Life Sciences Bulletin Board
November 2011
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On October 27, 2011 Health Canada has informed sponsors that drug submissions for brand name changes to their product which require a brand name assessment and/or Look-alike Sound-alike (LA/SA) assessment will no longer be acceptable for processing as an administrative drug submission pursuant to the Policy " Changes in Manufacturer's Name and/or Product Name".
As international consensus on a definition for the products of nanotechnology has not been reached yet, Health Canada has adopted a working definition for nanomaterials. The working definition is described in the Policy Statement on Health Canada's Working Definition for Nanomaterial that can be found on Health Canada's website.
Last October 11, Health Canada has published its Guidance document entitled Data Protection under C.08.004.1 of the Food and Drug Act aiming clarifications to section 2.1 of its Guidance Document: Data Protection under C.08.004.1 of the Food and Drug Regulations.
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Health Canada has published its final version of the Guidance Document: Preparation of Summary Technical Documentation (STED)-based Class III and Class IV Premarket Medical Device Licence Applications, not including In Vitro Diagnostic Devices (IVDDs)
This Guidance, since November 1st, 2011, replaces the 2003 Guidance for Manufacturers preparing a Premarket Application Using the Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices. Therefore, from now on, all premarket device licence applications for the medical devices mentioned in the title shall be made in accordance with theses new guidelines.
Health Canada has announced its decision to begin regulating Energy Drink as Food
Until now, energy drinks were classified as a Natural Health Product (NHP), as a result, were not required to put a nutrition facts table on their products. After this change, most energy drinks will be classified in legal terms as a food, and will be subject to the nutrition, ingredient and allergen labelling requirements applicable to all foods.
Health Canada seeks to classify cosmetic contact lenses as class II medical devices
The proposed Bill C-313 has been introduced to House of Commons last October 5, 2011 to amend Food and Drug Act to classify cosmetic contact lenses as Class II medical devices, the same as corrective lenses. Once this legislation is passed, the products to be sold in Canada will now required to be licensed through Health Canada and distributors of the products will now be required to obtain a medical device establishment licence.
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