C-38.8Controlled Drugs and Substances ActSOR/2002-35920029
24
200512
14
201301
28
20062
24
CONTROLLED DRUGS AND SUBSTANCES ACTPrecursor Control RegulationsP.C.2002-161520029
24
Whereas a provision of the annexed Regulations deals with the communication of information obtained under the Regulations to certain classes of persons, and in the opinion of the Governor in Council, pursuant to paragraph 55(1)(s) of the Controlled Drugs and Substances Acta, it is necessary to communicate the information to those classes of persons for the proper administration of the Act and the Regulations;Therefore, Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 55(1) of the Controlled Drugs and Substances Acta, hereby makes the annexed Precursor Control Regulations.S.C. 1996, c. 19INTERPRETATIONThe following definitions apply in these Regulations.Act means the Controlled Drugs and Substances Act. (Loi)Class A export permit means a permit to export one or more Class A precursors, issued under section 33. (permis d’exportation de catégorie A)Class A import permit means a permit to import one or more Class A precursors, issued under section 26. (permis d’importation de catégorie A)Class A precursor means,any substance set out in Part 1 of Schedule VI to the Act; andany preparation or mixture referred to in Part 3 of Schedule VI to the Act that contains a substance referred to in paragraph (a). (précurseur de catégorie A)Class B export permit means a permit to export one or more Class B precursors, issued under section 70. (permis d’exportation de catégorie B)Class B precursor means,any substance set out in Part 2 of Schedule VI to the Act; andany preparation or mixture referred to in Part 3 of Schedule VI to the Act that contains a substance referred to in paragraph (a). (précurseur de catégorie B)competent authority means a public authority of a foreign country that is authorized under the laws of the country to approve the importation or exportation of precursors into or from the country. (autorité compétente)customs officer means an officer as defined in subsection 2(1) of the Customs Act. (agent des douanes)designated criminal offence meansany offence involving the financing of terrorism against sections 83.02 to 83.04 of the Criminal Code;any offence involving fraud against sections 380 to 382 of the Criminal Code;the offence of laundering proceeds of crime against section 462.31 of the Criminal Code;an offence involving organized crime against sections 467.11 to 467.13 of the Criminal Code; ora conspiracy or an attempt to commit, being an accessory after the fact in relation to, or any counselling in relation to, an offence referred to in paragraphs (a) to (e). (infraction désignée en matière criminelle)designated drug offence meansan offence against section 39, 44.2, 44.3, 48, 50.2 or 50.3 of the Food and Drugs Act, as those provisions read immediately before May 14, 1997;an offence against section 4, 5, 6, 19.1 or 19.2 of the Narcotic Control Act, as those provisions read immediately before May 14, 1997;an offence under Part I of the Act, except subsection 4(1), and an offence against section 46 of the Act; ora conspiracy or an attempt to commit, being an accessory after the fact in relation to, or any counselling in relation to, an offence referred to in paragraphs (a) to (c). (infraction désignée en matière de drogue)drug in dosage form means a drug in a form that is ready for use by the consumer without requiring any further manufacturing. (drogue sous forme posologique)extract means, in respect of a precursor, to isolate the precursor from a preparation or mixture by any physical or chemical process including distillation. (extraire)Harmonized System Code means, in respect of goods, the numeric identifier set out for those goods in the Harmonized Commodity Description and Coding System published by the World Customs Organization. (numéro de code du système harmonisé)hospital means a facility thatis licensed, approved or designated as a hospital by a province under the laws of the province to provide health care or treatment to persons or animals; andis owned or operated by the Government of Canada or a province and that provides health services. (hôpital)INCB means the International Narcotics Control Board. (OICS)internal controls means, in respect of an undertaking conducting activities pertaining to a precursor, the internal processes and procedures used by the undertaking to assist in achieving the objective that, to the extent practical, it has reliable information about its precursor activities governed by these Regulations. (contrôles internes)international obligation means an obligation in respect of a controlled substance or a precursor set out in a convention, treaty or other multilateral or bilateral instrument that Canada has ratified or to which Canada adheres. (obligation internationale)licence means a licence issued to a licensed dealer under section 16. (licence)licensed dealer means the holder of a licence. (distributeur autorisé)peace officer means a peace officer as defined in section 2 of the Criminal Code. (agent de la paix)pharmacist means an individual whois registered or otherwise authorized under the laws of a province to practise pharmacy; andis practising pharmacy in that province. (pharmacien)prescription means, in respect of a preparation or mixture containing a Class A precursor, an authorization from a practitioner stating that a specific amount of the preparation or mixture may be sold or provided for the individual or animal under the practitioner’s care named in the authorization. (ordonnance)produce means, in respect of a precursor, to obtain the precursor by any method or process, includingmanufacturing, synthesizing or using any means of altering the chemical or physical properties of the precursor, orcultivating, propagating or harvesting the precursor or any living thing from which the precursor may be isolated or otherwise obtainedand includes offer to produce. (production)registered dealer means the holder of a registration certificate. (distributeur inscrit)registration means registration by the Minister under section 62. (inscription)registration certificate means a certificate issued under section 62. (certificat d’inscription)responsible person in charge means the individual designated under subsection 13(2) having responsibility for the supervision of activities carried out at the licensed site by the licensed dealer under their licence. (personne responsable)retail means a sale or provision of goods for the purpose of end-use but not resale. (au détail)senior person in charge meansin respect of a licensed dealer, the individual designated under subsection 13(1) to have overall responsibility for management of the licensed dealer’s Class A precursor activities at the licensed site; andin respect of a registered dealer, the individual designated under subsection 59(1) to have overall responsibility for management of the registered dealer’s Class B precursor activities (responsable principal)site means, in respect of a licensed dealer or a registered dealer carrying on one or more activities mentioned in section 6 or 57, respectively,a building or place in a building used by the licensed dealer or registered dealer; oran area occupied exclusively by buildings used by the licensed dealer or registered dealer. (installation)transhipment means, in respect of a Class A precursor that has been unloaded or in any way removed from the means of transportation by which it came into Canada, its loading or placing on board or within or on the same or any other means of transportation used for its departure from Canada. (transbordement)
SOR/2005-365, s. 1.
CLASS A PRECURSORSExemptionWith respect to a drug in dosage form, a person who sells or provides or possesses for the purpose of sale or provision, or who conducts an activity mentioned in section 9 or 47, is exempt from the requirements of these Regulations in respect of that activity if the drug containsa Class A precursor listed in Schedule F to the Food and Drug Regulations; ora Class A precursor and one or more controlled substances listed in Schedule I, III or IV to the Act.
SOR/2005-365, s. 2.
With respect to a Class A precursor that is a preparation or mixture, a person who conducts an activity mentioned in section 6, 9, 10 or 47 is exempt from the requirements of these Regulations, except requirements in respect of the production of the preparation or mixture or the possession of a precursor for the purpose of producing the preparation or mixture, ifthe preparation or mixture is a fragrance or flavouringcontaining anthranilic acid, N-anthranilic acid, gamma butyrolactone, phenylacetic acid, piperonal or piperidine in a total concentration equal to or less than 20% by weight or volume in the case of a solid or liquid, respectively, andintended to be used in a food, drug, cosmetic or household product;it is a silicone product that is a sealant, adhesive or coating containing acetic anhydride in a concentration equal to or less than 1% by weight or volume in the case of a solid or liquid, respectively; orit contains gamma butyrolactone or 1,4-butanediol in a total concentration equal to or less than 20% by weight or volume in the case of a solid or liquid respectively, and is intended to be used in the following products or processes:a control product as defined in the Pest Control Products Act, R.S., c. P-9, before the coming into force of subsection 2(1) of the Pest Control Products Act, S.C. 2002, c. 28,a pest control product as defined in the Pest Control Products Act, S.C. 2002, c. 28, after the coming into force of subsection 2(1) of that Act,cleaning or etching preparations for electronic devices, components and parts,biofermentation for polyester production,melamine coatings,automotive coatings, orresin systems for manufacturing polyurethane.
SOR/2005-365, s. 3.
A person who uses a Class A precursor that is described in section 3 or is the subject of an authorization certificate under section 49, to produce another Class A precursor that is a preparation or mixture, is exempt from the requirements of these Regulations in respect of that production.With respect to a preparation or mixture produced under subsection (1), a person who conducts any activity mentioned in section 6, 9, 10 or 47 is exempt from the requirements of these Regulations in respect of the activity.
SOR/2005-365, s. 4.
With respect to any Class A precursor, a person who only sells, provides or possesses for the purpose of sale or provision is exempt from the requirements of these Regulations in respect of the activity if the personsells or provides a selection of goods that is not limited to chemicals or chemicals and equipment used in the chemical industry for the production, processing or storage of chemicals; andsells or provides Class A precursorsonly on a retail basis,in the case of a precursor set out in column 1 of the schedule, only in a quantity, per transaction, that does not exceed the maximum quantity, expressed as an absolute amount or per package, specified for the precursor in column 2 of the schedule, andin the case of a preparation or mixture containing a precursor set out in column 1 of the schedule, only in a quantity, per transaction, that does not exceed the maximum quantity, expressed as an absolute quantity or per package, specified for the contained precursor in column 2 of the schedule.
SOR/2003-153, s. 1;
SOR/2005-365, s. 4.
Limitation on ActivitiesNo person other than a licensed dealer mayproduce a Class A precursor;package a Class A precursor; orsell or provide a Class A precursor.No person may possess a Class A precursor for the purpose of an activity mentioned in subsection (1), except to the extent necessary to conduct the activity in relation to the precursor, as authorized by the person’s licence.A licensed dealer may import or export a Class A precursor or possess a Class A precursor for the purpose of export if the dealer complies with the conditions set out in section 7.No person may possess a Class A precursor for the purpose of producing a controlled substance unless the person is the holder ofa licence issued under section G.02.003.2 or J.01.007.2 of the Food and Drug Regulations, section 21 of the Benzodiazepines and Other Targeted Substances Regulations or section 9.2 of the Narcotic Control Regulations that authorizes the production of the substance; oran exemption issued under section 56 of the Act.
SOR/2005-365, s. 5.
Conditions Applicable to Licensed DealersA licensed dealer may carry out an activity referred to in section 6 ifthe licensed dealer is licensed to carry out the activity with respect to the Class A precursor;the licensed dealer carries out the activity in accordance with all conditions set out in the licence;in the case of import, the licensed dealer is the holder of a Class A import permit for the precursor and acts in accordance with all conditions set out in the permit; andin the case of export, the licensed dealer is the holder of a Class A export permit for the precursor and acts in accordance with all conditions set out in the permit.End-use DeclarationA licensed dealer who intends to sell or provide, to a person who is not a licensed dealer, a Class A precursor set out in column 1 of the schedule in a quantity, per transaction, greater than the maximum quantity, expressed as an absolute quantity or per package, specified for the precursor in column 2 of the schedule shall, before entering into the transaction, obtain an end-use declaration signed and dated by the person acquiring the precursor.The end-use declaration shall includethe name of the licensed dealer, being, in the case of a corporation, its corporate name, as well as their address and telephone number and facsimile transmission number, if any;the name of the person acquiring the precursor, being, in the case of a corporation, its corporate name, as well as their address and telephone number and facsimile transmission number, if any;the name of all Class A precursors involved in the transactions mentioned in the end-use declaration;all uses for which the precursor is being acquired; anda certification by the signatory stating that the person is acquiring the precursor as the end user, for the uses mentioned in the end-use declaration.If a licensed dealer intends to sell or provide, to a person who is not a licensed dealer, a Class A precursor that is a preparation or mixture containing a precursor set out in Part 1 of Schedule VI to the Act, an end-use declaration under subsection (1) is required if the quantity of the contained precursor, per transaction, is greater than the maximum quantity, expressed as an absolute quantity or per package, specified for the contained precursor in column 2 of the schedule.An end-use declaration obtained under subsection (1) or (2) applies to any subsequent transaction between the licensed dealer and the signatory to the declaration that occurs in the same calendar year as the transaction mentioned in the declaration if the subsequent transaction involves the same Class A precursor and the same end-uses.For greater certainty, another end-use declaration must be obtained in respect of a subsequent transaction between the licensed dealer and the signatory to the declaration that occurs in the same calendar year as the transaction mentioned in the declaration if the transaction involves a different Class A precursor or a different end-use.A licensed dealer required to obtain an end-use declaration must take reasonable steps to verify the identity of the signatory to the declaration if that person or their signature is unfamiliar to the licensed dealer.
