Single Window clearance simplified for drugs and cosmetics consignments through PEC declarations and risk based ADC referrals. Single Window clearance for drugs, cosmetics and related items is simplified: chemical items out of regulatory scope should be declared under the PEC to avoid ADC referral; dual use items/excipients that are non pharmaceutical grade and contain no API and have non medicinal end uses need not be referred to ADC when so declared; risk based sampling will limit re sampling of already tested batches; digitally signed integrated declarations will substitute for hardcopy undertakings; ICES locations are mapped to nearest ADCs and IT upgrades will enable regulator access.
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Provisions expressly mentioned in the judgment/order text.
Single Window clearance simplified for drugs and cosmetics consignments through PEC declarations and risk based ADC referrals.
Single Window clearance for drugs, cosmetics and related items is simplified: chemical items out of regulatory scope should be declared under the PEC to avoid ADC referral; dual use items/excipients that are non pharmaceutical grade and contain no API and have non medicinal end uses need not be referred to ADC when so declared; risk based sampling will limit re sampling of already tested batches; digitally signed integrated declarations will substitute for hardcopy undertakings; ICES locations are mapped to nearest ADCs and IT upgrades will enable regulator access.
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