Guidance on procedures and administrative requirements for master files: Definitions and abbreviations

The terminology used in this guidance document is the same as that used in the ICH guidelines. Please refer to these guidelines for terminology that is not defined here.

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• Definitions
• Glossary of Abbreviations

Definitions

Active pharmaceutical ingredient: Refer to the definition for 'drug substance'.

Applicant: The company submitting a drug submission, DIN application or CTA. This may or may not be the dosage form manufacturer (also referred to as the sponsor).

Applicant's part: The non-CBI contained in an MF, formerly called the open part (refer to the information in the "Health Canada master files" section).

Authorized MF agent: Any person appointed by the MF holder to file an MF or serve on behalf of the MF holder. The authorized MF agent may file MF-related transactions and/or sign documents on behalf of the MF holder. An MF agent or third party authorization letter signed by the MF holder is required with the initial MF registration transaction or any transaction where a new agent is appointed or the agent's role has changed.

Bovine/transmissible spongiform encephalopathy (BSE/TSE) declaration: A confirmation/attestation of whether the materials used during the manufacture of the product are susceptible to contamination with agents that may transmit BSE/TSE and that the risk of transmitting agents of animal spongiform encephalopathies has been minimized.

Confidential business information: In respect of a person to whose business or affairs the information relates, means (subject to the regulations) business information:

1. that is not publicly available
2. in respect of which the person has taken measures that are reasonable in the circumstances to ensure that it remains not publicly available and
3. that has actual or potential economic value to the person or their competitors because it is not publicly available and its disclosure would result in a material financial loss to the person or a material financial gain to their competitors

(Food and Drugs Act)

Cover letter: A letter accompanying an MF transaction that explains the purpose and content of the transaction provided to Health Canada.

Dosage form: A pharmaceutical product type (for example, tablet, capsule, solution, cream) that contains a drug substance generally, but not necessarily, in association with excipients.

Dosage form manufacturer: The company that manufactures the finished dosage form.

Drug product: The dosage form in the final immediate packaging intended for marketing.

Drug substance (active pharmaceutical ingredient): Any substance or mixture of substances intended to be used to manufacture a drug product and that, when used in the production of a drug, becomes an active ingredient of the drug product.

Letter of access: A letter written and signed by the MF holder, authorized MF agent or authorized third party filing on behalf of the MF holder. The LoA indicates to Health Canada that the applicant and the MF holder have agreed that the MF can be referred to during the assessment of the applicant's drug submission or CTA.

Manufacturer: The company that manufactures the product covered by the MF. This may be a manufacturer of a drug substance, CCS or CCS component, an excipient or a finished dosage form.

MF holder: The company that submitted the MF. This may be the manufacturer of the product described in the MF and/or the originator of the CBI.

MF update: A revision or change to any information provided in an existing MF and/or replacement of an existing MF.

Regulatory activity: A collection of all regulatory transactions sent by the applicant throughout the process of a specific activity. These include, for example, an NDS, ANDS, DIN application, CTA and YBPR.

Regulatory transaction (sequence): Any information package sent by the MF holder or by the applicant as part of a regulatory activity. Examples include a new MF registration, LoA or response to clarification request.

Restricted part: The CBI contained in an MF, formerly called the closed part (refer to the information in the "Health Canada master files" section).

Statement of commitment: A declaration from the MF holder or authorized MF agent that the information provided in the MF is true and accurate.

Third party filing on behalf of the MF holder: Any person acting and/or signing documents and/or managing regulatory transactions on behalf of the MF holder must be appointed to do so. This is usually done through an MF agent or third party authorization letter signed by the MF holder. This letter is required for the initial MF registration transaction and any transaction where a new agent is appointed or the agent's role has changed.

Glossary of Abbreviations

AEUNDS

Abbreviated Extraordinary Use New Drug Submission

ANDS

Abbreviated New Drug Submission

API

Active Pharmaceutical Ingredient

BRDD

Biologic and Radiopharmaceutical Drugs Directorate

BPS

Bureau of Pharmaceutical Sciences

BSE/TSE

Bovine/Transmissible Spongiform Encephalopathy

CBI

Confidential Business Information

CEP

Certificates of Suitability to the Monographs of the European Pharmacopeia

CESG

Common Electronic Submissions Gateway

CPID

Certified Product Information Document

CTA

Clinical Trial Application

CTA-A

Clinical Trial Application Amendment

CTA-N

Clinical Trial Application Notification

DIN

Drug Identification Number

DINA

Drug Identification Number Application

DINB

Drug Identification Number Application for Biologics

eCTD

Electronic Common Technical Document

EDQM

European Directorate for the Quality of Medicines & HealthCare

ESC

Experimental Studies Certificate

EUNDS

Extraordinary Use New Drug Submission

EUSANDS

Extraordinary Use Supplemental Abbreviated New Drug Submission

EUSNDS

Extraordinary Use Supplemental New Drug Submission

GMP

Good Manufacturing Practices

ICH

International Council for Harmonisation

IGDRP

International Generic Drug Regulators Programme

IND

Investigational New Drug

INN

International Non-proprietary Name

LoA

Letter of Access

MF

Master File

NC

Notifiable Change

NDS

New Drug Submission

NDS CV

New Drug Submission with flexibilities for designated COVID-19 drugs

NHP

Natural Health Product

NNHPD

Natural and Non-prescription Health Products Directorate

NOC

Notice of Compliance

NOL

No Objection Letter

NON

Notice of Non-compliance

NSN

Not Satisfactory Notice

PDC

Post-authorization Division 1 Change

PDC-B

Post-authorization Division 1 Change for Biologics

PDD

Pharmaceutical Drugs Directorate

PDF

Portable Document Format

QOS

Quality Overall Summary

SANDS

Supplemental Abbreviated New Drug Submission

SNDS

Supplemental New Drug Submission

XML

Extensible Markup Language

YBPR

Yearly Biologic Product Report