FOOD & DRUGS Registration FAQs
Trinidad & Tobago Product Registration Information & Requirements
Frequently Asked Questions
INTRODUCTION
According to Trinidad & Tobago laws - Section 2, Division 3 – New Drugs, Food & Drugs Regulations
No person shall import, sell or advertise for sale a new drug unless the Minister has issued a notice of approval in respect of the new drug
to the manufacturer or importer and
A supplementary submission is required when there is /are the following change(s) to the original submission that are significantly different from the information
contained in the original submission:
(a) The conditions for use of the drug including indications and route of administration
(b) Labels – including change of source, change in the name of the manufacturer etc.
(c) Packaging
(d) Pharmaceutical form
(e) Dosage
(f) Strength, purity or quality
In practice, compliance with every area of the requirements for registration is important, since the omission of the smallest detail results in the
rejection of the application, delayed product launch and ultimately reduced sales for the projected period. At the outset it, is essential to understand what is defined as manufacture and which country is considered the country of origin.
The Food and Drugs Regulation defines manufacture as:
“manufacture” includes mixing, compounding, preparation, and similar physical processes, synthesis or any similar process and packaging for
wholesale, but does not include dividing, sub-dividing, and re-packaging for sale by wholesale or retail.” - Second Schedule Division 8 Food and Drugs Regulation.
The country where the last manufacturing action occurs is considered the country of origin and therefore the place where the CPP must be generated.
Both definitions impact on the label, where documents must be sourced, how the registration package is compiled and whether the application is
ultimately accepted or rejected.
LABEL REQUIREMENTS
What is required on the label?
On the main panel of both the inner and the outer labels
The proper name and the standard under which the drug was manufactured or if there is no proper name, the common name
On both the inner and outer labels
(a) The name of the manufacturer, packager if relevant and/or distributor of the drug; the full address of the manufacturer or
distributor including the country , except that where the immediate container contains five millilitres or less, this statement need not be made on the inner label
(b) Where a drug is intended for internal or parenteral use, the lot number or batch number
(c) Adequate directions for use in the English Language
(d) The proper name, or, if there is no proper name, the common name, of each medicinal ingredient
(e) The expiry date
(f) The type of storage necessary
On the outer label
(i) A correct statement of net contents in terms of weight,measure, or number; and
(ii) Where the drug is intended for parenteral use, the name and
proportion of any preservative present.
What must be included in the address on the label?
The name of the manufacturer, packager and/or distributor and full address including the country. eg. USA. The statement must include one or more of the
following -
Manufactured by, Made by or Packaged by.
Are stickers allowed? ( If the samples of the finished product does not have the labels that will be exported to T&T )
Stickers are allowed for non-antibiotic products with a letter of commitment from the supplier to export trade stock with the amended label.
THE ELEMENTS SUBMITTED ARE TO BE SUBMITTED IN DUPLICATE AND PLACED INTO 4 SEPERATE DOSSIERS AS SEEN BELOW .
BIOEQUIVALENCE STUDIES MUST BE SUBMITTED IN A SEPERATE FOLDER .
REQUIREMENTS
TRINIDAD AND TOBAGO
MINISTRY OF HEALTH
CHEMlSTRY / FOOD AND DRUGS DIVISION
SUMMARY OF REQUIREMENTS FOR NEW DRUG SUBMISSION
DOSSIER 1 (Administrative Dossier)
Application forms
Certificate in respect of Imported Drugs
. Free Sale Certificate – Original or
. Certificate of Pharmaceutical Product – Original (Certificates are to be submitted in English or translated by official translator and notarised or apostilled )
DOSSIER 2 (Chemical Dossier )
(2) Chemical Documentation
(A) Finished Product
. Specifications
. Method of Analysis ( FULL DESCRIPTION IS REQUIRED ,REFERENCES ARE NOT ACCEPTABLE)
. Certificate of Analysis - Original
. Stability Data
. Disintegration
. Dissolution Profile
. Five (5) Samples
(B) Active Ingredient(s)
. Specifications
. Method of Analysis
. Certificate of Analysis (each ingredient) - Original
. One (1) gram of each
(3) Pharmaceutical Documentation
(A) Pharmacodynamic data
. General Pharmacology
. Tests supporting efficacy
(B) Pharmacokinetic data
. Distribution
. Biotransformation / Metabolism
. Excretion
. Biological equivalence
DOSSIER 3 (Clinical Dossier )
(C) Pharmacotherapeutic data
. Therapeutic uses
. Clinical trials
. Therapeutic equivalence
(D) Toxicity data
. All types
N.B. Data: - Published and In-house.
