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  • Notice To Importers NDS Submission Feb 2022

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    Daniyl Jones
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    The document provides guidelines for pharmaceutical importers and manufacturers to submit new drug applications electronically to the Drug Registration Unit in Trinidad and Tobago due to the suspension of in-person interviews during the COVID-19 pandemic. Applicants must submit all required documents and forms via email and be prepared for an appointment to submit physical drug samples and payment. Dossiers must follow specific formatting and inclusion guidelines to ensure a complete submission.

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    The document provides guidelines for pharmaceutical importers and manufacturers to submit new drug applications electronically to the Drug Registration Unit in Trinidad and Tobago due to the suspension of in-person interviews during the COVID-19 pandemic. Applicants must submit all required documents and forms via email and be prepared for an appointment to submit physical drug samples and payment. Dossiers must follow specific formatting and inclusion guidelines to ensure a complete submission.

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    © All Rights Reserved
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    Download as pdf or txt
    29 views4 pages

    Notice To Importers NDS Submission Feb 2022

    Uploaded by

    Daniyl Jones
    The document provides guidelines for pharmaceutical importers and manufacturers to submit new drug applications electronically to the Drug Registration Unit in Trinidad and Tobago due to the suspension of in-person interviews during the COVID-19 pandemic. Applicants must submit all required documents and forms via email and be prepared for an appointment to submit physical drug samples and payment. Dossiers must follow specific formatting and inclusion guidelines to ensure a complete submission.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
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    of 4

    March 2022

    Notice to Pharmaceutical Importers/Manufacturers

    In light of the COVID-19 pandemic, the Food & Drugs Inspectorate has suspended face to face
    interviews for the submission of new drug applications.

    ALL applicants are now required to submit dossiers electronically via email.
    This can be done via email attachment, a shared drive or any other online platform where
    documents can be safely and easily retrieved for review.

    Please note that the Drug Registration Unit (DRU) acts on behalf of the Drug Advisory
    Committee, under the Second Schedule, Division 3-New Drugs, Chapter 30:01, Food and Drugs
    Act and Regulations, in accepting applications for the registration of new drugs.

    The DRU does not act as a consultant for importers. Therefore, it is the importer’s/distributor’s
    responsibility to ensure that documents and forms are accurate, completed, valid, organized,
    readily accessible and identifiable within each dossier.

    Online Submission Guidelines


    Requesting an Appointment:
    ● Ensure you have read all the information provided in conjunction with this notice.
    ● Gather all documentation to ensure your application is complete and ready for
    submission.
    ● Email the Drug Registration Unit with your completed Forms A, B and C, and Summary
    Document (see attached) at [email protected] indicating your
    readiness and to request an appointment only when your application is complete.
    ● You will then receive an email indicating your appointment date.
    Drug Samples:
    ● Three (3) physical samples in its finished pharmaceutical form must be submitted on or
    before your appointment date at the Food & Drugs Inspectorate Office.
    ● Requests for Permission to Import Samples for New Drug Registration can be made to
    the Food & Drugs Inspectorate Office accompanied by the commercial invoice.
    ● If samples cannot be submitted by your appointment date, a commitment letter must be
    submitted with your application.
    ● Samples of active ingredients are not required at this time and will be requested if
    needed.
    ● Samples should be addressed to the Drug Registration Unit and clearly and boldly tagged
    “New Drug Registration Samples” followed by the date of the appointment on the
    outer envelope/box/bag containing the samples.

    Registration Payment:
    ● Registration Fee- TT$ 750.00 per drug
    ● Payments are to be made on or before appointment date with one (1) drug per receipt at
    one of the following locations:
    ○ Accounts Department, Ground Floor, Ministry of Health, Park & Edward Street.,
    Port of Spain OR
    ○ District Revenue Office/Warden's Office nearest to you 

    Submission of Documents & Requirements:  


