ARCHIVED - Letter to Associations Regarding Transfilling of Medical Gases

(January 13, 2003)

Contact Name: Drugs GMP Inspection Unit
Tel: (613) 957-1492
Fax: (613) 952-9805
E-Mail: GMP_Questions_BPF@hc-sc.gc.ca

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Letter to Associations

Health Products and Food
Branch Inspectorate
Holland Cross, Tower "A"
2nd Floor, 11 Holland Avenue
Address Locator: 3002C
OTTAWA, Ontario
K1A 0K9

January 13, 2003

02-117222-401

TO: Associations

The Compressed Gas Association (CGA) submitted a request to the Health Products and Food Branch Inspectorate (Inspectorate) to exempt medical gas transfilling activity from the Good Manufacturing Practices (GMP) and Establishment Licence (EL) requirements.

The request was analysed, and the Inspectorate considers that this activity is subject to the GMP and EL regulatory requirements of the Food and Drugs Act and Regulations. In addition, since this activity could be associated with a relatively high risk to health, it would not be appropriate to exempt it from the regulatory requirements.

Should you have any questions, please contact Ms. France Dansereau, Manager, Inspection Unit, National Coordination Centre, Health Products and Food Branch Inspectorate, by telephone at (613) 957-1492, by fax at (613) 952-9805, or by email at GMP_Questions_BPF@hc-sc.gc.ca.

Original signed by
Danièle Dionne (for)

Jean Lambert
Director General

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