Health Canada Site License Database

Reported side effects - disclaimers. A Foreign Site Reference Number FSRN is issued by the Natural and Non-prescription Health Products Directorate NNHPD of Health Canada to a manufacturer packager andor labeller of NHPs located outside of Canada referred to as a foreign siteA FSRN indicates that the foreign site is found to be in compliance with Part 3 Good Manufacturing Practices GMP of the Natural Health.

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The site licence holder and foreign site reference number extracts are updated on a periodic basis.

Health canada site license database. The last Licence holder and Licence name are displayed. Description The Health Canada Drug Product Database contains product specific information on drugs approved for use in Canada. The Natural Health Products Regulations require any Canadian site where natural health products are manufactured imported labelled packaged distributed andor stored to have a site license.

Medical Device Incidents - disclaimers. Natural health products site licensing - Canadaca Natural health products site licensing The site licensing system requires that all manufacturers packagers labellers and importers be licensed. The database is managed by Health Canada and includes human pharmaceutical and biological drugs veterinary drugs and disinfectant products.

A Medical Device Establishment Licence MDEL is a licence issued to Class I manufacturers as well as importers or distributors of all device classes to permit them to import or distribute a medical device in Canada. Upon completion of the audit a new ISO 134852003 certificate will be issued. The Licensed Natural Health Products Database contains information about natural health products that have been issued a product licence by Health Canada.

The site licence holder extracts indicate sites that have been authorized to manufacture package label andor import natural health products by Health Canada. Active Licence Search Selecting the Archived Licence Search link takes you to the new Medical Devices Licence History Archive Search window. The capability is limited to search Licence Number Device Name and Device Identifier.

Sites must have procedures in place for distribution records and product recalls and for the handling storage and delivery of their products. Multiple sites or an individual license for each site. The site licence holder extracts indicate sites that have been.

Harmonized Site Licence and FSRN Application form. Before you use the form Health Canada must assign a company code a number for your company. About the Drug and Health Product Register.

Report a serious adverse drug reaction for hospitals Report a medical device problem for health care professionals Prescription Drug List. The web-based harmonized site licence and foreign site reference number FSRN application form web SLA is designed to be completed online and saved on the applicants workstation. Manufacturers must have ISO 134852003 reaudited by a Registrar accredited by Health Canada under CMDCAS.

Businesses can choose to have a single site license for all their operations ie. This data extract contains information on. 11 rows Site Licence Holders List.

Health Canada Health Canada Medical Devices Medical Device Active License. Only products which appear in this database listing may be offered for general marketing purposes in Canada. An MDEL provides Health Canada assurance that medical devices sold or imported into Canada meet the safety requirements set out.

Search licensed natural health products From Health Canada Note - The product information found within this database originates from organizations not subject to the Official Languages Act and is available in the language in which it was written and submitted to Health Canada. Apply for a Medical Device Establishment License if you are going to. Site Licenses Registrations.

The foreign site reference number extracts indicate sites outside of Canada which have been assessed against Part 3 of the Natural Health. The database is managed by Health Canada and provides a source of information about Canadian clinical trials involving human pharmaceutical and biological drugs. Additional information on Health Canadas CTD is available at.

Health Canadas Clinical Trials Database is a listing of information about phase I II and III clinical trials in patients. The Bureau maintains a database of all licensed Class II III and IV medical devices offered for sale in Canada. Data and review decisions.

If you do not already have a company code email us at. You identify who your Canadian importer is and if they do not already have a site license we work with the company to. Eventually some of the information will be part of the application process to Health Canada but they are the only people outside of ourselves to which anything will be disclosed.

Class I medical devices do not require a medical device licence and are monitored by the Health Products and Food Branch Inspectorate Compliance and Enforcement through Establishment Licensing. Online search Establishment Registration.

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