The Administration of Health Canada Acts and Regulations Relating to Certain Controlled, Prohibited or Regulated Goods
Memorandum D19-9-1

Ottawa, January 24, 2017

ISSN 2369-2391

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In Brief

1. This memorandum amalgamates and updates Memorandum D19-9-1 Importation of Human Drugs, Natural Health Products and Medical Devices Regulated by the Food and Drugs Act and the Memorandum D19-5-1 Importation of Consumer Products, Cosmetics and Radiation Emitting Devices. This update reflects a title change to D19-9-1 and cancellation of Memorandum D19-5-1.

2. This memorandum includes new information on the importation of pest control products regulated by the Pest Control Products Act and importation of hazardous products regulated by the Hazardous Products Act.

3. This memorandum includes information on the Single Window Initiative and updates the contact information for the Canada Border Services Agency (CBSA) and Health Canada.

The CBSA assists Health Canada with the administration and enforcement of acts and regulations associated with Health Canada that relate to travellers, conveyances, cargo and certain controlled, prohibited, hazardous or regulated goods under CBSA and Health Canada's legislation.

This memorandum includes border policies and procedures related to the importation of human drugs, natural health products, medical devices, consumer products, cosmetics, radiation emitting devices, hazardous products and pest control products, herein referred to as goods when used in general terms.

This memorandum does not include border policies and procedures related to the importation requirements for blood and blood components for transfusion; cells tissues and organs for transplantation; semen for assisted conception, or veterinary drugs. For more information on these products, please see Health Canada's Guidance Document on the Import Requirements for Health Products under the Food and Drugs Act and its associated Regulations (GUI-0084).

For information regarding the Health Canada legislated importation requirements under the Controlled Drugs and Substances Act please refer to Memorandum D19-9-2, Importation and Exportation of Controlled Substances and Precursors.

This document does not amend or supersede the relevant legislation. In case of any discrepancy between this document and the legislation, the legislation will prevail.

Legislation

The following list identifies key legislation pertaining to this memorandum.

Acts

Regulations

                                                  

Guidelines and General Information

Definitions

For the purpose of this memorandum, the following definitions are used:

Goods
Defined as human drugs, natural health products, medical devices, consumer products, cosmetics, radiation emitting devices, hazardous products and pest control products.
Minister
The Minister of Public Safety administers the Customs Act, Canada Border Services Agency Act, and their regulations. The Minister of Health and the Department of Health ("Health Canada") administers the other legislations in the list above.

Human Drugs, Natural Health Products and Medical Devices

Drug Identification Number (DIN)
An eight (8) digit numerical code assigned to each drug marketed in accordance with the Food and Drugs Act and its Food and Drug Regulations.
Human Drugs
These are drugs as defined in the Food and Drugs Act (except for natural health products) and regulated under the Food and Drug Regulations. They include non-prescription and prescription drugs.
Note: Drugs regulated under the Controlled Drugs and Substances Act are not included in the definition of 'Human Drugs'. Controlled substances and precursors are covered in the Memorandum D19-9-2,  Importation and Exportation of Controlled Substances and Precursors.
Medical Device
A device within the meaning of s.2 of the Food and Drugs Act, but does not include any device that is intended for use in relation to animals. Medical devices are classified as Class I, II, III, or IV, depending on their risk level.
Natural Health Products
For a complete definition, please refer to the Natural Health Products Regulations. Natural health products include traditional medicines, vitamins, minerals, and homeopathic medicines, manufactured, sold or represented for use as Natural Health Products.
Natural Product Number (NPN or DIN-HM)
An eight (8) digit numerical code assigned to each natural health product or homeopathic medicine approved to be marketed under the Natural Health Products Regulations.
Non-Prescription Drugs
Any human drug that is not a prescription drug.
Prescription Drugs
Any drug containing a substance listed on the Prescription Drug List. The Prescription Drug List can be found on the Health Canada website or the following link: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/index-eng.php.

Consumer Products, Cosmetics and Radiation Emitting Devices

Consumer Product
A product, including its components, parts or accessories that may reasonably be expected to be obtained by an individual to be used for non-commercial purposes, including for domestic, recreational and sports purposes, and includes its packaging.
Danger to human health or safety:
Any unreasonable hazard — existing or potential — that is posed by a consumer product during or as a result of its normal or foreseeable use and that may reasonably be expected to cause the death of an individual exposed to it or have an adverse effect on that individual's health — including an injury — whether or not the death or adverse effect occurs immediately after the exposure to the hazard, and includes any exposure to a consumer product that may reasonably be expected to have a chronic adverse effect on human health.
Cosmetic
Includes any substance or mixture of substances manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth, and includes deodorants and perfumes
Radiation Emitting Device
Any device that is capable of producing and emitting radiation, or any component of or accessory to a device that is capable of producing and emitting radiation.

Pest Control Products

Pest Control Product
  • (a) A product, an organism or a substance, including a product, an organism or a substance derived through biotechnology, that consists of its active ingredient, formulants and contaminants, and that is manufactured, represented, distributed or used as a means for directly or indirectly controlling, destroying, attracting or repelling a pest or for mitigating or preventing its injurious, noxious or troublesome effects;
  • (b) an active ingredient that is used to manufacture anything described in paragraph (a); or
  • (c) any other thing that is prescribed to be a pest control product.

Note: Pest control products are classified as domestic, commercial, restricted or manufacturing. A pest control product can include a chemical, a device or a microbial agent.

Device
An article, an instrument, an apparatus, a contrivance or a gadget. Devices that are contained in Schedule 1 of the Pest Control Products Regulations are regulated under the Pest Control Products Act.
Microbial Agent
A pest control product whose active ingredient is a micro-organism. It includes any metabolites and toxins produced by the micro-organism. Note: A micro-organism is any organism too small to be visible to the naked eye, and includes viruses, bacteria, protozoa, algae, etc., that are represented for or used in controlling pests.
Pest Control Product Registration Number (PCP Reg. No.)
Numerical code assigned to each pest control product approved under the Pest Control Products Act for import, distribution and use. The code consists of up to five digits, and sometimes two additional characters at the end (12345 or 12345.xx).
Research Authorization Certificate Number (RA No.)
Alphanumerical code assigned to each Research Authorization Certificate, authorizing specific pest control products for specific research purposes. The code consists of four digits, RA, and then the last two digits of the year issued (1234-RA-12). Research Authorization Certificates are issued by Health Canada after review and approval of the appropriate information as outlined in the Pest Control Products Regulations, to conduct research on pest control products in support of registration or amendments to existing registrations.
Research Notification Certificate Number (RN No.)
Alphanumerical code assigned to each Research Notification Certificate, authorizing specific pest control products for specific research purposes. The code consists of four digits, RN, and then the last two digits of the year issued (1234-RN-12). Research Notification Certificates are issued by Health Canada after review and approval of the appropriate information as outlined in the Pest Control Products Regulations, to conduct research on pest control products in support of registration or amendments to existing registrations.
Foreign Product Use (FPU) Certificate Number
Numerical code assigned to each Foreign Product Use Certificate issued according to the Grower Requested Own Use (GROU) Program, authorizing importation of specific unregistered pest control products for specific agricultural purposes. The code consists of six or seven digits, a dash, then three digits (123456-123 or 1234567-123).
Scheduled under the Pest Control Products Act
This statement refers to pest control products that are not required to be registered (and as such would not have a PCP Reg. No.) in order to be imported and distributed for sale and use (they are "are exempt from registration"). For a complete list, please refer to the Pest Control Products Regulations Schedule 2.

Hazardous Products:

Hazardous Product
Any product, mixture, material or substance that is classified in accordance with the Hazardous Products Regulations in a category or subcategory of a physical or a health hazard class listed in Schedule 2 of the Hazardous Products Act. Note: A hazardous product cannot be a "consumer product" as defined under the Canada Consumer Product Safety Act or a "pest control product" as defined under the Pest Control Products Act.
Label
A group of written, printed or graphic information elements that relate to a hazardous product. Labels are designed to be affixed to, printed on or attached to the hazardous product or the container in which the hazardous product is packaged.
Safety Data Sheet
A document that contains, under the headings that, by virtue of the Hazardous Products Regulations, are required to appear in the document, information about a hazardous product, including information related to the hazards associated with any use, handling or storage of the hazardous product in a work place.
HMIRA Registry Number
An identification number assigned to the hazardous product by Health Canada in the context of the Hazardous Materials Information Review Act to exempt a supplier subject to the Hazardous Products Act from having to disclose confidential business information (CBI), such as the chemical name of one or more trade-secret hazardous ingredient, on the safety data sheet or label of the hazardous product. As a replacement for CBI, the HMIRA registry number is required to be shown on the safety data sheet of the hazardous product and, for certain claims, on the label of the hazardous product.

