Tender Details
Structured Product Labeling (SPL) - To manage, process, and complete initial labeling and labeling changes in electronic structured product label document submissions to the FDA
RT Ref. 2690786
Summary Structured Product Labeling (SPL) - To manage, process, and complete initial labeling and labeling changes in electronic structured product label document submissions to the FDA
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Detailed Description Structured Product Labeling (SPL) - To manage, process, and complete initial labeling and labeling changes in electronic structured product label document submissions to the FDA

To manage, process, and complete initial labeling and labeling changes in electronic structured product label document submissions to the FDA. Structured Product Labeling (SPL) is a Health Level Seven (HL7) standard based on Clinical Document Architecture and HL7 Reference Information Model (RIM) accredited by the American National Standards Institute (ANSI) for the exchange of product information. The DHA R&D – MRDC currently has 2 licensed New Drug Application (NDA) products which require SPL submissions for up to 5 levels of primary and secondary labeling.....View Full Tender Details in Tender Documents
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