加拿大 Drug Identification Number (DIN) 注册

3. FEES FOR THE REVIEW OF DRUG SUBMISSIONS, SUPPLEMENTS AND APPLICATIONS

 

Check the appropriate box to indicate the applicable submission, supplement or application class.   

 

Do not send fee payment with your submission, supplement or application. Health Canada will verify the fee and issue an invoice accordingly. 

 

#	Submission Class	Submission Description		✓Check one
1	New active substance	Submissions in support of a drug,  other than a disinfectant, that contains a medicinal ingredient not previously approved in a drug for sale in Canada and that is not a variation of a previously approved ingredient such as a salt, ester, enantiomer, solvate or polymorph
2	Clinical or non-clinical data and chemistry and manufacturing data	Submissions based on clinical or non-clinical data and chemistry and manufacturing data for a drug that does not include a new active substance
3	Clinical or non-clinical data only	Submissions based only on clinical or non-clinical data for a drug that does not include a new active substance
4	Comparative studies	Submissions based on comparative studies (e.g., clinical or non-clinical data, bioavailability data, and data on the pharmacokinetics and pharmacodynamics of the drug) with or without chemistry and manufacturing data for a drug that does not include a new active substance
5	Chemistry and manufacturing data only	Submissions based only on chemistry and manufacturing data for a drug that does not include a new active substance
6	Clinical or non-clinical data only, in support of safety updates to the labelling	Submissions based only on clinical or non-clinical data, in support of safety updates to the labelling materials for a  new drug that does not include a new active substance
7	Labelling only	Submissions, other than those described in item 8, 11, or 12,  of labelling material, that include data in support of the following: brand name assessment, standardized or published test methods, in vitro or in vivo photostability or applications for a drug identification number in support of changes to brand names of non-prescription drugs (but not including examination of other supporting clinical or non-clinical data, comparative data, or chemistry and manufacturing data)
8	Labelling only (generic drugs)	Submissions in support of a change to the labelling to be  consistent with the Canadian reference product that do not include any additional labelling updates requiring a labelling assessment
9	Administrative submission	Submissions in support of a change in the manufacturer’s name or brand  name,  including the following: changes in ownership of the drug, request for an additional brand name or changes resulting from a licensing agreement being entered into by two manufacturers that do not require an assessment of labelling material or brand name (e.g., post-authorization label changes filed by licensees to remain identical to licensor’s drug and post-authorization chemistry and manufacturing updates for drugs listed in Schedule C or D of the Food and Drugs Act)
10	Disinfectant – Full Review	Submissions  other than those described in item 11, that include data in support of a disinfectant
11	Labelling Only (Disinfectants)	Submissions  in support of changes to the labelling of disinfectants that do not require supporting data, submissions in support of  safety updates for disinfectants that are new drugs or submissions in support of a change in the manufacturer’s name or  brand name that requires  a review of labelling material due to deviations from the previously authorized labelling or drug
12	Drug identification number application - labelling standards	Applications, including those that pertain to changes to brand names for non-prescription drugs, that include an attestation of compliance  with a labelling standard or Category IV Monograph for a drug and that do not include clinical or non-clinical data or chemistry and manufacturing data

 

 

4. MITIGATION MEASURES

 

The following mitigation measures are available (select one). Sponsors must certify that they meet the criteria as outlined in the Food and Drug Regulations.

 

 

Small Business

 

 We certify that we meet the definition of small business at the time of this filing, have applied for small business status for our company with Health Canada, and have received confirmation prior to submitting this submission/application. We understand that failure to hold a valid small business status with Health Canada at the time of submitting this submission/application will result in the full fee being charged.

 

 

 We have not previously filed a submission/application in respect of a drug with Health Canada. We are filing our first drug submission/ application.

