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FOR MANUFACTURER Application for the grant of license for manufacture of notified or non-notified devices must be made to the State Licensing Authority (SLA) or Central Licenses Approving Authority (CLAA) depending upon product categorization, accompanied by the requisite fee in the manner prescribed in the Rules along with a copy to the office of DCG(I).
IMPORT NOC/CERTIFICATE Any pharmaceutical company eager for obtaining an import certificate shall apply in a prescribed manner and submit the documents details at (IV) of Annexure. Apart from these documents, some other information with respect to companies approaching this office for the first time for grant of import Certificates shall also submit the documents detailed at (VII) of Annexure. The import of narcotic drugs and Psychotropic substances is administrated by estimate system. When the Import Certificate is allowed, it is confirmed that the projected requirement of a particular narcotic drug and psychotropic substance (as reported to the INCB and subsequently published by INCB) does not cross the limit of requirement in respect of India. The import license is granted only under following conditions: 1. The importer of narcotic drug and psychotropic substances will submit all the import details as soon as possible after effecting import. 2. And any kind of extension and amendment in validity of Export Authorisation will not be allowed. According to rule 54 of the NDPS Rules, 1985, the Central Government hereby informs the manufacturers to import codeine, morphine, the baine and their derivatives for use in manufacturing of products to be exported or for importing small quantities of codeine, morphine, and the baine and their salts not above a total of 1 kilogram throughout the financial year for analytical purposes after following the practice under rule 55 of the said rules and subject to such conditions as may be specified in the import certificate issued in Form No. 4A.
FOR MANUFACTURER Application for the grant of license for manufacture of notified or non-notified devices must be made to the State Licensing Authority (SLA) or Central Licenses Approving Authority (CLAA) depending upon product categorization, accompanied by the requisite fee in the manner prescribed in the Rules along with a copy to the office of DCG(I).
4 The area not including the top, bottom, flange at top and bottom of cans, and shoulders and neck of bottle and jars shall be determined in the following manner, namely:- In the case of a rectangular package, where one entire side can properly be considered to be the principal display panel side, the product of the height multiplied by the width of that side; In case of a cylindrical or nearly cylindrical package, 40 per cent. Of the product of the height of the package multiplied by the circumference; In case of any other shaped package, 40 per cent. Of the total surface of the package, or an area considered to be a principal display panel of the package.
The area not including the top, bottom, flange at top and bottom of cans, and shoulders and neck of bottle and jars shall be determined in the following manner, namely:- (a) In the case of a rectangular package, where one entire side can properly be considered to be the principal display panel side, the product of the height multiplied by the width of that side; (b) In case of a cylindrical or nearly cylindrical package, 40 per cent. Of the product of the height of the package multiplied by the circumference; (c) In case of any other shaped package, 40 per cent. Of the total surface of the package, or an area considered to be a principal display panel of the package.
NOC for Export Any pharmaceutical company/applicant looking to obtain the NOC for export of selected number of precursor chemicals is required to apply to the Narcotics Commissioner in a prescribed manner along with the documents mentioned in (V) of Annexure. Some additional data with respect to companies approaching the following office for the first time for grant of such NOC must also be submitted as detailed in (VII) of Annexure. The System of Pre-Export Notification (PEN) governs the export of Precursor Chemicals. This office uses a system of PEN to verify the authenticity of the transaction and to notify the Competent Consultant of the importing and transhipping country of the impending export. Such NOCs are granted by Central Bureau of Narcotics under following terms and conditions:
NOC for Import Any pharmaceutical company/applicant wishing to obtain the NOC for import of selected number of precursor chemicals is required to apply to the Narcotics Commissioner in a prescribed manner along with the documents mentioned in (VI) of Annexure. Some additional data with respect to companies approaching the following office for the first time for grant of such a NOC must also be submitted as detailed in (VII) of Annexure. Such import NOCs are granted under following conditions: 1. The importer will submit the import details immediately after effecting import 2. The change of any kind as well as extension in validity of Export Authorisation would not be allowed.
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