SOR/2005-365, s. 6.
Limitation on TransportationNo person may send, transport or deliver a Class A precursor, or possess the precursor for such a purpose, excepta licensed dealer, to the extent necessary to conduct an activity permitted by the licence in respect of the precursor;a representative of the licensed dealer;the end user of the precursor; ora representative of the end user.A person sending, transporting or delivering a Class A precursor set out in column 1 of the schedule in a quantity greater than the maximum quantity, expressed as an absolute quantity or per package, specified for the precursor in column 2 of the schedule, shall ensure that the precursor is accompanied by documentation indicatingthe name and quantity of the precursor;the name of the licensed dealer selling or providing the precursor;the name of the person to whom the precursor is being sent, transported or delivered; andthe date the precursor was sent.A licensed dealer must, when transporting an imported Class A precursor between the port of entry and the site set out in the licence, or when sending, delivering or transporting a Class A precursor to a destination, including the port of exit, take all steps necessary to ensure the safekeeping of the precursor during transportation or ensure that all steps are taken so as to prevent the diversion of the precursor to an illicit market or use.
SOR/2005-365, s. 7.
If a rail car, reusable container, intermodal tank container or other container, having a capacity of 9,000 L or more, was used to provide or send red or white phosphorus and the rail car or container is returned to the person who produced the phosphorous with residual amounts that cannot be offloaded under normally accepted operating procedures in the chemical industry, the person returning the rail car or container in that state is exempt from the requirements of these Regulations in respect of that activity.
SOR/2005-365, s. 8.
A person shall not transport a Class A precursor in transit through Canada or tranship a Class A precursor in Canada that is coming from one country and going to another or possess a Class A precursor for either of those purposes except in accordance with a permit issued under section 40.Authorization Concerning Preparations and MixturesDespite sections 6 to 10 and 47, with respect to a Class A precursor that is a preparation or mixture, a person may sell, provide, send, transport, deliver, import, export, transport in transit through Canada, tranship in Canada, destroy or possess for those purposes ifthe preparation or mixture is the subject of an authorization certificate under section 49; andno notice indicating that the certificate has been revoked or is under suspension appears on the following Health Canada Internet site:http://www.hc-sc.gc.ca/dhp-mps/substancontrol/index_e.html
SOR/2005-365, s. 9.
IndividualsAn individual entering or returning to Canada and having in their possession a Class A precursor that is a preparation or mixture may import the preparation or mixture ifthe preparation or mixture is intended to treat a medical condition of the individual or an accompanying person for whom the individual is responsible;in the case of a preparation or mixture containing ephedra, ephedrine or pseudoephedrine, the preparation or mixture is packaged and labelled as a consumer product and the total quantity imported of the precursor contained in the preparation or mixture does not exceedin the case of ephedra, 20 g,in the case of ephedrine, 0.4 g, andin the case of pseudoephedrine, 3 g; andin the case of a preparation or mixture containing ergometrine or ergotamine, the preparation or mixture is packaged in a container with a label showing that it was dispensed under prescription in a pharmacy or hospital or by a physician and the total quantity imported of the precursor contained in the preparation or mixture does not exceed the lesser ofa single prescribed course of treatment, anda 90-day supply, based on the normal daily dose for the precursor.An individual leaving Canada and having in their possession a Class A precursor that is a preparation or mixture may export the preparation or mixture if the requirements of subsection (1) are met, with any modifications that the circumstances require.LicenceEligibility for a LicenceTo be eligible to apply for a licence, a person must bean individual who ordinarily resides in Canada; ora corporation that has its head office or a branch office in Canada.Senior Person in Charge and Responsible Person in ChargeA licensed dealer must designate a senior person in charge, who may, if appropriate, be the licensed dealer, to have overall responsibility for management of the licensed dealer’s Class A precursor activities at the licensed site.A licensed dealer must designate a responsible person in charge, who may, if appropriate, be the senior person in charge, to work at the site set out in the licence and have responsibility for supervising, on behalf of the licensed dealer, the licensed dealer’s Class A precursor activities at the site and for ensuring that the activities comply with these Regulations.A licensed dealer may designate an alternate responsible person in charge to work at the site set out in the licence and have authority to replace the responsible person in charge when that person is absent.The senior person in charge, responsible person in charge and the alternate responsible person in chargemust be familiar with the provisions of the Act and these Regulations that apply to the licence held by the licensed dealer by whom they are designated; andmust not have been convicted, as an adult, within the previous 10 years, ofa designated drug offence,a designated criminal offence, oran offence committed outside of Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii).The responsible person in charge and the alternate responsible person in charge must have sufficient knowledge concerning the use and handling of Class A precursors to which the licence applies, including the risk of those precursors being diverted to an illicit market or use, to enable them to properly perform their responsibilities.Application for a LicenceAn application for a licence or to renew a licence pertaining to a Class A precursor shall be made to the Minister and contain the following informationthe applicant’s name or, if the applicant is a corporation, its corporate name, any other registered name with a province and any other trade name under which the applicant intends to carry out the activities set out in the licence or intends to identify itself;a description of the nature of the business conducted or intended to be conducted by the applicant;the length of time, if any, the applicant has been in business;for each Class A precursor sought to be licensed,its name, if any, otherwise a description of its chemical composition,if it is a salt, the name of the salt,if it is a preparation or mixture, its brand name, if any, and the names of all precursors set out in Part 1 of Schedule VI to the Act that it contains;if it is a drug containing a precursor for which a drug identification number has been assigned under section C.01.014.2 of the Food and Drug Regulations, the drug identification number, andif it is a natural health product containing a precursor for which a product number has been assigned under section 8 of the Natural Health Products Regulations, the product number;for each precursor mentioned in the application,the Class A precursor activity referred to in section 6 that is sought to be licensed and that would be conducted at the site to which the licence would apply,the names of the persons from whom the applicant intends to obtain the precursor, if applicable, andthe type of clientele to whom the applicant intends to supply the precursor;if an establishment licence under section C.01A.008 of the Food and Drug Regulations has been issued to the applicant in respect of a Class A precursor, the number of the licence;if a site licence under section 29 or 36 of the Natural Health Products Regulations has been issued to the applicant in respect of a Class A precursor, the number of the licence;the address, telephone number, facsimile transmission number and e-mail address of the site sought to be licensed and each building within the site where the activity sought to be licensed is to be carried out;the postal address for the site and each building referred to in paragraph (d), if different from the address provided under that paragraph;the name, date of birth, gender, position with the applicant, telephone number, facsimile transmission number and e-mail address of the senior person in charge for the site;the name, date of birth and gender of the responsible person in charge for the site and the alternate responsible person in charge, if any;a description of the proposed security measures to be used at the site and when a precursor is transported, sent or delivered, including the measures required under subsection 9(2), section 83 and subsection 85(3);a description of the internal controls proposed with respect to precursor activities at the site; andin the case of an application to renew, the number of the licence sought to be renewed.If the applicant intends to engage in an activity referred to in section 6 respecting Class A precursors at more than one site, a separate application must be made for each site.The application for a licence or its renewal mustbe signed by the senior person in charge for the site mentioned in the application; andinclude a statement thatthe information and documents provided in the application are correct and complete to the best of the knowledge of the signatory, andthe signatory has the authority to bind the applicant.An application for a licence or its renewal must be accompanied bydeclarations signed by the senior person in charge, the responsible person in charge and the alternate responsible person in charge, if any, stating that they have not, as an adult, been convicted within the previous 10 years ofa designated drug offence,a designated criminal offence, oran offence committed outside of Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii);a document issued by a Canadian police force with respect to each of the persons referred to in paragraph (a), setting out the person’s criminal record for the previous 10 years, as an adult, in respect of designated drug offences and designated criminal offences, or indicating that the person has no such record;if any of the persons mentioned in paragraph (a) has ordinarily resided in a country other than Canada in the preceding 10 years, a document issued by a police force of that country setting out the person’s criminal record for the previous 10 years, as an adult, in respect of an offence that would have constituted a designated criminal offence or a designated drug offence if committed in Canada, or indicating that the person has no such record; andif applicable, a copy ofthe certificate of incorporation or other constituting instrument for the applicant, andany document filed with the province in which the site sought to be licensed is located that states the applicant’s corporate name and any other name registered with the province under which the applicant will carry out the activities set out in the licence or will identify itself.The documents referred to in paragraphs (4)(b) and (c) are not required if the persons referred to in those paragraphs consent in writingto having a criminal record check carried out for them, as an adult, in respect of the offences mentioned in those paragraphs during the preceding 10 years;to provide all information and to submit to any means of identification required to obtain the criminal record check; andto pay the fee established by the Royal Canadian Mounted Police, Criminal Record Verification for Civil Purposes Fee Regulations.
SOR/2003-153, s. 2(E);
SOR/2005-365, s. 10.
Additional InformationThe Minister may, on receiving an application made under this Part, require the submission of any additional information that pertains to the information contained in the application and that is necessary for the Minister to process the application.Pre-licence InspectionThe Minister may, in respect of an applicant or a licensed dealer, at any reasonable time,require the inspection of the site used or intended to be used in producing, packaging, selling or providing a Class A precursor or to or from which a Class A precursor has been or is to be imported or exported;examine, as part of the inspection, the security measures used or put in place at the site and in respect of the sending, transportation or delivery of precursors;examine, as part of the inspection, the internal controls used or put in place at the site with respect to precursor activities; andexamine, as part of the inspection, the books, registers, electronic data and other records held or put in place in accordance with section 85.
SOR/2005-365, s. 11.
Issuance of LicenceSubject to section 17, if the requirements of section 14 are met, the Minister shall issue or renew a licence that indicatesthe licence number;the name of the licensed dealer or, if the applicant is a corporation, their corporate name;the names of all Class A precursors to which the licence applies;for each precursor to which the licence applies, the Class A precursor activities authorized by the licence;the address of the licensed site where the authorized activities are to be conducted;the effective date of the licence;the date of expiry of the licence, which may not be later than three years after the effective date; andany conditions that are necessary toensure that the international obligations of Canada are respected, orensure compliance with the Act and these Regulations, including reducing the risk of a Class A precursor being diverted to an illicit market or use.Grounds for RefusalSubject to subsection (2), the Minister shall, in accordance with subsection 84(1), refuse to issue, renew or amend a licence ifthe applicant is not eligible under section 12;the Minister has reasonable grounds to believe that any information or document included in the application is false or misleading;additional information required under section 15 has not been provided or is insufficient to enable the Minister to process the application;the issuance, renewal or amendment of the licence would permit an activity that would not be in compliance with an international obligation of Canada;information received from a competent authority, the United Nations or a peace officer raises a reasonable belief that the applicant has been or will be involved in the diversion of a controlled substance or precursor to an illicit market or use;the applicant does not have in place the security measures required under subsection 9(2), section 83 and subsection 85(3) with respect to the precursors sought to be licensed;the applicant is not, or within the previous 10 years has not been, in compliance witha provision of the Act or any regulation made or continued under the Act, ora term or condition of a licence, registration or import or export permit issued to the applicant under any regulation made or continued under the Act;the senior person in charge for the site, the responsible person in charge or the alternate responsible person in charge, if any, has been convicted, as an adult, within the previous 10 years, ofa designated drug offence,a designated criminal offence, oran offence committed outside of Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii);the proposed internal controls referred to in paragraph 14(1)(i) are not sufficient tosupport a reliable system of record-keeping in respect of Class A precursor activities and Class A precursor inventory at the site, orpermit the Minister to audit these precursor activities; orthe issuance, renewal or amendment of the licence would likely create a risk to public health, safety or security, including the risk of a Class A precursor being diverted to an illicit market or use.The Minister is not required to refuse to issue, renew or amend a licence under paragraph (1)(b) or (g) if the applicantdoes not have a history of non-compliance with the Act and any regulation made or continued under the Act; andhas carried out, or signed an undertaking to carry out, specified corrective measures to ensure compliance with the Act and these Regulations.
SOR/2005-365, s. 12.
ExpirationA licence is valid until the earlier ofthe expiry date set out in the licence; orthe suspension or revocation of the licence under section 22, 23 or 24.Amendment of Licence[SOR/2005-365, s. 13(E)]A licensed dealer proposing to amend the information on their licence shall provide the following documents to the Ministeran application in writing describing the proposed amendment, accompanied by any supporting documents mentioned in section 14 that are relevant to the proposed amendment; andthe original licence.The application mustbe signed by the senior person in charge for the site; andinclude a statement that the information and documents provided in the application are correct and complete to the best of the knowledge of the signatory.Subject to section 17, if the application complies with subsections (1) and (2), the Minister shall amend the licence accordingly and may add any condition necessary to ensurethat the international obligations of Canada are respected, orcompliance with the Act and these Regulations, including reducing the risk of a Class A precursor being diverted to an illicit market or use.
SOR/2003-153, s. 3(E).
Amendment of Application InformationA licensed dealer must obtain the Minister’s approval beforedesignating a replacement for the senior person in charge;designating a replacement for either the responsible person in charge or the alternate responsible person in charge, or designating an individual to be the alternate responsible person in charge;making a change to the security measures used at the site with respect to Class A precursors kept there or described in the licence application under paragraph 14(1)(h) or in a request for approval under this section; ormaking a change to the internal controls applicable to the Class A precursor activities conducted at the site, as described in the licence application or a request approved under this section.With a request for approval under paragraph (1)(a) or (b), the licensed dealer must provide the Minister with the following information and documents with respect to the proposed designation:in the case of a replacement designation for the senior person in charge,the information specified in paragraph 14(1)(f), andthe declaration specified in paragraph 14(4)(a) and, subject to subsection 14(5), the documents specified in paragraphs 14(4)(b) and (c); andin the case of a replacement designation for either the responsible person in charge or the alternate responsible person in charge, or the designation of an individual to be the alternate responsible person in charge,the information specified in paragraph 14(1)(g), andthe declaration specified in paragraph 14(4)(a) and, subject to subsection 14(5), the documents specified in paragraphs 14(4)(b) and (c).When requesting an approval under paragraph (1)(b.1) or (c), the licensed dealer must provide the Minister with the information that permits the Minister to make an evaluation required under paragraphs 17(1)(f) and (i).If a senior person in charge ceases to act in that capacity due to death or other unforseen circumstance, the licensed dealer may authorize another person who satisfies the requirements of subsection 13(4) to act as the interim senior person in charge until approval is granted by the Minister pursuant to paragraph (1)(a) concerning the designation of a replacement for the senior person in charge.
SOR/2005-365, s. 14.
A licensed dealer shall advise the Minister within 10 days if the senior person in charge, responsible person in charge or alternate responsible person in charge for the site ceases to act in that capacity.A licensed dealer shall advise the Minister not later than the next business day if the responsible person in charge for the site ceases to act in that capacity and there is no person designated to act in the capacity of alternate responsible person in charge for the site.Revocation or Suspension of LicenceThe Minister shall revoke a licence at the request of the holder or if the holder informs the Minister that the licence has been lost or stolen.Subject to subsection (2), the Minister shall revoke a licence in accordance with subsection 84(1) ifthe holder is no longer an eligible person under section 12;the licence was issued on the basis of false or misleading information or false or falsified documents;the licensed dealer has failed to comply with a provision of the Act or any regulation under the Act or a term or condition of a licence, a registration or an import or export permit issued under any regulation made or continued under the Act;it is discovered that the senior person in charge, the responsible person in charge or the alternate responsible person in charge has been convicted, as an adult, within the previous 10 years ofa designated drug offence,a designated criminal offence, oran offence committed outside of Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii); orinformation received from a competent authority, the United Nations or a peace officer raises a reasonable belief that the licensed dealer has been or will be involved in the diversion of a controlled substance or precursor to an illicit market or use; orthe continuation of the licence would likely create a risk to public health, safety or security, including the risk of a Class A precursor being diverted to an illicit market or use.The Minister is not required to revoke a licence under paragraph (1)(b) or (c) if the licensed dealerdoes not have a history of non-compliance with the Act and any regulation made or continued under the Act; andhas carried out, or signed an undertaking to carry out, specified corrective measures to ensure compliance with the Act and these Regulations.The Minister may revoke a licence if the licensed dealer fails to comply with the decision of the Minister to suspend the licence under section 24 or if the situation giving rise to the suspension is not rectified.
SOR/2005-365, s. 15.
The Minister shall suspend a licence without prior notice if the Minister has reasonable groundsto believe that the suspension is necessary to protect public health, safety or security; orto suspect that the continuation of the licence presents a risk of a Class A precursor being diverted to an illicit market or use.
SOR/2005-365, s. 16.
ImportationApplication for Import PermitTo apply for a Class A import permit, a licensed dealer shall make an application to the Minister that contains the following information and statement:the licensed dealer’s name and address and the number of their licence;the licensed dealer’s business registration number assigned by the Minister of National Revenue;for the Class A precursor sought to be importedits name or a description of its chemical composition, as stated in the licence, and Harmonized System Code,if it is a salt, the name of the salt,if it is a preparation or mixture, its brand name, if any, and the names of all precursors set out in Part 1 of Schedule VI to the Act that it contains,the quantity sought to be imported, and, if it is a preparation or mixture, the quantity of all precursors set out in Part 1 of Schedule VI to the Act that it contains, andin the case of a raw material, its purity;the name of the exporter from whom the precursor is being obtained and their address in the country of export;the proposed means of transportation;the name of any proposed country of transit or transhipment;the name of the carrier that is proposed to transport the precursor into Canada;the proposed port of entry into Canada;the proposed date of entry into Canada;the name and address of the proposed customs broker for the licensed dealer, if any; anda statement that the licensed dealer consents to the disclosure of information contained in the application to the INCB and the competent authority in the country of export for the purpose of verifying information contained in the application.The application mustbe signed by the responsible person in charge or the alternate responsible person in charge, if any, for the site to which the Class A precursor will be transported after being released under the Customs Act; andinclude a statement that all information set out in the application is correct and complete to the best of the knowledge of the signatory.The application may deal with more than one Class A precursor for the same shipment.
SOR/2005-365, s. 17.
Issuance of Import PermitSubject to section 27, if the requirements of section 25 are met, the Minister shall issue to the licensed dealer a Class A import permit that indicatesthe permit number;the information referred to in paragraphs 25(1)(a) to (i);the effective date;the date of expiry, being the earlier ofa date determined by the Minister that is not more than 180 days after the effective date, andthe expiry date set out in the applicant’s licence; andany conditions that are necessary toensure that the international obligations of Canada are respected, orensure compliance with the Act and these Regulations, including reducing the risk of a Class A precursor being diverted to an illicit market or use.A Class A import permit is valid until the earliest ofthe expiry date set out in the permit,the suspension or revocation under section 22, 23 or 24 of the licence pertaining to the permit, andthe suspension or revocation of the permit under section 29, 30 or 31.Grounds for RefusalThe Minister shall refuse to issue a Class A import permit ifa circumstance described in any of paragraphs 17(1)(b) to (g) and (j), with any modifications that the circumstances require, exists with respect to the permit application;the applicant does not hold a licence that applies to the Class A precursor sought to be imported or the applicant’s licence will expire before the proposed date of entry to Canada;the applicant has been informed that one of the following applications made by the applicant with regard to the licence pertaining to the Class A precursor sought to be imported is to be refused under section 17, namely,an application under section 14 to issue or renew the licence, oran application under section 19 to amend the licence; orthe Minister has reasonable grounds to believe that the import shipment to which the permit would apply would contravene the laws of the country of export or any country of transit or transhipment.Surrender of Import PermitThe holder of a Class A import permit shall ensure that an official copy of the permit is surrendered to a customs officer at the port of entry at the time of import.DeclarationWithin 15 days after a shipment containing a Class A precursor is released under the Customs Act, the holder of the Class A import permit for the shipment shall provide the Minister with a declaration containing the following information:the name of the holder and permit number for the shipment;the port of entry into Canada for the shipment;the date the shipment was released under the Customs Act;the name of the precursor being shipped or a description of its chemical composition, as stated in the permit; andthe quantity of the precursor being shipped and, if it is a preparation or mixture, the quantity of all of the precursors set out in Part 1 of Schedule VI to the Act that it contains.The declaration mustbe signed by the responsible person in charge or the alternate responsible person in charge for the licensed site to which the shipment will be transported after being released under the Customs Act; andinclude a statement that all information set out in the declaration is correct and complete to the best of the knowledge of the signatory.
SOR/2005-365, s. 18.
Revocation or Suspension of PermitThe Minister shall revoke a Class A import permit at the request of the holder or if the holder informs the Minister that the permit has been lost or stolen.Subject to subsection (2), the Minister shall revoke a Class A import permit in accordance with subsection 84(1) ifa circumstance described in any of paragraphs 23(1)(a) to (f) exists with respect to the licence pertaining to the Class A precursor to be imported; orthe permit was issued on the basis of false or misleading information or false or falsified documents.The Minister is not required to revoke a Class A import permit under subsection (1) if the holder of the permit meets the conditions referred to in subsection 23(2).The Minister may revoke a Class A import permit if the holder fails to comply with the decision of the Minister to suspend the permit under section 31 or if the situation giving rise to the suspension is not rectified.
SOR/2005-365, s. 19.
The Minister shall suspend a Class A import permit without prior notice ifthe licence pertaining to the Class A precursor sought to be imported has expired or has been suspended or revoked;the Minister has reasonable grounds to believe that the suspension is necessary to protect public health, safety or security;the Minister has reasonable grounds to suspect that the continuation of the permit presents a risk of a Class A precursor being diverted to an illicit market or use; orit is discovered that the import would contravene the laws of the country of export or a country of transit or transhipment.
SOR/2005-365, s. 20.
ExportationApplication for Export PermitTo apply for a Class A export permit, a licensed dealer shall make an application to the Minister that contains the following information and statements:the licensed dealer’s name and address and the number of their licence;the licensed dealer’s business number assigned by the Minister of National Revenue;for the Class A precursor sought to be exportedits name or a description of its chemical composition, as stated in the licence, and Harmonized System Code,if it is a salt, the name of the salt,if it is a preparation or mixture, its brand name, if any, and the names of all precursors set out in Part 1 of Schedule VI to the Act that it contains,the quantity sought to be exported, and, if it is a preparation or mixture, the quantity of all precursors set out in Part 1 of Schedule VI to the Act that it contains, andin the case of a raw material, its purity;the name of the importer and their address in the country of final destination;the proposed means of transportation;the name of any proposed country of transit or transhipment;the name of the carrier that is proposed to transport the precursor through the port of exit;the proposed port of exit from Canada;the proposed date of export;the name and address of the proposed customs broker for the licensed dealer, if any;a statement by the licensed dealer that to the best of their knowledge the export would not contravene the laws of the country of final destination or any country of transit or transhipment; anda statement that the licensed dealer consents to the disclosure of information contained in the application to the INCB and the competent authority in the country of import for the purpose of verifying information contained in the application.The application mustbe signed by the responsible person in charge or the alternate responsible person in charge, if any, for the site from which the Class A precursor will be transported to the port of exit; andinclude a statement that all information set out in the application is correct and complete to the best of the knowledge of the signatory.The application may deal with more than one Class A precursor for the same shipment.