Role of the Canada Border Services Agency

1. The CBSA assists Health Canada in administering Health Canada legislation as it relates to the importation of goods.

2. The CBSA is not required to verify, validate, stamp, and/or return any permits or licenses for goods on behalf of Health Canada.

3. The CBSA may detain goods under the authority of the Customs Act and refer them to Health Canada for an admissibility recommendation, either as a result of specific information or on the occasion that the border services officers find/determine suspected contraventions of Health Canada's legislation.

4. The CBSA's enforcement role beyond the initial detention is limited to Customs Act contraventions. In such cases, the CBSA may seize the goods under the Customs Act.

Role of Health Canada

5. Health Canada is responsible for the administration and enforcement of all Health Canada legislation.

6. Health Canada will identify to the CBSA certain goods that may contravene Health Canada legislation or pose a potential risk to human health or the safety of Canadians or to the environment. Health Canada will request the CBSA to detain these goods at the time of importation.

7. Health Canada's inspectors may examine, open, test, seize and/or sample goods detained by the CBSA and may make copies of any record and/or document related to the detained goods in accordance with the relevant provisions of Health Canada's legislation.

8. Health Canada will provide a recommendation to the CBSA regarding the admissibility of detained goods that are suspected to be in contravention of Health Canada legislation.

Role of Importers

9. Importers are responsible for ensuring that every good imported is compliant with the requirements of CBSA and Health Canada legislation.

10. Importers must also obtain and have available for examination all required licences, permits, registry numbers, labels, safety data sheets and/or documents as required by the Health Canada legislation. In some circumstances these documents should accompany the shipment to facilitate the importation. Such documents may include a copy of the establishment license, a copy of the site license, a No Objection Letter for clinical trial drugs, a Letter of Authorization under the Special Access Program, a Research Authorization or Research Notification Certificate, a Foreign Product Use certificate, or product label.

11. Importers, distributors, suppliers, transporters, manufacturers and/or retailers may obtain more information about Health Canada requirements by visiting Health Canada's website (www.hc-sc.gc.ca)

Single Window Initiative (SWI)

12. The CBSA SWI launched a new Integrated Import Declaration (IID) release service option (SO911) that allows importers and customs brokers (must be registered with the CBSA) to submit and obtain electronic release for commercial goods regulated by participating  Government of Canada departments and agencies.

13. The SWI IID Electronic Commerce Client Requirements Document (ECCRD)  provides technical and system requirements information. Appendix B of the ECCRD includes a list of required data elements for Health Canada.

14. For more information on the SWI, please refer to the CBSA Web site at www.cbsa-asfc.gc.ca//prog/sw-gu/menu-eng.html.

For further information on release of commercial goods please refer to D17-1-4 Release of Commercial Goods.

Commercial Importation of Human Drugs, Natural Health Products, and Medical Devices

Health Canada generally considers the following to be examples of commercial importations:

15. The Food and Drugs Act and its regulations require that all human drugs be labelled with a Drug Identification Number (DIN) and that all natural health products be labelled with a Natural Product Number (NPN) or Homeopathic Medicines Number (DIN-HM).

16. Shipments of human drugs and natural health products not available in Canada may be authorized for importation through the Special Access Program or the clinical trial provisions of the Food and Drug Regulations or the Natural Health Products Regulations. These shipments may not be labelled with a DIN/NPN/DIN-HM but will be accompanied by a Health Canada authorization letter (No Objection Letter, Notice of Authorization, or Letter of Authorization, as appropriate).

17. Importers of commercial shipments must hold an Establishment Licence (EL) or Site License (SL) for the activity of importation. The foreign manufacturing site must be listed on the Importer's EL.

18. The CBSA may detain and refer human drugs and natural health products to Health Canada for an admissibility recommendation when these requirements are not met.

Commercial Importation of Medical Devices

19. The Medical Device Regulations require that Class II, III and IV medical devices have a device licence for each device. 

