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Guidance document on submission information for biologic drugs (Division 4, Schedule D): Requirements – Division 4

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General information

The regulations in Division 4 are specific to biologic drugs. Division 4 applies additional requirements to appropriately address the risks associated with biologic drugs.

All regulations in the following divisions in Part C of the Food and Drug Regulations (FDR) also apply, unless specific regulations exempt biologic drugs:

Changes to the FDR

Changes to the FDR for biologic drugs as a result of the Agile Regulations are to:

Visually, the new Division 4 looks very different from the former Division 4 (numbering, length, drafting style). Operationally, it reflects current practice.

For a detailed comparison of the new Division 4 to current practice and to the former Division 4, refer to Comparison of Division 4 – Former and new.

C.04.001 – Definitions

Regulation

C.04.001 The following definitions apply in this Division.

biological source material means

  • (a) biological material sourced or derived from humans;
  • (b) animals, including insects, or any biological material sourced or derived from them;
  • (c) plants or any biological material sourced or derived from them; or
  • (d) micro-organisms, including bacteria, viruses, fungi and bacteriophages, or any biological material sourced or derived from them. (matériel d’origine biologique)

drug means a drug that is listed in Schedule D to the Act that is in dosage form or an active ingredient that can be used in the preparation of a drug listed in that Schedule. (drogue)

holder, in respect of a drug identification number assigned for a drug, means the manufacturer to whom a document setting out the number was issued under subsection C.01.014.2(1). (titulaire)Footnote 1Footnote 2

The new C.04.001 replaces the former C.04.001.

Explanation in comparison to current practice

There is no change to current practice.

For guidance on what is and is not included within the scope of the biological source material definition as it relates to C.04.001 and C.04.004, refer to Biological source material.

For guidance on labelling biological source material as it relates to C.4.001 and C.04.009(1)(e) and (f), refer to Labelling, labelling of prescription drugs.

C.04.002, C.04.003 – Prohibitions on sale

Regulation

C.04.002 It is prohibited for a distributor or importer of a drug to sell the drug unless it has been fabricated, packaged/labelled and tested in accordance with this Division.

C.04.003 It is prohibited for a person to sell a drug that they have fabricated, packaged/labelled or tested unless they have fabricated, packaged/labelled or tested it, as the case may be, in accordance with this Division.Footnote 1Footnote 2

The new C.04.002 and C.04.003 replace the former C.04.001.1.

Explanation in comparison to current practice

There is no change to current practice.

The prohibitions support the regulations in Division 4:

C.04.004 – Biological source material

Regulation

  • C.04.004 (1) It is prohibited for a person to use biological source material in the fabrication of a drug unless
    • (a) the biological source material is
      • (i) prepared and stored in a manner that ensures its suitability for use in the fabrication of the drug, and
      • (ii) collected, in the case of material of human or animal origin, under medical or veterinary supervision, as the case may be;
    • (b) the person collects the information that is necessary to allow the tracing of the biological source material; and
    • (c) any human from whom, or animal from which, the biological source material is collected — or any animal that is such material — is free from any disease that would make the material unsuitable for use in the fabrication of the drug.
  • (2) A person who uses biological source material in the fabrication of a drug must ensure that the material meets any specifications for the material that have been provided to the Minister in connection with the drug.
  • (3) A person who uses biological source material in the fabrication of a drug must retain any documents containing the information referred to in paragraph (1)(b) for a period that they determine after taking into account the following factors, but the period must end no earlier than five years after the day on which the biological source material was last used in the fabrication of the drug:
    • (a) the nature of the biological source material;
    • (b) the risks associated with the biological source material;
    • (c) the manner in which the biological source material is used in the fabrication of the drug; and
    • (d) if the fabricated drug is in dosage form, the intended use of the drug.Footnote 1Footnote 2

C.04.004:

Explanation in comparison to current practice

There is no change to current practice.

C.04.004 is to ensure that biological source materials are suitable for use in fabricating the drug, are collected under medical or veterinary supervision, with recordkeeping to allow for the material to be traced.

