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Found 10 records similar to Notice: Revision to the Guidance Document: Management of Drug Submissions and Applications

Federal

Health Canada’s Veterinary Drugs Directorate (VDD) is clarifying the expectations for the information about Good Manufacturing Practices (GMP) status that should accompany veterinary drug submissions.

Last Updated: Jul. 8, 2021
Date Published: Feb. 16, 2021
Organization: Health Canada
Formats: HTML
Keywords:  Notice, submission filing recommendations, veterinary drugs, good manufacturing practices, drug establishment licences
Federal

This guidance document provides clarification to submission sponsors on how to comply with (Veterinary Drugs Directorate of Health Canada) VDD's policies, governing statutes and regulations.

Last Updated: Jul. 8, 2021
Date Published: Nov. 6, 2009
Organization: Health Canada
Formats: HTML
Keywords:  Guidance document, industry, sponsors, management of regulatory submissions, Veterinary Drugs Directorate of Health Canada, VDD, VDD's policies
Federal

This guidance document is intended to provide sponsors with an outline of the chemistry and manufacturing, clinical, and human safety requirements for the filing of the following submission types with the Veterinary Drugs Directorate (VDD): Abbreviated New Drug Submission (ANDS); Changes to ANDS - Supplemental Abbreviated New Drug Submission (SANDS) and Notifiable Change (NC).

Last Updated: Jul. 8, 2021
Date Published: Feb. 8, 2010
Organization: Health Canada
Formats: HTML
Keywords:  Guidance for industry, veterinary abbreviated new drug submissions, preparation of veterinary abbreviated new drug submissions, supplemental abbreviated new drug submission, notifiable change, generic drugs, chemistry and manufacturing, clinical, and human safety requirements
Federal

Health Canada is publishing this document to be transparent about the principles and factors that it considers when deciding whether a drug would be best sold as a prescription or nonprescription product. This document is also designed to help the public, industry and healthcare professionals, including veterinarians, as well as other stakeholders, better understand and predict when a drug will be authorized as a prescription or nonprescription product.

Last Updated: Jul. 7, 2021
Date Published: Jun. 21, 2013
Organization: Health Canada
Formats: HTML
Keywords:  Guidance document, determining prescription status for human drugs, determining prescription status for veterinary drugs, authorized as a prescription or nonprescription product
Federal

The objective of this guidance document is to outline the procedures that veterinary Master File (MF) holders must follow to file confidential business information (CBI) directly with Health Canada's Veterinary Drugs Directorate (VDD) that is cross-referenced in support of an Applicant's veterinary drug submission (including DIN (Drug Identification Number) applications.)

Last Updated: Jul. 8, 2021
Date Published: Jan. 20, 2021
Organization: Health Canada
Formats: HTML
Keywords:  Guidance document, veterinary master files, veterinary products, procedures and administrative requirements, confidential business information, an applicant's veterinary drug submission
Federal

The Guidance Document: Management of Drug Submissions and Applications (MDSG) gives sponsors and Health Canada staff operational direction and guidance when managing information submitted in accordance with the Food and Drugs Act and its Regulations.

Last Updated: Jul. 7, 2021
Date Published: May 26, 2021
Organization: Health Canada
Formats: HTML
Keywords:  Guidance document, management of drug submissions and applications, sponsors, operational direction, managing information submitted during drug submissions and applications
Federal

The purpose of this document is to assist stakeholders with the interpretation of legislation and regulatory requirements about distributing samples of prescription drugs, non-prescription drugs and natural health products.

Last Updated: Jul. 6, 2021
Date Published:
Organization: Health Canada
Formats: HTML
Keywords:  Guidance document, distributing samples, distribution of drugs as samples, legislation and regulatory requirements, prescription drugs, non-prescription drugs, natural health products
Federal

The purpose of this document is to assist stakeholders with the interpretation of legislation and regulatory requirements about distributing samples of prescription drugs, non-prescription drugs and natural health products.

Last Updated: Sep. 9, 2021
Date Published: Apr. 27, 2020
Organization: Health Canada
Formats: HTML
Keywords:  Guidance document, distribution of drugs as samples, distributing samples, prescription drugs, non-prescription drugs, natural health products, stakeholders, interpretation of legislation and regulatory
Federal

This document provides information for industry on how Health Canada's Health Products and Food Branch interprets and applies the 2014 Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) for non-prescription (Over-the-Counter, OTC) drug products. These amendments are commonly referred to as the Plain Language Labelling (PLL) Regulations.

Last Updated: Jul. 7, 2021
Date Published: Sep. 28, 2018
Organization: Health Canada
Formats: HTML
Keywords:  Guidance document, plain language labelling regulations, non-prescription drugs, 2014 Regulations Amending the Food and Drug Regulations, labelling, packaging and brand names, drugs for human use for non-prescription
Federal

When Health Canada authorizes a drug to be marketed in Canada, a Drug Identification Number (DIN) is issued to the manufacturer and printed on the package labels. A DIN indicates that the evaluation of the drug determined that it met the relevant requirements of the Food and Drugs Act and its regulations and the drug has a favourable risk/benefit profile. Manufacturers of prescription and non-prescription drugs must obtain a DIN before they are marketed in Canada

Last Updated: Jul. 6, 2021
Date Published:
Organization: Health Canada
Formats: HTML
Keywords:  Guidance document, regulatory requirements, DIN, drug identification numbers, summary, a drug to be marketed in Canada, DIN printed on the package labels, prescription and non-prescription drugs, obtain a DIN
Date modified: