Import-use verification: applicants must ensure imported inputs are actually required and used in exported pharmaceutical products. Determination of the proportion of various inputs is the operative compliance mechanism; applicants shall ensure imported goods are those used or required in the export product. The policy lists Metronidazole and MDPE granules as primary inputs for Metronidazole I.V. 100 ml packed in MDPE bottles on FFS machines and prescribes per-unit input quantities. The product entry is currently suspended by public notice, affecting the application of standard input norms.
Cases where this provision is explicitly mentioned in the judgment/order text; may not be exhaustive. To view the complete list of cases mentioning this section, Click here.
Provisions expressly mentioned in the judgment/order text.
Import-use verification: applicants must ensure imported inputs are actually required and used in exported pharmaceutical products.
Determination of the proportion of various inputs is the operative compliance mechanism; applicants shall ensure imported goods are those used or required in the export product. The policy lists Metronidazole and MDPE granules as primary inputs for Metronidazole I.V. 100 ml packed in MDPE bottles on FFS machines and prescribes per-unit input quantities. The product entry is currently suspended by public notice, affecting the application of standard input norms.
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