ARCHIVED - Natural Health Products: 53 Recommendations of the Standing Committee on Health
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Table of Contents
- Recommendations re: Definitions
- Recommendations re: Expertise and Regulatory Structure
- Recommendations re: Safety
- Recommendations re: Quality/Good Manufacturing Practices
- Recommendations re: Efficacy
- Recommendations re: Product Licensing
- Recommendations re: Labelling
- Recommendations re: Section 3 and Schedule A of the Food and Drugs Act
- Recommendations re: Importation of Human-Use Drugs for Personal Use
- Recommendations re: Cost Recovery
- Recommendations re: Appeal Process
- Recommendations re: Informed Choice
- Recommendations re: NHP Practitioners
- Recommendations re: Enforcement
- Recommendations re: Aboriginal Healers
- Recommendations re: Plant Conservation
- Recommendations re: Transition
- Appendix A
- Appendix B
1. Health Canada, in conjunction with a new separate Natural Health Products Expert Advisory Committee (EAC), set out an appropriate definition of natural health products (NHPs) and amend the Food and Drugs Act accordingly.
2. Health Canada, in conjunction with the new NHP Expert Advisory Committee, examine the status of bulk herbs for legislative purposes.
3. The government give consideration to the advisability of creating a new regulatory authority for NHPs that reports directly to the Assistant Deputy Minister of the Health Protection Branch.
4. The structure for this new regulatory authority be established within the next six months and be permanently staffed by individuals with expertise and experience in the field of NHPs.
5. The selection of personnel be agreeable to both government and NHP stakeholders.
6. When necessary, working groups reflecting the various segments that make up the NHP category be set up to advise the new regulatory authority.
7. All relevant inspection personnel be provided with training specific to NHPs.
8. The necessary process to amend the Food and Drugs Act not delay in any way the implementation of the regulatory and administrative changes that can proceed at this time.
10. This Expert Advisory Committee review the re-establishment options for an NHP section with research and laboratory capacities and report its findings to Health Canada.
11. The selection of members for the Expert Advisory Committee be agreeable to both NHP stakeholders and Health Canada.
12. The new regulatory authority assume primary responsibility for assessing safety of products.
13. General safety protocols be developed by the Expert Advisory Committee based on EAC judgements of reasonable evidence.
14. When necessary, this regulatory authority establish appropriate working groups to assess the safety of specific products.
15. Health Canada, in collaboration with the NHP industry, establish appropriate GMP guidelines reflective of the different nature of NHPs.
16. GMP standards for NHPs include specific quality control and testing for herbal products.
17. Manufacturers, packagers, importers and distributors of NHPs, whether located in Canada or abroad, be obliged to hold valid establishment licences.
18. Inspection activities be performed consistently and on a regular basis by inspectors knowledgeable about the products.
19. NHPs be allowed to make health claims, including structure-function claims, risk-reduction claims and treatment claims.
20. Claims be assessed to ensure that there is reasonable evidence supporting the claim.
21. The evidence not be limited to double-blind clinical trials but also include other types of evidence such as generally accepted and traditional references, professional consensus, other types of clinical trials and other clinical or scientific evidence.
22. The evidence required vary depending on the type of claim being made, with different evidence being required for structure-function claims and risk-reduction claims for minor self-limiting conditions than for therapeutic or treatment claims.
23. The label indicate clearly the type of evidence used to support the claim.
24. The new product licensing framework be based on a risk management approach that emphasizes the margin of safety associated with a particular product.
25. Health Canada, in conjunction with the Expert Advisory Committee, establish categories within the NHP class to determine what level of regulation is appropriate for a particular product.
26. A product licensing system based on monographs be used when they are available. Such a system should rely on a pre-market approval process and the regulator should have a short period of time (for example, 30 days) to review the application.
27. Health Canada, in conjunction with the Expert Advisory Committee (EAC), establish procedures to create new Canadian monographs based on work already accomplished in other countries.
28. Manufacturers of products that do not have monographs be required to provide evidence to Health Canada before a product is marketed. The level of evidence would be consistent with the margin of safety associated with the product.