SOR/2005-365, s. 21.
Issuance of Export PermitSubject to section 34, if the requirements of section 32 are met, the Minister shall issue to the licensed dealer a Class A export permit that indicatesthe permit number;the information referred to in paragraphs 32(1)(a) to (i);the effective date;the date of expiry, being the earliest ofa date determined by the Minister that is not more than 180 days after the effective date,the expiry date set out in the applicant’s licence, andthe expiry date of any import authorization pertaining to the Class A precursor shipment that has been issued by the competent authority in the country of final destination; andany conditions that are necessary toensure that the international obligations of Canada are respected,ensure compliance with any requirement of the country of final destination or any country of transit or transhipment, orensure compliance with the Act and these Regulations, including reducing the risk of a Class A precursor being diverted to an illicit market or use.A Class A export permit is valid until the earliest ofthe expiry date set out in the permit,the suspension or revocation under section 22, 23 or 24 of the licence pertaining to the permit, andthe suspension or revocation of the permit under section 36, 37 or 38.Grounds for RefusalThe Minister shall refuse to issue a Class A export permit ifa circumstance described in any of paragraphs 17(1)(b) to (g) and (j), with any modifications that the circumstances require, exists with respect to the permit application;the applicant does not hold a licence that applies to the Class A precursor sought to be exported or the applicant’s licence will expire before the proposed date of export;the applicant has been informed that one of the following applications made by the applicant with regard to the licence pertaining to the Class A precursor sought to be exported is to be refused under section 17, namely,the application under section 14 to issue or renew the licence, oran application under section 19 to amend the licence;the Minister has reasonable grounds to believe that the export shipment to which the permit would apply would contravene the laws of the country of final destination or any country of transit or transhipment;within seven days after the Minister sends pre-export notification of the proposed export to the competent authority in the country of final destination, the Minister receives written notice from the authority that it has refused to authorize the proposed import or that it objects to the import; orthe shipment would not be in conformity with the import authorization or letter of non-objection issued by the competent authority in the proposed country of final destination.Surrender of Export PermitThe holder of a Class A export permit shall ensure thatan official copy of the permit is attached to the Class A precursor shipment; andan official copy of the permit is surrendered to a customs officer at the port of exit at the time of export.DeclarationWithin 15 days after a shipment containing a Class A precursor is exported, the holder of a Class A export permit for the shipment shall provide the Minister with a declaration containing the following information:the name of the holder and permit number for the shipment;the port of exit from Canada for the shipment;the date of export;the name of the precursor being shipped or a description of its chemical composition, as stated in the permit; andthe quantity of the precursor being shipped and, if it is a preparation or mixture, the quantity of all precursors set out in Part 1 of Schedule VI to the Act that it contains.The declaration mustbe signed by the responsible person in charge or the alternate responsible person in charge for the licensed site from which the shipment will be transported to the port of exit; andinclude a statement that all information set out in the declaration is correct and complete to the best of the knowledge of the signatory.
SOR/2005-365, s. 22.
Revocation or Suspension of PermitThe Minister shall revoke a Class A export permit at the request of the holder or if the holder informs the Minister that the permit has been lost or stolen.Subject to subsection (2), the Minister shall revoke a Class A export permit in accordance with subsection 84(1) ifa circumstance described in any of paragraphs 23(1)(a) to (f) exists with respect to the licence pertaining to the Class A precursor to be exported; orthe export permit was issued on the basis of false or misleading information or false or falsified documents.The Minister is not required to revoke a Class A export permit under subsection (1) if the holder of the permit meets the conditions referred to in subsection 23(2).The Minister may revoke a Class A export permit if the holder fails to comply with the decision of the Minister to suspend the permit under section 38 or if the situation giving rise to the suspension is not rectified.
SOR/2005-365, s. 23.
The Minister shall suspend a Class A export permit without prior notice ifthe licence pertaining to the Class A precursor sought to be exported has expired or has been suspended or revoked;the Minister has reasonable grounds to believe that the suspension is necessary to protect public health, safety or security;the Minister has reasonable grounds to suspect that the continuation of the permit presents a risk of a Class A precursor being diverted to an illicit market or use;the shipment would not be in conformity with an import authorization or letter of non-objection issued by the competent authority in the country of final destination; orit is discovered that the export would contravene the laws of the country of final destination or a country of transit or transhipment.
SOR/2005-365, s. 24.
In Transit and TranshipmentApplication for a Permit for Transit or TranshipmentIf a Class A precursor is to be shipped from one country to another country by a route that requires it to be in transit through Canada or to be transhipped in Canada, the exporter in the country of export or an agent in Canada of that exporter must apply to the Minister for a permit for transit or transhipment by providing the following information:the name of the exporter and their address and telephone number in the country of export;the name of the importer and their address and telephone number in the country of final destination;the name, address and telephone number of the person who will be responsible for the precursor while it is in Canada;with respect to the Class A precursor for which the permit is requested,its name, if any, otherwise a description of its chemical composition, and Harmonized System Code,if it is a salt, the name of the salt,if it is a preparation or mixture, its brand name, if any, and the names of all precursors set out in Part 1 of Schedule VI to the Act that it contains,the quantity sought to be shipped and, if it is a preparation or mixture, the quantity of all precursors set out in Part 1 of Schedule VI to the Act that it contains, andin the case of a raw material, its purity;the expected date of transit or transhipment in Canada;the proposed ports of entry into and exit from Canada;each proposed means of transportation that is to be used in Canada for the precursor; andin the case of a transhipment, the address, if applicable, of every place in Canada at which the precursor will be stored during the transhipment and the expected duration of each storage.The application must be accompanied bya copy of the export authorization issued by the competent authority in the country of export, if applicable; anda copy of the import authorization issued by the competent authority in the country of final destination, if applicable.The application mustbe signed by a person who is authorized for that purpose by the exporter, who may be an agent in Canada of the exporter; andstate that all the information submitted in support of the application is correct and complete to the best of the knowledge of the signatory.
SOR/2005-365, s. 25.
Issuance of a Permit for Transit or TranshipmentSubject to section 41, if the requirements of section 39 are met, the Minister shall issue to the applicant a permit for transit or transhipment that contains the following information:the permit number;the information referred to in paragraphs 39(1)(a) to (h);the countries of export and final destination and the numbers and expiry dates of the export and import authorizations issued by a competent authority in each of those countries, if applicable; andthe effective date and the expiry date of the permit.Grounds for RefusalThe Minister shall refuse to issue a permit for transit or transhipment if the Minister has reasonable grounds to believe thatthe issuance of the permitwould not be in conformity with an international obligation of Canada,would not be in compliance with the Act, any regulation under the Act, or a law of the country of export, of the country of final destination or of a country of transit or transhipment, orwould likely create a risk to public health, safety or security, including the risk of a Class A precursor being diverted to an illicit market or use; orthe import authorization issued by a competent authority in the country of final destination has expired or has been suspended or revoked.Surrender of PermitThe holder of a permit for transit or transhipment shall surrender an official copy of the permit to a customs officer at the port of entry set out in the permit.Notice of Transit or TranshipmentWithin 15 days after a shipment departs from Canada, the holder of a permit for transit or transhipment that applies the shipment must notify the Minister in writing of the departure date.Revocation or Suspension of PermitThe Minister shall revoke a permit for transit or transhipment at the request of the holder or if the holder informs the Minister that the permit has been lost or stolen.Subject to subsection (2), the Minister shall revoke a permit for transit or transhipment in accordance with subsection 84(1) ifthe permit was issued on the basis of false or misleading information or false or falsified documents;the holder of the permit has failed to comply with a provision of the Act or any regulation under the Act or a term or condition of a permit for transit or transhipment issued under these Regulations;information received from a competent authority, the United Nations or a peace officer raises a reasonable belief that the licensed dealer has been or will be involved in the diversion of a controlled substance or precursor to an illicit market or use; orthe continuation of the permit would likely create a risk to public health, safety or security, including the risk of a Class A precursor being diverted to an illicit market or use.The Minister is not required to revoke a permit under paragraph (1)(a) or (b) if the holder of the permitdoes not have a history of non-compliance with the Act and any regulation made or continued under the Act; andhas carried out, or signed an undertaking to carry out, specified corrective measures to ensure compliance with the Act and these Regulations.The Minister may revoke a permit if the holder fails to comply with the decision of the Minister to suspend the permit under section 46 or if the situation giving rise to the suspension is not rectified.
SOR/2005-365, s. 26.
The Minister shall suspend a permit for transit or transhipment without prior notice ifthere has been an expiration, suspension or revocation ofthe export permit issued by the competent authority in the country of origin, orthe import permit issued by the country of final destination;the Minister has reasonable grounds to believe that the suspension is necessary to protect public health, safety or security; orthe Minister has reasonable grounds to suspect that the continuation of the permit presents a risk of a Class A precursor being diverted to an illicit market or use.
SOR/2005-365, s. 27.
DestructionNo licensed dealer may destroy a Class A precursor except in accordance with subsections (2) to (4).A licensed dealer may destroy, at the site set out in their licence, a Class A precursor named in it ifprior to the destruction, the licensed dealer makes a record showing;the name of the precursor, if any, otherwise a description of its chemical composition, andthe quantity of the precursor to be destroyed and, in the case of a preparation or mixture, the quantity of all precursors set out in Part 1 of Schedule VI to the Act that it contains;the destruction is conducted in accordance with a method that complies with all federal, provincial and municipal environmental protection legislation applicable to the place of destruction;the licensed dealer makes a record of the date and method of destruction;the destruction occurs in the presence of at least two qualified witnesses who work for the licensed dealer, one of whom is the responsible person in charge or the alternate responsible person in charge, if any, for the licensed site; andonce the destruction is completed, the person carrying out the destruction and each person mentioned in paragraph (d) sign and date a joint declaration certifying that the precursor was completely destroyed, to which each signatory shall add their name in printed letters.A person is qualified to witness the destruction of a Class A precursor ifthe person is the responsible person in charge for the site or, if applicable, the alternate responsible person in charge for the site set out in the licence; orthe person works for or provides services to the licensed dealer and acts in a senior position.If a Class A precursor is to be destroyed elsewhere than at the licensed site, the licensed dealer must ensure thatappropriate measures are taken to ensure security of the precursor during transit in order to prevent the diversion of a Class A precursor to an illicit market or use;the destruction is carried out by a business that specializes in the destruction of dangerous goods;the destruction is conducted in accordance with a method that complies with all federal, provincial and municipal environmental protection legislation applicable to the place of destruction; andonce the destruction is completed, the individual within the business carrying out the destruction provides the licensed dealer with a declaration attesting to the complete destruction of the precursor, showingthe name of the precursor, if any, otherwise a description of its chemical composition, andthe quantity of the precursor destroyed and, in the case of a preparation or mixture, the quantity of all precursors set out in Part 1 of Schedule VI to the Act that it contains;the date of destruction,the method of destruction, andtheir name and signature as well as the name and signature of another person within the business who witnessed the destruction.
SOR/2005-365, s. 28.
