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Implementation of the Track and Trace system for export of Pharmaceuticals and drug consignments.

.04.2018 Public Notice no. 64/2018 Sub: - reg. Attention of the Exporters, Custom Brokers and all concerned is invited to the Notice No. 52/2015-2020 dated 05.01.2016 issued by the DGFT on the above subject as amended by Public Notice No. 03/2015-2020 dated 21.04.2016 (copies enclosed). 2. As per the aforesaid notice, all drugs manufactured by Non-SSI units with manufacturing date on or after 01.04.2016 and all drugs manufactured by SSI units with manufacturing date on or after 01.04.2017 can be exported only if all primary, secondary and tertiary packaging carry one or two dimensional (ID or 2D) barcode encoding unique and universal "global product identification code" in the format of 14 digits "Global Trade Item Number (GT .....

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vels of packaging will be applicable as prescribed. b) Extended Date of Exemption to SSI Manufacturers: All SSI drug manufacturers are exempted from requirement of maintaining Parent-Child relationship in packaging levels for a further period up to 31.03.2017. However, they are required to upload Tertiary level data on the central portal mandatorily as prescribed in public notice no. 13/2015-2020 dated 22.05.2015. (ii). The data mentioned in (ii) above shall be uploaded on the central portal of the Government of India by the manufacturer or exporter or its designated agency before release of the drug formulations for sale or distribution. (iii). The responsibility of the correctness, completeness and ensuring timely upload of data on the ce .....

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e Central Portal. Explanation: a) For the purpose of this rule, (i) Drug formulation means a formulation manufactured with a license from Drug Control Authority under the provisions of Drugs & Cosmetics Act and Rules made there under and registered as "Drug" with FDA of importing country. (ii) Primary packaging means the package which is in direct physical contact with the active ingredient. (iii) Secondary packaging means a carton containing one or more primary packs and includes a mono carton containing one primary pack. (iv) The tertiary packaging means a shipper containing one or more secondary packs. b) All relevant guidelines regarding grant of specific exemption (s) if any, procedure or data requirement / maintenance / .....

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