THE FOOD AND DRUGS ACT
(under section 21)
THE FOOD AND DRUGS REGULATIONS, 1975
(Made by the Minister on the 3rd day of March 1975)
[4th August, 1975]
PART I. Definitions
1. These Regulations may be cited as the Food and Drugs Regulations. 1975. 2 In these Regulations unless the context otherwise requires- "can" means any hermetically sealed container;
"cubic centimetre" and its abbreviated form "cc"
shall be interchangeable with the term "millilitre" and its abbreviated form
"ml". "declared'' means written on the label attached to or accompanying the food, drug or substance in respect of which the declaration is required, in letters of the prescribed size;
'ice" means the product obtained by freezing potable water which has been kept, stored and delivered under such hygienic conditions as to prevent contamination;
"inner label" means the label on or affixed to an immediate can or package of food. drug, cosmetic or device;
"main panel" means the principal label affixed to the package or container identifying its contents by stating the name of the food. drug. cosmetic or device, the ingredients. weight. manufacturer, place of manufacture and such other information as may be required by these Regulations;
"official method" means a method of analysis or examination designated as such by the Minister for use in the administration of the Act;
"outer label" means the label on or affixed to the outside of a package of a food, drug, cosmetic or device; "parts per million" means part by weight per million parts by weight except where otherwise stated; "percent" means percent by weight (weight in weight) except where otherwise stated; "potable water" means water which is clear. colourless and free from any pathogenic micro-organism.
PART II. Foods, Drugs, Cosmetics and Devices
Division I. General
3. (1) A person shall not advertise any food, drug, cosmetic or device unless such advertisement complies with the requirements of the Act and these Regulations.
(2) Unless specifically required to do so by any enactment, no label or advertisement shall either directly or indirectly make reference to the Ministry of Health and Environmental Control or these Regulations.
4 (1) A person shall not advertise any drug unless he has first been granted approval in writing by the Minister to do so, and such approval has not been withdrawn at the time of publication of the advertisement.
(2) The Minister may refuse to grant approval or may withdraw the approval granted in respect of any advertisement by notifying in writing the applicant for the approval or the person to whom the approval was granted, as the case may be, in cases where-
(a) he has reasonable grounds to believe that the application on which approval in respect of any such advertisement was granted contained false or misleading statements; or
(b) the advertisement in respect of which approval was given does not comply with the requirements of these Regulations.
5. (1) Any information required by these Regulations to be included on a label shall be clearly and prominently displayed thereon, so as to be readily discernible to the public under normal conditions of purchase and of use.
(2) For the purposes of paragraph (1). the name by which any food, drug, cosmetic or device is generally known consisting of more than one word shall be deemed to be clearly and prominently displayed on the main panel of the label if each word other than articles, conjunctions and prepositions, is in identical type and identically displayed.
6. All information required by these Regulations to be declared shall be in durable characters, and in boldfaced capital letters written in such colour or colours as to afford a distinct contrast with the background.
Division II Food
7. In this Division- "artificial (non-nutritive) sweetening agent" means any chemical compound which is sweet to the taste but does not include sugar or other carbohydrate or polyhydric alcohols;
"bulk container" means a container in which more than one duly labelled package of a food and its contents are placed for wholesale purposes, but in which the packages and their contents are not intended to be retailed;
"close proximity" means with reference to a common name, written or graphic matter placed immediately adjacent to that common name;
"common name" means with reference to a food, the name by which the food is generally known;
"food additive" means any substance, including any source of radiation, the use of which results, or may reasonably be expected to result, in it or its by-products becoming a part of or affecting the characteristics of a food excepting-
(a) any nutritive material that is used, recognized, or commonly sold as an article or ingredient of food;
(b) vitamins, minerals, and amino acids unless added for flavourings;
(c) spices, seasoning, flavouring preparations essential oils, oleoresins and natural extractives;
(d) pesticides;
(e) food packaging materials and components thereof; and
(f) drugs recommended for administration to animals that may be a source of food for human beings;
"unstandardized food" means any food for which a standard has not been prescribed.
8. A person shall not prepare, pack, store or transport any food intended for sale in any manner which renders it injurious to health or which injuriously affects its nutritive properties, or which renders it unwholesome, nor shall a person sell any food which has become injurious to health, which has had its nutritive properties injuriously affected, or which has become unwholesome.
9. A person shall not sell any canned food the container of which is blown or punctured, or any frozen food which has been thawed in the package and subsequently refrozen.