Preparations and Mixtures[SOR/2005-365, s. 29]Application for Authorization Certificate[SOR/2005-365, s. 29]With respect to a Class A precursor that is a preparation or mixture, a person who produces or imports, or desires to do so, may apply for an authorization certificate with respect to the preparation or mixture by submitting an application to the Minister containing the following information and statements:the applicant’s name or, if the applicant is a corporation, their corporate name;if the applicant is a licensed dealer, the number of their licence;if the applicant is not the producer of the preparation or mixture, the name of the person who produced the precursor or, if the person is a corporation, its corporate name;the address, telephone number and facsimile transmission number, if any, of the person who produced the preparation or mixture;in respect of the preparation or mixture for which the application is madeits name, if any, otherwise a description of its chemical composition, and its brand name, if any,its qualitative and quantitative composition including all chemical ingredients,its physical and chemical properties and any difference between those properties and the physical and chemical properties of the chemical ingredients that are precursors set out in Part 1 of Schedule VI to the Act,the type of analyses used to evaluate its purity and stability, andits intended use;a statement, by the person who produced the preparation or mixture, that the preparation or mixture is made in such a way that no precursors set out in Part 1 of Schedule VI to the Act can be readily extracted, having regard to the complexity and cost of extraction, and that the preparation or mixture cannot be used in the production of a controlled substance; anda statement, by the person who produced the preparation or mixture, justifying the application for the certificate, and identifying the scientific principles and any other information in support of the statement under paragraph (d).The application mustbe signed bya person working for the applicant having supervisory responsibilities pertaining to the preparation or mixture and sufficient knowledge to confirm the information set out in the application, orthe senior person in charge for the site, if the applicant is a licensed dealer; andinclude a statement that all information set out in the application is correct and complete to the best of the knowledge of the signatory.
SOR/2005-365, s. 30.
Issuance of Authorization Certificate[SOR/2005-365, s. 31]Subject to section 50, if an application complies with the requirements of section 48, the Minister shall issue to the applicant an authorization certificate that indicatesthe certificate number;the name, if any, of the preparation or mixture that is the subject of the certificate, otherwise a description of its chemical composition, and its brand name, if any;the name of the applicant or, if the applicant is a corporation, their corporate name;if the applicant is not the producer of the preparation or mixture, the name of the person who produced the precursor or, if the person is a corporation, its corporate name;the effective date; andany conditions that are necessary toensure that international obligations of Canada are respected, andensure compliance with the Act and these Regulations, including reducing the risk of a Class A precursor being diverted to an illicit market or use.The holder of an authorization certificate shall, on request, provide a copy of the certificate to any person conducting an activity in relation to the preparation or mixture to which the certificate applies.
SOR/2005-365, s. 32.
Grounds for RefusalThe Minister shall refuse to issue an authorization certificate if, according to the information provided and scientific data or other information or evidence available, a precursor set out in Part 1 of Schedule VI to the Act can be readily extracted from the preparation or mixture that is the subject of the application, having regard to the complexity and cost of extraction, or the preparation or mixture can be used in the production of a controlled substance.
SOR/2005-365, s. 33.
Document Accompanying ShipmentA person who imports or exports a Class A precursor that is a preparation or mixture mentioned in an authorization certificate shall ensure that the shipment is accompanied by a document containing:a statement that the preparation or mixture is subject to an authorization certificate under section 49; andthe certificate number for the preparation or mixture.
SOR/2005-365, s. 34.
Revocation or Suspension of CertificateThe Minister shall revoke an authorization certificate at the request of the holder.
SOR/2005-365, s. 34.
The Minister shall, in accordance with subsection 84(1), revoke an authorization certificate if the certificatewas issued on the basis of false or misleading information, or false or falsified documents; orhas been the subject of a suspension under paragraph 54(a) and subsection 84(2) and the suspension has not been complied with.The Minister may revoke an authorization certificate if the holder fails to comply with a decision of the Minister to suspend the certificate under section 54, or if the situation giving rise to the suspension is not rectified.
SOR/2005-365, s. 34.
The Minister shall, without prior notice, suspend an authorization certificate ifnew scientific evidence or other new information demonstrates that a precursor set out in Part 1 of Schedule VI to the Act can be readily extracted from the preparation or mixture mentioned in the certificate, having regard to the complexity and cost of extraction, or demonstrates that the preparation or mixture may be or has been used in the production of a controlled substance;the Minister has reasonable grounds to believe that the suspension is necessary to protect public health, safety or security; orthe Minister has reasonable grounds to suspect that the continuation of the certificate presents a risk of a Class A precursor being diverted to an illicit market or use.
SOR/2005-365, s. 34.
CLASS B PRECURSORSExemptionWith respect to a Class B precursor that is a preparation or mixture, a person who conducts an activity mentioned in section 57 is exempt from the requirements of these Regulations, except requirements applying to production for the purpose of sale or provision, if the preparation or mixture contains a precursor set out in Part 2 of Schedule VI to the Act and the contained precursor, either alone or with any other precursor of the same type, does not constitute more than 30% of the preparation or mixture by weight or volume, in the case of a solid or liquid, respectively.
SOR/2005-365, s. 35.
A person who uses a Class B precursor that is described in section 55 or is the subject of an authorization certificate under section 77, to produce another Class B precursor that is a preparation or mixture, is exempt from the requirements of these Regulations in respect of that production.
SOR/2005-365, s. 35.
Limitation on ActivitiesNo person other than a registered dealer may produce a Class B precursor for the purpose of sale or provision.A registered dealer may import a Class B precursor.Subject to subsection (4), a registered dealer may export a Class B precursor and may possess the precursor for the purpose of the export.In the case of a country named in a table referred to in paragraph (a) or (b) and a Class B precursor identified in the table as one requiring notice of pre-exportation to that country, a registered dealer may only export the Class B precursor to the country if the registered dealer holds a Class B export permit in respect of the precursor and complies with the terms and conditions of the permit:the table entitled “Governments that have requested pre-export notifications pursuant to article 12, paragraph 10(a), of the 1988 Convention”, contained in the most recent INCB annual report concerning the implementation of article 12 of the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988; orthe table entitled Supplementary Table of Countries Requiring Pre-Export Notification With Regard to Class B Precursors, published by the Department of Health, as amended from time to time, listing the countries that, according to notification from the INCB to the Minister since publication of the most recent annual report referred to in paragraph (a), have made a formal request to the United Nations to receive notice of pre-exportation in respect of the shipment to the country of Class B precursors.Authorization Concerning Preparations and MixturesDespite section 57, with respect to a Class B precursor that is a preparation or mixture, a person may import, export or possess for those purposes ifthe preparation or mixture is the subject of an authorization certificate under section 77; andno notice indicating that the certificate has been revoked or is under suspension appears on the following Health Canada Internet site:http://www.hc-sc.gc.ca/dhp-mps/substancontrol/index_e.html
SOR/2005-365, s. 36.
RegistrationEligibilityTo be eligible to apply for registration, a person must bean individual who ordinarily resides in Canada; ora corporation that has its head office or a branch office in Canada.A registered dealer must designate a senior person in charge, who may, if appropriate, be the registered dealer, to have overall responsibility for management of the registered dealer’s Class B precursor activities.A registered dealer must designate a contact person, for each site where the registered dealer conducts Class B precursor activities, to work at the site, who may, if appropriate, be the senior person in charge, and who has good knowledge of the Class B precursor activities carried out at the site and the use and handling of the relevant precursors including the risk of those precursors being diverted to an illicit market or use.The senior person in chargemust be familiar with the provisions of the Act and these Regulations that apply to the registered dealer’s Class B precursor activities and have sufficient knowledge concerning the use and handling of the Class B precursors dealt with by the registered dealer to which the registration applies, including the risk of those precursors being diverted to an illicit market or use, to enable them to properly perform their responsibilities; andmust not have been convicted, as an adult, within the previous 10 years, ofa designated drug offence,a designated criminal offence, oran offence committed outside of Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii).ApplicationAn application for registration or to renew a registration shall be made to the Minister and contain the following information and statement:the applicant’s name or, if the applicant is a corporation, their corporate name and any other name registered with a province, under which the applicant will carry out the activities set out in the application or will identify itself;the applicant’s address or, if the applicant is a corporation, their head office address in Canada, if applicable;the applicant’s precursor activity profile concerning Class B precursors, beingthe name, if any, of each Class B precursor that the applicant intends to produce for sale or provision, import, export or have in possession for export, otherwise a description of its chemical composition,if a Class B precursor referred to in subparagraph (i) is a preparation or mixture, its product classification having regard to its intended use and the names of all precursors set out in Part 2 of Schedule VI to the Act that it contains;the Class B precursor activity mentioned in section 57 that the applicant intends to carry out in respect of each precursor identified under subparagraphs (i),the address of each site where the applicant intends to conduct Class B precursor activities, andthe postal address of each site to which subparagraph (iv) applies, if different,the name, date of birth and gender of the senior person in charge and their telephone number, facsimile transmission number and e-mail address;for each site referred to in subparagraph (c)(iv), the name, telephone number, facsimile transmission number and e-mail address of the contact person to be reached to obtain information concerning precursor activity at the site;in the case of an application to renew a registration, the number of the registration to be renewed; anda statement that the internal controls pertaining to Class B precursors are sufficient to support a reliable system of record-keeping in respect of the precursor activities and precursor inventory applicable to the registered dealer’s precursor activity profile and to permit the Minister to verify those activities.The application mustbe signed by the senior person in charge for the applicant; andinclude a statement by the signatory thatthe information and documents provided in the application are correct and complete to the best of the knowledge of the signatory, andthe senior person in charge has the authority to bind the applicant.The application must be accompanied bya statement signed by the senior person in charge stating that they have not, as an adult, been convicted within the previous 10 years ofa designated drug offence,a designated criminal offence, oran offence committed outside of Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii);a statement signed by the senior person in chargeconsenting to having a criminal record check carried out for them, as an adult, in respect of the offences mentioned in paragraph (a) during the preceding 10 years,agreeing to provide all information and to submit to any means of identification required to obtain the criminal record check, andto pay the fee established by the Royal Canadian Mounted Police, Criminal Record Verification for Civil Purposes Fee Regulations; andif applicable, a copy ofthe certificate of incorporation or other constituting instrument for the applicant, andany document filed with a province in which there is a site referred to in subparagraph (1)(c)(iv) that states the applicant’s corporate name and any other name registered with the province under which the applicant will carry out activities in respect of precursors or will identify itself.Additional InformationThe Minister may, on receiving an application made under this Part, require the submission of any additional information that pertains to the information contained in the application and that is necessary for the Minister to process the application.Registration and CertificateSubject to section 63, if the requirements of section 60 are met, the Minister shall register the applicant or renew the applicant’s registration, and issue a registration certificate indicatingthe registration number;the name of the registered dealer or, if the registered dealer is a corporation, its corporate name;the applicant’s address or, if the applicant is a corporation, its head office address in Canada, if applicable;the effective date of the certificate;the date of expiry of the certificate; andany conditions that are necessary toensure that the international obligations of Canada are respected, orensure compliance with the Act and these Regulations, including reducing the risk of a Class B precursor being diverted to an illicit market or use.Grounds for RefusalSubject to subsection (2), the Minister shall refuse to register an applicant or renew an applicant’s registration ifthe applicant is not eligible under section 58;the Minister has reasonable grounds to believe that any information or document included in the application is false or misleading;additional information required under section 61 has not been provided or is insufficient to process the application;the registration would permit an activity that would not be in compliance with an international obligation of Canada;information received from a competent authority, the United Nations or a peace officer raises a reasonable belief that the applicant has been or will be involved in the diversion of a controlled substance or precursor to an illicit market or use;the applicant is not, or within the previous 10 years has not been, in compliance witha provision of the Act or a regulation made or continued under the Act, ora term or condition of a licence, registration certificate or permit issued to it under any regulation made or continued under the Act;the senior person in charge mentioned in the application has been convicted, as an adult, within the previous 10 years ofa designated drug offence,a designated criminal offence, oran offence committed outside of Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii); orthe registration would likely create a risk to public health, safety or security, including the risk of a Class B precursor being diverted to an illicit market or use.The Minister is not required to refuse to register an applicant or renew an applicant’s registration under paragraph (1)(b) or (f) if the applicantdoes not have a history of non-compliance with the Act and any regulation made or continued under the Act; andhas carried out, or signed an undertaking to carry out, specified corrective measures to ensure compliance with the Act and these Regulations.
SOR/2005-365, s. 37.
