SCHEDLE D-II FORMAT.docVIP

SCHEDULE D (ll) (See rule 21 (d) and rule 24 A) Information required to be submitted by the manufacturer or his authorised agent with the Application Form for the registration of a bulk drug/formulation/special product for its import into India. The format shall be properly filled in and the detailed information, secret in future, may be furnished on a Computer Floppy. GENERAL Name of the drug/formulation/special product, a brief description and the therapeutic class to which it belongs. 1. Regulatory status of the drug. Free Sale Certificate and/or Certificate of Pharmaceutical Products (CPP) issued by the Regulatory Authority of the country of origin. Free sale approval issued by the Regulatory Authorities of other major countries. Drugs Master File (DMF) for the drug to be registered (duly notarised). . GMP Certificate in WHO formats or Certificate of Pharmaceutical Products (CPP) issued by National Regulatory Authority of the country of origin (duly notarised). List of countries where marketing authorization or import permission for the said drug is granted with date (respective authorization shall been closed). List of countries where marketing authorization or import permission for the said drug is cancelled/withdrawn with date. List of countries where marketing authorisation or import permission for the said drug is pending since (date) Domestic price of the drug in the currency followed in the country of origin. List of countries where the said drug is patented. ? 2 CHEMICALS AND PHARMACEUTlCAL INFORMATION OF DRUGS. Chemical name, Code name or number, if any, Non-proprietory or generic name, if any Structure Physico-chemical properties Dosage form and its composition, Qualitative and quantitative composition in terms of the active substance(s) and excipient(s), List of active substance(s) separately from the constituent(s) of excipients Specifications of active and inactive ingredient(s) including pharmacopeal referen