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We talked to manufacturers of popular natural and homeopathic products to find out what kind of evidence they submitted to Health Canada to get their product licensed. Here is one response.
Оригинальное название
HELIXIA Pendopharm's Letter to CBC Marketplace
We talked to manufacturers of popular natural and homeopathic products to find out what kind of evidence they submitted to Health Canada to get their product licensed. Here is one response.
We talked to manufacturers of popular natural and homeopathic products to find out what kind of evidence they submitted to Health Canada to get their product licensed. Here is one response.
PENDOPHARI, division defo
(7 PENDOPHARM
OPEN MINDS THINK ALIK
February 9", 2015
Ms. Tyana Grundig
Associate Producer
CBC News Marketplace
Dear Mrs. Grundig,
‘We thank you for your email of February Sth, 2015 and the opportunity to respond to CBC
Marketplace regarding the upcoming expose of Natural Health Products (NHPs) and th
registration process in Canada. As the regulatory approval pathways for healthcare product are
complex in nature, Pendopharm is hereby providing a written response to your questions and
respectfully declines the invitation for an on-air interview.
Firstly and most importantly, Pendopharm is fully committed to providing healthcare products
that are of high quality, efficacious and safe for all Canadians. We abide to the highest level of
ethics for the industry and adhere to the rigorous standards of evidence as required by Canadian
law and as interpreted in Health Canada policies and guidelines.
Helixia Cough Prospan is a NHP that is derived from the extract of the dried ivy leaf. In Canada,
Helixia Cough Prospan is considered as a NHP with non-traditional, non-compendial claims that
require at least 2 pieces of scientific evidence (e.g. clinical trials). ‘The evidence required by
Health Canada to support this type of NHP is more rigorous than a NHP making a traditional use
claim. Pendopharm provided above and beyond the Health Canada requirements including data
from 3 clinical studies which led to an approval in 2011.
‘As further evidence of its safety and effectiveness, Prospan Cough Syrup (as it is known
internationally) has been available on the market for over 2 decades and used by millions of
consumers, The product was first launched in Germany in 1991 and is distributed in over 85
countries worldwide.
Aga
., Pendopharm thanks you for the opportunity to respond to your inquiry.
Sincerely,
(
Didier pévonond, MD
Senior Director, Medical Affairs
latmascience ine, 6111, avenue Royalmount Ave
Tai (514) 340.5045. TelecopieuriFax: 1 866 926-7664 Service aia cienele/Cusiomer Service. 1 865 826-7589
Infarmation médicale et scienfique/Medieal nd Scent infomation Servioes' 1 988 550-6060
seauiSute 100, Montréal, Québec, HAP 214, CANADA