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  • DMFSept2012 - Medsafe

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    SenthamaraiShanmugham
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    This document is an application form to accompany a new or updated drug master file, plasma master file, or certificate of suitability. It requests information such as the active ingredient, file number, CAS number, contact details for the DMF holder and manufacturing sites. The applicant must declare whether GMP has been provided for all sites and if the submission is part of a new marketing application or change notification. Required documents including a cover letter, full submission copies, summary of changes, and letter of access must also be included.

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    This document is an application form to accompany a new or updated drug master file, plasma master file, or certificate of suitability. It requests information such as the active ingredient, file number, CAS number, contact details for the DMF holder and manufacturing sites. The applicant must declare whether GMP has been provided for all sites and if the submission is part of a new marketing application or change notification. Required documents including a cover letter, full submission copies, summary of changes, and letter of access must also be included.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as DOC, PDF, TXT or read online from Scribd
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    101 views1 page

    DMFSept2012 - Medsafe

    Uploaded by

    SenthamaraiShanmugham
    This document is an application form to accompany a new or updated drug master file, plasma master file, or certificate of suitability. It requests information such as the active ingredient, file number, CAS number, contact details for the DMF holder and manufacturing sites. The applicant must declare whether GMP has been provided for all sites and if the submission is part of a new marketing application or change notification. Required documents including a cover letter, full submission copies, summary of changes, and letter of access must also be included.

    Copyright:

    Attribution Non-Commercial (BY-NC)
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    A completed and signed copy of this form must accompany any new or updated Drug Master File, Plasma

    Master File or Certificate of Suitability.

    APPLICATION TO ACCOMPANY A

    Drug Master File / Plasma Master File / Certificate of Suitability

    Active Ingredient (INN): Oxybutynin Chloride / Oxybutynin


    Hydrochloride

    File No: TT60-


    Not allocated yet

    CAS Number: DMF Holder Name and Postal Address: Name and Address of Manufacturing Site(s): DMF Holder Contact Details:
    Title: Phone: Name: E-mail: Position:

    This submission relates to:


    A new Drug Master File An updated Drug Master File A new Certificate of Suitability R-CEP --Rev An updated Certificate of Suitability R-CEP --Rev A new Plasma Master File An updated Plasma Master File GMP has been provided for all manufacturing sites? This DMF/PMF/CEP has been provided as part of a NMA? This DMF/PMF/CEP has been provided as part of a CMN? Yes / No Yes / No Yes / No

    The following documents are required to be included with all submissions: Cover letter Hard copy of full submission Electronic copy of the submission (if available) Summary of changes (if an update) Letter of Access (if not previously provided)

    I declare that the New Zealand sponsor has been notified of the update to the Drug Master File / Plasma Master File / Certificate of Suitability

    Signature: _________________________________________

    Date:

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