10. A person shall not use water other than potable water as an ingredient in the manufacture or preparation of any food.
Labelling
11.(1) A person shall not sell a package of food which is not labelled or which bears a label that does not comply with the provisions of these Regulations.
(2) The provisions of paragraph (1) shall not apply to food packaged from bulk on the premises where that food is retailed, so, however, that where any food so packaged bears any statement, mark or device regarding the ingredients or the substances contained therein other than the name of the food, the name and address of the retailer and the net contents, it shall be labelled as required by the Act.
12 (1) Unless otherwise specifically provided in these Regulations. every package of food offered for sale shall bear a label stating legibly and conspicuously in conformity with regulations 5 and 6-
(a) on the main panel-
(i) the brand name or trade name, if any; and
(ii) the common name of the food; and
(iii) a statement of the weight, volume, number or measure of contents; and
(b) on the remainder of the label-
(i) a declaration of added colour, if present; and
(ii) the name and address of the manufacturer, packer, importer, vendor or of any person who assumes the responsibilities of the manufacturer, packer, importer or vendor and indicates in conjunction with his name and address that he is not the manufacturer, packer importer or vendor.
(2) Notwithstanding paragraph (i) of subparagraph (b) of paragraph (1). a list of ingredients is not required to indicate the presence of caramel as a food colour in-
(a) non-excisable fermented beverages;
(b) spirituous liquors other than gin;
(c) wine.
13. Except where the quantity of the contents marked on a package of food is stated in terms of minimum weight, volume, number or measure, there shall be permitted from the stated quantity, variations-
(a) due exclusively to weighing, measuring or counting that occur in packaging conducted in compliance with good commercial practice;
(b) due exclusively to difference in the capacities of containers resulting solely from unavoidable factors in manufacturing;
(c) due exclusively to the ordinary and customary exposure of the package to evaporation under usual atmospheric conditions.
14. Unless otherwise specifically permitted by these Regulations, a person shall not sell a synthetic food as substitute for any food unless-
(a) it is clearly indicated on the label or in any advertisement in respect thereof that it is a substitute, imitation, artificial or synthetic food; and
(b) the label of every package of such food other than imitation flavouring preparations includes legibly and conspicuously, the common names of all the ingredients of that food in descending order of their proportionate content.
15. A person shall not sell any food bearing a label which suggests or implies the presence of one or more vitamins, that the food contains vitamins, or that it is rich in vitamins, unless there is written on the label in letters of not less than eight points, the actual vitamin content per 100 grammes of food.
16. Where any colouring or any flavouring has been added to any food, every package to which that colouring or flavouring has been added shall bear a label including the words "artificially coloured", "artificially flavoured" or "artificially coloured and flavoured'', as the case may require.
17. Any colouring substance or mixture of colouring substances which is sold or packaged for use in food shall bear a label on which shall be written legibly and prominently-
(a) the name or names of the colouring substance or substances present; and
(b) the words "food colour" in letters of not less than 4 inch in height.
Adulteration of Foods and Special Foods.
18. A person shall not add any colouring, flavouring, preservative or anti-oxidant to any food, extender, stabilizing or modifying agent other than to food in its natural form, or of a standard specified in these Regulations, or add any such substance to any food or sell any food containing any such substance unless the addition or presence of any such substance is specifically permitted by these Regulations.
19. (1) A person shall not add any artificial sweetening agent, mineral oil, parffi, mineral salt (except sodium chloride), resin, glycol derivative, coumarin or any substance containing coumarin, to any food, or sell any food containing any such substance unless the addition or presence is permitted by these Regulations.
(2) The provisions of this Regulation with respect to paraflin shall not apply to chewing gum.
20. A person shall not use or sell for use in or upon a food, any ingredient, unless it is of a purity that renders it safe and appropriate for use in foods.