For currently authorized biologic drugs, there would be no need to file additional information to support the suitable control of biological source materials. The regulation of biologic drugs in Canada has always included considerations for the suitability of materials from biologic sources used to fabricate a drug.

The former Division 4 stated that records are to be kept. It did not specify the period of time during which these records must be kept, thus implying that records must be kept indefinitely. C.04.004 clarifies the record retention expectations for biologic drugs.

C.04.004 puts a time limit on an activity that is already performed, which is to retain records for biological source material to support the safety, quality and efficacy of the biologic drug. It applies record retention to tracing biological source material (C.04.004(1)(b)), where a retention period must be determined that cannot be less than 5 years (C.04.004(3)).

Details

The following is interpretation on in scope materials as they relate to each of the different regulations for biological source materials.

Scope of biological source material in C.04.001, C.04.004 and C.04.009

The scope of the definition of biological source material in C.04.001 is source materials, starting materials, raw materials and auxiliary materials. The definition in regulation is broad on purpose to encompass different and specific contexts for the oversight of biological source materials. The scope of biological source material required for the label in C.04.009 is different from the scope of biological source material for record retention in C.04.004. Record retention requirements for biological source materials apply to source materials, starting materials, raw materials and auxiliary materials used to fabricate a drug. However, the requirement to indicate the species name (animal or human) of a biological source material on the label applies only to the medicinal ingredient that is derived from a human or animal source material.

Record retention in C.04.004(3)

Together, C.04.004(1)(b) and C.04.004(3) support the current practice of traceability through recordkeeping.

In general, for biological source materials that fall under C.04.001(a) and (b) (human and animals), records of the source material and the starting material are expected. For example, records of the human donor (source) and the human-derived material used as the starting material for manufacture are both expected.

In general, for biological source materials that fall under C.04.001(c) and (d) (plants and microorganisms), it is the biological starting material used to fabricate the drug that is subject to record retention, not the original source of that material. For example, records are expected for the cell bank used to manufacture purified protein product, but not for the original source from which the cell bank was obtained (for example, soil).

The 5-year minimum time limit in C.04.009(3) is chosen on purpose to be consistent with Division 2 and the Good Manufacturing Practices Guide for Drug Products (GUI-0001) (refer to References). There is overlap between materials captured under the new Division 4 regulation and those captured under the record retention regulation in Division 2 for raw materials.

A retention period for information would have already been determined for existing biological source materials. There is no requirement to do a new risk assessment to determine the retention period.

Medical or veterinary supervision in C.04.004(1)(a)(ii)

The wording in C.04.004(1)(a)(ii) is broad on purpose to not be prescriptively defined nor restricted. It maintains the wording from the former Division 4, which has been sufficient.

The requirement for medical or veterinary supervision only applies to biological source materials of human or animal origin. If an entomologist, or other profession like a beekeeper, may be more appropriate for insects, this is considered equivalent to veterinary supervision.

Specifications in C.04.004(2)

C.04.004(2) is designed to capture only those biological source materials with specifications. There are several biological source materials for which specifications are established and provided to the Minister by the sponsor. In those cases, the materials must meet those specifications for use in fabricating the drug. For example, viral seed banks used in the manufacture of a vaccine have specifications provided to the Minister in connection with the drug. That said, if a biological source material does not have specifications, then this regulation would not apply.

C.04.005 – Prevention of contamination

Regulation

  • C.04.005 (1) Every person who fabricates a drug and every person who packages a drug in an immediate container must
    • (a) segregate all work involving infectious agents that require special handling, including spore-bearing pathogenic micro-organisms; and
    • (b) minimize the possibility of contamination of biological source material and drugs at the premises where the person fabricates or packages the drug, including by taking measures to protect against infection any individual who has access to the area where the person fabricates or packages the drug.
  • (2) It is prohibited for a person to conduct laboratory procedures of a diagnostic nature in their premises unless the conduct of those procedures is segregated from the fabrication, packaging/labelling and testing of drugs.Footnote 1Footnote 2

C.04.005(1) and (2):

Explanation in comparison to current practice

There is no change to current practice.

