Information

June 1997

Facts at a glance - Establishment licences

The Role of Health Canada is...

To ensure that Canadians have full information that they can trust and that all medicines available to Canadians are safe, of high quality and effective. It is not to limit access to medicines.

Regulations

Are designed to protect Canadians. Canadians must be able to trust that a medicine approved for sale in Canada will do what it says it will do and has been produced in a safe, clean facility.

What are Establishment Licences?

An establishment licence is the certificate which is issued to a facility after an inspection by Health Canada has indicated that the facility meets the appropriate Good Manufacturing Practices (GMP). GMPs are uniform requirements for all facilities wishing to fabricate, package, import, distribute, wholesale or test drugs in Canada.

While the licence is new, the requirement to meet high quality standards is not. Drugs, including herbal remedies have been subject to Good Manufacturing Practices (GMP) for more than two decades. Health Canada inspectors have been working with the industry for years to ensure facilities meet these requirements.

To what do the GMP standards and Establishment Licences apply?

The standards, and eventually the licencing requirements apply to manufacturers, distributors and importers of all drugs including:

• pharmaceuticals
• radiopharmaceuticals
• biologics
• blood and blood products
• vaccines
• herbal remedies
• homeopathic medicines.

Why has the date for implementing establishment licences and the associated fees been delayed?

An additional six months have been given for implementation to allow for a number of things. The extra time provides more time for the industry to understand the licencing requirements and, through working with Health Canada inspectors, meet the standards. It will also afford Health Canada, in consultation with stakeholders, including the Advisory Panel on Herbal Medicines, the opportunity to review the regulatory framework for establishment licences and potentially amend it.

Will this delay jeopardize the safety of Canadians?

No. Drug manufacturers must continue to meet the Good Manufacturing Practices standards for quality and cleanliness. Health Canada officials will continue to inspect facilities and work with the industry to ensure the standards are met.

Will this ensure that herbal medicines continue to be available?

Health Canada never intended a campaign to sweep products from the shelves of retail stores. However, consumer and industry complaints about products will continue to be investigated to ensure the safety of Canadians.

Does this affect applications that have already been submitted to Health Canada?

Not at all. The establishment licence requirement has only been delayed, it has not been cancelled. Applications should continue to be submitted to Health Canada where they will be reviewed for the January 1, 1998 implementation date. The additional six months allows more time for the industry to submit their applications.