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Master File

Overview

The Health Canada Drug Master File (DMF)is a type of document submitted to Health Canada to provide important information about an Active Pharmaceutical Ingredient (API), finished dosage form, excipients and container closure systems, and processes used in the manufacturing, processing, packaging, and storing of human drugs. It is submitted to support the drug application. Submission of Master Files is not mandatory. However, manufacturers can submit the DMF to maintain the confidentiality of proprietary information for the holder.

The information submitted in the Master File can only be accessed by Health Canada if the File holder provides a Letter of Access (LOA) to the applicant and Health Canada. Additionally, the DMF holders can also submit the copy of Certificates of Suitability (CEP) for quicker review and acceptance of the Master File.

Freyr has a Regulatory team with in-depth understanding and experience in handling the Health Canada Drug Master File registration activities in eCTD format, along with managing and updating the MFs in alignment with the latest guidelines by Health Canada.

Freyr Expertise

  • 01

    Serve as an agent between the Agency and the manufacturer for interactions with Health Canada.

  • 02

    Regulatory submission strategy for different types of Master Files (MFs) for drug substance (Type I), packaging materials (Type II), and Excipients (Type III).

  • 03

    Guidance on selection of Regulatory starting material and route of synthesis for drug substance in line with HC expectations.

  • 04

    Support in designing the limits for impurities in starting materials, intermediates, and their carry-over to APIs.

  • 05

    Designing of specifications for starting materials, in-process, intermediates, and drug substance.

  • 06

    Support in setting the strategy and limits for genotoxic impurities and elemental impurities in intermediates or drug substance.

  • 07

    Guidance on designing the protocols for stability studies, process validation, hold time study, and forced degradation studies for MF submission.

  • 08

    Preparation and submission of Type I/II/III Master Files in line with Health Canada requirements.

  • 09

    Publishing of MFs in the eCTD format as per the current HC guidelines and requirements.

  • 10

    Change control evaluation and Regulatory strategy, preparation and submission of amendments, and annual reports for already registered Master Files.

  • 11

    Regulatory strategy, preparation, and submission of responses to Health Authority queries.

  • 12

    Conversion of existing paper/non-CTD MFs into the eCTD format.

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