21. A food shall be deemed to be adulterated if any of the following substances or classes of substances are present therein or have been added thereto-
(a) mineral oil, pare wax, or any preparation thereof;
(b) coumarin, extracts of tonka beans, the seed of Dipteryx odorataWilld, or Dipteryx oppositi-folia Willd;
(c) synthetic sweetening agents other than saccharin;
(d) cottonseed flour that contains more than four hundred and fifty parts per million of free gossypol; (e) fatty-acids and their salts containing toxic factors; (f) dihydrosafarole;
(g) isosafrole;
(h) oil of American sassafras from sassafras alkidum (nut) Nees;
(i) oil of Brazilian sassafras from Ocotca cymbarum H.B.K.;
(j) oil of camphor sassafras from Cinnamon camphorum sieb;
(k) oil of micranthum Hyata; or
(l) safrole;
Provided that-
(i) a food shall not be adulterated if it contains not more than 0.3 percent mineral oil, where the normal manufacturing practices require the use of mineral oil;
(ii) chewing gum shall not be adulterated if it contains a paraffin wax base;
(iii) fresh fruits and vegetables (with the exception of turnips) shall not be adulterated if they are coated with not more than 0.3 percent paraffin wax and petrolatum, where normal manufacturing practices require the use of such coating; and
(iv) turnips and cheese shall not be adulterated if they are coated with paraffin wax in accordance with normal manufacturing practice
22 Except in the case of special formulae, bakery products, and special dietary foods, a person shall not sell a food that is represented as being for babies if that food contains a food additive.
23. Where a statement or claim implying a special dietary use is made on the label of, or in any advertisement for a food, the type of diet for which that food is recommended shall be included in such label or advertisement.
24. (1) Special dietary foods recommended for carbohydrate or sugar reduced diets shall be foods that contain not more than 50% of the glycogenic carbohydrates normally present in foods of the same class, except that confectionery and pudding powders shall contain not more than 70% of the glycogenic carbohydrates normally present in such foods.
(2) For the purpose of these Regulations, a food may be described as "sugarless", "sugar-free" or by any other synonymous term if that food contains not more than 0.25 percent glycogenic carbohydrates.
(3) Where a statement of claim relating to the carbohydrate. sugar or starch content of any food is made on the label of, or in any advertisement for that food, such label or advertisement shall include a statement of the carbohydrate content in grammes per 100 grammes or on a percentage basis.
25. (1) Special dietary foods recommended for calorie reduced diets shall be foods that contain not more than 50 percent of the total calories normally present in foods of that same type.
(2) Where a statement or claim relating to the calorie content of any food is made on the label of, or in any advertisement for that food, such label or advertisement shall include a statement of the calorie content in calories per 100 grammes.
(3) For the purpose of these Regulations, a food may be described as "low-caloried" or by any other synonymous term if it contains not more than 15k calories per average serving and 30k calories in a reasonable daily intake.
27. (1) A person shall not sell a food containing a non-nutritive sweetening agent unless-
(a) the label bears a declaration that contains a non-nutritive artificial sweetener and the name of that sweetener;
(b) the label includes a statement specifying a special dietary use;
(c) that food meets the requirements for special dietary foods prescribed in these Regulations; and
(d) the label includes a warning that the food should only be used on the advice of a registered medical practitioner.
(2) The substances listed in the First Schedule may be used as artificial (non-nutritive) sweetening agents in foods.
28. (1) Where a standard for a 'food is prescribed in these Regulations-
(a) that food shall conform to the requirements prescribed in that standard;
(b) each ingredient shall be incorporated in the food in a quantity within the limits prescribed for that ingredient; and
(c) if the standard includes an ingredient to be used as a food additive for a specified purpose, that ingredient shall be a food additive approved by the Minister for use as an additive to that food for that purpose.
(2) Where a standard for a food is not prescribed in these Regulations-
(a) the food shall not contain any food additives other than food additives approved by the Minister for use as additives to that food for that purpose; and
(b) each food additive so approved shall be incorporated in the food in a quantity within the limits approved for that food and that food additive.
(3) The provisions of sub-paragraph (c) of paragraph (1) and sub-paragraph (a) of paragraph (2) shall not apply-
(a) the spices, seasonings, flavouring preparations essential oils, oleoresins and natural extractives; or
(b) in any case where a standard has been prescribed under any other enactment.
