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20242025 OFFICIAL NCPA DISTRIBUTOR IFB/CONTRACT ATTACHMENTS ATTACHMENT A BRAND AND GRADE LABELS IDENTIFICATION LOT 1 and LOT 1A Bidders Only Provide sample labels and identify grade definition of
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How to fill out structured product labeling spl
How to fill out structured product labeling spl
01
Determine which structured product labeling (SPL) template is required for your product.
02
Obtain the required software and tools to create and validate SPL files.
03
Gather all the necessary product information, such as active ingredients, dosage forms, and indications.
04
Organize the information according to the SPL template's specifications.
05
Input the data into the SPL file using the designated fields and formats.
06
Validate the SPL file to ensure it meets the standards set by the FDA.
07
Submit the SPL file to the FDA's Electronic Submissions Gateway for approval.
Who needs structured product labeling spl?
01
Pharmaceutical companies
02
Biotech companies
03
Medical device manufacturers
04
Healthcare providers
05
Regulatory agencies
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What is structured product labeling spl?
Structured Product Labeling (SPL) is a document markup standard approved by the Food and Drug Administration (FDA) for exchanging product and facility information.
Who is required to file structured product labeling spl?
Manufacturers, packers, and distributors of prescription drugs, biologics, and over-the-counter drugs are required to file SPL.
How to fill out structured product labeling spl?
SPL files can be created using software tools provided by the FDA such as the SPL Editor, or by outsourcing the creation to a third-party service provider.
What is the purpose of structured product labeling spl?
The purpose of SPL is to improve communication about pharmaceutical products by providing a standardized format for presenting product information.
What information must be reported on structured product labeling spl?
Key information such as product ingredients, dosage forms, strength, packaging, route of administration, and regulatory information must be reported on SPL.
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