TaxTMI 
TaxTMI 
Can excipients be imported along with bulk drugs under SION for manufacture of Unregistered Drugs under Advance Authorisation Scheme ?
Import of Excipients
11 Feb 2021 
5 Replies 
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Import of Excipients treated as dual use items; typically not routed for drug controller clearance under SWIFT.
Excipients are distinct raw materials and not catalysts; proper Customs Tariff classification determines admissibility under import authorisation schemes. Under the single-window system and the PGA Exemption Category, chemicals that are not drugs and many dual-use items or excipients declared in the integrated import declaration will normally not be referred to drug controller offices for clearance, subject to the published exemption mapping and ongoing updates. (AI Summary)
Excipients are distinct raw materials and not catalysts; proper Customs Tariff classification determines admissibility under import authorisation schemes. Under the single-window system and the PGA Exemption Category, chemicals that are not drugs and many dual-use items or excipients declared in the integrated import declaration will normally not be referred to drug controller offices for clearance, subject to the published exemption mapping and ongoing updates. (AI Summary)