Find out if your submission or supplement may meet the requirements for deeming under the Reliance Order

• No
• Yes

Is the drug subject to the submission or supplement in a drug class listed on the applicable part of the Incorporated by Reference (IbR) list?

• No
• Yes

Is the submission or supplement for a drug that’s been authorized by a foreign regulatory authority (FRA) listed on the applicable part of the IbR list for the class of drugs to which the drug belongs?

• No
• Yes

Does the drug submission or supplement that you intend to submit for authorization in Canada have the same medicinal ingredient, strength, dosage form and route of administration as the foreign drug authorized by the FRA?

• No
• Yes

Do the conditions of use for the drug in the submission or supplement that you intend to submit for authorization in Canada fall within the conditions of use authorized for the foreign drug by the FRA? Conditions of use include indications, dosage and administration instructions, contraindications, precautions, cautions and warnings.

• No
• Yes

Will you be submitting a complete regulatory package as required under the Food and Drug Regulations for this drug submission or supplement?

• No
• Yes

Are you seeking deeming for any or all clinical, non-clinical and chemistry and manufacturing information in your drug submission or supplement?

• No
• Yes

If differences related to one of these sets of information (clinical, non-clinical, chemistry and manufacturing) exist between the foreign drug authorized by the FRA and the drug package in the Canadian submission or supplement, do these differences impact the safety and effectiveness of the drug?

• No
• Yes

Do you possess or have immediate access to information submitted to the FRA to obtain the foreign drug’s authorization?

• No
• Yes

Do you possess or have immediate access to information submitted to, or received from, the FRA in respect of post-market measures imposed by the FRA with respect to the foreign drug authorization?

• No
• Yes

Have you previously filed another drug submission or supplement to Health Canada for review, where the result was a refusal or withdrawal after you received a notice of non-compliance (NON) or a notice of deficiency (NOD)?

• No
• Yes

Did the FRA rely on a decision made by another FRA, in whole or in part?

• No
• Yes
• Uncertain

• No
• Yes

Is the new drug subject to the submission or supplement in a drug class listed on the applicable part of the Incorporated by Reference (IbR) list?

• No
• Yes

Was the submission or supplement for a drug filed with a FRA listed on the applicable part of the IbR list for the class of drugs to which the drug belongs filed no more than 120 days prior to the Canadian submission or supplement?

• No
• Yes

Does the drug submission or supplement that you intend to submit for authorization in Canada have the same medicinal ingredient, strength, dosage form and route of administration as the foreign drug filed with the FRA?

• No
• Yes

Do the conditions of use for the drug in the submission or supplement that you intend to submit for authorization in Canada fall within the conditions of use for the foreign drug submitted to the FRA? Conditions of use include indications, dosage and administration instructions, contraindications, precautions, cautions and warnings.

• No
• Yes

Will you be submitting a complete regulatory package as required under the Food and Drug Regulations for this drug submission or supplement?

• No
• Yes

Are you also seeking deeming for all clinical, non-clinical and chemistry and manufacturing information in your drug submission or supplement?

• No
• Yes

If differences related to one of these sets of information (clinical, non-clinical, chemistry and manufacturing) exist between the foreign drug that would be authorized by the FRA and the drug in the Canadian submission or supplement, would these differences impact the safety and effectiveness of the drug?

• No
• Yes

Will you possess or have immediate access to information submitted to the FRA to obtain the foreign drug’s authorization?

• No
• Yes

Will you possess or have immediate access to information submitted to, or received from, the FRA in respect of post-market measures that would be imposed by the FRA with respect to the foreign drug authorization?

• No
• Yes

Have you previously filed another drug submission or supplement to Health Canada for review, where the result was a refusal or withdrawal after you received a notice of non-compliance (NON) or a notice of deficiency (NOD)?

• No
• Yes

Will the FRA rely on a decision made by another FRA, in whole or in part?

• No
• Yes
• Uncertain

• No
• Yes

Is the drug subject to the submission or supplement in a drug class listed on the applicable part of the Incorporated by Reference (IbR) list?

• No
• Yes

Will the submission or supplement be filed as part of a joint review with 1 or more FRAs listed on the applicable part of the IbR list in relation to the class of drugs to which the drug belongs?

• No
• Yes

Has Health Canada agreed or do you anticipate they will agree, to conduct a joint review with those FRAs?

• No
• Yes

Does the drug submission or supplement that you intend to submit for authorization in Canada have the same medicinal ingredient, strength, dosage form and route of administration as the foreign drug filed with the FRA?

• No
• Yes

Do the conditions of use for the drug for the submission or supplement that you intend to submit for authorization in Canada fall within the conditions of use for the foreign drug submitted to the FRA? Conditions of use include indications, dosage and administration instructions, contraindications, precautions, cautions and warnings.

• No
• Yes

Will you be submitting a complete regulatory package as required under the Food and Drug Regulations for this drug submission or supplement?

• No
• Yes

If differences related to a set of information (clinical, non-clinical, chemistry and manufacturing) exist between the foreign drug submitted to the FRA and the drug that would be subject to the Canadian submission or supplement, do these differences impact the safety and effectiveness of the drug?

• No
• Yes