Notice To Importers NDS Submission Feb 2022
Notice To Importers NDS Submission Feb 2022
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.
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
■ 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.
● 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.
______________________________________________________________________________