DOSSIER 4 ( Others Dossier)
(4) Manufacturing Details
. Manufacturing / Unit Composition Formula
. Brief Manufacturing Direction / Procedure
. Brief Manufacturing Controls
. Sampling and Testing Procedures
GMP Certificate
(5) Packaging Materials (Containers and Closures)
. Description
. Composition
. Size and dimension requirements (guage, thickness, etc.) with target value and acceptable tolerances
. Colour
. Processes necessary to make the article acceptable to pharmaceutical production (e.g., coating, washing, sterility of surfaces, etc.)
. Samples
(6) Ink and Printing
. Colour of ink
. Chemical Composition of Ink
. Description of Ink (colourfast, light resistant, rub resistant, reflectance, etc.)
. Other characteristics of Ink (odour, distribution, etc.)
. Printing - capacity to smear, smudge, scoff or be removed during normal handling of the package
(7) Package Insert
. Where applicable (Prescription Drugs)
. Standard Requirement
COST
Type of Application Cost ($TT)
New Drug 750.00
Supplementary 100.00
Label Examination 30.00
N.B. Unless stated the answers apply to both non-antibiotic and antibiotic product.
GENERAL INFORMATION
There are two (2) pharmaceutical review committees in Trinidad & Tobago:
The Drug Advisory Committee representing lay and professional interests and comprised of persons considered suitable by reason of their knowledge, interest
and experience.
The Antibiotic Committee which consists of the Chief Medical Officer, one member to be appointed by the Council of the Medical Board of Trinidad & Tobago, two registered members of the Medical Board, one person to be appointed by the Minister of Health and two members to be appointed by the Branch Council of the British Medical Association constituted in Trinidad & Tobago.
The Committees operate in the interest of and for the protection of public health to assist and advise the Minister of Health with respect to drug standards, schedules of drugs, condition of sale of drugs and any other matters connected therewith. The Committees consist of persons with an interest in chemistry, pharmacy, pharmacology conventional medicine, complementary medicine, veterinary medicine and other human sciences.
How often does the Drug Advisory Committee meet?
Meetings are usually held 4 or 5 times per year. Applications are usually accepted during the 3- 4 week period prior to the meeting date. New meeting dates are announced 7-14 days after the last meeting held. eg. Applications will usually be accepted from May 15th to June 19th for a meeting to be held on July 17th. Responses are usually received within 4-5 weeks after the meeting and Notices of Approval are received within another 6-8 weeks.
How often does the Antibiotic Control Committee meet?
They meet four (4) times per year. – The second Thursday of January, April, July & October. The deadline date for submission of applications is 30 days before the meeting date. This committee registers the manufacturing firm as an approved site from which antibiotics may be importedand registers the antibiotic product as 2 distinct applications.
The manufacturing firm registration is a one time application and must be published in the Trinidad & Tobago Gazette before importation of the products manufactured there can begin.
Is CD format accepted?
One hard copy & one soft copy are required.
When should an application to register a product intended for Government tender be submitted?
The application should be submitted by June of the previous year to allow enough time for deferrals, approval and if necessary applications to Hospital Formulary, National Formulary and lobbying to the relevant groups.
How many samples are required?
For non-antibiotic products - Five (5) finished product samples are required.
For antibiotic products - Five (5) samples are required.
How much active ingredient is required? ( Reference standards may be acceptable providing a reasonable letter of explanation why the active ingerdients cannot be submitted )
A minimum of 1 gram is required.
How many samples of packaging material (empty container, cover, foil, carton, inner label, insert) are required?
For non-antibiotic products - Five (5)
For antibiotic products - Five (5).
How much time is required for customs clearance of samples?
Seven (7) working days
Does each size of a product require a separate application?
For non- antibiotics products - a separate application is not required
For antibiotic products - A separate application must be filed for each size.
How do I obtain permission to import a cosmetic?
Submit a certificate of Free Sale, 1 sample & COA, product monograph and receipt for payment of TT$ 30.00 for a label examination.
How do I obtain permission to import a device?
Submit certificate of Free Sale, 1 sample & COA, product monograph and receipt for payment of TT$ 30.00 for a label examination.
How do I obtain a certified copy of a Notice of Approval
A certified copy of a notice of approval can be requested from the FOOD and DRUGS
ADMINISTRATIVE DOCUMENTATION
What type of authentication is accepted for Certificate of Free Sale (CFS) and Certificate of Pharmaceutical Product (CPP)?
Documents must be apostilled or consularized
Can a CPP from Korea be accepted
Yes once it complies with the WHO standards and it is in English .
Can the product name on the CPP and the product name on the sample differ in any way?
No. The name on the CPP must be identical to that on the finished product. Similar names although they may describe the same product are not
always accepted.
Can registration be granted for a product that is licensed but not sold in the country of origin?