Division III Drugs
39. In this Division-
"adequate directions for use" includes all information as may be necessary for proper use, including cautions as to the possible adverse reactions and contra-indications;
"antibiotic" means any drug or combination of drugs prepared from certain micro-organisms, or which formerly was prepared from micro-organisms but is now made synthetically and which possesses inhibitory action on the growth of other micro-organisms; "common name" means. with reference to a drug. the name in the English language by which the drug is commonly known;
"expiration date" means any date prescribed in relation to a particular drug, as the date after which that drug is not recommended for use; "generic drug" means an unpatented drug product, including a drug whose patent has expired and one which has never been patented;
"generic name" means the official name or international nonproprietary nomenclature;
"internal use" means ingestion by mouth or application for systemic effect to any part of the body in which the drug comes into contact with mucous membrane;
"parenteral use" means administration of a drug by means of a hypodermic syringe, needle or other instrument through or into the skin or mucous membrane;
"pharmacist" or "druggist" means any person registered as such under any enactment for the time being in force relating to the registration of druggists or pharmacists;
"medical practitioner" means any person registered as such under the Medical Act or any enactment for the time being in force relating to practise of medicine;
"pr" means, when used in relation to a List 4 Drug, to be sold on prescription only; "practitioner" means any dentist medical practitioner, veterinary surgeon or veterinary practitioner registered respectively as such under any relevant enactment for the time being in force;
"prescription" means an order given by a practitioner directing that a stated amount of any drug or mixture of drug specified therein be dispensed for a person named in the order;
"proper name" means, with reference to a drug, the name in the English language of that drug;
"teaspoon" means for the purpose of calculation of dosage, a volume of five cubic centimeters.
40. (1) A person shall not sell, manufacture, import or distribute a drug unless-
(a) that drug has been registered with the Ministry of Health; and
(b) a fee of $25.00 has been paid in respect of such registration.
(2) The Minister may, in his discretion, exempt any person or any drug from the requirements of paragraph (1).
41. (1) A person shall not manufacture a drug unless he has applied for and been granted a permit to do so by the Minister.
(2) A permit to manufacture a drug shall be in the form set out as Form A in the Third Schedule.
(3) A fee of one thousand dollars ($1,000) shall be paid in respect of each product for which a permit to manufacture is sought.
42. (1) A person licensed to manufacture a drug pursuant to regulation 41 shall not sell a drug in dosage form unless the drug has been prepared, manufactured, preserved. packaged, stored, labelled and tested under suitable conditions.
(2) For the purposes of paragraph (1) "suitable conditions" require
(a) that the construction, fittings and furnishings in a building where a drug is processed and packaged shall be of such material and finish as to permit the ready and efficient cleaning of all surfaces, to prevent the introduction of extraneous materials into drugs during their processing and testing, and to prevent the migration of dust. in accordance with good pharmaceutical practices;
(b) that the premises used for the processing, testing, finishing distribution and storage of the drug, and all auxiliary facilities, shall be maintained in a clean, sanitary and orderly condition, free from vermin, infestation, accumulated waste or debris;
(c) in cases where d.rugs for parenteral use are processed, that all fillings and aseptic processes shall be carried out in a separate and enclosed area designed for the processing and filling of such drugs and operated in a manner that will prevent contamination of the drug to be compounded and filled;
(d) that the personnel used as supervisors in the formulation processing, testing, packaging and labelling of drugs, and the personnel responsible for the maintenance of machinery. equipment and sanitation shall have such technical training as is deemed necessary by the Minister, having regard to the duties and the responsibilities involved;
(e) that each lot or batch of raw bulk material used in the processing of a drug in dosage form shall be tested to ensure the identity and purity of such raw bulk materials;
(f) that each lot or batch of a drug in dosage form shall be tested to ensure its identity, potency and purity for its recommended use;
(g) that adequate quality controls shall be used, having regard to the nature of each drug;
(h) that a system of control shall be applied which will permit a complete and rapid recall of any lot or batch of the drug from the market, if necessary; and
(i) that records shall be maintained relating to each drug, in a form and manner satisfactory to the Minister showing-
(i) the tests canied out on each lot or batch of raw bulk materials used in the processing of the drugs;
(ii) the tests carried out on each lot or batch of drugs in the dosage form;
(iii) the quality controls applied;
(iv) all information received pertaining to the quality or hazards of any drug;
(v) the results of tests to determine the stability of each drug; and
(vi) the measures taken to ensure the recall of unsatisfactory lots or batches of drugs from the market.
(3) The records required to be maintained by sub-paragraph (i) of paragraph (2) shall be kept until the expiration of three years from the date of the testing of each lot or batch of each drug, or until the expiration date of that drug, whichever first occurs, and an adequate sample of each such batch or lot shall be submitted to the Minister, on his request, for analysis and examination.
43. (1) A person shall not import a drug unless he has applied for and obtained permission to do so from the Minister and has paid a fee of two hundred dollars ($200) in respect of each permit bearing a maximum of ten products.
