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Found 7370 records

The purpose of this document is to suggest elements for consideration when designing clinical trials dealing with eradication of H. …

Record Modified: Jul 7, 2021
Record Released: Jul 7, 2021
Publisher: Health Canada
Formats: HTML
Keywords: Guidance developing therapeutic regimens eradication eradication of helicobacter pylori GI diseases

These guidelines interpret the requirements for good manufacturing practices (GMP) in Part C, Division 2 of the Regulations. Guidance documents …

Record Modified: Jul 7, 2021
Record Released: Jul 7, 2021
Publisher: Health Canada
Formats: HTML
Keywords: Good manufacturing practices guide drug products GUI-0001 requirements for good manufacturing practices Part C Division 2 of the Regulations industry health care professionals Health Canada staff comply with regulations enforced in a fair ...

The purpose of this document is to assist stakeholders with the interpretation of legislation and regulatory requirements about distributing samples …

Record Modified: Jul 6, 2021
Record Released: Jul 6, 2021
Publisher: 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

When Health Canada authorizes a drug to be marketed in Canada, a Drug Identification Number (DIN) is issued to the …

Record Modified: Jul 6, 2021
Record Released: Jul 6, 2021
Publisher: 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

On December 13, 2017, Health Canada published the Regulations Amending the Food and Drug Regulations (DIN Requirements for Drugs in …

Record Modified: Jul 6, 2021
Record Released: Jul 6, 2021
Publisher: Health Canada
Formats: HTML
Keywords: Guidance document DIN drug identification numbers schedule C drugs radiopharmaceuticals and Kits regulatory amendment Food and Drug Regulations drugs in dosage form the requirement a DIN a drug to be sold in Canada the labelling requirements ...

(DIN) has been assigned for that drug and the assignment of the number has not been cancelled pursuant to section …

Record Modified: Jul 6, 2021
Record Released: Jul 6, 2021
Publisher: Health Canada
Formats: HTML
Keywords: Guideline drug identification number DIN preparation of DIN Submissions ssection C.01.014 Food and Drug Regulations section C.01.014.6. a new drug a new drug submission an application for a DIN

This guidance document outlines the information considered necessary to support the safety and effectiveness of chemical products that are represented …

Record Modified: Jul 6, 2021
Record Released: Jul 6, 2021
Publisher: Health Canada
Formats: HTML
Keywords: Guidance document safety and effectiveness requirements high-level disinfectants and sterilants reusable semi-critical critical medical devices safety and effectiveness of chemical products reusable semi-critical critical medical devices

This guidance document outlines the information considered necessary to support the safety and effectiveness of contact lens disinfectants, which are …

Record Modified: Jul 6, 2021
Record Released: Jul 6, 2021
Publisher: Health Canada
Formats: HTML
Keywords: Guidance document safety and effectiveness requirements contact lens disinfectants medical devices medical device regulations

Canada’s obligations under the North American Free Trade Agreement and the Agreement on Trade-Related Aspects of Intellectual Property Rights require …

Record Modified: Jul 5, 2021
Record Released: Jul 5, 2021
Publisher: Health Canada
Formats: HTML
Keywords: Data protection Food and Drug Regulations North American Free Trade Agreement agreement trade intellectual property rights undisclosed test safety and effectiveness pharmaceutical product a new chemical entity

President Meeting with Judith Robertson, Commissioner of the Financial Consumers Agency of Canada, September 16, 2019

Record Modified: Jun 30, 2021
Record Released: Jun 21, 2021
Publisher: Public Service Commission of Canada
Formats: DOCX PDF HTML
Keywords: PSC Note Financial Consumers Agency of Canada FCAC Staffing President Meeting with Judith Robertson