Dossier ID request form for biocide dossiers
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- Footnote 1
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A biocide dossier is a collection of biocide product(s) under one biocide market authorization for a company, including the pre-submission meeting/advice, initial market authorization application and all subsequent post authorization activities. The format of the dossier identifier (ID) is a lowercase "q" followed by six (6) unique numbers (e.g. q123456).
A dossier ID must be requested prior to filing the first regulatory transaction. A request for a dossier ID should only be placed a maximum of eight weeks prior to filing.
- Footnote 2
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Company ID (or company code): is a 5 digit unique number assigned by Health Canada to the company of the market authorization holder. For information on the company ID (company code) refer to the sections 2.3 Company Enrolment/Amendment of the Guidance Document: The Regulatory Enrolment Process (REP): Drugs for Human/Veterinary Use and Disinfectants.
- Footnote 3
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The brand name under which the product is proposed to be sold or advertised. The brand name is also the name used to identify the product in all submission correspondence, Product Label(s) and Package Insert, if applicable.
The primary brand name(s) must be established at the time the dossier ID request is submitted.For information on difference between primary and alternate brand name refer to the guidance document: Guidance on biocide application pathways and general requirements: One application for one market authorization.
- Footnote 4
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Active Ingredient: A component of a biocide that is directly responsible for any of the biocide's intended effects (subsection 1(1) of the regulations).
- Footnote 5
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For the information on the pre-submission meeting refer to the guidance document: Guidance on biocide application pathways and general requirements.
- Footnote 6
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Indicate the application pathway you will use to submit as your first filing under this dossier ID. For the full list of eligible application pathways, refer to the guidance document: Guidance on biocide application pathways and general requirements: Overview.
- Footnote 7
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Provide the licensor's company name and reference primary brand name. Refer to Guidance on biocide application pathways and general requirements: Obligations for biocides authorized based on comparison biocides.
- Footnote 8
- Footnote 9
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The Alternate contact is the person to be contacted by Health Canada if there are any issues or clarifications required when enrolling a dossier, in addition to the Primary contact.
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