Guidance Document Post-Drug Identification Number (DIN) Changes

Date Adopted: 2009/12/19
Revised Date: 2022/08/02
Effective Date: 2022/08/02

Document change log

Information regarding general submission requirements, contact information, and target performance standards may be found in the following Health Canada guidance documents: Guidance Document: Management of Drug Submissions and Applications for drugs for human use and disinfectants, and Veterinary drugs – Management of Regulatory Submissions Guidance.

• Guidance Document: Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs
• Guidance Document for Industry - Review of Drug Brand Names
• Frequently Asked Questions - Guidance Document for Industry - Review of Drug Brand Names
• Guidance documents on disinfectants: Summary Preparation of Drug Identification Number Submissions
• Questions and Answers: Plain Language Labelling Regulations for Prescription Drugs document
• Guidance Document: Questions and Answers: Plain Language Labelling Regulations for Non-prescription Drugs

4.2 Specific information

In addition to the above common information, recommendations are provided in Section 4.2.1, with respect to the applicable conditions, supporting data, and filing process for specific changes as outlined in the Regulations. All changes are numbered to facilitate referencing.

How to use the Tables in 4.2

The information summarized in the tables provides recommendations for the conditions and supporting data for each change:

In cases where some or all of the conditions or supporting data may apply, the document identifies these recommendations as "potentially" applying. For example, in table C.01.014.1(2)(b), a new DIN application may be required if there is an addition or change to the dosage form where the new dosage form has been previously authorized in Canada. Other conditions may be applicable such as if the change to dosage form raises concerns about the sterility of the drug, and/or the change in dosage form introduces materials where a Bovine spongiform encephalopathy/transmissible spongiform encephalopathy (BSE/TSE) risk assessment is needed and/or the change to dosage form affects the release parameters (dissolution, duration, onset, etc.) of the drug. If certain conditions do not apply, then the corresponding supporting data will not be necessary.

4.2.1 Changes to information captured by C.01.014.1(2) of the Regulations

4.2.1.1 Changes outlined in C.01.014.1(2)(a)-(f)

The following filing processes and supporting data are required in order to ensure that the proposed changes are consistent with the intent of the Act and Regulations:

Conditions

1. The recommendations outlined in the Guidance Document: Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs are met.

Supporting Data

1. Common Information for Notifications and Drug Identification Number Applications (as outlined in 4.1).

Conditions

1. The dosage form is previously authorized for the product type under Division 1 in Canada (for example, [e.g.] - Sponsor has cough and cold capsules on the market and wishes to add a cough and cold syrup to their product line. The syrup dosage form has been previously authorized in Canada for cough and cold products).
2. The change to dosage form raises concerns about the sterility of the drug.
3. The change in dosage form introduces materials where a Bovine spongiform encephalopathy/transmissible spongiform encephalopathy (BSE/TSE) risk assessment is needed.
4. The change to dosage form affects the release parameters (dissolution, duration, onset, etc.) of the drug as described under C.01.012 of the Regulations.
5. The dosage form is not previously authorized for the specified product type under Division 1 in Canada (e.g.- Sponsor for human drug has an acne treatment cream on the market and seeks to add an acne wipe to their product line. For veterinary drugs, sponsor has an approved acetylsalicylic acid (ASA) bolus and seek to add an ASA oral solution to their product line. No Division 1 products with these dosage forms and product types exist in Canada. This product falls within the definition of a New Drug in section C.08.001 of the Regulations).
6. The change only affects the appearance and does not involve a change in functionality of the dosage form (e.g. addition of a film coating for aesthetic purposes only).

Supporting Data

1. A signed and dated cover letter on company letterhead with a description of the change.
2. Common Information for Notifications and Drug Identification Number (DIN) Applications (as outlined in 4.1).
3. If condition 2 applies, file supporting chemistry data according to the recommendations outlined in Quality Guidance: Applications for Drug Identification Numbers (DINAs) for Pharmaceuticals.
4. If condition 3 applies, file Animal Tissue form and/or data outlined in section P.4 of Quality Guidance: Applications for Drug Identification Numbers (DINAs) for Pharmaceuticals.
5. If condition 4 applies, file supporting chemistry data as per the recommendations outlined in Quality Guidance: Applications for Drug Identification Numbers (DINAs) for Pharmaceuticals and the clinical or comparative bioavailability data according to the guidance documents available on the Health Canada Web site: Bioavailability and Bioequivalence.
6. New Drug Requirements: Consult the guidance documents, Preparation of New Drug Submissions in CTD format and the Guidance Document: Management of Drug Submissions and Applications. For veterinary drugs, Guidance for Industry Preparation of Veterinary New Drug Submissions and Veterinary drugs - Management of regulatory submissions guidance: Overview.

