each NDC is required to certify the product.

    Self-Identification

    The Generic Drug User Fee Amendments of 2012 (GDUFA) requires that human generic drug facilities, and certain sites and organizations identified in a generic drug submission, provide identification information annually to FDA. This information will assist in constructing an accurate inventory of facilities, sites and organizations involved in the manufacture of generic drugs, setting annual facility fee amounts, and targeting inspections. Reporting period for self-identification opens May 1st to June 1st of every year.

    MABH helps generic industry facilities, sites, and organizations to self-identify with FDA.

    Current establishment registration

    Under FD&C act section 510 (c) (d) and (i), establishments must be registered within 5 days of beginning operations. In addition, establishments must renew registration annually between October 1st and December 31st of each year.

    Firms that send their initial or annual registrations during October 1st to December 31st period are considered registered until the end of following year. If a firm submits its initial, updated or annual registration outside this time frame, it is considered registered until the end of the current year and shall renew before December 31.

    MABH offers generic industry facilities, sites, and organizations:

  • Establishment Registration
  • Establishment De-Registration