new drug submission form - Trinidad & Tobago

ChecklistTo be completed by Applicant(1) Certificate in respect of Imported Drugs Completed Application FormTRINIDAD AND TOBAGOMINISTRY OF HEALTHCHEMISTRY/FOOD AND DRUGS DIVISIONDETAILED OF REQUIREMENTS FOR NEW DRUG SUBMISSIONFree Sale Certificate - Original, Apostille and Attested1.1. Certificate of Free Sale Issued by the Drug Regulatory Authority of the Manufacturing Country or Exporting Country.a) Brand name of the product (if any)b) Generic name (INN) of the active ingredient(s)c) Dosage strength and dosage formd) Complete name and address of the manufacturere) A statement that the product is freely sold in the country of origin.or Certificate of Pharmaceutical Product - Original, Apostille and Attested1.2 Issued in accordance with the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving inInternational Commerce (CPP). It applies to the case of imported medicines, as it is the certificate issued by the NationalRegulatory Authority (NRA) that issues the registration. This certificate also attests to the Good Manufacturing Practices(GMP) of the manufacturing laboratory(ies).(2) Chemical Documentation(A) Finished Product2.A.1 Specifications(a) Provide a complete description of the quality indexes or specifications(physical, chemical, and microbiological) and acceptable limits in tableformat, independently of the methods of analysis and quality reference(reference pharmacopeia or manufacturer);(b) Justify any omission of the quality indexes established in the referencePharmacopoeias for the product whose registration is being requested;(c) All solid forms of controlled or modified release (tablets, capsules, ovules)require time-release testing.2.A.2 Method of Analysis(a) Provide information on the methods of analysis used for quality control: A specific monograph, when from a reference pharmacopeia; A complete description of the method of analysis, when fromthe manufacturer.2