20. Importers of commercial shipments of medical devices must hold an Establishment Licence (MDEL). However, the following are exempt from the requirement of having an MDEL to import medical devices:

21. Shipments of medical devices not available in Canada may be authorized for importation through the Special Access Program or the investigational testing provisions of the Medical Device Regulations. These shipments of medical devices may not have a Medical Device Licence but will be accompanied by a Health Canada authorization letter (Investigational Testing Authorization or Letter of Authorization).

Personal Importation of Prescription Drugs

Health Canada considers a personal importation as an importation by an individual for their own use or for the use of a person under their care or guardianship and which does not meet the definition of a commercial importation as set out in paragraph 16 of this memorandum.

22. Under C.01.045 of the Food and Drug Regulations, importation of prescription drugs is restricted to practitioners, drug manufacturers, wholesale druggists or registered pharmacists, or a resident of a foreign country while a visitor in Canada. Note that drugs imported by practitioners for treating patients are not considered to be personal importations but rather commercial importation for sale.

Canadian Residents

23. Health Canada may exercise enforcement discretion to permit a Canadian returning from abroad to bring with them, on their person, a single course of treatment or a 90-day supply based on the directions for use, whichever is less, of a prescription drug. This discretion is generally reserved for Canadian residents returning to Canada with prescription drugs which were dispensed for a treatment prior to leaving Canada, or drugs obtained through a filled prescription to treat an illness while abroad.

24. Prescription drugs imported in this fashion must be for the individual's personal use or the use of a person for whom they are responsible and with whom they are travelling.Additionally, all personal importations of prescription drugs must be packaged in the hospital, pharmacy dispensing or retail packaging, or have the original label affixed to it clearly indicating what the product is and what it contains.

25. The CBSA may detain and refer prescription drugs to Health Canada when these conditions are not met.

26. Canadian residents may not import prescription drugs by mail or courier.

Non-Residents of Canada

27. Visitors to Canada and non-residents arriving from abroad are permitted to import a single course of treatment or a 90-day supply of a prescription drug hand-carried for their personal use or the use of a person under their care and with whom they are travelling.

28. Visitors and non-residents are allowed to import a single course of treatment or a 90 day supply of a prescription drug by mail or courier.

29. All  personal importations of prescription drugs must be packaged in the hospital, pharmacy dispensing or retail packaging, or have the original label affixed to it clearly indicating what the product is and what it contains.

30. The CBSA may detain and refer prescription drugs to Health Canada when these conditions are not met.

Personal Importation of Natural Health Products and Non-Prescription Drugs

31. Residents, non-residents and visitors to Canada can import for their own use or for a person under that individual's care a single course of treatment or a 90-day supply of natural health products and non-prescription drugs. The drug must be packaged in the hospital, pharmacy dispensing  or retail packaging, or have the original label affixed to it clearly indicating what the product is and what it contains.

32. The CBSA may detain and refer natural health products and non-prescription drugs to Health Canada when these requirements are not met.

Personal Importation of Medical Devices

33. Personal use generally does not include medical devices that require the intervention of a healthcare professional. The Medical Device Regulations do not apply to importation of medical devices for personal use.

Importation of Consumer Products

34. Under the Canada Consumer Product Safety Act, the importation into Canada, manufacture, sale and advertisement of consumer products are regulated by Health Canada.

35. This legislation applies to commercial and non-commercial importations of new or used consumer products (including their components, parts or accessories and packaging), and allows inspectors designated under the Act to examine, test, seize, detain and/or take samples of consumer products imported into Canada.

For the purposes of this memorandum, consumer products may be grouped into two categories: prohibited and regulated products.

Prohibited Consumer Products

36. Schedule 2 of the Canada Consumer Product Safety Act in Appendix A of this memorandum) lists certain products which are prohibited from importation, sale, manufacture or advertisement in Canada. Importers may contact one of the regional Health Canada Consumer Product Safety Offices to verify whether specific products are prohibited (refer to Appendix B of this memorandum).

37. The CBSA will detain prohibited products listed under the Canada Consumer Product Safety Act, and refer them to Health Canada.

Regulated Consumer Products

38. The Canada Consumer Product Safety Act stipulates that no person shall import, sell, or advertise a consumer product that does not meet the requirements set out in the regulations or that is a danger to human health or safety. These products must meet the prescribed requirements and conditions set out in the Canada Consumer Product Safety Act and regulations made thereunder to be legally imported into Canada.

39. The CBSA will detain regulated consumer products and refer them to Health Canada to verify import requirements when it is suspected that a regulated product may pose a danger to human health and/or safety.

Importation of Cosmetics

40. The CBSA will detain cosmetics and refer them to Health Canada to determine import requirements when it is suspected that a product may contravene the Food and Drugs Act or the Cosmetic Regulations.

Importation of Radiation Emitting Devices

41. The CBSA will detain radiation emitting devices and refer them to Health Canada to determine import requirements when it is suspected that a radiation emitting device may pose a danger to human health or safety, or may contravene the Radiation Emitting Devices Act or its regulations.

Importation of Pest Control Products

42. Pest control products imported into Canada (including those imported solely for the purpose of export) must meet the requirements in the Pest Control Products Act and its regulations. They must be:

43. The CBSA will detain pest control products and refer them to Health Canada to verify import requirements when it is suspected that the product endangers human health or safety or the environment, or may otherwise contravene the Pest Control Products Act or its Regulations.

Personal Importation of Pest Control Products

44. There is an exemption from the Pest Control Products Regulations, for any pest control product imported into Canada, when the following conditions are met:

Commercial Importation of Hazardous Products

45. The importation into Canada, and sale of hazardous products intended for use, handling or storage in a work place in Canada are regulated under the Hazardous Products Act, and the Hazardous Products Regulations. This legislation applies to commercial importations of hazardous products (including their packaging), and allows inspectors designated by Health Canada to examine, test, seize, detain or take samples of hazardous products imported into Canada.

46. The following products are not subject to the Hazardous Products Act and the Hazardous Products Regulations:

47. In accordance with Hazardous Products Act, an importer must obtain or prepare, on or prior to the importation of the hazardous product, a safety data sheet that meets the requirements set out in the Hazardous Products Regulations. However the safety data sheet may travel separately from the imported product or the safety data sheet may have already been obtained by the importer. The importer must also affix, print or attach to the hazardous product or the container in which the hazardous product is packaged a label that meets the requirements set out in the aforementioned regulations. However, a non-compliant label is permitted for importation if the hazardous product is imported for the purpose of being brought into compliance with the labelling requirements before it is used or sold.

48. No supplier shall sell or import a hazardous product that is intended for use, handling or storage in a work place in Canada if the hazardous product or the container in which the hazardous product is packaged has affixed to, printed on or attached to it information about the hazardous product that is false, misleading or likely to create an erroneous impression, with respect to the information that is required to be included in a label or safety data sheet for that hazardous product in order for the supplier to comply with the Hazardous Products Act.

49. The CBSA will detain hazardous products and refer them to the Workplace Hazardous Materials Bureau of HC to verify import requirements when it is suspected that a hazardous product may contravene the Hazardous Products Act or its Regulation.

Detention and Seizure

50. Imported goods that the CBSA suspects may be in contravention of Health Canada Legislation may be detained and the nearest Health Canada Border Centre will be contacted in order to obtain a response regarding import requirements.

51. In some cases, a recommendation of admissibility into Canada of goods cannot be made until further analysis has been completed by Health Canada.

52. Health Canada has the authority to seize and detain goods under the following legislation: the Food and Drugs Act, Hazardous Products Act, Canada Consumer Product Safety Act, Radiation Emitting Devices Act and Pest Control Products Act, and of any regulations made under these Acts.

53. Health Canada will advise the CBSA of the appropriate course of action, once the admissibility recommendation of the goods has been completed.

Penalty Information

54. Penalties (including administrative monetary penalties, fines and imprisonment) may apply for failure to comply with the Food and Drugs Act,Canada Consumer Product Safety Act, Radiation Emitting Devices Act, Pest Control Products Act, Hazardous Products Act,Hazardous Materials Information Review Act, and/or the Customs Act. The penalties are outlined in the respective legislation.

Canada Border Services Agency Contact Information

55. For more information regarding the CBSA's administration of Health Canada legislation as it relates to goods, within Canada call the Border Information Service at 1-800-461-9999. From outside Canada call 204-983-3500 or 506-636-5064. Long distance charges will apply. Agents are available Monday to Friday (08:00 – 16:00 local time / except holidays). TTY is also available within Canada: 1-866-335-3237.