 

 

 

Urgent Public Health Need Drug

 

 We certify that the drug in our submission/application is on the List of Drugs for an Urgent Public Health Need as per the Access to Drugs in Exceptional Circumstances Regulations, and

 

a)     the drug has the same medicinal ingredient, strength and route of administration, and is in a comparable dosage form, as a drug that may be imported under subsection C.10.001(2) of those Regulations;

b)    no drug identification number has been assigned under section C.01.014.2 of those Regulations for the drug or for another drug that has the same medicinal ingredient, strength and route of administration and is in a comparable dosage form; and

c)     no notice of compliance has been issued under section C.08.004 of those Regulations in respect of the drug or another drug that has the same medicinal ingredient, strength and route of administration and is in a comparable dosage form;

 

 

Publicly Funded Health Care Institution

 

 We certify that our institution is funded by the Government of Canada or the government of a province or territory and that it is

 

a)     licensed, approved or designated by a province in accordance with the laws of the province to provide care or treatment to persons or animals suffering from any form of disease or illness; or

b)    owned or operated by the Government of Canada or the government of a province and that provides health services.

 

 

Government Organization

 

 We certify that our organization is a branch or agency of the Government of Canada or of a province or territory.

 

5. CERTIFICATION

 

I, the undersigned, certify that:

 

1. The information and material included in this form is accurate and complete.
2. No information is false or misleading and no omissions have been made that may affect its accuracy and completeness.

 

Name of Authorized Signing Official	Signature	Date
		YYYY					MM		DD
Title	Telephone No.		Fax No.

 

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      f)    extracts or tinctures of (C.01.038. (b)):

i)       Strychnos nux vomica

ii)      Strychnos Ignatii

iii)     a Strychnosspecies containing strychnine, other than those species mentioned in subparagraph i) and ii)

      g)    Methapyrilene or any of its salts (C.01.038. (c))

h)    Echimidine or any of its salts (C.01.038. (d))

      i)     any of the following plant species or extracts or tinctures thereof (C.01.038. (e)):

i)       Symphytum asperum

                      ii)      Symphytum X uplandicum

                      iii)     any other plant species containing echimidine

      j)     chloroform (C.01.040 (a)) (C.01.036.(1))

      k)    arsenic or any of its salts or derivatives (C.01.040 (b))

      l)     methyl salicylate (as a medicinal ingredient in a drug for internal use) (C.01.040.1)

m)   mercury or a salt or derivative thereof, unless the drug is one of the following 
C.01.036. (1) c) (ii)):

A)     an ophthalmic drug or other drug to be used in the area of the eye

B)      a drug for nasal administration

C)      a drug for otic administration

D)     a drug for parenteral administration that is packaged in a multi-dose container

 

in which the mercury or the salt or derivative thereof is present as a preservative and the manufacturer or importer has submitted evidence to the Director demonstrating that the only satisfactory way to maintain the sterility or stability of the drug is to use that preservative.

 

6.     The product does not contain any colouring agent, with the exception of those listed in Section C.01.040.2 of the Food and Drug Regulations(this does not apply to hard surface or instrument disinfectants).

 

7.   If the product contains animal tissue or animal tissue was used as an intermediate during manufacturing, the required information has been submitted (Animal Tissues Form).

 

8. The product has been assessed to determine the applicability of bioequivalence, pharmacodynamic/clinical studies or pharmaceutical equivalence requirements. Where applicable, the data have been submitted.  Excluded from this assessment are: 

 

-      injectable or prescription homeopathic preparations

-      injectable or prescription traditional herbal medicines

-      hard surface or instrument disinfectants

-      injectable or prescription vitamin, mineral or vitamin/mineral preparations

 

 

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-      nonprescription products subject to a standardized proprietary medicine monograph (SPMM)

-      nonprescription products subject to a labelling standard where the standard specifies that a bioavailability assessment for the purpose of a DIN application is not required

-      peritoneal dialysis

-      hemodialysis

-      contact lens solutions

-      artificial tears

-      eye washes

 

9.   Signature of the responsible officer of the company certifying the accuracy of this document.

 

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Signature                                                                                                                                                                                                    Date

 

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Name                                                                                                                            Position Title

 

Company