Length of ValidityA registration is valid for a maximum of five years from the effective date of the registration.Notice of Change of InformationA registered dealer shall give notice to the Minister in writing of any change of information provided in the application for registration or any subsequent notice of change given under this subsection.Subject to subsection (5), the notice shall be given not later than 10 days after the change takes effect.If the change deals with information shown on the registration certificate, the registered dealer shall include the original certificate with the notice given under subsection (1).Subject to paragraphs 67(1)(e) and (f), if the requirements of subsections (1) to (3) are met, the Minister shall amend the registration certificate accordingly.If the change deals with the designation of a replacement for the senior person in charge, the registered dealer shallapply for the approval of the Minister before making the change; andinclude with the application the information mentioned in paragraph 60(1)(d) and the statements mentioned in paragraphs 60(3)(a) and (b).If the senior person in charge ceases to act in that capacity due to death or an unforseen circumstance, the registered dealer may authorize another person who satisfies the requirements of subsection 59(3) to act as the interim senior person in charge until approval is granted by the Minister concerning the designation of a replacement for the senior person in charge.A registered dealer shall advise the Minister within 10 days if the senior person in charge for the site ceases to act in that capacity.Revocation or SuspensionThe Minister shall revoke a registration and the corresponding registration certificate if the registered dealer so requests or notifies the Minister that the certificate has been lost or stolen.Subject to subsection (2) and subsection 84(1), the Minister shall revoke a registration and the corresponding registration certificate ifthe registered dealer is no longer an eligible person under section 58;the registration was made on the basis of false or misleading information or false or falsified documents;the registered dealer has contravened the Act or any regulation under the Act, a condition of the registration or a provision of a registration certificate, a licence or an import or export permit issued under any regulation under the Act;it is discovered that the senior person in charge has been convicted, as an adult, within the previous 10 years ofa designated drug offence,a designated criminal offence, oran offence committed outside of Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii);information received from a competent authority, the United Nations or a peace officer raises a reasonable belief that the registered dealer has been or will be involved in the diversion of a controlled substance or precursor to an illicit market or use;the continuation of the registration would likely create a risk to public health, safety or security, including the risk of a Class B precursor being diverted to an illicit market or use; orthe registration would permit, having regard to an activity mentioned in a notice of change of information, an activity that would not be in compliance with an international obligation of Canada.The Minister is not required to revoke a registration and the corresponding certificate under paragraph (1)(b) or (c) if the registered dealerdoes not have a history of non-compliance with the Act and any regulation made or continued under the Act; andhas carried out, or signed an undertaking to carry out, corrective measures to ensure compliance with the Act and these Regulations.The Minister may revoke a registration and the corresponding certificate if the registered dealer fails to comply with the decision of the Minister to suspend the registration and certificate under section 68 or if the situation giving rise to the suspension is not rectified.
SOR/2005-365, s. 38.
The Minister shall suspend a registration and the corresponding certificate without prior notice if the Minister has reasonable groundsto believe that the suspension is necessary to protect public health, safety or security; orto suspect that the continuation of the registration and the certificate presents a risk of a Class B precursor being diverted to an illicit market or use.
SOR/2005-365, s. 39.
ExportApplication for Export PermitAn application for a Class B export permit shall be made by a registered dealer to the Minister in writing and contain the following information and statements:the registered dealer’s name and address and the number of their registration certificate;the business number assigned to the registered dealer by the Minister of National Revenue;for the Class B precursor sought to be exportedits name or a description of its chemical composition, and its Harmonization System Code,if it is a preparation or mixture, its brand name, if any, and the names of all precursors set out in Part 2 of Schedule VI to the Act that it contains,the quantity sought to be exported, and in the case of a preparation or mixture, the quantity of all precursors set out in Part 2 of Schedule VI to the Act that it contains, andin the case of a raw material, its purity;the name of the importer and their address in the country of final destination;the proposed means of transportation;the name of any proposed country of transit or transhipment;the name of the carrier that is proposed to transport the precursor through the port of exit;the proposed port of exit from Canada;the proposed date of export;the name and address of the proposed customs broker for the registered dealer, if any;a statement by the registered dealer that to the best of their knowledge the shipment would not contravene the laws of the country of final destination or any country of transit or transhipment; anda statement that the registered dealer consents to the disclosure of information contained in the application to the INCB and the competent authority in the country of final destination for the purpose of verifying information contained in the application.The application mustbe signed by the senior person in charge; andinclude a statement that the information and statements provided in the application are correct and complete to the best of the knowledge of the signatory.The application may deal with more than one Class B precursor for the same shipment.
SOR/2005-365, s. 40.
Issuance of Export PermitSubject to section 71, if the requirements of section 69 are met, the Minister shall issue to the applicant a Class B export permit that indicatesthe permit number;the information referred to in paragraphs 69(1)(a) to (i);the effective date;the date of expiry, being the earliest ofa date determined by the Minister that is not more than 180 days after the effective date,the date of expiry of the registration of the applicant, andthe date of expiry for any import authorization issued by the competent authority in the country of final destination in respect of the importation of the Class B precursor; andany conditions that are necessary toensure that the international obligations of Canada are respected,ensure compliance with a requirement of the country of final destination or any country of transit or transhipment, orensure compliance with the Act and these Regulations, including reducing the risk of a Class B precursor being diverted to an illicit market or use.A Class B export permit is valid until the earliest ofthe expiry date set out in the permit;the suspension or revocation under section 66, 67 or 68 of the registration; orthe suspension or revocation under section 73, 74 or 75 of the export permit.Grounds for RefusalThe Minister shall refuse to issue a Class B export permit ifthe applicant is not a registered dealer or is a registered dealer whose registration will expire prior to the proposed date of export;a circumstance described in any of paragraphs 63(1)(b) to (f) and (h), with any modifications that the circumstances require, exists with respect to the permit application;the Minister has reasonable grounds to believe that the export shipment to which the permit would apply would contravene the laws of the country of final destination or any country of transit or transhipment;within seven days after the Minister sends pre-export notification of the proposed export to the competent authority in the country of final destination, the Minister has received written notice from the authority that it has refused to authorize the proposed import or that it objects to the import; orthe proposed shipment would not be in conformity with an import authorization or letter of non-objection issued by the competent authority in the country of final destination.Surrender of Export PermitThe holder of a Class B export permit shall ensure thatan official copy of the permit is attached to the Class B precursor shipment; andan official copy of the permit is surrendered to a customs officer at the customs office at the port of exit set out in the permit.DeclarationWithin 15 days after a shipment containing a Class B precursor is exported, the holder of a Class B export permit for the shipment shall provide the Minister with a declaration containing the following information:the name of the holder and permit number for the shipment;the port of exit from Canada for the shipment;the date of export;the name of the precursor being shipped or a description of its chemical composition, as stated in the permit; andthe quantity of the precursor being shipped and, if it is a preparation or mixture, the quantity of all precursors set out in Part 2 of Schedule VI to the Act that it contains.The declaration mustbe signed by the senior person in charge designated by the registered dealer; andinclude a statement that all information set out in the declaration is correct and complete to the best of the knowledge of the signatory.
SOR/2005-365, s. 41.
Revocation or Suspension of PermitThe Minister shall revoke a Class B export permit at the request of the holder or if the holder informs the Minister that the permit has been lost or stolen.Subject to subsection (2), the Minister shall revoke a Class B export permit in accordance with subsection 84(1) ifa circumstance described in any of paragraphs 67(1)(a) to (f) exists with respect to the registration of the holder of the permit; orthe export permit was issued on the basis of false or misleading information or false or falsified documents.The Minister is not required to revoke a Class B export permit under subsection (1) if the holder of the permit meets the conditions referred to in subsection 63(2).The Minister may revoke a Class B export permit if the holder fails to comply with the decision of the Minister to suspend the permit under section 75 or if the situation giving rise to the suspension is not rectified.
SOR/2005-365, s. 42.
The Minister shall suspend a Class B export permit without prior notice ifthe registration certificate of the holder of the permit has expired or has been suspended or revoked;the Minister has reasonable grounds to believe that the suspension is necessary to protect public health, safety or security;the Minister has reasonable grounds to suspect that the continuation of the permit presents a risk of a Class B precursor being diverted to an illicit market or use;the shipment would not be in conformity with an import authorization or letter of non-objection issued by the competent authority in the country of final destination; orit is discovered that the export would contravene the laws of the country of final destination or a country of transit or transhipment.
SOR/2005-365, s. 43.
Preparations and Mixtures[SOR/2005-365, s. 44]Application for Authorization Certificate[SOR/2005-365, s. 44]With respect to a Class B precursor that is a preparation or mixture, a person who produces for the purpose of sale or provision, or imports, or desires to do either, may apply for an authorization certificate for the preparation or mixture, by submitting an application to the Minister containing the following information and statements:the applicant’s name or, if the applicant is a corporation, their corporate name;if the applicant is a registered dealer, the number of their registration certificate;if the person is not the producer of the preparation or mixture, the name of the producer or, if the producer is a corporation, its corporate name;the address and the telephone number and facsimile transmission number, if any, of the producer of the preparation or mixture;in respect of the preparation or mixture for which the application is madeits name, if any, otherwise a description of its chemical composition, and its brand name, if any,its qualitative and quantitative composition including all chemical ingredients,its physical and chemical properties and any difference between those properties and the physical and chemical properties of the chemical ingredients that are precursors set out in Part 2 of Schedule VI to the Act,the type of analyses used to evaluate its purity and stability, andits intended use;a statement, by the producer of the preparation or mixture, that the preparation or mixture is made in such a way that no precursor set out in Part 2 of Schedule VI to the Act contained in it can be readily extracted, having regard to the complexity and cost of extraction, and that the preparation or mixture cannot be used in the production of a controlled substance; anda statement, by the producer of the preparation or mixture, justifying the application for the certificate, and identifying the scientific principles and any other information in support of the statement under paragraph (d).The application mustbe signed bya person working for the applicant having supervisory responsibilities pertaining to the preparation or mixture and sufficient knowledge to confirm the information set out in the application, orthe senior person in charge for the site, if the applicant is a registered dealer; andinclude a statement that all information set out in the application is correct and complete to the best of the knowledge of the signatory.
SOR/2005-365, s. 45.
Issuance of Authorization Certificate[SOR/2005-365, s. 46]Subject to section 78, if an application complies with the requirements of section 76, the Minister shall issue to the applicant an authorization certificate that indicatesthe certificate number;the name, if any, of the preparation or mixture that is the subject of the certificate, otherwise a description of its chemical composition, and its brand name, if any;the name of the applicant or, if the applicant is a corporation, their corporate name;the effective date; andany conditions that are necessary toensure that international obligations of Canada are respected, andensure compliance with the Act and these Regulations, including reducing the risk of a Class B precursor being diverted to an illicit market or use.The holder of an authorization certificate shall, on request, provide a copy of the certificate to any person conducting an activity in relation to the preparation or mixture to which the certificate applies.
SOR/2005-365, s. 47.
Grounds for RefusalThe Minister shall refuse to issue an authorization certificate if, according to the information provided and scientific data or other information or evidence available, a precursor set out in Part 2 of Schedule VI to the Act can be readily extracted from the preparation or mixture that is the subject of the application, having regard to the complexity and cost of extraction, or the preparation or mixture can be used in the production of a controlled substance.
SOR/2005-365, s. 48.
Document Accompanying ShipmentA person who exports a preparation or mixture mentioned in an authorization certificate shall ensure that the shipment is accompanied by a document containing:a statement that the preparation or mixture is subject to an authorization certificate under section 77; andthe certificate number for the preparation or mixture.
SOR/2005-365, s. 49.
Revocation and SuspensionThe Minister shall revoke an authorization certificate at the request of the holder.
SOR/2005-365, s. 49.
The Minister shall, in accordance with subsection 84(1), revoke an authorization certificate if the certificatewas issued on the basis of false or misleading information, or false or falsified documents; orhas been the subject of a suspension under paragraph 82(a) and subsection 84(2) and the suspension has not been complied with.The Minister may revoke an authorization certificate if the holder fails to comply with a decision of the Minister to suspend the certificate under section 82, or if the situation giving rise to the suspension is not rectified.