Conditions

1. The change does not result in the modification of labels for other routes of administration, which continue to be marketed.
2. The change results in the modification of labels for other routes of administration which continue to be marketed (for example, [e.g.] - If a product is labelled for both otic and ophthalmic use and the otic route of administration is being withdrawn).
3. The route of administration is previously authorized for the specified product type under a Category IV Monograph or Labelling Standard.
4. The route of administration is previously authorized for the specified product type under Division 1 in Canada but is not captured under a Category IV Monograph or Labelling Standard (e.g.- a sponsor has an antibiotic product for human use on the market currently applied as an otic preparation and wishes to add an ophthalmic indication. An ophthalmic route of administration for the antibiotic ingredient has been previously authorized in Canada).
5. The change to route of administration raises concerns about the sterility of the drug.
6. The change in route of administration introduces materials where a Bovine spongiform encephalopathy/transmissible spongiform encephalopathy (BSE/TSE) risk assessment is needed.
7. The change to route raises concerns about absorption or delivery of the drug.
8. The route of administration is not previously authorized for the specified product type under Division 1 in Canada (e.g.- Sponsor has acetaminophen oral tablets on the market and wishes to declare on the label that the product can be used as a suppository. Acetaminophen via the rectal route of administration is listed on the New Drug list and meets the definition of a New Drug in section C.08.001 of the Regulations).

Supporting Data

1. A signed and dated cover letter on company letterhead with a description of the change.
2. Common Information for Notifications and Drug Identification Number (DIN) Applications (as outlined in 4.1).
3. If condition 5 applies, file supporting chemistry data according to the recommendations outlined in Quality Guidance: Applications for Drug Identification Numbers (DINAs) for Pharmaceuticals.
4. If condition 6 applies, file Animal Tissue form and/or data outlined in section P.4 of Quality Guidance: Applications for Drug Identification Numbers (DINAs) for Pharmaceuticals.
5. If condition 7 applies, file supporting chemistry data as per the recommendations outlined in Quality Guidance: Applications for Drug Identification Numbers (DINAs) for Pharmaceuticals and the clinical, comparative bioavailability data, or waiver according to the guidance documents available on the Health Canada Web site: Bioavailability and Bioequivalence.
6. New Drug Requirements: Consult the guidance documents, Preparation of New Drug Submissions in CTD format and Management of Drug Submissions and Applications. For veterinary drugs, Guidance for Industry Preparation of Veterinary New Drug Submissions and Veterinary drugs - Management of regulatory submissions guidance: Overview.

Conditions

1. The drug is for use on hard surfaces.

Supporting Data

1. File according to the recommendations outlined in the Guidance document on Disinfectants: Summary.

Conditions

1. The change in or form of the medicinal ingredient is previously authorized for the specified product type under Division 1 in Canada (e.g. Sponsor has a sunscreen product which contains avobenzone, octinoxate and oxybenzone. The sponsor wishes to add an additional ingredient titanium dioxide. There are other products on the market with this combination for this product type).
2. The change in or form of the medicinal ingredient causes the product to meet the definition of New Drug as per C.08.001 (e.g. the sponsor wishes to add the ingredient, diethylamino hydroxybenzoyl hexyl benzoate, to their sunscreen product which contains avobenzone, octinoxate and oxybenzone. Products containing the medicinal ingredient, diethylamino hydroxybenzoyl hexyl benzoate, have never been marketed either alone or in combination with other medicinal ingredients in Canada. As such, this change would make the product a New Drug.)
3. The change in the medicinal ingredient is impacted by the Prescription Drug List (e.g. an increase in the amount of benzoyl peroxide in the product to greater than 5% becomes a prescription product).
4. The medicinal ingredient is derived from animal sources where a Bovine spongiform encephalopathy/transmissible spongiform encephalopathy (BSE/TSE) risk assessment is needed.
5. The change in medicinal ingredient meets the definition of an identical medicinal ingredient as described in the interim policy Updated Notice: Interim Policy on Health Canada's Interpretation of Medicinal Ingredient and Assessment of Identical Medicinal Ingredient. Similar conditions apply for veterinary drugs.
6. The change in medicinal ingredient does not meet the definition of an identical medicinal ingredient as described in the interim policy Updated Notice: Interim Policy on Health Canada's Interpretation of Medicinal Ingredient and Assessment of Identical Medicinal Ingredient. Similar conditions apply for veterinary drugs. Further, the change does not meet the criteria for a New Drug. For example, in an allergy medication diphenhydramine citrate is changed to diphenhydramine hydrochloride. Both ingredients have been previously authorized for this category of product.
7. The change does not affect the actual final delivered quantities (dose) of the medicinal ingredient, but is an alternate and equivalent declaration of amount delivered or present in the drug (e.g. a transdermal patch which has "X milligram" (mg) of medicinal ingredient revises the labels to also declare the delivery rate as "Ymg/hour", but both were authorized for that drug product).
8. The change does not affect the actual final delivered quantity (dose) of the medicinal ingredient nor the pharmaceutical form of the drug. It does, however, change the delivery rate (e.g. a transdermal patch previously delivered Xmg/hour or X mg/square inch to give X mg overall dose, but now delivers Ymg/hour or Ymg/square inch to give Xmg overall dose).
9. The pharmacopeial standard used at time of original market authorization will be maintained but the standard itself has been revised (e.g. authorized as United States Pharmacopeia (USP) grade, but USP revises the standard).
10. The pharmacopeial standard has been changed (e.g. from British Pharmacopeia (BP) to USP).

Supporting Data

1. Common Information for Notifications and Drug Identification Number (DIN) Applications (as outlined in 4.1).
2. Scientific rationale for the proposed change.
3. If condition 3 applies, the sponsor must ensure they meet prescription status requirements (for example, labelling).
4. If condition 4 applies, file Animal Tissue form and/or data outlined in section P.4 of Quality Guidance: Applications for Drug Identification Numbers (DINAs) for Pharmaceuticals.
5. New Drug Requirements: Consult the guidance documents, Preparation of New Drug Submissions in CTD format and Management of Drug Submissions and Applications. For veterinary drugs, Guidance for Industry Preparation of Veterinary New Drug Submissions and Veterinary drugs - Management of regulatory submissions guidance: Overview.

Conditions

1. For a human, disinfectant, or veterinary drug, a change to the colour or font size of the brand name originally listed on the HC/SC 3011 form / REP forms.
2. For a human, disinfectant, or veterinary drug, any change to the brand name originally listed on the HC/SC 3011 form / REP forms, other than those listed under Condition #1.
3. The recommendations according to the guidance document entitled Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs are met.

Supporting Data

1. Common Information for Notifications and Drug Identification Number Applications (as outlined in 4.1).

4.2.1.2 Changes outlined in C.01.014.1(2)(g)-(k)

The following filing processes and supporting data are strongly recommended in order to ensure that the proposed changes are consistent with the intent of the Act and Regulations:

Conditions

1. The change in intended user (or species) of the drug is previously authorized for the specified product type under Division 1 in Canada.
2. The change in intended user (or species) of the drug is not previously authorized for the specified product type under Division 1 in Canada and meets the definition of a new drug under C.08.001 of the Regulations.

Supporting Data

1. Common Information for Notifications and Drug Identification Number Applications (as outlined in 4.1).
2. Recommendations may vary depending on the proposed use/ user. Contact the appropriate Directorate/ Bureau for pre-submission enquiries.
3. New Drug Requirements: Consult the guidance documents, Preparation of New Drug Submissions in CTD format and Management of Drug Submissions and Applications. For veterinary drugs, Guidance for Industry Preparation of Veterinary New Drug Submissions and Guidance for Industry Management of Regulatory Submissions.

Conditions

1. The colourant is listed in the Regulations under C.01.040.2
2. The colourant is not listed in the Regulations under C.01.040.2

Supporting Data

1. A signed and dated cover letter on company letterhead with a description of the change.
2. Common Information for Notifications and Drug Identification Number Applications (as outlined in 4.1).
3. New Drug Requirements: Consult the guidance documents, Preparation of New Drug Submissions in CTD format and Management of Drug Submissions. For veterinary drugs, Guidance for Industry Preparation of Veterinary New Drug Submissions and Veterinary drugs - Management of regulatory submissions guidance: Overview.

