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Structured Product Labeling Release 4 validation procedures v2.0 Structured Product Labeling Validation Procedures for Drug Establishment Registration and Drug Listing Version 2 Revision 201008021527

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What is structured product labeling?

Structured Product Labeling (SPL) is a standard format used for exchanging regulated product information between organizations, such as pharmaceutical manufacturers, regulators, and other stakeholders.

Who is required to file structured product labeling?

Pharmaceutical manufacturers and other regulated entities are required to file structured product labeling for their products in compliance with regulatory guidelines.

How to fill out structured product labeling?

Structured product labeling can be filled out using XML-based templates provided by regulatory authorities. The information about the product, including its ingredients, dosage, contraindications, and other related details, needs to be accurately entered into the template.

What is the purpose of structured product labeling?

The purpose of structured product labeling is to ensure the accurate and consistent communication of product information throughout its lifecycle. It facilitates the exchange of regulatory information, enhances patient safety, and supports regulatory review and decision-making processes.

What information must be reported on structured product labeling?

Structured product labeling requires reporting various information including, but not limited to, product identification, active ingredients, dosage form, route of administration, indications and usage, contraindications, warnings, precautions, adverse reactions, and other relevant details.

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