SOR/2005-365, s. 49.
The Minister shall, without prior notice, suspend an authorization certificate ifnew scientific evidence or other new information demonstrates that a precursor set out in Part 2 of Schedule VI to the Act can be readily extracted from the preparation or mixture mentioned in the certificate, having regard to the complexity and cost of extraction, or demonstrates that the preparation or mixture may be or has been used in the production of a controlled substance;the Minister has reasonable grounds to believe that the suspension is necessary to protect public health, safety or security; orthe Minister has reasonable grounds to suspect that the continuation of the authorization certificate presents a risk of a Class B precursor being diverted to an illicit market or use.
SOR/2005-365, s. 49.
GENERAL PROVISIONSRestricted Access to Class A PrecursorsEvery licensed dealer shall restrict access to locations at the licensed site where Class A precursors are kept to persons whose presence is required by their work responsibilities.Notice of Refusal, Revocation or SuspensionIf the Minister proposes to refuse to issue, amend or renew, or proposes to revoke, a licence, a registration and the corresponding registration certificate, an authorization certificate, an import or export permit or a permit for transit or transhipment, issued under these Regulations, the Minister shall provide the applicant or the holder witha notice of the intended action and a written report that sets out the reasons for the proposed refusal or revocation; andan opportunity to be heard within a reasonable time in respect of the proposed refusal or revocation.A decision of the Minister to suspend a licence, a registration and the corresponding registration certificate, an authorization certificate, an import or export permit or a permit for transit or transhipment, issued under these Regulations, takes effect as soon as the Minister notifies the holder of the decision and provides a written report of the reasons for the suspension.A person who receives a notice of suspension referred to in subsection (2) may, within 10 days after receiving the notice, provide the Minister with reasons why the suspension is unfounded.
SOR/2005-365, s. 50.
Books, Registers, Electronic Data and Other RecordsA licensed dealer shall keep at the licensed site books, registers, electronic data and other records pertaining to each Class A precursor brought to the site, produced or packaged at the site, used at the site for their own purposes, destroyed at the site or removed from the site, showingin respect of the precursorits name, if any, otherwise a description of its chemical composition,if it is a salt, the name of the salt, andif it is a preparation or mixture, its brand name, if any, and the names of all precursors set out in Part 1 of Schedule VI to the Act that it contains;the type of activity pertaining to the precursor, whether purchase, receipt, production, packaging, use for their own purposes, sale, provision, sending, delivering, transporting, importation, exportation or destruction;the quantity of precursor and, in the case of a preparation or mixture, the quantity of all precursors set out in Part 1 of Schedule VI to the Act that it contains;the date the activity occurred; andin the case of a precursorpurchased or otherwise acquired, the name, address and telephone number of the person from whom the precursor was purchased or acquired,sold or provided, sent, delivered or transported, the name and address of the purchaser or recipient,that is imported, the name and address of the exporter in the country of export and the name of any country of transit or transhipment, orthat is exported, the name and address of the importer in the country of final destination and the name of any country of transit or transhipment.A licensed dealer shall keep in their books and registers all end-use declarations obtained under section 8.A licensed dealer shall keep, at the licensed site, a record showing, for each day on which a person has access to a place at the site where a Class A precursor is kept, the person’s name and the date of access.With respect to each Class B precursor brought to a site following import, produced at the site or removed from the site for export, a registered dealer shall keep at the site books, registers, electronic data and other records showingin respect of the precursor,its name, if any, otherwise a description of its chemical composition, andif it is a preparation or mixture, its brand name, if any, and the name of all precursors set out in Part 2 of Schedule VI to the Act that it contains;the type of activity pertaining to the precursor, whether production for sale or provision, import or export;the date the activity occurred; andin the case of a precursorthat is imported, the name and address of the exporter in the country of export and the name of any country of transit or transhipment, orthat is exported, the name and address of the importer in the country of final destination and the name of any country of transit or transhipment.Information referred to in subsections (1) to (4) and a record referred to in section 86 shall be retained for at least two years after the information was recorded or the record was made, except that an end-use declaration shall be kept for at least two years after the calendar year in which it was obtained.A licensed dealer and a registered dealer shall make the records and documents required to be kept under this Part available for inspection by an inspector.A licensed dealer and a registered dealer, if requested by the Minister in writing, shall provide to the Minister a copy of any record or document required to be kept under this Part.
SOR/2005-365, s. 51(F).
If a licence expires without being renewed or is revoked the former licensed dealer shall,retain the records and information that they were required to keep or make under sections 85 and 86 for at least two years after the expiry or revocation; andat the written request of the Minister, provide the Minister with a copy of any record or document required to be kept under paragraph (a).
SOR/2005-365, s. 52.
Suspicious TransactionsA licensed dealer and a registered dealer shall, on becoming aware of the transaction, make a record of every transaction occurring in the course of their activities in respect of which there are reasonable grounds to suspect that the transaction is related to the diversion of a precursor to an illicit market or use.For the purpose of subsection (1), the factors to be considered in assessing if a transaction or group of transactions give rise to reasonable grounds to suspect that the transaction or group of transactions is related to the diversion of a precursor to an illicit market or use includethe composition and chemical properties of the precursor involved, the illicit use that may be made of it and the risk of its diversion to an illicit market or use having regard to those factors;the quantity of the precursor involved and, in the case of a preparation or mixture, the quantity of all precursors set out in Parts 1 or 2 of Schedule VI to the Act that it contains;the intended use of the precursor stated by the other party to the transaction;the proposed means of transportation, route of delivery, place of origin or place of destination;the method of payment involved; andin the case of prior dealings between the dealer and the other party to the transaction, any suspicious departure from the pattern of the prior dealings.A suspicious transaction record shall includethe name, address, telephone number and position with the dealer of the individual making the record;the identification of the other party to the transaction;details of the transaction involved, includingthe date and time of the transaction,the type of transaction, andthe name and quantity of the precursor and, in the case of a preparation or mixture, the quantity of all precursors set out in Parts 1 or 2 of Schedule VI to the Act that it contains; anda detailed description of the reasons for suspecting that the transaction is related to the diversion of a precursor to an illicit market or use.No licensed dealer or registered dealer shall disclose that they have made a suspicious transaction record under this section or disclose the contents of the record, with the intent to prejudice a criminal investigation, whether or not a criminal investigation has begun.No criminal or civil proceedings lie against a licensed dealer or registered dealer for making a suspicious transaction record under this section in good faith.The Minister is authorized to receive information that is provided voluntarily by a dealer referred to in subsection (1) in respect of a transaction mentioned in that subsection.Annual ReportA licensed dealer shall make a report to the Minister, in paper or electronic form, within three months after the end of each calendar year, showingthe name and total quantity of each Class A precursor purchased, received, produced, used for their own purposes, sold, provided, imported, exported or destroyed during the calendar year;the quantity of each Class A precursor in physical inventory taken at the site at the end of the calendar year; andthe name and quantity of any Class A precursor that has been lost or wasted in the course of conducting authorized activities during the calendar year.
SOR/2005-365, s. 53.
If a licence expires without being renewed or is revoked and the expiry or revocation occurs within the first three months of a calendar year, the former licensed dealer shallin respect of the portion of the three calendar months during which the licence was valid, make the report to the Minister referred to in section 87 within three months after the expiry or revocation; andin respect of the preceding calendar year, make the report to the Minister referred to in section 87 within three months after the end of that calendar year.If a licence expires without being renewed or is revoked and the expiry or revocation occurs after the first three months of the calendar year, the licensed dealer shall, in respect of the portion of the calendar year during which the licence was valid, make the report, referred to in section 87, to the Minister within three months after the expiry or revocation.For the purpose of paragraph (1)(a) and subsection (2), the information to be furnished is that pertaining to operations for the portion of the calendar year during which the licence was valid and pertaining to the quantity in physical inventory on the date of expiry or revocation.
SOR/2005-365, s. 54.
Notice of Precursor RemovalIf a licensed dealer or registered dealer intends to close a site at which one or more precursors are kept, or to remove all precursors from the site, the dealer shall, at least 30 days before the closure or removal, notify the Minister in writing ofthe date of the intended closure or removal;the site to which the precursors will be moved; andthe quantity of each precursor to be moved.
SOR/2005-365, s. 54.
Unauthorized ChangesNo one may add to, delete or obliterate from, or alter in any other way, a licence, a registration or authorization certificate, an import or export permit or a permit for transit or transhipment, issued under these Regulations.
SOR/2005-365, s. 61.
Return of DocumentsIf a licence or a registration or authorization certificate is renewed, the holder shall, as soon as possible after the effective date of the replacing document, return the replaced document to the Minister.If a licence, a registration or authorization certificate, an import or export permit or a permit for transit or transhipment, issued under these Regulations, expires without being renewed or is revoked, the holder shall, within 30 days after the expiry or revocation, return the licence, registration or exemption certificate or permit to the Minister.
SOR/2005-365, ss. 55, 61.
Security and Reporting of Loss or TheftThe holder of a licence, a registration or authorization certificate or an import or export permit issued or granted under these Regulations shall maintain measures necessary to ensure the security of any precursor in their possession, as well as the licence, certificate or permit.If a licensed dealer or registered dealer experiences a theft of a precursor or an unusual waste or disappearance of a precursor that cannot be explained on the basis of normally accepted business activities, the licensed dealer or registered dealershall provide notice of the occurrence to a member of a police force within 24 hours after becoming aware of the occurrence; andshall provide notice of the occurrence to the Minister, in writing, within 72 hours after becoming aware of the occurrence and confirm that the notice required under paragraph (a) has been provided.If a licence, a registration or authorization certificate, an import or export permit or a permit for transit or transhipment issued under these Regulations is lost or stolen, the holder of the document shall provide notice of the occurrence to the Minister, in writing, within 24 hours after becoming aware of the occurrence.
SOR/2005-365, ss. 56, 61.
Disclosure of Information by the MinisterThe Minister may, for the purpose of verifying whether an import or export of a Class A precursor or an export of a Class B precursor complies with an import or export permit issued under these Regulations, communicate the following information to a customs officer in Canada:the name and address of the holder of the permit and the number of the permit;the type of permit;the business registration number assigned to the holder of the permit by the Minister of National Revenue;in respect of the precursor that may be imported or exported under the permitits name, if any, otherwise a description of its chemical composition,if it is a salt, the name of the salt,if it is a preparation or mixture, its brand name, if any, and the name of all precursors set out in Parts 1 or 2 of Schedule VI to the Act that it contains,the quantity sought to be imported or exported and, if the precursor is a preparation or mixture, the quantity of all precursors set out in Parts 1 or 2 of Schedule VI to the Act that it contains, andin the case of a raw material, its purity;the duration of validity of the permit;the name and address of the importer in the country of final destination or of the exporter in the country of origin;the port of entry into or exit from Canada mentioned in the permit;the proposed date of import or export;the proposed means of transportation;the name of the proposed carrier that is to bring the precursor to the port of entry or the port of exit in Canada, whichever applies;the name and address of the proposed customs broker involved, if any;any conditions that apply to the permit; andwhether the permit has been revoked or suspended.The Minister may, for the purpose of the administration of these Regulations, communicate to a customs officer in Canada the name of an applicant who has been refused a permit to export a precursor, the precursor involved and the date of the refusal.The Minister may, for the purpose of verifying whether the transportation of a Class A precursor in transit through Canada or the transhipment of a Class A precursor in Canada complies with a permit for transit or transhipment issued under these Regulations, communicate the following information to a customs officer in Canada:the number of the permit;the type of permit;the name and address of the exporter in the country of export;in respect of the Class A precursor that may be transported in transit or transhipped under the permitits name, if any, otherwise a description of its chemical composition,if it is a salt, the name of the salt,if the precursor is a preparation or mixture, its brand name, if any, and the names of all precursors set out in Part 1 of Schedule VI to the Act that it contains,the quantity sought to be transported in transit or transhipped and, if the precursor is a preparation or mixture, the quantity of all precursors set out in Part 1 of Schedule VI to the Act that it contains; andin the case of a raw material, its purity;the duration of validity of the permit;the countries of export and final destination and the numbers and expiry dates of the export and import authorizations issued by a competent authority in each of those countries, if applicable;the proposed ports of entry into and exit from Canada;the expected date of transit or transhipment in Canada;each means of transportation that is proposed to be used in Canada for the precursor;the name and address of the person who is responsible for the precursor while it is in Canada;in the case of a transhipment, for every place in Canada where the precursor will be stored during the transhipment, the address and the expected duration of storage; andwhether the permit has been revoked or suspended.The Minister may, for the purpose of verifying whether a precursor that is a preparation or mixture is the subject of an authorization certificate under these Regulations and may be imported, exported, transported in transit through Canada or transhipped in Canada without the appropriate permit under these Regulations, communicate the following information to a customs officer in Canada:the number of the certificate;the name of the preparation or mixture, if any, otherwise a description of its chemical composition, and its brand name, if any;the name of the person who applied for the authorization certificate, or, if the applicant is a corporation, its corporate name;the effective date of the certificate;any conditions that apply to the certificate; andwhether the certificate has been revoked or suspended.The Minister may, for the purpose of enabling Canada to fulfil its international obligations under section 12 of the United Nations Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988, communicate the following information to the INCB or a competent authority for the administration of these Regulations:information pertaining to an activity authorized by a licence, registration or authorization certificate or permit issued or granted to a person under these Regulations, including the person’s name, the nature of the authorized activity and any applicable conditions; andinformation in respect of precursor activities pertaining to a precursor obtained under the Act or these Regulations, includinginformation contained in the books, records and other documents mentioned in subsections 85(1) to (4),information provided in an annual report made under section 87, andinformation obtained by an inspector under section 31 of the Act.The Minister is authorized to receive, for the purpose of the administration of these Regulations, information provided by the INCB, a competent authority, the United Nations or a peace officer.