Health Canada Contact Information

56. Any questions concerning Health Canada's administration of its legislation should be directed to Health Canada. Please refer to Appendix B for a list of Health Canada contacts.

Appendix A

Prohibited Consumer Products

Under the Canada Consumer Product Safety Act, section 5, it is prohibited to manufacture, import, advertise or sell a Consumer Product listed in Schedule 2. Those consumer products are:

Appendix B

Health Canada Product Specific Contact Information

Human Drugs, Natural Health Products and Medical Devices

General Enquiries
Tel: 1-800-267-9675

Atlantic Region
Email: insp.aoc-coa@hc-sc.gc.ca
Tel: 1-902-426-4775

Quebec Region
Email: QC.UIF-BIU@hc-sc.gc.ca
Tel: 1-800-561-3350

Ontario Region
Email: ON.BIU-UIF@hc-sc.gc.ca
Tel: 1-416-973-1600

Prairie Region
Provinces of Manitoba and Saskatchewan
Email:  insp_msoc_coms@hc-sc.gc.ca
Tel: 1-204-594-8061

Province of Alberta, Northwest Territories, Nunavut, and Yukon
Email:  insp_aboc-coa@hc-sc.gc.ca
Tel: 1-780-495-0490

British Columbia Region
Email: insp_woc-coo@hc-sc.gc.ca
Tel: 1-604-666-3350

Consumer Products and Cosmetics

General Enquiries
Tel: 1-866-662-0666

Atlantic Region
Email: Atlantic.ProdSafe@hc-sc.gc.ca

Quebec Region
Email:Quebec.Prod@hc-sc.gc.ca

Ontario Region
Email: Tor.ProdSafe@hc-sc.gc.ca

Prairie Region
Provinces of Manitoba and Saskatchewan
Email: MBSK.ProdSafe@hc-sc.gc.ca
Province of Alberta, Northwest Territories, Nunavut and Yukon
Email: Alberta.ProdSafe@hc-sc.gc.ca

British Columbia Region
Email: Bby.ProdSafe@hc-sc.gc.ca

Enquiries from the United States of America
Tel: 1-866-662-0666

Enquiries from international locations other than the United States
Africa
Email: Alberta.ProdSafe@hc-sc.gc.ca

Asia
Email: Bby.ProdSafe@hc-sc.gc.ca

Australia
Email: Alberta.ProdSafe@hc-sc.gc.ca

Central and South America
Email: MBSK.ProdSafe@hc-sc.gc.ca

Europe
Email: Atlantic.ProdSafe@hc-sc.gc.ca

Radiation Emitting Devices

Consumer and Clinical Radiation Protection Bureau
Email: ccrpb-pcrpcc@hc-sc.gc.ca
Tel: 613-954-6699

Pest Control Products

Health Canada Pest Management Information Service
http://www.hc-sc.gc.ca/contact/cps-spc/pmra-arla/infoserv-eng.php
Email: pmra.infoserv@hc-sc.gc.ca
Tel: 613-736-3799
Tel (Toll-Free): 1-800-267-6315

Regional Contacts
http://hc-sc.gc.ca/contact/cps-spc/pmra-arla/region-eng.php

Hazardous Products

General Enquiries
Tel: 1-855-407-2665

Regarding the Hazardous Products Act or its Regulations
Email: WHMIS_SIMDUT@hc-sc.gc.ca

Regarding the Hazardous Materials Information Review Act or its Regulations
Email: WHMIS-SIMDUT.conf@hc-sc.gc.ca

References

Issuing office:
Other Government Department Programs Unit
Commercial Border Programs Division
Border Programs Directorate
Programs Branch
Headquarters file:
 
Legislative references:
Customs Act
Food and Drugs Act
Controlled Drugs and Substances Act
Canada Consumer Product Safety Act
Radiation Emitting Devices Act
Pest Control Products Act
Hazardous Products Act
And Regulations associated with the above Acts
Other references:
D19-9-2
SWI ECCRD
Superseded memorandum D:
D19-9-1, August 20 , 2014 
(D19-5-1 March 20, 2014 – Cancelled - January 24, 2017)
Date modified: