21 Nov Importing Pharmaceuticals into T&T: The Regulatory Regime
The Covid-19 Pandemic has placed an increased focus on healthcare industries globally with the drive for Covid-19 vaccination resulting in enhanced public scrutiny of the types of drugs being imported into countries for use as a vaccine or otherwise. In the face of heightened interest in available medication Regulators may now be subject to increased scrutiny by the general population when permitting pharmaceuticals for use in their given jurisdictions, Trinidad and Tobago being no different. This begs the question, ‘What laws regulate the importation of pharmaceuticals in Trinidad and Tobago?’.
What are Pharmaceuticals?
Pharmaceuticals generally refer to ‘drugs’ which are used for medicinal purposes, the term ‘drug’ being defined in the Food and Drugs Act of Trinidad and Tobago Chap 30:01 as amended (the ‘FDA’) as any substance or mixture of substances for use in:
(a) the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical state, or the symptoms thereof, in man or animal; or
(b) restoring, correcting or modifying organic functions in man or animal.
While the regulatory framework governing the general importation and regulation of pharmaceuticals in Trinidad and Tobago include multiple Acts of Parliament, the FDA and the Food and Drugs Regulations (created to give effect to the provisions of the FDA) provide a useful starting point in understanding the main regulations.
Requirements to Import Pharmaceuticals
In order to understand the requirements necessary to import pharmaceuticals into Trinidad and Tobago one must first understand the type of drug which is to be imported. The FDA makes provision for several classes of drugs, chief among them being i. New Drugs, ii. Third Schedule Drugs (included in the category of prescription drugs) and iii. Controlled Drugs.
The general requirements for importing each category of drug listed above are set out below.
A ‘New Drug’ refers to a drug which contains a substance (whether an active or inactive component) that has not yet been imported for use as a drug in Trinidad and Tobago or alternatively a drug which is a combination of two or more drugs in a proportion or manner which has not been previously imported for use as a drug in Trinidad and Tobago.
In order to import a New Drug into Trinidad and Tobago the proposed importer must file a Drug Submission Form in the prescribed format, with the Minister of Health (the ‘Minister’). The Drug Submission Form must contain, among other things:
- a description of the drug (including the name of its manufacturer);
- the proper name of the drug;
- the proposed name under which the drug is to be sold;
- statement of ingredients;
- route of administration;
- proposed dosage; and
- the contra-indications and side-effects of the new drug if known.
Notably, the details of the tests applied to control the potency and safety of the New Drug as well as a draft of every label proposed to be used in connection with the drug is also to be included in the submission to the Minister.
Following receipt of the Drug Submission Form, the Minister may in his discretion (where applicable) or on the recommendation of the Drug Advisory Committee, notify the person filing the Drug Submission Form whether the information submitted satisfies the requirements of the FDA and in the event said requirements are satisfied (and after consultation with the Drug Advisory Committee) the Minister may, by Notice of Approval, signify his approval in respect of that Drug.
Third Schedule Drugs
Only persons falling within a specified category of persons (as identified in the Food and Drugs Regulations) can import a drug listed in the Third Schedule of the FDA (which are included in the category of prescription drugs). These persons include:
- a practitioner (dentist, physician, or veterinary surgeon);
- a drug manufacturer;
- an importer, wholesaler, jobber, or agent, dealing in drugs;
- a pharmacist; or
- a resident of a foreign country while a visitor in Trinidad and Tobago.
Although the drugs which form part of the Third Schedule are expressly and definitively listed, it is noteworthy that the Minister may, on the advice of the Drug Advisory Committee, add any new drug to the Third Schedule. The addition of a drug to the Third Schedule is required to be published by Notice in the Gazette and becomes effective from the date of publication of the Notice.
‘Controlled drug’ refer to any drug which has been classified as such under the Food and Drugs Regulations and expressly listed in Division 2 of the said Regulations. Commonly known controlled drugs include: Alprazolam (Xanax), Methamphetamine and Methylphenidate (Ritalin).
Controlled drugs can only be imported by persons who:
- are Licensed Dealers (defined to include a medical practitioner, pharmacist or holder of a license); and
- have obtained the requisite permit to import the said controlled drugs from the Chief Chemist and Director of Food and Drugs.
Upon the relevant application being submitted by the Licensed Dealer, the Chief Chemist and Director of Food and Drugs may issue a license to permit to the given dealer to import a controlled drug. Following importation, a licensed dealer may only sell or supply a controlled drug to another licensed dealer, a hospital or any person having the requisite prescription.
Standard of Pharmaceuticals Which Can Be Imported
Regardless of the class of drug being imported, the FDA appears to maintain certain standards which each imported drug must satisfy. Notably, the FDA requires that any drug being imported into Trinidad and Tobago must first be wholly in conformity with the law of the country in which it was manufactured and is accompanied by a certificate evidencing same. Further, the FDA prohibits the importation of adulterated drugs, that is, drugs which fail to meet the legal standard and drugs which have been manufactured, prepared, packed and stored in unsanitary conditions.
The FDA also prescribes certain requirements for the labelling of drugs which must be adhered to if the given drug is to be imported in Trinidad and Tobago. For instance, the label of a drug (both inner and outer label) is required to have, among other things, the proper name and standard under which the drug was manufactured, the name and address of the manufacturer or distributor of the drug (where applicable), adequate directions for use in English, the name of each medical ingredient contained therein and an expiry date, if applicable. These requirements do not apply to drugs sold on a prescription basis within certain parameters.
Administration and Enforcement
The Minister may appoint one or more persons to be analysts or inspectors for the purpose of enforcing the provisions of the FDA, said inspectors are granted certain inspection and seizure powers which allows them to aid in the enforcement of the Act.
By way of example, the appointed inspectors may:
- at any reasonable time enter any place where upon reasonable grounds he believes any article to which the FDA or its regulations apply (e.g. Pharmaceuticals) are being manufactured, prepared, preserved, packaged or stored and take samples thereof;
- examine anything that he reasonably believes is used or capable of being used for said manufacturing, preparation, preservation, packaging or storage;
- open and examine any package which he believes may contain any article to which the FDA may apply;
- examine any books, documents, or other records which he reasonably believes are likely to contain any information relevant to the enforcement of the FDA or Food and Drugs Regulations; and
- seize and detain for such time as may be necessary any article, by any means of or in relation to which, he reasonably believes violates any provision of the FDA.
Any article seized by an inspector may be submitted to any analyst for analysis or examination. The report setting forth the results of the examination or analysis is admissible as evidence in the prosecution of an offence under the FDA.
Infringement of Import Regulations
Every person who commits an offence under the FDA is liable on summary conviction for a first offence to a fine of $1,500.00 and to imprisonment for three (3) months and for a subsequent offence to a fine of $3,000.00 and imprisonment for six (6) months. Persons liable to conviction on indictment under the FDA is liable to a fine of $15,000.00 and to imprisonment for three years.
As outlined above, there are several factors to consider when importing pharmaceuticals into Trinidad and Tobago. Persons or companies desirous of importing pharmaceuticals must first identify the category within which the drug they wish import falls within and ensure that all relevant obligations are satisfied prior to attempting importation.
This article does not consider the regulations regarding the importation of Antibiotics into Trinidad and Tobago as the importation of Antibiotics must be completed in accordance with the Antibiotics Act and any Regulations made thereunder.
Disclaimer: This Document Provides General Guidance Only And Nothing In This Document Constitutes Legal Advice. Should You Require Specific Assistance, Please Contact Your Attorney-At-Law.
This Article was authored by Ajay Maraj, Associate at M. Hamel-Smith & Co. can be reached at firstname.lastname@example.org.