The outcome-based regulation is a general framework to minimize the potential for contamination of drugs, active ingredients and biological source material between processes.

For currently authorized biologic drugs, there is no expected need for additional filing of information to support measures in place to prevent cross-contamination. Current practice in the regulation of biologic drugs in Canada already includes expectations for appropriate segregation between manufacturing steps in cases where cross-contamination with an infectious agent could be of concern.

Infectious agents or the impacts of their propagation during the manufacturing process for a biologic drug (for example, unintended contamination of a cell culture for a recombinant product) may have negative consequences for the quality and safety of the finished product. This is the case even if infectious agents are not directly communicable to humans. All materials of biologic origin should be sourced and controlled appropriately, and appropriate controls should be in place where cross-contamination could reasonably be foreseen.

Details

Examples for how C.04.005(1) applies to biologic drugs

C.04.005(1) is a general regulation that replaces specific requirements for specific products. For example, C.04.005(1) addresses a problem posed by the former C.04.071(b). The former C.04.071(b) requires that everyone employed in the manufacture of the Bacille Calmette-Guérin (BCG) vaccine have a chest X-ray for tuberculosis every 6 months. This requirement applies even if they do not have symptoms of, or have not been exposed to, persons infected with tuberculosis.

Health Canada has used enforcement discretion of C.04.071(b) for years. This is based on the known human health risks of X-ray exposure and the availability of diagnostic blood tests that are suitably sensitive to detect active and latent disease.

C.04.005(1)(b) is designed to minimize the possibility of contaminating biological source material. This regulation supports current practice and:

Note for C.04.005(2)

Segregation is to be from any and all listed activities: fabrication, packaging/labelling and testing of drugs.

C.04.006 – Reference preparations

Regulation

C.04.006 Reference preparations that are used to test the purity or potency of a drug must allow for the control of the quality of the drug.Footnote 1Footnote 2

C.04.006:

Explanation in comparison to current practice

There is no change to current practice.

The regulation clearly outlines the expectation that reference preparations be appropriate for their intended function. Unless there are extenuating circumstances (such as product efficacy failure, observed potency drift), there is no need to file information for existing products other than for reportable changes.

For more information on reportable changes, consult the Guidance Document - Post-Notice of Compliance (NOC) Changes: Quality Document (refer to References).

Sponsors are not expected to see a change from current practice for information or materials to support reference preparations of clinical trial materials as a consequence of C.04.006.

C.04.007 – Lot release

Regulation

  • C.04.007 (1) In this section, suitable for sale, in respect of a lot of a drug, means that the lot has been fabricated, packaged/labelled and tested in accordance with these Regulations and in a manner that is consistent with information provided to the Minister regarding the quality and safety of the drug.
  • (2) The Minister may, for the purpose of assessing whether a lot of a drug in dosage form is suitable for sale, request that the following persons provide the Minister with any information, samples of the drug or its active ingredients, or material to be used to test the samples:
    • (a) a fabricator of the drug;
    • (b) a packager/labeller of the drug;
    • (c) an importer of the drug; or
    • (d) the holder of the drug identification number.
  • (3) It is prohibited for a person who is requested to provide information, samples or material under subsection (2), and any other person whom the Minister notifies of the request, to sell drugs from the lot to which the request relates unless the Minister notifies the person that the lot is suitable for sale.Footnote 1Footnote 2

C.04.007(1) to (3):

Explanation in comparison to current practice

There is no change to current practice or to the existing lot release program.

C.04.007(2) provides authority to the Minister to ask for information, samples of the drug or its active ingredients, or material to be used to test the samples. When C.04.007(2) indicates if a request is made for information or samples of a drug lot, C.04.007(3) sets out that the lot cannot be sold until the request is met and the Minister indicates the lot is suitable for sale. This currently takes the form of a lot release decision letter.

Health Canada uses a risk-based, tiered approach to administer the lot release program set out in Guidance for Sponsors: Lot Release Program for Schedule D (Biologic) Drugs (refer to References).

C.04.007(1) to (3) support the guidance on lot release. The regulations and guidance continue to provide flexibility by allowing for biologic drugs to be moved between evaluation groups on a case-by-case basis, with each group having different levels of regulatory oversight based on the degree of risk associated with the drug.

For DIN holders of biologic drugs currently on the Canadian market, there is no expected change from current practice for information or materials to support lot release as a consequence of C.04.007. As a risk-based oversight program, lot release activities and the materials required are evaluated periodically to assess if they are still appropriate. Changes in sample requirements or in materials needed to carry out testing would be communicated directly to the DIN holder as an outcome of a periodic review.

For sponsors, there is no expected change from current practice for information or materials to support lot release of clinical trial materials as a consequence of C.04.007.

Details

Flexibility in C.04.007

C.04.007 is flexible by design and allows Health Canada to determine the lot release requirements, if any. The regulation does not prevent a risk-based approach and offering additional risk-based flexibilities where appropriate.

Requesting information, samples or materials for testing is at the discretion of the Minister. As such, Health Canada may decide to not solicit information, samples or materials for any given product regulated under Division 4. The discretion also allows flexibilities to accommodate unique challenges posed by some new types of products (for example, products with unique sampling or testing requirements can be addressed through guidance, policy or specified on a per product basis). The regulation does not prevent the alignment of international testing if or when deemed appropriate.

C.04.007 reflects current practice with respect to “fabricator, packager/labeller or importer of the drug, or the holder of the drug identification number”. While the request is most often directed to the DIN holder, this is not always the case.

Health Canada’s guidance on lot release reflects the flexibility of C.04.007.

C.04.008 – Periodic quality reporting

Regulation

C.04.008 The holder of the drug identification number for a drug in dosage form must, at the request of the Minister, provide the Minister, on an annual basis or at any longer interval specified by the Minister, with information regarding the quality of the drug and its active ingredients, including information regarding the consistency of the fabrication and packaging processes for the drug and the ingredients.Footnote 1Footnote 2

Explanation in comparison to current practice

There is a change to current practice, which is increased flexibility.

C.04.008 formalizes Health Canada's current discretionary practice of periodic quality reporting to monitor the state of control and consistency of the manufacturing process for biologic drugs (for example, yearly biologic product reports, or YBPRs). C.04.008 aligns with current practice, which is that the use of periodic quality reporting is discretionary and risk-based (in other words, YBPRs are not mandatory for all biologic drugs at all times). The regulation thus maintains current flexibility, with periodic quality reporting reserved for when the Minister makes such a request.

C.04.008 also introduces the flexibility for the Minister to extend the interval between periodic reports from an annual basis to a longer interval if circumstances warrant.

The regulation aligns with current practice, which is that the use of this type of reporting supports the lot release program with periodic information as necessary. The purpose of C.04.008 is to ask for information when needed, which supports current practice. In principle, the lot release program is a risk-based oversight strategy, for which Health Canada has a responsibility to revisit the current context over time. Periodic quality reporting provides that context to enable a streamlined and less resource-intensive lot release grouping for many products.

Finally, periodic quality reporting supports the life cycle approach to biologic drugs to:

Details

C.04.008 is discretionary and flexible by design. It allows Health Canada to continue the current practice of taking a risk-based approach to requesting information now and in the future.

The default is that periodic quality reporting is not mandatory: it is only when solicited. The reporting, when needed, supports the lot release program with periodic information. The regulation addresses the differences in approach to different biologic drugs (in other words, some have periodic quality reporting and some do not).

The regulation does not prescriptively state specific formats of periodic quality reporting. It is outcome-based for quality information regarding the fabrication, testing and packaging processes for the drug and its ingredients. For example, Health Canada currently accepts information presented in the format of an annual product quality report with additional information included.

While it is recommended to use the template specified in the Guidance for Sponsors: Lot Release Program for Schedule D (Biologic) Drugs (refer to References), alternate formats are accepted. The sponsor may submit a report prepared for another competent regulatory authority that has similar information as the periodic quality report. If an alternative is chosen, it is recommended that the sponsor update it with Canadian-specific information.