SOR/2005-365, ss. 57, 61.
PHARMACISTS, PRACTITIONERS AND HOSPITALSNon-applicationWith respect to a Class A precursor, the requirements of paragraph 6(1)(c) and subsections 6(2) and 9(1) concerning sale or provision, possession for the purpose of sale or provision and transport do not apply to a pharmacist, practitioner or hospital that sells or provides preparations or mixtures containing Class A precursors only on a retail basis.
SOR/2005-365, s. 58.
PharmacistsActivities Authorized Under a PrescriptionA pharmacist may, pursuant to a prescription, compound a preparation or mixture using a precursor.
SOR/2005-365, s. 58.
A pharmacist may sell or provide a preparation or mixture that contains a Class A precursor set out in column 1 of the schedule, in a quantity, per transaction, exceeding the maximum quantity, expressed as an absolute quantity or per package, specified for the contained precursor in column 2 of the schedule, if the pharmacist sells or provides preparations or mixtures containing Class A precursors exclusively on a retail basis and the transaction is made under a prescription.The prescription must bewritten, dated and signed by the practitioner who issued it;provided verbally by a practitioner; ortransferred to the pharmacist in accordance with the requirements of section 91.7.
SOR/2005-365, s. 58.
Information to Be RecordedA pharmacist who receives a verbal prescription for a preparation or mixture containing a Class A precursor must, before filling it, record the following information:the name and address of the individual or owner of the animal for whose benefit the prescription is provided;the date on which the prescription was provided;the name and quantity of the preparation or mixture specified in the prescription;the name of the recording pharmacist and the name of the practitioner who issued the prescription;the directions for use specified by the practitioner; andif the prescription is to be refilled, the number of times it may be refilled and, if applicable, the interval between refills.The pharmacist must retain, in accordance with section 91.95, a hard copy of the prescription or a written record of it.
SOR/2005-365, s. 58.
Subject to section 91.6, a pharmacist who fills a written or verbal prescription for a preparation or mixture containing a Class A precursor must record the following information:the date the prescription was filled;the quantity of the preparation or mixture provided when the prescription was filled;the pharmacist’s name or initials; andthe number assigned to the prescription.A pharmacist who fills a written prescription shall retain the prescription in accordance with section 91.95.
SOR/2005-365, s. 58.
Refill of PrescriptionA pharmacist may only refill a prescription for a preparation or mixture containing a Class A precursor ifthe practitioner who issued the prescription expressly directs that it may be refilled and specifies the number of refills;the pharmacist makes a record of each refill in accordance with subsection 91.5(1), with any modifications that the circumstances require;at least one refill remains on the prescription; andif an interval between refills has been specified by the practitioner, the interval has expired.
SOR/2005-365, s. 58.
Transfer of PrescriptionA pharmacist may transfer a prescription for a preparation or mixture containing a Class A precursor to another pharmacist or to a hospital.Before a pharmacist sells or provides a preparation or mixture containing a Class A precursor to an individual under a prescription that is transferred under subsection (1), the pharmacist shallin the case of a verbal transfer, record the information required by subsection 91.4(1);in the case of a written transfer, obtain from the transferring pharmacist a copy ofthe prescription written by the practitioner, orthe written record, made in accordance with subsection 91.4(2), of the practitioner’s verbal prescription; andin all cases, recordthe name and address of the transferring pharmacist,the number of authorized refills remaining and, if applicable, the specified interval between refills, andthe date of the last refill.
SOR/2005-365, s. 58.
PractitionersA practitioner may, with respect to a preparation or mixture containing a Class A precursor, prescribe it for or administer it to an individual or animal, or sell or provide it to or for an individual or for the benefit of an animal, only ifthe individual or animal is being treated by the practitioner in their professional capacity; andthe preparation or mixture is required to treat the individual’s or animal’s medical condition.
SOR/2005-365, s. 58.
A practitioner who sells or provides a preparation or mixture containing a Class A precursor set out in column 1 of the schedule to an individual for self-administration or administration to an animal in a quantity that exceeds the maximum quantity, expressed as an absolute quantity or per package, specified for the contained precursor in column 2 of the schedule, may do so only if the transaction is made under a prescription and shall make a record of the following information:the name and quantity of the preparation or mixture;the name and address of the person to whom the preparation or mixture was provided; andthe date on which the preparation or mixture was provided.
SOR/2005-365, s. 58.
HospitalsA hospital that sells or provides a preparation or mixture containing a Class A precursor exclusively on a retail basis may do so subject to sections 91.92 to 91.94.
SOR/2005-365, s. 58.
The person in charge of a hospital shall not permit a preparation or mixture containing a Class A precursor set out in column 1 of the schedule to be sold or provided to a patient or for the benefit of an animal under treatment as an in-patient or an out-patient of the hospital in a quantity, per transaction, that exceeds the maximum quantity, expressed as an absolute quantity or per package, specified for the contained precursor in column 2 of the schedule, unless the transaction is made under a prescription or another authorization of a practitioner practising in the hospital.The person in charge of the hospital shall keep the following information or ensure that it is kept:the name and quantity of the preparation or mixture provided when the prescription was filled;the name and address of the person for whom the prescription was issued;the date on which the prescription was filled; andthe number assigned to the prescription.
SOR/2005-365, s. 58.
The person in charge of a hospital shall not permit a prescription for a preparation or mixture containing a Class A precursor to be refilled at the hospital unless the requirements of section 91.6 are satisfied, with any modifications that the circumstances require.
SOR/2005-365, s. 58.
The person in charge of a hospital shall not permit a preparation or mixture containing a Class A precursor to be sold or provided pursuant to a prescription that has been transferred to the hospital, unless the requirements of subsection 91.7(2) are satisfied, with any modifications that the circumstances require.
SOR/2005-365, s. 58.
Information to be recorded and records to be kept under this Part shall be retained for at least two years after the date the information was obtained or the record was made.
SOR/2005-365, s. 58.
Security Measures and Communication of InformationA pharmacist, practitioner or hospital that sells or provides only on a retail basis, or possesses for the purpose of sale or provision, preparations or mixtures containing Class A precursors, shalltake reasonable steps to ensure the security of the Class A precursors;on discovering an unusual waste or disappearance of a Class A precursor that cannot be explained on the basis of normally accepted business practices, notifya member of a police force within 24 hours after the discovery, andthe Minister, in writing, within 72 hours after making the discovery, and confirm that the notice required under subparagraph (i) has been provided;on discovering a theft of a Class A precursor set out in column 1 of the schedule, if the package in which it is contained is not intended for retail sale and contains a quantity of the precursor exceeding the maximum quantity specified for the precursor in column 2 of the schedule, notify the persons mentioned in subparagraphs (b)(i) and (ii) within the applicable time-periods; andon request, provide to the Minister or make available for examination by the Minister, any information or record required to be kept or made under this Part.
SOR/2005-365, s. 58.
TRANSITIONAL AND COMING INTO FORCETransitionalDuring the year following the day these Regulations are published in the Canada Gazette, Part II, the maximum package size set out in column 2 of the schedule for the precursors listed in column 1 for items 4, 5 and 17 does not apply to the sale or provision of any of these precursors, or any preparation or mixture containing any of them, if the precursor or the preparation or mixture was produced and packaged before the day these Regulations are published in the Canada Gazette, Part II and, in respect of the sale of provision, the person who makes the sale or provisionis deemed to conform with paragraph 5(1)(c) regardless of the package size; anddoes not require an end-use declaration under section 8.Coming into ForceSubject to subsections (2) to (4), these Regulations come into force on the later of January 1, 2003 and the expiry of 90 days after the day on which these Regulations are published in the Canada Gazette, Part II.Subsections 6(1) and (2) and sections 7, 9, 12 to 24 and 47 come into forcein respect of a person who produces, packages, imports or exports a Class A precursor, on the later of January 1, 2003 and the expiry of 90 days after the day on which these Regulations are published in the Canada Gazette, Part II; andin respect of a person who carries out any other activity pertaining to a Class A precursor, on July 7, 2003.Section 8 comes into force on July 7, 2003.Sections 55 to 82 come into force on January 1, 2004.
SOR/2003-153, s. 4.
(Sections 5, 8, 9, 91.3, 91.9, 91.92 and 92)
Column 1Column 2ItemPrecursor set out in Part 1 of Schedule VI to the ActMaximum Quantity (expressed as an absolute amount or per package)1.Acetic anhydride1000 kg2.N-Acetylanthranilic acid (2-acetamidobenzoic acid)1 kg3.Anthranilic acid (2-aminobenzoic acid)1 kg4.Ephedra20 g per package5.Ephedrine (erythro-2-(methylamino)-1-phenyl-propan-1-ol)0.4 g per package6.Ergometrine (9,10-didehydro-N-(2-hydroxy-1-methylethyl)-6-methylergoline-8-carboxamide)07.Ergotamine (12′-hydroxy-2′-methyl-5′-(phenylmethyl)ergotaman-3′,6′,18-trione)08.Isosafrole (5-(1-propenyl)-1,3-benzodioxole)0.5 kg9.Lysergic acid (9,10-didehydro-6-methylergoline-8-carboxylic acid)010.3,4-Methylenedioxyphenyl-2-propanone (1-(1,3-benzodioxole)-2-propanone)011.Norephedrine (Phenylpropanolamine)012.Phenylacetic acid1 kg13.1-Phenyl-2-propanone014.Piperidine0.5 kg15.Piperonal (1,3-benzodioxole-5-carboxaldehyde)0.5 kg16.Potassium permanganate50 kg17.Pseudoephedrine (threo-2-(methylamino)-1-phenyl-propan-1-ol)3 g per package18.Safrole (5-(2-propenyl)-1,3-benzodioxole)0.25 kg19.Gamma-butyrolactone (dihydro-2(3H)- furanone)020.1,4-butanediol021.Red Phosphorus022.White Phosphorus023.Hypophosphorous acid, its salts and derivatives024.Hydriodic acid0