Conditions

1. There are no safety issues instigating or related to the removal of the claim.
2. The claim, direct or implied, is listed as an acceptable statement in the most current Category IV monograph or Labelling standard and the therapeutic class is not being modified (for example [e.g.] - An antiseptic skin cleanser wishes to add the additional claim "for personal hand hygiene to help prevent the spread of certain bacteria". This is an acceptable claim under the Antiseptic Skin Cleansers monograph).
3. The claim, direct or implied, is not an acceptable statement in a Category IV monograph or Labelling standard and/or the therapeutic class is modified. However, the claim for that product category and/or the therapeutic class of the drug has been previously reviewed and authorized by Health Canada for the product category in question and does not cause the product to meet the definition of a New Drug under C.08.001 of the Regulations (e.g. change in claim- adding photostability claims for a sunburn protectant; change in therapeutic class - diphenhydramine can be used as a sleep aid, antitussive or an antihistamine).
4. The change in claim(s) or change in the therapeutic class causes the product to meet the definition of a New Drug under C.08.001 of the Regulations.
5. The non-therapeutic claims highlight only existing flavours, fragrances or colour already authorized previously for this drug product.^{Footnote 10}
6. The non-therapeutic claims are taken verbatim from the Guidelines for Cosmetic Advertising and Labelling. The claim also meets the requirements of other Authorities (Healthy Environments and Consumer Safety, Pest Management Regulatory Agency, Natural and non-prescription Health Products Directorate, etc)
7. All other changes other than 5 and 6.

Supporting Data

1. Common Information for Notifications and Drug Identification Number (DIN) Applications (as outlined in 4.1).
2. Rationale or justification of the proposed change
3. Data provided may include chemistry, clinical, and/or comparative data to support the proposed change(s). Please consult the Quality Guidance: Applications for Drug Identification Numbers (DINAs) for Pharmaceuticals and the guidance documents regarding bioequivalence/bioavailability studies available on the Health Canada Web site: Bioavailability and Bioequivalence.
4. New Drug Requirements: Consult the guidance documents including Preparation of New Drug Submissions in CTD format, and Management of Drug Submissions and Applications. For veterinary drugs, Guidance for Industry Preparation of Veterinary New Drug Submissions and Veterinary drugs - Management of regulatory submissions guidance: Overview.

Conditions

1. The proposed changes to the dosage recommendations are in compliance with the dosing criteria in the Category IV monograph or Labelling standard.
2. The proposed changes to the dosage recommendations are not in compliance with the criteria in the Category IV monograph or Labelling standard, but have been previously reviewed and authorized by Health Canada for that product category as a Division 1 product.
3. The proposed changes to the dosage recommendations are not in compliance with the dosing criteria in a Category IV monograph or Labelling standard, have not been previously reviewed and authorized by Health Canada for that product category, but do not meet the definition of a New Drug under C.08.001 of the Regulations (for example, [e.g.] - the total daily dose remains the same, but the dosing schedule is changed).
4. The dose is not acceptable under a Category IV monograph or Labelling standard, or has not been previously reviewed and authorized by Health Canada for that product category, and meets the definition of a New Drug under C.08.001 of the Regulations.

Supporting Data

1. Common Information for Notifications and Drug Identification Number (DIN) Applications (as outlined in 4.1).
2. Rationale or justification of the proposed change.
3. Submission of supporting data which may include clinical data depending on the type of claim being made.
4. New Drug Requirements: Consult the guidance documents including Preparation of New Drug Submissions in CTD format and Management of Drug Submissions and Applications. For veterinary drugs, Guidance for Industry Preparation of Veterinary New Drug Submissions and Veterinary drugs - Management of regulatory submissions guidance: Overview.
5. Submission of a complete residue depletion study done in the intended species and with the same dosage and route of administration. In a case where there is more than one route of administration, a particular route must be specified.

Conditions

1. No other changes to the manufacturer other than the address (for example, Manufacturer X moves from Richmond Hill to Markham, Ontario); or to the importer other than name and/or address and the change in address does not affect the conditions set out in C.01.004.1.

Supporting Data

1. A signed and dated cover letter on company letterhead with a description of the change.
2. Confirmation of which products (identify the Drug Identification Number, and Dossier ID, for submissions under review, refer to the Dossier ID and control number. In both scenarios, include all establishment licences which are affected by the change.

4.2.1.3 Changes outlined in C.01.014.1(2)(l)-(n)

The following filing processes and supporting data are strongly recommended in order to ensure that the proposed changes are consistent with the intent of the Act and Regulations: