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Found 10 records similar to Veterinary Biologics Licensed in Canada

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

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

This Guidance Document is to be used in the preparation of Veterinary Drug Submissions for presentation to Health Canada. Some sections of this Guidance Document are general in nature. Therefore, this Guidance Document should be used in conjunction with the complete Food and Drugs Act and Regulations, and with specific Health Canada Policies and Guidance Documents applicable to veterinary drugs.

Last Updated: Jul. 8, 2021
Date Published: Mar. 2, 2007
Organization: Health Canada
Formats: HTML
Keywords:  Guidance for industry, veterinary new drug submissions, preparation of veterinary new drug submissions, Food and Drugs Act and Regulations, policies on veterinary drugs.
Federal

The NOC is issued to a manufacturer following the satisfactory review of a submission for a new drug, and signifies compliance with the Food and Drug Regulations. The database is updated nightly and contains NOC information on human drugs from January 1, 1994 to date. It also contains NOC information on Veterinary drugs from September 19, 2000 to date.

Last Updated: Feb. 24, 2022
Date Published: Dec. 18, 2017
Organization: Health Canada
Formats: XML JSON HTML
Keywords:  NOC, veterinary drugs, DIN
Federal

Following several successful joint reviews between Australia, New Zealand and Canada, there has been interest by others within industry to explore this as a model for bringing new veterinary drug products to market. Industry has been keen to understand how to initiate discussions and how the overall process would work. This document is therefore provided as guidance for industry about the joint review process for veterinary drugs.

Last Updated: Jul. 8, 2021
Date Published: Feb. 12, 2021
Organization: Health Canada
Formats: HTML
Keywords:  Guidance, veterinary drug, veterinary drug joint reviews
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

The site licensing system requires that all manufacturers, packagers, labellers, and importers be licensed. Sites must have procedures in place for distribution records and product recalls and for the handling, storage and delivery of their products. They must also demonstrate that they meet good manufacturing practice requirements.

Last Updated: Sep. 9, 2021
Date Published:
Organization: Health Canada
Formats: HTML
Keywords:  Natural health products, NHP, site licensing, natural health products site licensing, good manufacturing practice requirements
Federal

The Licensed Natural Health Products Database contains information about natural health products that have been issued a product licence by Health Canada.

Last Updated: Sep. 9, 2021
Date Published: Nov. 9, 2020
Organization: Health Canada
Formats: HTML
Keywords:  Natural Health Products, NHP, licensed natural health products database, LNHPD, product licence
Federal

A biosimilar is a biologic drug that is highly similar to a biologic drug that was already authorized for sale. Health Canada authorizes biosimilars for sale using the same rigorous regulatory standards for quality, efficacy and safety as for all other biologic drugs.

Last Updated: Jun. 7, 2022
Date Published: Aug. 27, 2019
Organization: Health Canada
Formats: HTML
Keywords:  biosimilar, biosimilar biologic drugs, authorized for sale, biosimilars for sale, biologic drugs
Federal

Clinical Trial Applications for pharmaceutical (Schedule F), radiopharmaceutical (Schedule C) and biological (Schedule D) drugs are all regulated under Part C, Division 5 of the Food and Drug Regulations, and therefore all must adhere to the same regulatory requirements. However, biological drugs carry additional risks associated with complexity and variability in manufacturing.

Last Updated: Jun. 7, 2022
Date Published: May 18, 2017
Organization: Health Canada
Formats: HTML
Keywords:  Clinical Trial Applications, CTA for Biologics, CTA Radiopharmaceuticals, biological drugs
Date modified: