TMI BlogImplementation of the Track and Trace system for export of Pharmaceuticals and drug consignments.X X X X Extracts X X X X X X X X Extracts X X X X ..... 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 (GTIN) along with batch number, expiry date and a unique serial number of the secondary or tertiary pack. Further on, the relevant data is also required to be uploaded on the Central Portal. Further the said notification also stated that it will be the responsibility of the drug manufacturer/exporters as the c ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 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 central portal shall be with the manufacturer or exporter. (iv). In case, the Government of the importing country has mandated a specific requirement, the exporter has the option of adhering to the same and in such a case, it would not be necessary to comply with the stipulation ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ith 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 / upload on central portal and clarifications issued under this notification etc. will be available on the central portal i.e. http://dava.gov.in c) It will be the responsibility of the drug manufactures/exporters as the case may be, to satisfy the customs auth ..... X X X X Extracts X X X X X X X X Extracts X X X X
|
