Division 1A: Establishment Licences

C.01A.001. (1) The definitions in this subsection apply in this Division and in Divisions 2 to 4.

“antimicrobial agent” means a drug that is capable of destroying pathogenic micro-organisms and that is labelled as being for use in the disinfection of environmental surfaces or medical devices, as defined in the Medical Devices Regulations, that

(b) are intended to come into contact with intact skin only. (agent antimicrobien)

“batch certificate” means a certificate issued by the fabricator of a lot or batch of a drug that is exported within the framework of a mutual recognition agreement and in which the fabricator

(a) identifies the master production document for the drug and certifies that the lot or batch has been fabricated, packaged/labelled and tested in accordance with the procedures described in that document;

(i) a statement of all properties and qualities of the drug, including the identity, potency and purity of the drug, and

(c) identifies the analytical methods used in testing the lot or batch and provides details of the analytical results obtained;

(d) sets out the addresses of the buildings at which the lot or batch was fabricated, packaged/labelled and tested; and

(e) certifies that the lot or batch was fabricated, packaged/labelled and tested in accordance with the good manufacturing practices of the regulatory authority that has recognized those buildings as meeting its good manufacturing practices standards. (certificat de lot)

“class monograph” means a document prepared by the Department of Health that

(a) lists the types and strengths of medicinal ingredients that may be contained in drugs of a specified class; and

(b) sets out labelling and other requirements that apply to those drugs. (monographie de classe)

“dilute drug premix” means a drug for veterinary use that results from mixing a drug premix with a feed as defined in section 2 of the Feeds Act, to such a level that at least 10 kg of the resulting mixture is required to medicate one tonne of complete feed, as defined in section 2 of the Feeds Regulations, 1983, with the lowest approved dosage level of the drug. (prémélange médicamenteux dilué)

“dosage form class” means a parenteral, tablet, capsule, solution, suspension, aerosol, powder, suppository, medical gas or drug premix, or any other dosage form class designated by the Minister. (classe de forme posologique)

“drug premix” means a drug for veterinary use to which a drug identification number has been assigned, where the directions on its label specify that it is to be mixed with feed as defined in section 2 of the Feeds Act. (prémélange médicamenteux)

“fabricate” means to prepare and preserve a drug for the purposes of sale. (manufacturer)

“import” means to import into Canada a drug for the purpose of sale. (importer)

“MRA country” means a country that is a participant in a mutual recognition agreement with Canada. (pays participant)

“mutual recognition agreement” means an international agreement that provides for the mutual recognition of compliance certification for good manufacturing practices for drugs. (accord de reconnaisance mutuelle)

“package/label” means to put a drug in its immediate container or to affix the inner or outer label to the drug. (emballer-étiqueter)

“pharmaceutical” means a drug other than a drug listed in Schedule C or D to the Act. (produit pharmaceutique)

“recognized building” means, in respect of the fabrication, packaging/labelling or testing of a drug, a building that a regulatory authority that is designated under subsection C.01A.019(1) in respect of that activity for that drug has recognized as meeting its good manufacturing practices standards in respect of that activity for that drug. (bâtiment reconnu)

“regulatory authority” means a government agency or other entity in an MRA country that has a legal right to control the use or sale of drugs within that country and that may take enforcement action to ensure that drugs marketed within its jurisdiction comply with legal requirements. (autorité réglementaire)

“wholesale” means to sell any of the following drugs, other than at retail sale, where the seller’s name does not appear on the label of the drugs:

(a) a drug listed in Schedule C or D to the Act or in Schedule F to these Regulations or a controlled drug as defined in subsection G.01.001(1); or

(2) In this Division and in Division 2, “drug” means a drug in dosage form, or a drug that is a bulk process intermediate that can be used in the preparation of a drug listed in Schedule C to the Act or in Schedule D to the Act that is of biological origin. It does not include a dilute drug premix, a medicated feed as defined section 2 of the Feeds Regulations, 1983, a drug that is used only for the purposes of an experimental study in accordance with a certificate issued under section C.08.015 or a drug listed in Schedule H to the Act.

(3) Where the Minister designates additional dosage form classes, the Minister shall make a list of those classes available on request.

SOR/97-12, s. 5; SOR/98-7, s. 1; SOR/2000-120, s. 1; SOR/2002-368, s. 1; SOR/2004-282, S. 1.