(2) A person applying for permission to import a drug pursuant to paragraph (1) may be required by the Minister-
(a) to furnish information and evidence satisfactory to establish that the conditions of manufacture described in paragraph (2) of regulation 42 have been met in respect to such drug; and
(b) before such drug is released for sale. to conduct tests in Jamaica by an acceptable method, on that drug in the form in which it is sought to be imported.
(3) Where, in the opinion of the Minister, a drug, or lot or batch of drugs, does not conform with the requirements of these Regulations, the drug, or the lot or batch thereof, as the case may be. shall not be admitted into the Island for use as a drug.
44. (1) Except as otherwise provided in these Regulations, the label of a drug shall include-
(a) on the main panel of both the inner and the outer labels-
(i) the proper name; or
(ii) where there is no proper name, the common name;
(b) on both the inner and the outer labels-
(i) the name of the manufacturer or distributor of the drug;
(ii) the address of the manufacturer or distributor, except in cases where the immediate container contains 5 millilitres or less, when this statement need not be made on the inner label;
(iii) where a drug is intended for parenteral use. the lot number thereof;
(iv) a quantitative list of the medicinal ingredients contained therein by their proper names, or if they have no proper names, by their common names, except in the case of drugs sold on prescription; and
(v) adequate directions for use;
(c) on the outer label-
(i) a correct statement of net contents in terms of weight; and
(ii) where the drug is intended for parenteral use, the name and proportion of any preservative present therein.
(2) All the information required by this regulation to be included on a label shall be clearly and prominently displayed thereon, and shall be readily discernible to the public under the customary conditions of purchase and use.
(3) Where a package of a drug has only one label, that label shall include the information required by these Regulations to be shown on both the inner and outer labels.
(4) The provisions of paragraph (1) shall not apply to the label of a drug package from bulk on the premises where the drug is retailed. except that the name of the drug shall be included on the label and where the package of a drug bears a statement, mark or device regarding the ingredients declared therein, in addition to the name of the drug, including the name and address of the retailer, the net contents and adequate directions for use, the package shall be labelled as required by these Regulations.
(5) The provisions of this regulation shall not apply to drugs supplied on prescription.
45. Except as otherwise provided in these Regulations, a person shall not sell to the general public for human use, a drug, other than a preparation solely for external use. unless both the inner and outer labels on such drug include a statement of the quantitative content of each drug and the recommended single and daily adult dosage, and where the drug is recommended for children, the statement "dose for children, as directed by the physician".
46. (1) Both the inner and the outer labels of a drug for which a single or daily dosage or a statement of concentration in excess of the limits herein provided has been recommended shall include a caution that the product is to be used only on the advice of a physician.
(2) The provisions of paragraph (1) shall not apply to a drug supplied on prescription, or to the inner label of a single dose container.
47. The label of every prepacked drug shall include the cautionary phrase"keep out of the reach of children".
48 (1) A person shall not sell a drug containing-
(a) salicylic acid or its salts, acetylsalicylic acid or its salts or salicylamide, unless, where the drug is recommended for children, both its inner and outer labels include cautionary statements to the &at that the drug may be administered to children under two years of age only on the advice of a physician;
(b) hyoscine (scopolamine) or its salts, unless both its inner and outer labels include a cautionary statement to the effect that the drug is not to be used by persons suffering from glaucoma or where the drug causes blurring of the vision or pressure pain within the eye: and
(c) phenacetin, either singly or in combination with other drugs, unless its label bears the following statement- "CAUTION: May be injurious if taken in large doses or for a long time. Do not exceed the recommended dose without consulting a physician."
(2) The provisions of paragraph (1) shall not apply to any preparation containing a drug that is required by anyone to be sold on prescription, or for parenteral or injectable use
49.-(1) A person shall not sell a corticosteroid drug for ophthalmic use unless-
(a) the outer label of the package insert includes as part of the directions for use, the following statements-
"Contraindications
Viral disease of the cornea and conjuctiva; Tuberculosis of the eye; Fungal disease of the eye; Acute purulent untreated infection of the eye, which like other diseases caused by micro-organisms may be masked or enhanced by the presence of the steroid.
Side effects
Extended ophthalmic use of oorticosteroid drugs may cause increased intraocular pressure in certain individuals and in those diseases causing thinning of the cornea, perforation has been known to occur"; and
(b) the inner label includes the statement required by subparagraph (a) of paragraph (1) or instructions to refer to the outer label or package insert for information about contraindications and side effects.
(2) The provisions of paragraph (1) shall not apply to a conicosteroid drug that is dispensed by a registered pharmacist pursuant to a prescription.
(3) A person shall not disseminate to a practitioner promotional literature about corticosteroid drugs for ophthalmic use unless the statements required by subparagraph (a) of paragraph (1) are included in the literature.
(4) The provisions of paragraphs (1) and (3) shall not apply to a drug sold solely for veterinary use.
List 4 Drugs
50 (1) The drugs listed in the Fourth Schedule (hereinafter referred to as List 4 Drugs) are hereby prohibited from being retailed except on or in accordance with a prescription from a practitioner.
(2) A person shall not advertise any List 4 Drugs to the general public.
51. (1) Subject to regulations 52 and 58, a person shall not sell a List 4 Drug unless he has received a prescription therefor, either in writing or verbally.
(2) A person selling a List 4 Drug pursuant to a written prescription shall retain such prescription for at least two years from the date of the filling thereof.
(3) A person to whom a prescription for a List 4 Drug has been communicated verbally by a practitioner shall forthwith reduce the prescription to writing (which shall be validated by the practitioner within thirty-six hours) and shall upon the filling therefor, retain that written and validated prescription for a period of at least two years from the date of filling thereof.
(4) The person reducing a verbal prescription for a List 4 Drug to writing shall indicate on the written prescription-
(a) the date and number of the prescription;
(b) the name and address of the person for whom the drug was prescribed;
(c) the name and quantity of the drug prescribed;
(d) the name and address of the practitioner prescribing the drug;
(e) the directions for me given with the prescription, and if that prescription is to be repeated, the number of times and intervals of time at which it may be repeated;
(f) the name and address of the person receiving the prescription. if given verbally: and
(g) the name and address of the person dispensing the drug pursuant to a verbal prescription which has been reduced to writing
(5) A person repeating a prescription for a List 4 Drug shall record on the original prescription therefor, in respect of each repeat. the date of the repeat, the quantity of the drug dispensed, and the name and address of the person who dispensed the drug.
51A. (1) Where a prescription directs the dispensing of a named List 4 Drug and there is available a bioequivalent generic drug which is less costly than the named drug. the registered pharmacist shall. before supplying the drug. inform the person for whom the drug is supplied or the person presenting the prescription-
(a) that there is available a bioequivalent generic drug which is interchangeable with the named drug;
(b) that it is less costly than the named drug; and
(c) that the generic drug will be dispensed for the one prescribed except where the person objects or declines to accept the generic presentation.
(2) This regulation shall not apply where there is a direction from the person who issued the prescription that there shall not be any substitution.
(3) Where a person is supplying a drug for which a prescription is not required and there is available a generic drug which is less costly than the one requested, the pharmacist shall, before supplying the drug, inform the person requesting the drug- (a) that there is available a generic drug which is interchangeable with the drug requested; (b) that is less costly than the drug requested.
52. (1) A person may sell a List 4 Drug on the strength of a written order duly signed, to-
(a) a drug manufacturer;
(b) a practitioner;
(c) a registered pharmacist;
(d) a hospital or any nursing home duly registered under any law for the time being in force relating to the registration of nursing homes;
(e) any person to whom a written order signed by the Minister has been issued.
(2) A person selling a List 4 Drug in accordance with paragraph (1) shall, prior to effecting the sale, verify the signature of the person signing the order if there are grounds for reasonable doubt as to the authenticity thereof.
(3) A person selling a List 4 Drug in accordance with paragraph (1) shall retain the order on the strength of which the List 4 Drug was sold, for a period of at least two years from the date on which the sale was effected.
New Drugs
64. In this Division "new drug" means-
(a) a drug that contains or consists of a substance, whether as an active or inactive ingredient, carrier, coating. excipient. menstrum or other component, that has not been imported into the Island for use as a drug for a sufficient time and in sufficient quantities prior to the 4th of August 1975 to establish its efficacy and safety. or is a new drug in the country in which it was manufactured;
(b) a combination of two or more drugs. with or without other ingredients which have not been imported into the island prior to the 4th of August, 1975, in that combination or in the proportion in which those drugs are combined;
(c) a drug in relation to which the manufacturer prescribes, recommends, proposes or claims a use as a drug, or a condition of use as a drug, including dosage, demonstration or duration of action, and which has not been imported into the Island prior to the 4th of August. 1975, for that use or condition of use; or
(d) any other drug which the Minister may prescribe.
65.(1) A person shall not 'import; sell; advertise for sale, or manufacture, a new drug unless- .