    ● Completed dossiers must be submitted only on the date of appointment or 1 day
    before the appointment. Late submissions will not be accepted.
    ● If you cannot meet an appointment date, simply indicate your inability to submit on that
    date via email. When you have all the documentation required, you will indicate your
    readiness to submit via email.
    ● Scans/Photos of individual receipts must be submitted with online submission.
    ● Pictures of all sides of packaging of samples (both primary and secondary
    packaging) must be submitted with online submissions. Please ensure that lot or batch
    numbers and expiry dates are clearly visible.
    ● Use the New Drug Submission Application Form (See attached) as a guide on what is
    required in a dossier.
    ● Use the checklist (Form A, attached) to ensure ALL requirements are met.
    ● Complete and submit the Summary Document with your application (See attached).
    ● Ensure Forms A (Checklist), B and C are completed, signed and dated.
    ● Ensure the name, form, strength and indications of a drug, and Manufacturer’s and
    Importer’s/Distributor’s name and address is consistent and accurate on all forms
    submitted. Where the drug is to be marketed under a different name from the Reference
    Authority, a letter from the manufacturer of the drug shall be submitted stating the name
    that the drug is currently marketed under in the reference country as well as the intended
    marketing name of the drug in Trinidad and Tobago, and confirming there is no
    difference in the quality, safety, potency and efficacy of the drug.
    ● Dossiers must be complete at the time of submission.
    ● Provide documentation to justify any part of the dossier that is missing or not
    apostilled/attested.
    ● Please acquire CPPs/Free Sale Certificates from:
    ○ WHO Stringent Regulatory Authorities for biologics and large molecules :
    ■ EMA (European Union)
    ■ FDA (United States of America)
    ■ Health Canada (Canada)
    ■ Swissmedic (Switzerland)
    ■ Medsafe (New Zealand)
    ■ TGA (Australia)
    ■ MHRA (United Kingdom)

    ○ For ONLY small molecule and chemical drugs including generics:


    ■ PAHO level 4 Regulatory Authorities
    ● ANMAT (Argentina)
    ● ANVISA (Brazil)
    ● CECMED (Cuba)
    ● INVIMA (Colombia)
    ● COFEPRIS (Mexico)
    ● ISP de Chile (Chile)

    ■ European Union
    Belgium, Bulgaria, Czech Republic, Denmark, Germany, Estonia, Greece,
    Spain, France, Croatia, Ireland, Italy, Cyprus, Latvia, Lithuania,
    Luxembourg, Hungary, Malta, Netherlands, Austria, Poland, Portugal,
    Romania, Slovenia, Slovak Republic, Finland, Sweden, United Kingdom

    *The Chemistry, Food and Drugs Division relies on previous approval by the
    following Competent Reference Authorities to expedite the approval process.
    Competent Reference Authorities are subject to change based on changes by
    WHO or EU.

    N.B. Official documentation from international sources must be notarized and


    apostilled and may, in some cases, require further verification.

    ● Please note that stability data for our climate falls under Zone IVb.
    ● Comparability studies for biosimilars are to be submitted, where applicable.
    ● Bioequivalence studies for generics are to be submitted, where applicable.
    ● Ensure Pharmacovigilance Plans, Post-Market Surveillance Plans, Period Safety Update
    Records/Public Assessment Reports (PSUR/PAR) and Risk Management Plans are
    included in the dossier.
    ● Submit scanned copies of both sides (where needed) of all original documents (CPPs,
    GMP certificates etc).
    ● In addition to the documents required for e-submission for New Drug Registration, a hard
    copy of the original/apostilled Administrative Documents must be submitted to our office
    on your appointment date; including the Form A, Form B, Form C, CPP/ Free Sale
    Certificate, GMP Certificate and receipt (Please retain copies of your receipt for the
    collection of NOAs).
    ● A soft copy of the complete dossier and all supporting documents must be submitted to
    our office on your appointment date on a flash drive. Please label appropriately and
    ensure the date of your appointment and company name is on the label.
    ● All information provided in the dossiers must be true and correct at the time of
    submission.
    ● Documents shall be submitted in PDF format except for one copy of Forms A, B and C in
    Word format.
    ● Dossiers shall be formatted in the general structure of Form A i.e. Administrative
    Documentation, Chemical Documentation, Pharmaceutical Documentation and
    Manufacturing Documentation.
    ● Dossiers must include a Table of Contents.
    ● Ensure artwork of all packaging (primary and secondary packaging) is included in the
    dossier, along with ink and packaging material(s) safety data.
    ● All pages shall be rotated to either landscape or portrait to ensure the pages are
    right-side up and legible.
    ● Ensure all documents are in English or translated by an authorized translator.

    ______________________________________________________________________________

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