C.01A.002. (1) This Division does not apply to

(b) importing or compounding, pursuant to a prescription, a drug that is not commercially available in Canada by one of the following persons, namely,

(c) any activity with respect to a drug that is used only for the purposes of clinical testing in accordance with subsection C.05.006(1) or section C.08.005,

(d) fabricating, packaging/labelling, testing as required under Division 2, distributing as a distributer referred to in section C.01A.003, wholesaling or importing any of the following drugs for which prescriptions are not required and that are for human use in dosage form and not represented as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states set out in Schedule A to the Act, namely,

(ii) drugs that meet the requirements of a class monograph entitled “Vitamin Supplements”, “Mineral Supplements”, “Dietary Vitamin Supplements” or “Dietary Mineral Supplements”, as the case may be, and

(A) contain a plant, mineral or animal substance in respect of which therapeutic activity or disease prevention activity is claimed, including traditional herbal medicines, traditional Chinese medicines, ayurvedic (East Indian) medicines and traditional aboriginal (North American) medicines, and

(B) the medical use of which is based solely on historical and ethnological evidence from references relating to a medical system other than one based on conventional scientific standards; and

(e) fabricating, packaging/labelling, testing, distributing, and importing of antimicrobial agents.

(2) This Division and Divisions 2 to 4 do not apply to the affixing of a label to a previously labelled container.

C.01A.003. This Division and Divisions 2 to 4 apply to the following distributors:

(a) a distributor of a drug listed in Schedule C or D to the Act or in Schedule F to these Regulations, a controlled drug as defined in subsection G.01.001(1) or a narcotic as defined in the Narcotic Control Regulations, who does not hold the drug identification number for the drug or narcotic; and

(b) a distributor of a drug for which that distributor holds the drug identification number.

C.01A.004. (1) Subject to subsection (2), no person shall, except in accordance with an establishment licence,

(a) fabricate, package/label, distribute as set out in section C.01A.003, import or wholesale a drug; or

(2) A person does not require an establishment licence to perform tests under Division 2 if the person holds an establishment licence as a fabricator, a packager/labeller, a distributor referred to in paragraph C.01A.003(b) or an importer.

(3) No person shall carry on an activity referred to in subsection (1) in respect of a narcotic as defined in the Narcotic Control Regulations or a controlled drug as defined in subsection G.01.001(1) unless the person holds a licence for that narcotic or drug under the Narcotic Control Regulations or Part G of these Regulations, as the case may be.

C.01A.005. Subject to section C.01A.006, a person who wishes to apply for an establishment licence shall submit an application to the Minister, in a form established by the Minister, that contains the following information:

(a) the applicant’s name, address and telephone number, and their facsimile number and electronic mail address, if any;

(b) the name and telephone number, and the facsimile number and electronic mail address, if any, of a person to contact in case of an emergency;

(d) each category of drugs set out in Table II to section C.01A.008 for which the licence is requested;

(e) each dosage form class in respect of which the applicant proposes to carry out a licensed activity, and whether it will be in a sterile dosage form;

(f) whether the applicant proposes to carry out a licensed activity in respect of a drug that is a bulk process intermediate;

(g) the address of each building in Canada in which the applicant proposes to fabricate, package/label, test as required under Division 2 or store drugs, specifying for each building which of those activities and for which category of drugs and, for each category,

(i) the dosage form classes, and whether any drugs will be in a sterile dosage form, and

(i) whether any building referred to in paragraphs (g) and (h) is a dwelling-house;

(j) the drug identification number, if any, or a name that clearly identifies the drug,

(i) for each narcotic as defined in the Narcotic Control Regulations or each controlled drug as defined in subsection G.01.001(1) for which the licence is requested, and

(ii) for each other drug within a category of drugs for which the licence is requested, unless the licence is to perform tests required under Division 2, distribute as set out in paragraph C.01A.003(a), or wholesale;

(k) if any of the buildings referred to in paragraph (g) have been inspected under the Act or these Regulations, the date of the last inspection;

(l) evidence that the applicant’s buildings, equipment and proposed practices and procedures meet the applicable requirements of Divisions 2 to 4;

(m) in the case of an importer of a drug that is fabricated, packaged/labelled or tested in an MRA country at a recognized building,

(i) the name and address of each fabricator, packager/labeller and tester of the drug and the address of each building at which the drug is fabricated, packaged/labelled or tested, specifying for each building the activities and the category of drug and

(ii) in respect of each activity done in an MRA country at a recognized building, the name of the regulatory authority that is designated under subsection C.01A.019(1) in respect of that activity for that drug and that has recognized that building as meeting its good manufacturing practices standards in respect of that activity for that drug, and

