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The Official HL7 Blog. Structured Product Labeling, Release 4. Structured Product Labeling, Release 4 may also go by the following names or acronyms: Structured Product Labeling, Release 4 may also go by the following names or acronyms:. The HL7 Version 3 Structured Product Labeling SPL specification is a document markup standard that specifies the structure and semantics of the content of authorized published information that accompanies any medicine licensed by a medicines licensing authority. Clinical data elements include coded information about the clinical use of the product including indications and use, contraindications, drug interactions, warning and precautions and use in special populations.

SPL documents are known as "product label," "package insert," "prescribing information," "product information," "medicines information," and many other names. An SPL document is created by an organization that is required by law to submit product information document because it is responsible for the creation or marketing of a product, or any other person or organization compelled by other motives to submit information about products, whether originally created or not. This includes original manufacturers, repackagers, relabelers, and public agencies or private information publishers that submit product information documents. Structured Product Labeling, Release 4 may also go by the following names or acronyms: