TaxTMI 
TaxTMI 
Checklists for mandatory compliance for Cosmetics/Drugs/Medical Devices to be verified by the Customs officer before granting out-of-charge in case of PGA facilitated Bills of Entry
X X X X Extracts X X X X
X X X X Extracts X X X X
....ARM, 4. Pr. Director General, DG SYSTEMS Sir/Madam, Subject: Checklists for mandatory compliance for Cosmetics/Drugs/Medical Devices to be verified by the Customs officer before granting out-of-charge in case of PGA facilitated Bills of Entry- reg. The Central Drugs Standard Control Organization (CDSCO) in alignment with the Government's objective of enhancing the 'Ease of Doing Business' is taking measures to increase the facilitation of Cosmetics, Drugs and Medical Devices. 2. The said products require certain mandatory compliance in terms of licenses, permissions, registration certificates, etc., as per the provisions of the Drugs and Cosmetics Act, 1940 and Rules made thereunder. Considering the fact that inte....
X X X X Extracts X X X X
X X X X Extracts X X X X
....litate expedited clearance. 4. Difficulty faced, if any, in implementation of this Circular may be immediately brought to the notice of the Board. Yours Sincerely, Encl: As above. (Vivek Kumar) OSD (Customs Policy Wing) ANNEXURE-A Checklist for the custom official to be verified before Out-of-Charge The Checklists I to VII covering various class of commodities are as detailed below: Checklist I: Cosmetics S.No. Particulars 1 *Self-Certified copy of Registration Certificate (RC) in Form COS-2 in case of fresh registration or Form COS-4A in case of subsequent registration issued by CDSCO 2 Self-certified copy of invoice. • The invoice of the consignment shall mention the name of the co....
X X X X Extracts X X X X
X X X X Extracts X X X X
.... Form COS-3, the consignment shall be referred to concerned port office of CDSCO. ** No cosmetics shall be imported unless the Use Before/expiry is not more than six months from the date of import. # In case of any discrepancies or doubts, the consignment shall be referred to the concerned CDSCO O/o ADC(I), Port Office Checklist II: Drugs (API i.e. Active Pharmaceutical Ingredient, finished formulation) S.No. Particulars 1 Self-Certified copy of Registration Certificate (RC) in Form 41 along with Import License (IL) in Form 10 2 Self-Certified copy of invoice * The invoice of the consignment shall mention the name of the item and match with RC/IL with respect to the Pack size (in case of finished product). 3....
X X X X Extracts X X X X
X X X X Extracts X X X X
..... Serial shipping container code, x. Import licence no. xi. Special storage conditions required (if any). 6 Self-Certified copy of Certificate of analysis (COA) for each batch imported and shall match with RC/IL w.r.t. - Name and Composition in case of finished product. 7 Self-Certified copy of the licensed premises where Drugs are to be stored (valid wholesale license/manufacturing license) 8 Undertaking by the importer that the consignment packaging is not damaged/broken/destroyed and the content of the drug/cosmetic has not deteriorated. Note: The residual shelf life calculated on the date of import should be more than 60 %. If the Residual shelf life is less than 60%, the consignment should be r....
X X X X Extracts X X X X
X X X X Extracts X X X X
....y Circulars. To control misuse, as a precautionary measure, an undertaking from the importer also to be taken, and the details of the import to be informed to the State Drug Controller / Zonal Officer / DCGI immediately for post-import check. # In case of any discrepancies or doubts, the consignment shall be referred to the concerned CDSCO O/o ADC(I), Port Office. Checklist V: Medical Devices (Including IVD's i.e., in vitro diagnostics kits/devices) S.No. Particulars 1 Self-certified copy of Import License in Form MD-15 issued by CDSCO. *In case of Class A (non-sterile and non-measuring) medical devices, the registration number. 2 Self-Certified copy of invoice, packing list, certificate of country of or....
X X X X Extracts X X X X
X X X X Extracts X X X X
....e stored. 9 Undertaking by the importer that the consignment packaging is not damaged/broken/destroyed and the content of the drug/cosmetic has not been deteriorated. Checklist VI: Medical Devices a. for the purposes of Clinical Investigations Test or Evaluation or Demonstration or Training. b. For investigational medical device by a Government Hospital or Statutory Medical Institution for the treatment of patients. c. to import of small quantity of Medical Devices for personal use. S.No. Particulars 1 Self-Certified copy of the Import license granted in Form MD-17 or MD-19 or permission in Form MD-21 2 Self-Certified copy of invoice, packing list, certificate of country of origin * T....