News Release
1997-34
May 8, 1997
Health Canada to establish an advisory panel on herbal remedies
OTTAWA - The Honourable Raymond Chan, Member of Parliament for Richmond and Secretary of State (Asia-Pacific) announced today on behalf of Health Minister David Dingwall that an advisory panel will be established to provide advice on the regulatory framework for herbal remedies.
"In recent months, Canadian consumers and practitioners have expressed concerns about the regulation of and accessibility to herbal remedies in Canada," said Mr. Chan. "In response to these concerns, I welcome and recognize the value of an advisory panel in providing direction and advice to Health Canada." The process being established for herbal remedies is similar to that which has been in operation for reviewing the regulatory framework for functional foods and nutraceuticals. The two initiatives will be linked.
The role of the advisory panel will be to advise on issues relating to the appropriate regulatory framework for herbal remedies, including product licensing, establishment licensing, cost recovery, international harmonizations, and other issues that may need to be addressed. It will also make recommendations on the design and conduct of consultations with stakeholders on how best to ensure that Canadians have access to safe and effective products and to balanced, credible information on their use. The members of the panel will be selected for their knowledge, expertise and experience with the subject of herbal remedies.
Health Canada's proposed strategy for the review and development of a framework for the regulation of herbal remedies includes national consultations involving representatives of major stakeholder groups, to take place in the Fall of 1997.
Schedule No. 705, a proposed regulatory amendment to the existing Food and Drug Regulations, was published for comment in the Canada Gazette, Part 1, on December 19, 1992. No action has been taken to finalize Schedule No. 705. Rather, alternative strategies are being considered to deal with this issue. Consultations will be initiated in the near future with stakeholders to seek consensus on actions to limit public exposure to potentially harmful compounds without unnecessarily restricting access to beneficial products.
Drugs, including herbal remedies, have been subject to Good Manufacturing Practices (GMP) for a long time and to inspections to assure manufacturing and distribution facilities meet these requirements. As of July 1997, Health Canada regulations require an establishment licence to be issued annually to reflect that a manufacturer or distributor meets the appropriate standard. The intent of the establishment licensing initiative and to GMP standards is to ensure uniform requirements for all persons wishing to fabricate, package, import, distribute, wholesale or test drugs in Canada. The establishment licensing fee would not apply to retailers. Fees for manufacturers, importers, and distributors would be limited to 1.5% of total sales. This would apply only to total sales generated from products classified as drugs.
All aspects of the regulatory environment for these products will be reviewed by the advisory panel. The membership of the panel and its specific terms of reference will be announced shortly.
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Media Inquiries:
Steve Jeffery
Health Canada
(613) 957-2978
Public Inquiries:
(613) 957-2991
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