This document provides information to industry about how the proposed regulatory amendments to the Food and Drug Regulations, C.01.014.1(2)(m.1) and C.08.002(2)(j.1), the requirements to submit mock-ups of labels at the time of submission, will be applied by Health Canada. It is intended to complement the regulatory proposals which have been published in Canada Gazette Part I for consultation and will provide direction to industry regarding the specifics of the proposed provisions.
Note: proposals and approaches may be modified as a result of consultation feedback. More detailed information on how Health Canada will implement these regulatory amendments will be provided through guidance documents, which will be available for consultation prior to publication of the amendments in Canada Gazette Part II.
The proposed amendments to the Food and Drug Regulations are part of Health Canada's Plain Language Labelling (PLL) Initiative. The initiative is a multi-phased project that aims to improve the safe use of drugs by making drug labels and packaging information easier to read and understand. Some of the proposed regulatory provisions under PLL strengthen existing requirements, while others are new. The requirement to provide scale mock-ups of labels at the time of submission is new.
This project is an important step in modernising Canada's drug regulations, guidance documents and information. These coordinated measures will improve transparency while offering health benefits to Canadian families.
The Plain Language Labelling Initiative is an early deliverable under the Regulatory Roadmap for Health Products and Food. The Roadmap is a strategy to produce a sustainable regulatory future with the dual objectives of protecting the Canadian public from the sale and advertising of unsafe food and health products, and supporting the safest consumption of food and use of health products.
The current proposals amend C.01.014.1(2)(m.1) and C.08.002(2)(j.1), to require mock-ups of every label to be used in connection with drugs for human use in dosage form - including package inserts and any supplementary information on the use of the drug that is provided on request - and mock-ups of the drug's packages, to be submitted in the application for a drug identification number. A mock-up is a full-colour, actual size copy of the labels intended to be used for the sale of the drug, including all presentation/design elements, proposed graphics, fonts, and colours.
Additionally, there is also the intention to repeal the current C.01.014.3(c) and C.08.002(1)(d), the requirements to submit samples or facsimiles of all labels within 30 days after commencing sale of a drug, since the final approved mock-ups are expected to be the versions used for sale of the drug product.
The intent of the proposed regulations is to require manufacturers to provide mock-ups of every label and of the drug's packages, so that information filed with pre-market applications and submissions are accurate representations of the information that consumers and health professionals will see.
Reviewing the labels and packages in their actual size will also provide evidence that certain elements will not be confused with other authorized products.
Accurate mock-ups of the final packages and labels will allow for agreement on these elements at the time Health Canada authorizes the product and eliminates the need to submit final labels after the drug is available for sale. Significant changes to the label and package following authorization would be reviewed in accordance with existing policies.
The scope of this provision includes drug products for human use in dosage form (both Division 1 and Division 8) including, for the purpose of this regulatory amendment, radiopharmaceuticals and extraordinary use new drug submissions. However the following are exempt: hard surface disinfectants and whole blood or its components.
For prescription drug products and products for use under the supervision of a health professional, this regulatory amendment would come into force 6 months after registration in Canada Gazette Part II, in order to allow industry stakeholders time to adjust their internal business practices.
Non-prescription drug products will have this amendment apply three years after the coming into force date.
As of the coming into force date, mock-ups of all package inserts, packages and labels in full colour would be required with pre-market submission packages [for example, Drug Identification Number Applications (DIN), New Drug Submissions (NDS), Abbreviated New Drug Submission (ANDS), Extraordinary Use New Drug Submission (EUNDS)] in order for the package to be considered complete, and would be reviewed in the place of written label text. Final versions would not be required until a later stage in the review process. Therefore, operationally, the process would continue to be iterative, working with manufacturers through the submission review and achieving agreement on what the final packages and label would look like. Existing review performance targets and timelines will continue to apply.
Applications or submissions already in review at the time of coming into force of these provisions would be exempt from these requirements.
Several Health Canada guidance documents are anticipated to require revisions to reflect the new regulatory provisions and to provide direction to industry, including the following:
Please note that draft versions of new guidance documents and those which require significant revisions will be posted for comment prior to Canada Gazette Part II.
There is a connection between the requirement to submit mock-ups of labels and the new proposed regulatory amendment C.01.004.02(1), the requirement for a Fact Table for some drug products. For products which are required to have a Fact Table on their inner and outer labels, this table would need to be submitted in a to-scale mock-up at the time of submission.
There is also a change to the existing provision C.08.003(2) which adds significant change to a new drug's packages (C.08.003(2)(g.1) to the list of elements which require the filing of a new submission.
Failure to submit mock-ups with the submission would result in the submission being rejected at screening.
This requirement is consistent with international best practices in the European Union and Australia, where colour mock-ups are a pre-market submission requirement for both prescription and non-prescription drugs. The requirement for mock-ups in the United States is less prescriptive than the current Canadian approach however mock-ups of labels are provided to the regulator when requested.
Comments on the draft guidance should be provided to Health Canada, preferably in electronic format, within 75 days from the date of this notice. The comments provided during the stakeholder consultation period may be made available upon request. Health Canada will consider comments made on the regulatory proposal published in Canada Gazette, Part I in conjunction with comments made on the guidance.
To provide input on this document, please submit comments by September 6th, 2013 to:
Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
1600 Scott Street
Holland Cross, Tower B
2nd Floor, Address Locator 3102C1
E-mail: Policy_Bureau_Enquiries@hc-sc.gc.ca , Subject: Plain Language Labelling Initiative