FDA Guidelines on Unique Global Product IDs for Drugs

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FDA Circular No. 2015-11: FDA Guidelines on Unique Global Product IDs for Drugs

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Title Supreme Court: FDA Guidelines on Unique Global Product IDs for Drugs

Law: Fda Circular No. 2015-11

Decision Date: Jun 24, 2015

FDA Circular No. 011-15 requires all drug product applicants and holders to obtain a unique establishment identification number and a unique global product identification number, which must be indicated in the application and reflected on the product labeling materials by specific deadlines, in order to ensure the integrity of the drug supply chain.

fda circular

drug products

establishment identification number

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