(A) a certificate from a Canadian inspector indicating that the fabricator’s, packager/labeller’s or tester’s buildings, equipment, practices and procedures meet the applicable requirements of Divisions 2 to 4, or

(B) other evidence establishing that the fabricator’s, packager/labeller’s or tester’s buildings, equipment, practices and procedures meet the applicable requirements of Divisions 2 to 4;

(n) in the case of any other importer, the name and address of each fabricator, packager/labeller and tester of the drugs proposed to be imported and the address of each building at which the drugs will be fabricated, packaged/labelled and tested, specifying for each building which of those activities and for which category of drugs and, for each category,

(i) the dosage form classes and whether any drugs will be in a sterile dosage form, and

(i) a certificate from a Canadian inspector indicating that the fabricator’s, packager/labeller’s and tester’s buildings, equipment, practices and procedures meet the applicable requirements of Divisions 2 to 4, or

(ii) other evidence establishing that the fabricator’s, packager/labeller’s and tester’s buildings, equipment, practices and procedures meet the applicable requirements of Divisions 2 to 4.

C.01A.006. (1) A person who wishes to amend an establishment licence shall submit an application to the Minister, in a form established by the Minister, that contains the applicable information specified in section C.01A.005.

(a) to add an activity or category of drugs, as set out in the tables to section C.01A.008;

(b) in respect of a category of drugs and activity indicated in the licence, to authorize sterile dosage forms of the category;

(c) to add any building in Canada at which drugs are authorized to be fabricated, packaged/labelled, tested as required under Division 2 or stored, or to add, for an existing building, an authorization to fabricate, package/label, test or store a category of drugs, or sterile dosage forms of the category; and

(d) in addition to the matters set out in paragraphs (a) to (c), in the case of an importer,

(ii) to amend the name or address of a fabricator, packager/labeller or tester indicated in the licence, and

(iii) if the address of the buildings at which drugs are authorized to be fabricated, packaged/labelled or tested is indicated in the licence, to add additional buildings or, for an existing building, to add an authorization to fabricate, package/label or test a category of drugs, or sterile dosage forms of the category.

C.01A.007. (1) The Minister may, on receipt of an application for an establishment licence or an amended establishment licence, require the submission of further details pertaining to the information contained in the application that are necessary to enable the Minister to process the application.

(2) When considering an application for an establishment licence or an amended establishment licence, the Minister may require that

(a) an inspection be made during normal business hours of any building referred to in paragraph C.01A.005(1)(g) or (h); and

(b) the applicant, if a fabricator, a packager/labeller, a person who performs tests required under Division 2, a distributor referred to in paragraph C.01A.003(b) or an importer, supply samples of any material to be used in the fabrication, packaging/labelling or testing of a drug.

C.01A.008. (1) Subject to section C.01A.010, the Minister shall, on receipt of the information and material required by sections C.01A.005 to C.01A.007, issue or amend an establishment licence.

(a) each activity that is authorized and the category of drugs for which each activity is authorized, as set out in the tables to this section, specifying for each activity and category whether sterile dosage forms are authorized;

(b) the address of each building in Canada at which a category of drugs is authorized to be fabricated, packaged/labelled, tested as required under Division 2 or stored, specifying for each building which of those activities and for which category of drugs, and whether sterile dosage forms of the category are authorized; and

(i) the name and address of each fabricator, packager/labeller and tester from whom the importer is authorized to obtain the drug for import, and

(ii) the address of each building at which the drug is authorized to be fabricated, packaged/labelled or tested, specifying for each building the activities and the category of drugs that are authorized, and whether sterile dosage forms are authorized.

(3) The Minister may indicate in an establishment licence a period for which records shall be retained under Division 2 that, based on the safety profile of the drug or materials, is sufficient to ensure the health of the consumer.

(4) The Minister may, in addition to the requirements of subsection (2), set out in an establishment licence terms and conditions respecting

(a) the tests to be performed in respect of a drug, and the equipment to be used, to ensure that the drug is not unsafe for use; and

(b) any other matters necessary to prevent injury to the health of consumers, including conditions under which drugs are fabricated, packaged/labelled or tested.

C.01A.009. An establishment licence expires on December 31 of each year.

C.01A.010. (1) The Minister may refuse to issue or amend an establishment licence in respect of any or all matters indicated in subsection C.01A.008(2) if

(a) the applicant has made a false or misleading statement in relation to the application for the licence; or

(b) the applicant has had an establishment licence suspended in respect of the matter.