29. The level of post-market monitoring be based on the margin of safety associated with the product and include a NHP adverse event reporting system for industry and an adverse reaction hotline for practitioners and the general public.
30. Certain lower safety products be made available to consumers with appropriate warnings and other lower safety products only be made available with practitioner intervention.
31. The new framework be phased in over a period of months to allow sufficient time for the stakeholders and the regulator to review the current DIN system and conform to the new regulations.
32. Health Canada consult with its new separate NHP Expert Advisory Committee to determine what information is to be included on the labelling, consisting of, at a minimum, the items recommended by the Advisory Panel on Natural Health Products.
33. NHP labelling provide consumers with all relevant information needed to make informed choices.
34. NHP labelling be standardized to provide clear and consistent product information.
35. Health Canada immediately initiate a review of the diseases listed in Schedule A to ensure that only appropriate diseases are included and, where relevant, specific diseases be exempted by regulation from the broad terms found in Schedule A.
36. Health Canada, subsequently, conduct a study with the participation of representatives from consumer groups, the food, natural health products and pharmaceutical industries, and health practitioners to determine whether subsections 3(1) and (2) of the Food and Drugs Act or all of the diseases listed in Schedule A should be deleted.
37. When the new regulatory framework is implemented, the personal importation policy be reviewed by Health Canada and the Expert Advisory Committee to determine if it is still appropriate and to outline permissible changes.
38. Health Canada conduct a review analysing the impact of the overall cost recovery policy on the different segments of the NHP industry.
39. The NHP industry stakeholders be consulted in the establishment of the most appropriate fee structure and amount.
40. As a result of this review, the existing fee levels be re-examined if necessary.
41. As part of the immediate process for NHPs, Health Canada work with stakeholders to establish appropriate, accessible and effective appeal processes for relevant policies and possible inclusion into a revised regulatory and legislative framework.
42. Health Canada immediately utilise existing formats and forums for more open and transparent communication on NHPs with the broader public and practitioners.
43. Communication efforts include details about decisions and actions regarding NHP products (removal from market, change of status, etc.).
44. Relevant consumer, industry and practitioner groups be consulted on a regular basis about the nature of the required information.
45. The federal government research bodies, including Health Canada, begin immediately to encourage research on NHPs. This could include studies focussing on the interactions of herbal products with conventional medications as well as studies that explore different uses by various groups in Canada.
46. Health Canada undertake, through its various established avenues, the dissemination of the resulting information to health care professionals and consumers.
47. Health Canada inform its provincial and territorial counterparts of the regulatory changes with regard to NHPs and of the concerns raised by practitioners.
48. The new regulatory framework for NHPs be enforced in a regular and consistent manner and done in conjunction with education.
49. Sufficient resources be provided for enforcement activities.
50. If a product that is extemporaneously compounded for a particular person is not exempted from the regulatory framework, that such a product be exempted.
51. Health Canada work with Foreign Affairs and International Trade to ensure that existing International Agreements that currently protect biological diversity are not violated and that additional strategies are developed if needed to prevent depletion of these valuable health resources.
52. The interim enforcement policy regarding NHPs continue to be applied until the new framework is in place.
53. The Minister appoint, immediately, a transition team responsible for ensuring that the new framework is established quickly.
(see Recommendation 9)
Terms of Reference
The Expert Advisory Committee (EAC) has been selected from professional and scientific communities, to provide expert advice and opinion to the Natural Health Products Directorate (NHPD). Issues of interest related to the safety, quality and efficacy of Natural Health Products (NHPs), and matters regarding the development and implementation of regulations for NHPs, may be referred to the EAC. The collective expertise from the EAC will assist the management team in making decisions. However, final responsibility and authority remains within the NHPD.
The mandate of the EAC is to provide the Natural Health Products Directorate with timely expert advice for questions on the safety, claims, use, and regulation of Natural Health Products. Questions referred to the EAC from the NHPD may be from a broad range of issues, but will focus on areas where detailed or difficult evaluation is required. Such issues referred for advice and recommendation may include, but not be limited to, the following:
The inaugural EAC has been proposed by a screening committee selected by the Assistant Deputy Minister, Health Protection Branch (HPB) in consultation with members of the Transition Team. The EAC will be chaired by a member external to the Public Service of Canada, and chosen by the ADM, HPB. Subsequent members and Chairpersons will be chosen by the Director General, NHPD, taking into consideration recommendations made by current EAC members.
Members have been, and will be, identified through broad consultation with stakeholder groups, including health professional and scientific societies, academia, industry associations, consumer associations, and government agencies. The membership of the committee will endeavour to reflect an appropriate blend of gender, regional, ethnic and language representation for Canada.
Members have been and will be selected for their knowledge and expertise in NHPs, relevant medical sciences, and the practice of healthcare. Members have been and will be appointed as individuals on the basis of their individual expertise, and will not represent their firms, organizations or associations directly. They will serve in the best interests of all Canadians, recognizing the roles and responsibilities of consumers and health professionals in achieving optimal access to, and safe use of, NHPs.
The EAC may form sub-committees or seek out ad hoc members, where necessary, to ensure adequate expertise on matters referred to the committee. Sub-committee and ad hoc members will be selected by the EAC with concurrence of the Director General.
Health Canada staff will provide Secretariat support and may actively participate in discussions, as observers, at the call of the Chair.
The EAC Chairperson and committee members will be appointed for a two or three year term at the choice of the Director General, NHPD. There may be consideration for re-appointment to office, to a maximum period of six years. Appointments shall be scheduled to ensure continuity and systematic rotation of membership for the EAC.
Sub-committee and ad hoc members may be appointed for specific meetings or for specific subjects in which they have expertise, for a term up to three years. They may be re-appointed for a further term, for a maximum of six years.
Committee members who are absent from three consecutive meetings of the committee may forfeit their membership.
An individual may withdraw from service on the EAC at any time, upon written notification to the Director General. Membership may be terminated at any time, upon written notification from the Director General.
Security and Conflict of Interest
All Committee members will be required to undergo a governmental security clearance to the level of "enhanced reliability".
Documents provided by the Natural Health Products Directorate to members must be securely stored at all times. All information must be returned to the NHPD, including electronic and word processing records.
All members are expected to keep confidential any trade secrets or privileged information they obtain through their work on the EAC. Information obtained from the work of the EAC must not be discussed with persons not on the committee, nor released, until such time as this information has been officially released for public distribution.
EAC members must refrain from any conflict of interest. In situations where a real or potential conflict of interest arises in the course of the work of the committee, the individual involved must declare this conflict, and disqualify himself/herself from participation in any discussions on that subject matter.
Management and Administration
The specific questions and issues for discussion at the meetings of the EAC will be determined by the Director General in conjunction with the Chair, with input from Health Canada staff, Committee members and stakeholders. The agenda will be developed by the Director General in collaboration with the Chair.
Meetings will be held in the National Capital Region, or by teleconference. They will be scheduled as needed according to the requirements of the NHPD, while being sensitive to the schedules and other commitments of the EAC members. There will be a standing schedule of at least two meetings per year. Invitations to attend meetings will be issued in writing.
All members of the Committee shall have equal status during discussion. Decisions of the Committee are reached by consensus. In situations where consensus is not achieved, then the number of members in disagreement, and their issues, will also be recorded. In such cases, the EAC may also make a recommendation of further study of the issue. Decisions of the Committee are recommendations to the Director General.
The Committee will develop recommendations based on consensus and seventy percent (70%) out of the Fourteen (14) members rounded up to the next person ten (10), duly assembled, constitute a quorum for the transaction of business.
Members will be compensated for travel expenses according to Federal Government policy. Honorariums will be provided to those EAC members requesting one.
Terms of Reference approved by Wah Jun Tze, Phil Waddington, and EAC committee members.
Expert Advisory Committee minutes
Natural Health Products Directorate
July 18th and 19th, 2002
Ottawa Marriott Residence Inn Hotel
Laurie Chan, Frank Chandler, Patrick Choy, Albert Fok
Mark Goldberg, Ron Harris, Paul Saunders, Mary Wu, Valerie Assinewe
Health Canada - NHPD
Peter Chan - Product Review & Assessment
Joe-Anne Blanchette - Product Review Assessment
Wendy Simmons - Product Review & Assessment
Melissa Johnson - Product Review & Assessment
Chrissie Lees - Director General's Office
Peter Chan updated the group on the Directorate, and the recent reorganization activities within the Directorate. One of the major activities completed to date is the GMP consultation process. The Directorate consulted cross country on the proposed GMP regulations, and the responses to date have been positive. The GMP documents are posted on our website and we will be accepting comments until Aug. 15, 2002. The next step will be to post the Standards of Evidence document on the web for consultation. Following the approval of the Branch, the Directorate is planning on the best means to further consult on this document.
The Directorate is planning on going to Canada Gazette Part II about the end of the calendar year.
2. Listable Herbs
It was decided that NHPD would use the term "factor" rather than criteria to describe the points being developed that would determine if the herbs are NHP only.
The second half of the discussion focused on the proposed list of factors provided to the EAC by the NHPD. The group went through each factor and agreed on all of them with some minor edits to number two and the addition of another factor. Once factor was changed from "there is a significant potential for undesirable or severe side effects at normal therapeutic dosage levels" to now read "there is a risk of potential for undesirable or severe side effects at normal therapeutic dosage levels". The new one reads, "the action of the herb has significant physiological effects on specific organs or systems." It was also decided to delete the first factor as it did not apply.
An EAC subcommittee was formed and they will pick a number of herbs and apply the proposed factors to see how well they apply. They will report back to the NHPD with their comments and justification for their decisions by August 1, 2002.
3. Children's Herbs
The focus of this discussion was to develop a list of factors that would be used to determine which herbs may be suitable for use by children. The group revised the list of factors for listable herbs and modified some of them to suit children's herbs.
The list that was developed is as follows:
The group also discussed the recommendations that were made in the last meeting with respect to children's herbs. There was consensus on all of them, however number four was changed to read: "Duration of use must be limited to a maximum of 7 days, unless otherwise directed by a health care provider."
The last topic discussed under children's herbs was the decision to go with age as a opposed to weight in setting an appropriate dose for children's herbs. There were some members who felt age was more user-friendly, others felt that weight was more accurate. It was agreed however that they would go by age because the Food and Drugs Act already incorporates a table with acceptable doses for children based on age. It was noted for future reference that weight would be a more accurate measure.
There was also a brief discussion of the reasons for setting the cut-off limit for the use of botanicals in children at 5 yrs old. This had been a recommendation of Dr. Tze, and was agreed upon for three reasons: 1) because the child can communicate better with parents and their health care provider at that age; 2) age was consistent with TPD and the act as it now exists; 3) parents are more familiar with the child's age rather than weight.
An EAC subcommittee was formed to apply the proposed factors to a number of herbs under the children's herbs category and determine if they apply. They are to report back to the NHPD with their decisions and justification by August 1, 2002.
4. List of References
The EAC was tasked with determining how to distinguish appropriate references. The group began a brainstorming session to come up with a list of factors that would assist the NHPD select the appropriate references to use.
The 7 factors that the group came up with is as follows:
The next step is to see how the factors apply. An EAC subcommittee was formed to do this. The group will look at the definition and take the categories listed there, and then list references for them. They will then comment on the factors and how they apply as well as determine if any more should be added. In addition, they will also look at the current reference list and decide which ones should be removed.
5. Source Material
The discussion on source material began with reviewing the option analysis that had been discussed at the previous meeting. Some minor changes were made to points a) through l). They now read:
The main changes being the addition of the phrase "species and part" to the definitions, and the addition of the term "ore" where appropriate.
It should also be noted that with respect to the source material for homeopathic remedies there were some objections made to this section, however, the group will be looking at homeopathic as a separate topic as a future agenda item.
6. Traditional Claims
The discussion began with determining what period of time would be the minimum to allow for "traditional use". It was agreed that 50 years would be appropriate. This was long enough to cover one and a half generations and also long enough to determine effects of products on offspring.
The next topic was oral tradition. There were some concerns around this topic because of the misinterpretation that could take place when dealing with oral tradition, especially as to the origins of the tradition. While it was agreed that most herbs have documentation, the concerns could continue to be explored.
The group then discussed how Australia handles oral tradition and it was agreed that their version could be applicable to Canada. Australia allows "recorded oral history, as evidence of traditional use. The oral history must be written down by the appropriate practitioner or indigenous group(s) who maintain the history. The therapy for which the NHP is used should be properly identified as well as the holistic principles that are apart of this therapy because the theories, concepts and cultural context of the therapy must be considered." Therefore the EAC recommended that the NHPD review the oral history material in this context. The NHPD will therefore look further into the Australian process and report back to the EAC.
7. Equivalency Ratio
The main issue to be discussed was what is acceptable as equivalency and ratio. The group reviewed various options and decided that Option 4 would be appropriate. The EAC looked at the different ratios for traditional, and determined that the three dosage ranges found in acceptable references would be acceptable. However, for non-traditional, the dosage ranges given did not apply because they referred to "new" dosage forms and were not directly supported by documentation. Therefore the group agreed that for non-traditional, the dosage form should equate back to the dried herb. This topic will be discussed further at the next meeting.
8. Country of Origin
At the last meeting it was agreed that due to safety reasons, it may be necessary to list the country of origin on certain herbs. An EAC subcommittee was formed to determine which herbs should have a country designation on them. The committee will report back to the NHPD by August 1, 2002.
The main issue under monographs was duration of use. After some discussion, the EAC developed three general duration of use statements to be used on the monographs. For some products: "Must be taken for a minimum of (time period) for beneficial effects to be demonstrated. If symptoms persist, consult a health care provider."
For vitamins: "Consult a health care provider for prolonged use". The general statement for monographs: "May be used up to (time period), if symptoms persist consult a health care provider." The rest of discussion focused on going through the monographs. Most of the monographs were approved subject to some minor edits. These will be reviewed at the next meeting. It was also agreed that for vitamins and minerals the liquid form should be added.
10. Definition of Specifications
The main issue for this topic was to determine the depth and definition of an acceptable specification for all NHP's to be submitted in an application for a product licence. The group agreed to go with the option which suggested: "NHPD describe the type of testing which is required, the manufacturer may develop their own methods, limits are set by the NHPD." The new wording suggested was "NHPD specifies the method for heavy metals, pesticides and microbes; for all other assays the manufacturer may adopt a method of mutual recognition (including in house assays). Limits are set by NHPD for all assays." The group also suggested that metals, pesticides and composition assays are to be on the finished product, and the maximum allowable for all contaminants is to be based on body weight.
11. Forward Agenda Items
Composition of EAC
Definition of synthetic
List of TCM herbs
(see Recommendation 37)
Table of Contents:
The purpose of this document is to ensure that the policy and enforcement measures related to the importation of human-use drugs for personal use are uniform throughout the Health Products and Food Branch Inspectorate.
This directive supersedes any Regional guidance or procedures.
This directive provides guidance to help officials of Health Canada to confirm that the importation is for personal use and provides a uniform framework for enforcement.
The Food and Drugs Act and Regulations (the Regulations) do not regulate the importation of drugs for personal use unless the drugs sought to be imported are listed in Schedule F to the Regulations (prescription drugs). The Controlled Drugs and Substances Act regulates the importation of substances or drugs classified as controlled, narcotic or restricted. It has been the policy of the Health Products and Food Branch Inspectorate (HPFBI) to permit individuals to import a three-month supply of a drug for their own personal use unless prohibited by law. This policy is comparable to policies in other countries.
Respecting the importation of drugs for personal use, Health Canada is primarily concerned that these importations will not be diverted for commercial purposes. Recent attention has been drawn to commercial importations of drug products that have circumvented regulatory requirements by claiming that these importations were for "personal use." Foreign suppliers, which have commercial sales organizations in Canada, are claiming that individually packaged shipments, which are mailed directly to purchasers, qualify as an importation under the personal use import policy. The personal use exemption unfortunately provides an opportunity for these suppliers to conduct commercial activities, and to evade the submission review process for individual products, and/or the Establishment Licence requirements for importers, by supplying their drug products primarily through the mail to individual Canadians. These activities at times may include violative marketing and advertising activities by means such as the Internet. This has ramifications related to safety because large quantities of products, which have not been reviewed for safety and/or efficacy, and which are of unknown quality, can enter the country and be distributed. The lack of an importer also means no person is responsible for meeting GMP requirements such as appropriate record retention or recall mechanisms.
There is also evidence of patients ordering prescription drugs directly from foreign suppliers as a means of avoiding the higher costs of the same drugs available from Canadian suppliers. This situation results in a competitive disadvantage to domestic companies who are compliant with product and establishment regulations in addition to fee regulations.
This directive applies to all drugs in dosage form (including biologics), for human-use only.
For the purpose of this directive:
Sell as defined in the Food and Drugs Act includes offer for sale, expose for sale, have in possession for sale, and distribute, whether or not the distribution is made for consideration. Drugs imported into Canada for personal use have not been considered to fall within this definition of sell.
Personal use includes the importation for use by one person, either the importer or another individual member of the importer's immediate family. For the purpose of this clause, immediate family is defined as father, mother, children, or spouse (including a common-law spouse) with whom the importer permanently resides.
It is the policy of the Health Products and Food Branch Inspectorate to permit individuals to import a three-month supply of a given drug for their own personal use, once during each quarter of the year. The exceptions to this policy are stipulated by legislation or the Regulations, and include the following:
a) Section C.01.045 of the Regulations restricts the importation of a prescription drug; listed in Schedule F, Part I, or Schedule F Part II which is not for veterinary use; to a practitioner, a drug manufacturer, a wholesale druggist, a registered pharmacist or a resident of a foreign country while a visitor in Canada. However, persons (regardless of residence) coming from abroad will usually be permitted to import enough drug for a single course of treatment or a three-month supply, whichever is the lesser, of a Schedule F drug, if the drug is packaged in pharmacy or hospital dispensed packaging.
Controlled Drugs and Substances Act
b) Subsection 6.(1) of the Controlled Drugs and Substances Act restricts the importation of narcotic, controlled and restricted drugs to licensed dealers who have obtained an importation permit.
Any Drugs FOR SALE
c) Section A.01.040 of the Regulations prohibits the importation for sale of a drug if its sale in Canada constitutes a violation of the Food and Drugs Act and Regulations. Drugs destined for commercial establishments are considered to be imported for sale and therefore personal use exemptions cannot be applied.
Special Access Program
Individuals other than those listed in C.01.045 seeking to import prescription drugs listed in Schedule F to the Regulations for their personal uses are required to contact their physician to obtain a prescription for the medication. Drugs available in Canada should be obtained from a Canadian source. Drugs not available in Canada, (including prescription, controlled drugs, non-prescription drugs, or new drugs which have not yet been classified in any schedules), can be obtained through the emergency drug release provisions of section C.08.010. The Special Access Program (SAP), formerly the Emergency Drug Release Program (EDRP), provides for the release of drugs which are otherwise unavailable for sale in Canada to physicians, dentists and veterinarians. Through SAP, the HPFBI provides legal access to these drugs; however, it does not endorse their safety or efficacy. Practitioners who use the Program must agree to report on the outcome of the therapy with the drug, including any suspected adverse drug reactions. For drugs regulated by the Controlled Drugs and Substances Act, special permit procedures need to be followed involving the Bureau of Drug Surveillance.
The implementation of this directive is the responsibility of staff of the HPFBI.
Drugs Accompanying Travellers
When persons (regardless of residence) are coming from abroad, they will usually be permitted to import enough drug for a single course of treatment or a three-month supply, whichever is the lesser, of a prescription drug listed in Schedule F or any other drug which has been prescribed by a physician if it is packaged in pharmacy or hospital dispensed packaging, or of any non-prescription drug. Some discretion may be required in unusual
circumstances, e.g., long term visitors to isolated locations, long-term visitors where language or other barriers may impede establishing good communications with a Canadian physician, persons returning from countries which dispense in trade packages.
No person may bring any substance that is regulated by the Controlled Drugs and Substances Act into Canada unless they have obtained an authorization from the Bureau of Drug Surveillance.
Where a shipment of a drug is encountered at Canada Customs, a Health Canada official determines:
1. Whether the importer is a legal recipient of the imported drug.
a) Where the shipment contains a drug for human use listed in Schedule F to the Regulations that is not destined to a recipient as listed in C.01.045, it is normally refused entry. In order to not delay or interrupt a course of treatment or other situations in which refusal of entry could create a health risk, inspectors may allow entry of an initial 3-month supply of a drug, if the drug is packaged in hospital or pharmacy dispensed packaging. However, the recipient will be informed that all future shipments will be detained and that either a Canadian source should be used or that their physician should obtain a foreign supply through the Special Access Programme for drugs not available in Canada. Please see Appendix A for a copy of a suggested form letter which can be used for this purpose.
Controlled Drugs and Substances
b) Where the shipment contains any narcotic, controlled or restricted drug that is not destined to a licensed dealer who has obtained an importation permit, it is refused entry and further legal action is possible.
All Other Drugs (Usually in Trade Packaging)
2. Whether the importer is importing the drug for commercial purposes.
a) Where the shipment is destined for a retailer, distributor, or other commercial establishment, it will not be considered a personal shipment and A.01.040 will apply.
b) Where the shipment is part of a pattern of repeat personal importations of the same drug to the same individual or address within a three-month period, it is considered to be a commercial shipment and A.01.040 will apply.
c) Where the shipment is part of a larger shipment from a single foreign supplier, which consists of individually addressed parcels, and the importer of record as indicated on a separate customs invoice for each parcel, is not unique for each parcel, the shipment will be considered to be a commercial shipment and A.01.040 will apply. However, if each parcel is uniquely addressed, and if there is a separate invoice for each parcel, then entry is permitted.
d) Where the shipment is accompanied or associated with advertising or promotional material, except for patient information such as directions for use, the importer is considered to be a distributor. The shipment will therefore not be considered to be a personal shipment and A.01.040 will apply.
3. Whether the quantity of the drug which is sought to be imported represents a supply greater than three months of the drug for one individual's use, based on its directions for use or reasonable intake.
a) Where more than a three-month supply of a drug for use by one person is being imported, it is considered to be for sale and it is refused entry.
Available Measures of Enforcement
Refusal of entry or conditional entry at Customs to drug products which are not permitted entry due to conditions as stated in 1. a), b); 2. a), b) c), d); or 3. a) above.
Request voluntary detention, re-export, or voluntary disposal of drug
The first version of this Importation of Human-Use Drugs for Personal Use Enforcement Directive came into effect on January 1, 1998.
(HPB Office Address)
Re: Examination of Customs Parcel
Importation of Prescription Drugs
Your shipment has been examined under the provisions of the Food and Drugs Act and found to contain prescription medication. The importation of Schedule F (prescription) drugs is prohibited, except by certain designated persons (e.g., doctors or pharmacists). It is recommended that you contact your doctor to obtain a prescription for this medication which must be filled in Canada. Medications which are not available in Canada can often be obtained through Health Canada's Special Access Programme.
Your physician may contact the Special Access Program [Phone: (613) 941-2108 or Fax: (613) 941-3194] for authorization to obtain these for you.
Future importation of these or other prescription drugs could result in the return of those products to their origin.
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