Yes - with a valid reason. eg. Product was developed exclusively for the treatment of conditions not endemic in the exporting region.
Is a certificate of Good Manufacturing Practice GMP required for all applications?
For products fully manufactured in one country - if the CPP includes the GMP statement, a cGMP is not required. If a non-antibiotic product
is manufactured in Country A and packaged in Country B, a cGMP from country A and a CPP from country B are required. In some cases where the CPP states only
the corporate address, the cGMP can be used to for clarity.
What language is accepted for documentation?
All documents must have English language. Translations to English must be authenticated by a notary public.
What language is accepted for labeling?
English is required. Dual language is accepted. Finished product samples labeled in a foreign language with English final artwork is accepted with the
application. However, finished product samples labeled in English or dual language must be submitted in order to obtain the Notice of Approval.
CHEMICAL DOCUMENTATION
Is a copy of the Certificate of Analysis (COA) accepted?
No. The COA must be issued on an original letterhead, signed and dated. Electronic signatures are not accepted.
What type of stability data is required?
Data must include 3 lots for the shelf life of the product for Zone IV studies. Real time and accelerated data (6 months) are accepted. Zone
IV studies do not apply to cold storage products. Stability documents must be signed.
Are samples of API required for a supplementary registration?
It depends on the type of change eg. Yes for a change in formulation; No for change of artwork.
Change in route of synthesis of active product ingredient (API)
For non-antibiotic products - A notification letter – must also indicate that efficacy of the product has not been altered
For antibiotic products – Notification not required.
Change in manufacturer or supplier of API
For non-antibiotics products - A notification letter – must also indicate that efficacy of the product has not been altered
For antibiotics products – API must comply with current requirements of the International, European, Indian, Japanese or United States
Pharmacopeias. A copy of the monograph, reason for change, cGMP, certificate of analysis for 2 batches including results for impurities, results of stability
testing and description of methodology used, results of assay of active ingredient in finished product and results of testing for impurities in finished product. Procedures should be validated.
Change in Shelf life extension
For non-antibiotics and antibiotics - A notification letter and stability data are required for non-antibiotics and antibiotics.
Change in formulation (supplementary registration )
For non-antibiotics and antibiotics - CPP, samples & COA, actives & COA, packaging material samples, test methods, stability data,
bioavailability data & statement from supplier.
PHARMACEUTICAL DOCUMENTATION
What type of clinical data is required for branded oral dosage form?
The innovator’s bioavailability study and clinical data to support the indications . ( Studies must not appear to be downloaded from the internet )
What additional data is required for an oral generic product?
Bioequivalence (BE) study with a minimum of 24 subjects completing the study .Copies of case record files, assay details, plasma profiles and chromatograms are required. BE study performed on a higher strength is accepted for registration of the lower strength product provided the following criteria are met:
i) The higher strength of the formulation on which the BE studies were performed is registered and approved for sale in Trinidad & Tobago
ii) Comparative in vitro dissolution testing with the innovator product for the particular strength MUST be submitted
iii) The respective strengths MUST be manufactured by the same manufacturer, at the same manufacturing site and using the same equipment
iv) The qualitative composition between the respective strengths MUST be the same and
v) The ratio of active ingredients and excipients between the respective strengths MUST be the same.
Items ii), iii), iv) & V) must be in the form of a written, dated & signed statement.
What is the accepted range?
Regarding area under the curve (AUC), 90% confidence interval should generally be within the acceptance range 80 to 125%.
What type of data is required for an injectable generic product?
For non-antibiotics - Post marketing report and a dated, signed statement regarding
i) manufactured by the same manufacturer, at the same manufacturing site and using the same equipment
ii) The qualitative composition between the respective strengths
iii) The ratio of active ingredients and excipients between the respective strengths.
For antibiotic aqueous injectable products – bioequivalence data is not required.
For antibiotic oily injectable products – bioequivalence data is not required.
REQUIREMENTS FOR VARIOUS SITUATIONS
New Drug Registration
Product manufactured and sold in country A
For non-antibiotics & antibiotic products - CPP, samples COA, actives & COA, chemical documentation, pharmaceutical documentation,manufacturing details, packaging material, ink & printing and package insert.
Product manufactured in country A and packed in country B
For non-antibiotics - cGMP from country A and CPP from country B, samples & COA, actives & COA, chemical documentation, pharmaceutical documentation, manufacturing details, packaging material, ink & printing and package insert.
For antibiotic products – CPP from both country A & B, samples & COA, actives & COA, chemical documentation, pharmaceutical documentation, manufacturing details, packaging material, ink & printing and package insert.
Product manufactured but not sold in country A and packed in country B
For non-antibiotics - cGMP from country A and CPP from country B, samples & COA, actives & COA, chemical documentation, pharmaceutical documentation, manufacturing details, packaging material, ink & printing, package insert and a letter from the supplier stating why not sold in country A.
For antibiotic products – CPP from both country A & B, samples & COA, actives & COA, chemical documentation, pharmaceutical documentation, manufacturing details, packaging material, ink & printing and package insert and a statement from the supplier.
Product manufactured but not sold in country A and distributed from country B
For non-antibiotics & antibiotic products - CPP from country A and B, samples & COA, actives & COA, chemical documentation,pharmaceutical documentation, manufacturing details, packaging material, ink & printing, package insert and statement why not sold in country A.
Product X manufactured in country A to be sold as Product Y in Trinidad
For non-antibiotics & antibiotic products - CPP must state both trade names, samples & COA, actives & COA, chemical documentation,pharmaceutical documentation, manufacturing details, packaging material, ink & printing, package insert and statement from supplier.
SUPPLEMENTARY REGISTRATION ( Variations to original registration)
Change of source from country A to country B
For non-antibiotics & antibiotics - CPP, samples & COA, actives & COA, and statement from supplier.
Change in the name of the manufacturer
For non-antibiotics - CPP, samples & COA, packaging material and statement from supplier. Samples reflecting original name of manufacturer are accepted with mockups or artwork reflecting the change.
For antibiotic products – CPP, samples & COA, packaging material and statement from supplier. The name change of the manufacturer must be stated in the label of the samples to be submitted. Mock-ups and artwork reflecting the change are not accepted in place of samples.
Change in the name of the manufacturer when the product is manufactured in country A and packed in country B
For non-antibiotics - cGMP from country A, CPP from country B, samples & COA, packaging material and statement from supplier. Samples reflecting original name of manufacturer are accepted with mockups or artwork reflecting the change.
For antibiotic products – CPP from country A and B, samples& COA, packaging material and statement from supplier. The name change of the manufacturer must be stated in the label of the samples to be submitted.Mock-ups and artwork reflecting the change are not accepted in place of samples.
Change in marketing authorization holder
For non-antibiotics & antibiotics - Notification including when the label changes will come into effect and submission of individual product CPPs, samples & COA, legalized copy of legal transfer documents & statement from the supplier for any changes in label content and artwork.
Change of logo
For non-antibiotics - CPP & a statement
For antibiotics – 2 old & 2 new samples & a statement
Change of packaging size – volume or quantity remain the same
For non-antibiotics - not applicable
For antibiotic products – 2 samples, old & new packaging components and statement from supplier
Change of packaging (eg. bottle to blister)
For non-antibiotics & antibiotics - CPP, samples & COA, packaging components, stability data and statement from the supplier
Change of pharmaceutical form
For non-antibiotics & antibiotics - CPP, samples & COA, actives & COA, packaging components, stability data, test methods, bioavailability data and statement from the supplier
Change in name of product
For non-antibiotics & antibiotics - CPP, samples & COA,packaging material samples and statement from the supplier
Change in pack site – same manufacturer but new pack site at a different address (Country of origin unchanged)
For non-antibiotics - cGMP for manufacturing plant, cGMP pack site, samples & COA, packaging material samples and statement from supplier.
For antibiotic products – Notification with cGMP for manufacturing plant, cGMP for pack site, artwork and statement from supplier.
Change in pack site – same manufacturer but new pack site at same address (Country of origin unchanged)
For non-antibiotics - cGMP for manufacturing plant, cGMP pack site, samples & COA, packaging material samples and statement from supplier.
For antibiotic products – Notification with cGMP for manufacturing plant, cGMP for pack site, artwork and statement from supplier.
Additional indication
For non-antibiotics - CPP, samples & COA, Actives & COA, packaging components bioavailability, clinical data, stability data & test methods and statement from supplier
For antibiotic products - samples & COA, Actives & COA, packaging components bioavailability, clinical data, stability data & test methods and statement from supplier.
Change in artwork
For non-antibiotics - CPP, samples & COA, packaging components and statement from the supplier. If finished product samples of the new artwork are unavailable, samples with the old artwork and mockups of the new artwork are accepted.
For antibiotic products – old & new samples and a statement.
Change in colour of finished product
Notification required- must include stability data on 2 batches for at least 3 months under accelerated conditions or 1 year under non-accelerated conditions and an ongoing stability study on at least 2 batches for the full duration of the shelf life. Any new colours are permitted as per the European Union’s “List of Permitted food colours” or USFDA’s “Inactive ingredient guide”.
Change in coating
Notification is required - alteration of the quantitative composition must be less than 2% of the total weight of the tablet or capsule, the coating must have no modified release properties and contain no active product ingedients .