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Commonly Asked Questions about Health rep Canada Forms

What is the rep process?

The Regulatory Enrolment Process (REP) facilitates the filing and processing of regulatory information related to: company. dossier and product. regulatory activity. regulatory transaction.

What is the equivalent of FDA in Canada?

Health Canada : Health Canada is responsible for protecting human and animal health and the safety of Canadas food supply.

How do I get health Canada approval?

Before a drug product is authorized for sale in Canada, the drug manufacturer must submit scientific evidence of the products safety, efficacy, and quality to Health Canada for review and approval.

What is abbreviated new drug application Health Canada?

An Abbreviated New Drug Submission is used to obtain approval for generic drugs. This is in contrast to a New Drug Submission (NDS), which is used to obtain approval for a new brand name drug. An ANDS lists the related drugs brand name, chemical name, manufacturer name, dosage form(s), and strength(s).

Who needs to have the MDEL in Canada?

If you manufacture Class I medical devices or In Vitro diagnostic devices (IVDs) and plan to sell directly into Canada without a distributor, you must secure a Medical Device Establishment License (MDEL). If you choose to sell through distributors in Canada, your distributor is required to have an MDEL.

What is the drug approval process in Canada?

Regulatory approval Before a drug product is authorized for sale in Canada, the drug manufacturer must submit scientific evidence of the products safety, efficacy, and quality to Health Canada for review and approval.

What is new drug approval?

New drug approval procedure is defined as a stepwise method provided by regulatory agencies of each country that set guidelines for a drug manufacturer or a sponsor who wishes to seek marketing authorization (MA) in a specific country.

What is the new drug application in Canada?

Health Canadas New Drug Submission (NDS) is the process through which new drugs are approved and controlled by the Canadian Health Authority before entering the Canadian market. In Canada, new drugs are regulated under Part C, Division 8 of Food and Drugs Regulations.