(a) he has been issued a licence by the Minister 'in respect of the importing, sale, or manufacture, as the case may require, of that new drug, and which licence has not been withdrawn in accordance with regulation 69; and
(b) he has paid an initial fee of five thousand dollars in respect of that licence instead of the registration fee imposed pursuant to regulation 40.
(2) Any person desirous of obtaining a licence in accordance with paragraph (1) shall make an application to the Minister containing-
(a) a description of the new drug, including the name and address of the manufacturer thereof, and a declaration of the proper name, if any, and the name under which it is proposed to be sold;
(b) a statement of all the ingredients, the route of administration, the proposed dosage, the therapeutic or diagnostic claims for the new drug, if known, a description of the pharmaceutical dosage form in which the new drug is to be sold, and any known contra-indications and side effects thereof;
(c) details of the tests conducted to control the potency, purity and safety of the new drug;
(d) a draft of every label proposed to be used in connection with the new drug;
(e) samples of the new drug in the finished and pharmaceutical form in which it is to be sold;
(f) such samples of the components of the new drug as the Minister may require;
(g) a certificate from the competent authority in the country of manufacture or export certifying that the new drug is approved for use in that country and the conditions under which it may be used or sold in that country; and
(h) a certificate in the English language in addition. to any other language, from the manufacturer, respecting 'the safety of the new drug conditions of use recommended, and giving the conditions under which it may be sold, issued by an official " body or government department having authority to issue such certificate, such official body or government department having the experience and facilities for testing the safety of a new drug that are considered by the Minister as adequate to ensure the safety of the new drug under the conditions of use recommended.
(3) The Minister may in his discretion, refuse any application for a licence made pursuant to this regulation, or grant any such application which does not comply with the requirements of subparagraph (g) of paragraph (2) but is accompanied by-
(a) detailed reports of the tests made to establish the safety of the new drug for the purpose and under the conditions of use for which it is recommended; and
(b) such other information and material as the Minister may in any particular case require.
66. A person shall not import, sell, advertise for sale or manufacture a new drug in respect of which he has been granted a licence, if any material change has been made in respect of that new drug, in-
(a) the strength, purity or quality;
(b) the pharmaceutical dosage form in which it is sold;
(c) the conditions of use, including indications for use and the route of administration;
(d) the dosage; or
(e) the label,
unless he makes application for a new licence in respect thereof, giving full details of the changes and the manner in which the new drug in respect of which the original licence was granted, is affected by the change.
67. Where a person wishes to import, sell, advertise for sale or manufacture, a new drug in respect of which a licence has been previously granted to another applicant, that person shall make a separate application in accordance with regulation 65.
68. The Minister shall, within one hundred and twenty days after the filing of an application for a licence to import, sell, advertise for sale. or manufacture a new drug-
(a) notify the applicant whether or not his application is satisfactory; and
(b) if so, may grant a Licence to the applicant in accordance therewith.
69. (1) The Minister may withdraw a licence in respect of any new drug by sending a notice in writing to that effect to the person to whom a licence has been granted in respect of that new drug, and such a withdrawal may be made where-
(a) evidence obtained from clinical or other experience, or from tests by new methods or by methods not used before the approval was given, reveal that the new drug is not shown to be safe for the use represented in the application made to the Minister in respect of that new drug and on which the approval by the Minister was based; or
(b) the submission filed with the Minister in relation to that new drug and on which approval by the Minister was based, contained any untrue statement of material fact; or
(c) the withdrawal is necessary in the public interest.
(2) Notice of withdrawal of approval in respect of any new drug shall be published for three consecutive weeks in the Gazette and in at least one issue of a daily newspaper printed and circulating in Jamaica, for three consecutive weeks.
70. Where any person receives any report of any unexpected side effects, injury, toxicity or sensitivity reaction associated with clinical uses, studies, investigation and tests respecting any new drug, he shall immediately inform the Minister thereof, furnishing him with the full information available.
