Guidance for industry: Preparation of veterinary abbreviated new drug submissions (generic drugs) - Clinical and human safety requirements: Labelling requirements
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General information
According to the Food and Drug Regulations(FDR), as part of an ANDS (folder 1.7), the manufacturer is required to include a complete set of labels for the generic product that reflects its comparability relative to the CRP. Although the text on the generic product labels does not need to be entirely identical, specific sections of the labels of the generic product may need to be identical (or as close to identical as possible) to those on the reference product labels to comply with requirements under the FDR. For more information on general labelling requirements for veterinary drugs, refer to the Guidance on veterinary drug labelling.
The information provided in this section aims to clarify specific labelling requirements for an ANDS.
Strength
The labels for the reference product and generic product should both express the same medicinal strength of the dosage form.
Format
The veterinary generic drug is not required to have an identical format: net content, bottle size or package size can be different than those of the CRP. However, for some higher risk products (for example, antimicrobials intended for use in food-producing species and/or of very high importance in human medicine, or drugs with public health concern), VDD may require an identical format or a scientific rationale to justify the differences. The display, logo, colours and/or presentation of the generic product's labelling should be different from those of the CRP, to avoid user confusion and reduce possible medication errors.
Languages
The manufacturer should submit the proposed English and French draft labels (editable electronic format) for the generic drug product in the submission. An attestation to the complete and accurate translation of the labels in the second official language (either French or English) should also be submitted.
Indications/claims
According to paragraph C.08.002.1(1)(d) of the FDR, a generic drug product must have conditions of use that fall within the conditions of use for the CRP. An ANDS product may have fewer or reduced claims (or partial indications) compared to the CRP, so long as they fall within the claims or indications approved for the CRP. An ANDS sponsor may need to support differences between the claims or indications for their proposed generic drug and the CRP with a valid rationale, including to demonstrate that the ANDS drug's conditions of use fall within those of the CRP and that there are no other safety or efficacy issues.
Dosage and administration
This entire section should be similar to what appears on the CRP label, unless otherwise justified by a rationale.
Diluents/reconstitution solutions, dose rate (in mg/kg of body weight), route of administration, frequency of administration, delivery method (if applicable) and duration of treatment identified on the ANDS product label should fall within the conditions of use of the CRP.
If the CRP labels indicate a concomitant administration with other drugs, these drugs also need to appear on the generic product labels. However, these drugs should be identified with their common name and not their brand name.
Warnings
All warning statements (such as food safety-related, user safety and/or microbiological safety statements) appearing in the Warnings section of the CRP should generally be the same (unless AMR-related update is warranted) and included on the generic product labels. If other warning statements are different from those of the CRP labels, the changes should be justified by a rationale.
According to paragraph C.08.002.1(2)(e) of the FDR, withdrawal periods (or milk withholding periods) for an ANDS drug intended for administration to food-producing animals need to be identical to those of the CRP.
If the generic drug sponsor is only interested in pursuing some of the CRP's labelled indications, the Warnings section should be revised accordingly.
Contra-indications and cautions
All contra-indication and caution statements present on the CRP labels should also appear on the generic product labels (unless AMR-related update is warranted). If the statements are different, the changes should be justified by a rationale.
Adverse events
It is recommended that an adverse events section be present on the generic product labels and include information similar to that on the CRP label. Even if an adverse events section does not appear on the CRP labels, it is recommended to add one in the generic product labels. This section can contain adverse events/adverse drug reactions reported with the CRP from the public literature and/or reflect any foreign pharmacovigilance data collected on the generic product.
Package inserts
The data on the package insert (such as information for owners, clinical pharmacology, microbiology, safety, and efficacy sections) have been generated by the innovator company. These sections on the label of the generic drug product should be similar to those on the package insert of the CRP, except for the brand name. When present on a generic product label, information related to data generated by the innovator should always be written using the proper name or common name, or name of the medicinal ingredient(s). Any differences between the generic product and the CRP labels should be justified by a rationale.
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