(2) The Minister shall refuse to issue or amend an establishment licence in respect of any or all matters indicated in subsection C.01A.008(2) if the Minister has reasonable grounds to believe that issuing or amending an establishment licence in respect of the matter would constitute a risk to the health of the consumer.

(3) Where the Minister refuses to issue or amend an establishment licence, the Minister shall

C.01A.011. (1) Every person who holds an establishment licence shall comply with

(a) the requirements and the terms and conditions of the establishment licence; and

C.01A.012. (1) The Minister may amend the terms and conditions of an establishment licence if the Minister believes on reasonable grounds that an amendment is necessary to prevent injury to the health of the consumer.

(2) The Minister shall give at least 15 days notice in writing to the holder of the establishment licence of the proposed amendment, the reasons for the amendment and its effective date.

C.01A.013. Every person who holds an establishment licence shall notify the Minister in writing within 15 days after

(a) there is any change to the information referred to in any of paragraphs C.01A.005(a),(b),(e),(f),(h) and (i), and subparagraphs C.01A.005(g)(i) and (ii); or

(b) an event occurs that results in their being in contravention of any of the applicable requirements of Divisions 2 to 4, where it may affect the quality, safety or efficacy of a drug fabricated, packaged/labelled, tested as required under Division 2 or stored by them.

C.01A.014. (1) No licensee shall carry on a licensed activity in respect of any category of drugs if a change referred to in subsection (2) has occurred in respect of that category, unless

(a) they have filed with the Minister a notice that contains sufficient information to enable the Minister to assess the safety of the drug, taking into account the change; and

(b) the Minister has issued to them a letter indicating that the information will be reviewed and has not, within 90 days after issuing the letter, sent them a notice indicating that the change is not acceptable.

(2) Notification is required in respect of the following changes where they may affect whether a drug can be fabricated, packaged/labelled, tested or stored in accordance with the applicable requirements of Divisions 2 to 4:

(a) changes to the plans and specifications of a building where a drug is fabricated, packaged/labelled, tested or stored;

(b) changes to the equipment that is used in the fabrication, packaging/labelling or testing of a drug;

(d) in the case of an importer, other than an importer of a drug that is fabricated, packaged/labelled or tested in an MRA country at a recognized building, any change referred to in paragraphs (a) to (c) that relates to the fabricator, packager/labeller or tester of the drug being imported.

C.01A.015. (1) An importer of a drug that is fabricated, packaged/labelled or tested in an MRA country at a recognized building shall immediately notify the Minister if the fabricator, packager/labeller or tester indicated in the importer’s establishment licence no longer holds a valid permit, licence or other authorization issued by the regulatory authority that recognized that building.

(2) The Minister shall, on receiving a notification under subsection (1), amend the importer’s establishment licence by removing the name and address of that fabricator, packager/labeller or tester.

C.01A.016. (1) Subject to subsection (3), the Minister may suspend an establishment licence in respect of any or all matters indicated in subsection C.01A.008(2) if the Minister has reasonable grounds to believe that

(a) the licensee has contravened any provision of the Act or these Regulations; or

(b) the licensee has made a false or misleading statement in the application for the establishment licence.

(a) the licensee’s history of compliance with the Act and these Regulations; and

(b) the risk that allowing the licence to continue in force would constitute for the health of the consumer.

(3) Subject to subsection C.01A.017(1), the Minister shall not suspend an establishment licence until

(a) an inspector has sent the licensee a written notice that sets out the reason for the proposed suspension, any corrective action required to be taken and the time within which it must be taken;

(b) if corrective action is required, the time set out in the notice has passed without the action having been taken; and

C.01A.017. (1) The Minister may suspend an establishment licence without giving the licensee an opportunity to be heard if it is necessary to do so to prevent injury to the health of the consumer, by giving the licensee a notice in writing that states the reason for the suspension.

(2) A licensee may request of the Minister, in writing, that the suspension be reconsidered.

(3) The Minister shall, within 45 days after the date of receiving the request, provide the licensee with the opportunity to be heard.

C.01A.018. The Minister may reinstate an establishment licence after it has been suspended.

C.01A.019 (1) For the purposes of this Division and Divisions 2 to 4, a regulatory authority that is set out in column 1 of the table to this section is hereby designated in respect of the activities set out in column 3 for the drug or category of drugs set out in column 2.

(2) Whole blood and its components are excluded from the drugs and categories of drugs set out in column 2 of the table to this section.

(3) The lot release of drugs listed in Schedule D to the Act is excluded from the activity of testing set out in column 3 of the table to this section.