Note: The term “rapports périodiques sur la qualité” (the noun) is in the heading of the French version of C.04.008, while the term “periodic quality reporting” (the act) is in the heading of the English version. This is to satisfy legal rules on how to draft bilingually in the Food and Drug Regulations (FDR). Both terms in French and English refer to the act of providing information on a given subject. C.04.008 is drafted consistently with other instances in the FDR of the term “reporting” in English and “rapports” in French.

This does not legally mean that Health Canada is restricted to a single, specific report named “rapport périodique sur la qualité” and “periodic quality report” under C.04.008 now or in the future. The flexibility for annual product reports, reports prepared for another competent regulatory authority and YBPRs continues.

C.04.009, C.04.010 – Labelling, Labelling of prescription drugs

Regulation

  • C.04.009 (1) The principal display panel of both the inner and outer labels of a drug in dosage form must show
    • (a) the drug’s brand name, if any;
    • (b) the drug’s proper name, if any, which, if there is a brand name, must immediately precede or follow the brand name in type not less than one-half the size of that of the brand name;
    • (c) if there is no proper name, the drug’s common name, which, if there is a brand name, must immediately precede or follow the brand name in type not less than one-half the size of that of the brand name;
    • (d) the net quantity of the drug in the immediate container for the purpose of the inner label and the net quantity of the drug in the outer package for the purpose of the outer label;
    • (e) if the drug is sterile, an indication to that effect;
    • (f) if any of the drug’s medicinal ingredients are sourced or derived from human biological source material, an indication to that effect; and
    • (g) if any of the drug’s medicinal ingredients are sourced or derived from animal biological source material, the animal species from which each of those ingredients is sourced or derived.
  • (2) The inner and outer labels of a drug in dosage form must show on any panel
    • (a) the name of the holder of the drug identification number assigned for the drug;
    • (b) the potency of the drug, if applicable;
    • (c) the recommended dose of the drug;
    • (d) the lot number of the drug;
    • (e) the expiration date of the drug;
    • (f) adequate directions for use of the drug; and
    • (g) any other information that is necessary to prevent injury to human health.
  • (3) Paragraph (2)(f) does not apply if adequate directions for use of the drug must be displayed on the label in accordance with section C.01.004.02 or C.01.004.03.
  • (4) Despite paragraph (2)(g), if another provision of these Regulations requires that information referred to in that paragraph be shown on a particular panel of a label, the information must be shown on that panel.
  • (5) The outer label of a drug in dosage form must show on any panel
    • (a) the address of the holder of the drug identification number assigned for the drug;
    • (b) a quantitative list of any preservatives contained in the drug, by their proper names, or if a preservative has no proper name, by its common name;
    • (c) the approved storage conditions for the drug;
    • (d) any other information that is necessary for the proper storage and handling of the drug, accompanied, as the case may be, by any designated space for the addition of supplementary information in this regard by the person who stores or handles the drug; and
    • (e) in the case of a new drug for extraordinary use in respect of which a notice of compliance has been issued under section C.08.004.01, the following statement, displayed in capital letters and in a legible manner:
    • “HEALTH CANADA HAS AUTHORIZED THE SALE OF THIS EXTRAORDINARY USE NEW DRUG FOR [naming purpose] BASED ON LIMITED CLINICAL TESTING IN HUMANS.
    • SANTÉ CANADA A AUTORISÉ LA VENTE DE CETTE DROGUE NOUVELLE POUR USAGE EXCEPTIONNEL AUX FINS DE [indication de la fin] EN SE FONDANT SUR DES ESSAIS CLINIQUES RESTREINTS CHEZ L’ÊTRE HUMAIN.”
  • (6) The inner label requirements of these Regulations do not apply in respect of a drug in dosage form whose immediate container is too small to accommodate an inner label that meets those requirements if
    • (a) the inner label shows
      • (i) the drug’s brand name, if any,
      • (ii) the drug’s proper name, if any,
      • (iii) the drug’s common name, if there is no proper name,
      • (iv) the drug identification number assigned for that drug, preceded by the expression “Drug Identification Number” or “Drogue : identification numérique”, or both, or the abbreviation “DIN”,
      • (v) the name of the holder of the drug identification number assigned for the drug,
      • (vi) the net quantity of the drug in the container,
      • (vii) the drug’s potency, if applicable, unless the drug contains more than one medicinal ingredient and the drug’s brand name is unique for a particular potency of the drug,
      • (viii) the drug’s lot number,
      • (ix) the drug’s expiration date,
      • (x) the drug’s route of administration, and
      • (xi) any other information that is necessary to prevent injury to human health; and
    • (b) the outer label meets the applicable requirements of these Regulations.
  • (7) The expiration date referred to in paragraph (2)(e) and subparagraph (6)(a)(ix) may be omitted from the label of a drug that is to be stockpiled by the following entities for use in emergency situations if the date is communicated by an alternative means to the individuals who administer the drug:
    • (a) the Government of Canada or the government of a province for the use of a department or agency of that government; or
    • (b) a municipal government or an institution of a municipal government.
  • C.04.010 (1) In the case of a drug in dosage form that is a prescription drug, the symbol “Pr” must be shown on
    • (a) the upper left quarter of the principal display panel of both the inner and the outer labels; or
    • (b) if the drug is packaged in a single-dose container, on the upper left quarter of the principal display panel of the outer label.
  • (2) Subsection (1) does not apply to a drug that is
    • (a) sold to a person who holds an establishment licence under Division 1A; or
    • (b) sold by a pharmacist under a prescription or by a practitioner, if its label shows suitable directions for use and meets the requirements set out in section C.01.005.Footnote 1Footnote 2

