food and drug act pdf


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Marginal note:Where standard prescribed for drug. (2) A device that is not labelled or packaged as required by, or is labelled or packaged contrary to, the regulations shall be deemed to be labelled or packaged contrary to subsection (1).
(4) However, if the inspector decides under subsection (1) to give the owner or importer, or the person having possession, care or control of the food, drug, cosmetic or device the opportunity to take a measure in respect of it, the inspector, or any other inspector who is informed of the decision, shall decide whether the owner or importer, or the person having possession, care or control of it may remove it from Canada at their expense, consent to its forfeiture or take either of these measures, and shall notify or cause to be notified the owner or importer, or the person having possession, care or control of the food, drug, cosmetic or device that they may take that measure within the period specified by the inspector or other inspector, as the case may be. On this date, the Pure Food and Drug Act of 1906 (PL 59-384) passed in the U.S. House of Representatives, 240 to 17. Marginal note:Marketing authorization — representation. (l) seize and detain for the time that may be necessary any article that the inspector believes on reasonable grounds is an article by means of, or in relation to which, any provision of this Act or the regulations has been contravened.

(b) the vulnerability of consumers of the therapeutic product. (2) An analyst who has made an analysis or examination may issue a certificate or report setting out the results of the analysis or examination. Canada–United States–Mexico Agreement has the meaning assigned by the definition Agreement in section 2 of the Canada–United States–Mexico Agreement Implementation Act; (Accord Canada–États-Unis–Mexique), North American Free Trade Agreement[Repealed, 2020, c. 1, s. 58], WTO Agreement has the meaning given to the word Agreement by subsection 2(1) of the World Trade Organization Agreement Implementation Act. (Accord sur l’OMC), Marginal note:Regulations to implement General Council Decision.

(a) it is manufactured or prepared outside Canada; (b) it is imported solely for the purpose of export and is not sold for consumption or use in Canada; and. Pure Food and Drug Act (1906) United States.
0000014773 00000 n (c) a person who carries out functions relating to the protection or promotion of human health or the safety of the public. 754 0 obj <> endobj Short title 2. H��W�n�H}�W�#��i6��'�3��A0V��ł�Zw6�M������f7/�� �ERbu��9U7_���7����y�Ç���ؕ��8+���?��Z]}�]��v�lw���\���.������f;Ÿ�����]�x��w��W��/r9�����o�I����������7�g^�m�6��^}�]}����˙Sz�+��i�&�fB�^2��-m(�]/&+_�v��P.#����2d���Y�a�qt�0@=^��W�>���,�A�:��(�N�N֏�����ew��eAƣ-��$N������� (a) specify provisions of the regulations that are excluded from the scope of the exemption provided for in section 21.96; and. Marginal note:Importation and interprovincial movement of food, 6 (1) Where a standard for a food has been prescribed, no person shall, (b) send, convey or receive for conveyance from one province to another, or, (c) have in possession for the purpose of sending or conveying from one province to another. 754 28 (a) on notice to its owner or the person having possession, care or control of it at the time of its seizure, store it or move it at the expense of the person to whom the notice is given; (b) order its owner or the person having possession, care or control of it at the time of its seizure to store it or move it at the expense of the person being so ordered; or, (c) order its owner or the person having possession, care or control of it at the time of its seizure to dispose of it at the expense of the person being so ordered — or, on notice to its owner or the person having possession, care or control of it at the time of its seizure, dispose of it at the expense of the person to whom the notice is given — if. xref and defining for the purposes of this Act the expression new drug; (p) authorizing the advertising to the general public of contraceptive devices and drugs manufactured, sold or represented for use in the prevention of conception and prescribing the circumstances and conditions under which, and the persons by whom, those devices and drugs may be so advertised; (q) defining agricultural chemical, food additive, mineral nutrient, veterinary drug and vitamin for the purposes of this Act; (r) respecting marketing authorizations, including establishing the eligibility criteria for submitting an application for such authorizations or for amending such authorizations; (s) respecting the implementation, in relation to any food, drug, cosmetic or device, of international agreements that affect them; and. 0000000950 00000 n 0000011117 00000 n (i) risks that have been communicated outside Canada, and the manner of the communication, (ii) changes that have taken place to labelling outside Canada, and. (a) 14 days after it is made, unless it is approved by the Governor in Council, (c) the day on which a regulation made under this Act, that has the same effect as the interim order, comes into force, and.

