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Found 10 records similar to Service Standards for Site Licence Application Review under the Natural Health Product Regulations

Federal

The Health Products and Food Branch (HPFB) commits to issue a product licensing decision within the service delivery standards outlined in: Service standards for the management of Product Licence Applications (PLA) for Natural Health Products (NHP).

Last Updated: Sep. 9, 2021
Date Published: Dec. 11, 2019
Organization: Health Canada
Formats: HTML
Keywords:  Natural Health Product, NHP, Service Standards, service delivery standards, product licencsing, management of Product Licence Applications, PLA, natural health product application reviews, Natural Health Product Regulations
Federal

Before a drug is authorized for sale in Canada, it must be issued a DIN in accordance with the Food and Drug Regulations. Also in accordance with the Food and Drug Regulations, a manufacturer of a drug must annually, before October 1, notify Health Canada that the drug is still on the market and that all the information previously provided pertaining to the drug is correct. The Health Products and Food Branch (HPFB) commits to service delivery standard of 120 calendar days, from the receipt of annual notification, to update the Drug Product Database (DPD).

Last Updated: Sep. 17, 2020
Date Published: May 18, 2017
Organization: Health Canada
Formats: HTML
Keywords:  Food and Drug Regulations, Service Standard for the Right to Sell Drugs, the Right to Sell Drugs, authorized for sale in Canada, service delivery standard of 120 calendar days.
Federal

This document describes how Health Canada's Health Products and Food Branch (HPFB) interprets the flexibility allowing for the use of a URL on Category IV products, mouthwash and toothpaste as described in the Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health Products (GLPPG).

Last Updated: Sep. 10, 2021
Date Published: Oct. 12, 2020
Organization: Health Canada
Formats: HTML
Keywords:  Non-prescription drugs, natural health products, drug facts table, eCDFT, technical Standards, Category IV products, mouthwash, toothpaste, good label and package practices guide
Federal

The purpose of this guide is to help classify the level of severity of deviations noted as observations during inspections of clinical trials with drugs for human use and ensure uniformity in the assignment of ratings of observations among Inspectors of the Health Products and Food Branch (HPFB) Inspectorate.

Last Updated: Jun. 7, 2022
Date Published: May 18, 2017
Organization: Health Canada
Formats: HTML
Keywords:  Classification of observations, inspections, clinical trials, GUIDE-0043.
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 Electronic Product Licence Application (ePLA) form is for Natural Health Product Licence Applications and for post-licence changes. The ePLA is designed to be completed on the applicant's workstation where it can be saved and retrieved at any time.

Last Updated: Sep. 9, 2021
Date Published: May 18, 2017
Organization: Health Canada
Formats: HTML
Keywords:  Natural health products, NHP, natural health product licence application, licence application form, user manual
Federal

The Amendment and Notification Form (ANF) is the exclusive form to be used for submitting post licensing changes for a licensed natural health product (NHP) to the Natural and Non-prescription Health Products Directorate (NNHPD).

Last Updated: Sep. 9, 2021
Date Published: Dec. 9, 2020
Organization: Health Canada
Formats: HTML
Keywords:  Natural health product, NHP, natural health product licence amendment, notification form, user guide
Federal

Site licence holder and foreign site reference number data extracts.

Last Updated: Sep. 9, 2021
Date Published: Dec. 17, 2020
Organization: Health Canada
Formats: HTML
Keywords:  Natural health products, NHP, licensing, natural health products online system, licence application, list of site licence holders
Federal

The application process for most licence classes, including the information required in an application, is set out in the Cannabis Licensing Application Guide

Last Updated: Mar. 24, 2021
Date Published: Jul. 24, 2020
Organization: Health Canada
Formats: HTML
Keywords:  cannabis, cannabis Act, accessing cannabis, medical purposes, authorizing the use of cannabis, applying for a licence, a licensed producer
Federal

Outlines the limited circumstances under which Health Canada would consider the import or export of cannabis.

Last Updated: Mar. 25, 2021
Date Published: Aug. 12, 2019
Organization: Health Canada
Formats: HTML
Keywords:  import, export, licence holders, Cannabis Regulations, Cannabis Act, international drug treaties, drug control conventions, cannabis, authorized
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