News Release
1997-42
June 27, 1997
Health Minister annouces delay in establishment licencing for drugs
Ottawa - Health Minister Allan Rock today announced that the requirement for drug manufacturers, distributors and importers, including those relating to herbal remedies and natural health products, to hold an establishment licence from Health Canada, and the introduction of the associated fees, will be delayed from July 1, 1997 to January 1, 1998. The drug industry will also be provided with a 12 month phase-in period during which officials from the drug industry will work with Health Canada to comply with the regulations for licencing.
"We are delaying implementing these regulations to give the drug industry, including the manufacturers of herbal and homeopathic products, a better opportunity to comment on the proposed establishment licence requirements and fees," said Minister Rock. "I've listened carefully to concerns expressed by key stakeholders. I also look forward to receiving the advice of the Advisory Panel on Herbal Medicines regarding this matter."
Canadians will continue to have access to safe drugs. All drug manufacturers, distributors and importers are still required to meet the high standards of the Good Manufacturing Practices (GMP) for quality and cleanliness of their establishments. Although the establishment licence is new, the requirement to meet GMP standards has been in place for more than two decades.Health Canada officials will continue to inspect establishments and work with them to ensure they meet the GMP standards. They will also work with industry to enhance their understanding of the new licence requirements. Applications that have already been received by Health Canada for an establishment licence will be processed and reviewed for the January implementation date.Drugs such as biologics and radiopharmaceuticals, which require licences will have their current licences extended to December 31, 1997.The regulations governing Drug Identification ( DIN) and General Public ( GP) numbers, which have been in effect for decades and apply to all drugs, including herbal medicines, are not affected by the delay in the establishment licencing regulations. Canadians can continue to be assured of the safety and effectiveness of their drugs through the DIN or GP. These numbers, located on the label of all drug products approved for sale in Canada, indicate that a product has undergone and passed a review of its formulation, labelling and instructions for use and is an assurance that the product's content and health effects claims are accurate.
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Media Inquiries:
Krystyna Pottier
Health Canada
(613) 957-2985
Jennifer Lang
Minister's Office
(613) 957-0200
Public Inquiries:
(613) 957-2991
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