Center for Drug Evaluation and Research (CDER) (3) If a remission granted under subsection (1) is conditional and the condition is not fulfilled, then the remission is cancelled and is deemed never to have been granted. Marginal note:Accessibility of incorporated documents. Marginal note:Stopping or moving conveyance. 0 30.2 (1) Subject to regulations made under paragraph 30(1)(r), the Minister may issue a marketing authorization that exempts — if the conditions, if any, to which the marketing authorization is subject are met — an advertisement, or a representation on a label, with respect to a food from the application, in whole or in part, of subsection 3(1) or (2) or any provision of the regulations specified in the marketing authorization. 0000000016 00000 n Marginal note:Disclosure —  serious risk. Marginal note:Regulations — Canada–United States–Mexico Agreement and WTO Agreement.

(1.1) A regulation made under this Act may establish classes and distinguish among those classes.

(2) On production to the Federal Court, a certificate made under subsection (1) shall be registered in that Court and, when registered, has the same force and effect, and all proceedings may be taken on the certificate, as if it were a judgment obtained in that Court for a debt of the amount specified in the certificate and all reasonable costs and charges attendant in the registration of the certificate. Marginal note:Interpretation — definitions food, drug, cosmetic and device. 27.2 (1) An inspector who has reasonable grounds to believe that an imported food, drug, cosmetic or device does not meet the requirements of the regulations or was imported in contravention of a provision of this Act or the regulations may, by notice, whether the food, drug, cosmetic or device is seized or not, order its owner or importer, or the person having possession, care or control of it, to remove it from Canada at their expense or, if removal is not possible, to destroy it at their expense. advanced therapeutic product means a therapeutic product that is described in Schedule G or that belongs to a class of therapeutic products that is described in that Schedule; (produit thérapeutique innovant), advertisement includes any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of any food, drug, cosmetic or device; (publicité ou annonce), analyst means an individual designated as an analyst for the purposes of this Act under section 28 or under section 13 of the Canadian Food Inspection Agency Act; (analyste), clinical trial means a study, involving human subjects, for the purpose of discovering or verifying the effects of a drug, a device or a food for a special dietary purpose; (essai clinique), confidential business information, in respect of a person to whose business or affairs the information relates, means — subject to the regulations — business information, (b) in respect of which the person has taken measures that are reasonable in the circumstances to ensure that it remains not publicly available, and, (c) that has actual or potential economic value to the person or their competitors because it is not publicly available and its disclosure would result in a material financial loss to the person or a material financial gain to their competitors; (renseignements commerciaux confidentiels), contraceptive device means any instrument, apparatus, contrivance or substance other than a drug, that is manufactured, sold or represented for use in the prevention of conception; (moyen anticonceptionnel), cosmetic includes any substance or mixture of substances manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth, and includes deodorants and perfumes; (cosmétique), Department means the Department of Health; (ministère), device means an instrument, apparatus, contrivance or other similar article, or an in vitro reagent, including a component, part or accessory of any of them, that is manufactured, sold or represented for use in. 3.2 The holder of an authorization referred to in section 3.1 shall comply with any terms and conditions of the authorization that are imposed by the Minister under regulations made under paragraph 30(1)(b.3). (5) If a person is notified under subsection (4) that they may consent to the forfeiture of the food, drug, cosmetic or device and the person consents to its forfeiture, the food, drug, cosmetic or device is forfeited to Her Majesty in right of Canada and may be disposed of, as the Minister may direct, at the person’s expense. 182 A person that, immediately before the coming into force of section 166, is authorized under Part 4 of the Natural Health Products Regulations to sell or import a natural health product for the purposes of a clinical trial is deemed to be the holder, in respect of that natural health product, of an authorization referred to in section 3.1 of the Food and Drugs Act, as enacted by that section 166. (4) In this section, government means any of the following or their institutions: (b) a corporation named in Schedule III to the Financial Administration Act; (c) a provincial government or a public body established under an Act of the legislature of a province; (d) an aboriginal government as defined in subsection 13(3) of the Access to Information Act; (e) a government of a foreign state or of a subdivision of a foreign state; or. 5 (1) The maximum residue limit established for an agricultural chemical and its derivatives under the Food and Drug Regulations, as those regulations read immediately before the coming into force of this subsection, is deemed, if the agricultural chemical is a pest control product as defined in subsection 2(1) of the Pest Control Products Act, chapter 28 of the Statutes of Canada, 2002, to have been specified by the Minister under section 9 or 10 of that Act as the maximum residue limit for that agricultural chemical and its derivatives.

30.64 The Minister may withdraw or withhold a service, the use of a facility, a regulatory process or approval or a product, right or privilege under this Act from any person who fails to pay the fee fixed for it under subsection 30.61(1). Marginal note:Unsanitary manufacture, etc., of food. 31.7 If an offence under section 31.2 or 31.4 is committed or continued on more than one day, it constitutes a separate offence for each day on which it is committed or continued.

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