C.04.009(1) to (7) and C.04.010(1) and (2):

Explanation in comparison to current practice

There is no change to current practice.

The labelling regulations reflect current practice where the intent is no change for DIN holders. Thus, the labelling regulations come into force at the same time as the rest of the new Division 4.

If there happens to be non-compliance to current practice, then the approach to regulatory compliance is next filing for current products.

Details

Most labelling requirements in the new Division 4 have the same wording as in the former Division 4.

The following are explanations for differences in wording between the new Division 4 and the former Division 4. Some differences provide additional transparency on current expectations, as applicable (for example, C.04.009(1)(f) and (g), C.04.009(2)(g)). Other differences are a drafting change in how the regulations are set out in the FDR (for example, C.01.004(5)(c)).

There are no changes to current practice. The order of the following explanations matches the numerical order in C.04.009.

The connection between C.01.004(5)(c) and C.04.009 – Exclusion

The exclusion of biologic drugs from some Division 1 labelling is moved from Division 4 to Division 1, specifically into C.01.004(5)(c).

The former Division 4 had the exclusion:

C.04.019 The provisions of section C.01.004 do not apply to a drug as defined in this Division but every package of such drug shall carry

The revised Division 1 has the exclusion.

  • C.01.004 (5) Subsections (1) to (3) do not apply to a drug that is

C.04.009(1)(d) – Net quantity

C.04.009(1)(d) is for the labelling of net quantity:

The information is important to have on both the inner and outer labels as the net quantity will differ when there are multiple containers within a package.

C.04.009(1)(e) – Sterility

C.04.009(1)(e) is for the labelling of sterility.

The regulation is flexible to allow for the ISO symbol for sterile.

C.04.009(1)(f) and (g) – Biological source material

C.04.009(1)(f) and (g) are for the labelling of biological source material. The labelling is for human or animal biological source material from which the drug’s medicinal ingredients are sourced or derived.

The labelling requirement is to indicate human or the species of animal on the principal display panel of the inner and outer labels for drugs containing medicinal ingredients that are:

The following should be considered when meeting the labelling requirement to indicate the species of animal on the principal display panel of the label:

In most cases, the term “human” or the animal species is contained in the proper name, common name or medicinal ingredient name. This is sufficient to meet the requirements. Examples are human serum albumin, dog hair extract, wasp venom, purified pork insulin and equine diphtheria antitoxin. The term “autologous” may be acceptable for certain products whose medicinal ingredients are, or are derived from, a patient’s own tissues or cells.