71. (1) Notwithstanding anything to the contrary in these Regulations, a new drug may be imported for the use of investigators having such technical qualifications as is deemed necessary by the Minister in the circumstances for the sole purpose of obtaining clinical and scientific data with respect to its safety, stability, dosage or efficiency, if-
(a) the investigators have written authority from the Minister to carry out investigations on the new drug and the facilities for so doing:
(b) before the importation, the Minister is informed of the identifying name or mark by which the new drug may be recognized;
(c) both the inner and outer labels on any package of such new drug bear the statement "To be used for investigational purposes only";
(d) before the sale, the importer ensures that any person to whom the new drug is to be sold has written authority from the Minister to conduct investigations relating to that new drug. and obtains in writing from that person an undertaking that the new drug will be used solely by him or under his direction for investigational purposes
(2) A person who imports a new drug for the purpose of sale to any other person authorized by the Minister to carry out investigations in relation to that new drug shall keep accurate records of such sales. and shall make these records available for inspection by inspectors duly designated under the Act
72. Notwithstanding anything to the contrary in these Regulations. the Minister may grant permission in writing to any person to import any specified quantity of a new drug, for submission as a sample with an application for a licence in relation to that new drug.
73. Notwithstanding any other provision in these Regulations, the Minister may grant any emergency licence to a practitioner for the importation of a new drug, the application for which does not comply with the requirements of these Regulations, if that drug is required for the treatment of an urgent case, and the Minister is satisfied that it is in the best interest of the patient for whom the drug is intended, that the importation be effected without delay.
PART III Administration
83. A certificate of designation to be furnished to an inspector pursuant to subsection (4) of section 19 of the Act, shall be in the form set out as Form C in the Third Schedule.
84. When taking a sample in accordance with the provisions of section 19 of the Act, an inspector shall, after procuring a suitable quantity of the article in question, forthwith notify the owner thereof or the person from whom the sample was obtained, of his intention to have that sample examined or analysed and-
(a) where in his opinion, division of the procured quantity would not interfere with analysis or examination, the inspector shall-
(i) divide the quantity into three parts;
(ii) identify the three parts as the owner's portion, the sample, and the duplicate sample, and where only one part bears the label, that part shall be identified as the sample.
(iii) seal each part in such a manner that it cannot be opened without breaking the seal;
(iv) deliver the part identified as the owner's portion to the owner or to the person from whom the sample was obtained, and have the sample and the duplicate analysed or examined; or
(b) where, in his opinion division of the procured quantity would interfere with analysis or examination, the inspector shall- (i) identify the entire quantity as the sample;
(ii) seal the sample in such a manner that it cannot be opened without breaking the seal; and
(iii) have the sample analysed or examined:
(c) where the owner or the person from whom the sample was obtained objects to the procedure followed by an inspector at the time the sample was obtained, the inspector shall follow both procedures specified in this regulation, if the owner or the person from whom the sample was obtained supplies him with a sufficient quantity of the article to do so.
85.(1) A certificate of examination or analysis of an article or sample detained by an inspector shall be in the form set out as Form D in the Third Schedule.
(2) Where as a result of an examination or analysis it is reported that a food, drug. cosmetic or device. would, if sold in the Island. constitute a violation of the Act or these Regulations, that food, drug, cosmetic or device, shall not be admitted into the Island, for use as a food, drug, cosmetic or device, and the inspector shall send a written report of the analysis or examination to the Collector-General and a copy of such report to the importers.
86. Where a food, drug, cosmetic or device sought to be admitted into the Island, would, if sold in the Island, be contrary to the provisions of the Act or these Regulations, the food, drug, cosmetic or device may be admitted into the Island for the purpose of being relabelled or reconditioned under the supervision of an inspector in compliance with such conditions as may be specified in the report, and where such relabelling or reconditioning is not satisfactorily carried out within three months after the report is made or such lesser period as may be specified in the report, such food, drug, cosmetic or device. hall be re-exported and, if not re-exported within a further period of three months shall be disposed of as the Minister may direct, so however, that the Minister may, in his discretion, extend the time for complying with the conditions for re-exporting the said goods.
PART IV. Offences and Penalties
87. Any person who fails to comply with any of these Regulations shall be guilty of an offence, and upon summary conviction before a Resident Magistrate shall be liable to a fine not exceeding two thousand dollars or to a term of imprisonment not exceeding twelve months.
| # | Title | Download |
|---|---|---|
| 1 | The Food and Drug Regulations 1975 |  PDF |
| # | Name | Type | Agency | Description | Law | Valid To | Apply To |
|---|---|---|---|---|---|---|---|
| 1 | Pharmaceutical Chemical and Food Additives Import Permit | Permit Requirement | Ministry of Health & Wellness | A person shall not import any drugs unless (s)he has applied for and obtained a permit from the Ministry of Health and has paid a fee of $200. A single permit is only applicable to a maximum of ten (10) products. | The Food and Drug Regulations 1975 | 9999-09-09 | ALL |
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