Examples where human or animal species would not be required are:

C.04.009(2)(g) – Safety statements

C.04.009(2) is for the labelling of other information that is necessary to prevent injury to human health. Health Canada may require certain labelling statements for safety reasons on a case-by-case basis. Statements for safety reasons could cover situations such as:

Specific and definitive guidance on how often safety statements are to be put on labels is out of scope of this guidance document. Statements depend on products. A safety statement may be required to be added throughout the life cycle of a product. It is recommended that sponsors consult the relevant guidance documents and discuss with Health Canada about their specific product as necessary.

C.04.009(5)(c) and (d) – Storage and handling

C.04.009(5)(c) and (d) are to address different situations:

C.04.009(5)(d) is to accommodate for space on the outer label where information may be recorded after packaging and labelling. For example, this addresses situations where a drug carries a label claim that allows the product to be stored under different temperature conditions for different lengths of time. In such cases, the label is to have a designated location for the end user to indicate the necessary information (such as new expiry date or discard time) to ensure the product is not used past its expiry based on different storage conditions.

C.04.009(6) – Small containers

C.04.009(6) is for the labelling of small containers.

Flexibilities on labelling for small containers outlined in Division 1, while not in the former Division 4, have historically also been extended to DIN holders of biologic drugs. Labelling of small containers in C.04.009(6) has been slightly tailored to biologic drugs.

Small container labelling set out in C.04.009(6) is based on current practice and takes into consideration Health Canada’s guidance on all labelling for all biologic drugs in small containers.

C.04.009(7) – Expiry date exemption on the label of stockpiled drugs

C.04.009(7) is for an exemption of the expiry date on the label of drugs stockpiled by any level of government (federal, provincial, territorial, municipal) in Canada.

Although it is required that an expiry date be on a drug's label, there are situations involving stockpiles of biologic drugs that may be exempt from this requirement.

Under C.04.009(7), there is:

The expectation is that the alternate means of communication of the expiry date be kept up to date, and be easily accessible by most, if not all, persons. This includes the distribution chain to, and within, the community pharmacy.

Manufacturers may consider a 24-hour phone number that is accessible for the hearing impaired, a publicly available website, or QR codes as alternate means of communicating expiry dates.

Individuals who administer the drug is meant to be broad in scope. Those involved in distributing, administering or using the stockpiled drug are to be able to access up-to-date expiration date information in a timely manner. This includes a pharmacist, a pharmacy technician, those preparing the inventory for a public health administration of a vaccine and an individual person who self-administers a drug.

The labelling exemption for the expiry date is limited to the requirement to have expiry dates directly on the outer and inner labels. This exemption is not expected to be widely used. It is foreseen only for biologic drugs that are to be stockpiled for emergency use by Canadian governments, where the need for the drug is sporadic and infrequent.

The regulation is not for foreign or internationally labelled drugs. These labels do not meet several of the labelling requirements set out in the FDR. Thus, broadening the scope of this clause does not relieve the current barriers to bring such products to the Canadian market. This regulation is intended for drugs carrying Canadian labels that are stockpiled by Canadian governments only.

C.04.010 – Labelling of prescription drugs

C.04.010(1) is for the labelling of prescription drugs. It applies to manufacturers’ labels.

C.04.010(2)(b) is the exemption in prescription drug labelling to address the practice of pharmacy. It is for labels created by pharmacies. Prescription labelling requirements are part of the practice of pharmacy and regulated at the provincial and territorial level. Each province or territory has its own specific requirements and standards around what is expected of pharmacy professionals for the labelling of prescription drugs.

In regulation, Health Canada uses:

References

Footnote 1

For the official version of the regulation amending the FDR, refer to Canada Gazette Part II, Date 2024-12-18, Volume 158, Number 26, Title Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing). (https://gazette.gc.ca/rp-pr/p2/2024/2024-12-18/pdf/g2-15826.pdf)

Return to footnote 1 referrer

Footnote 2

For the official version of the regulation, refer to the Food and Drug Regulations. (https://laws.justice.gc.ca/eng/regulations/C.R.C.,_c._870/FullText.html)

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