Letter to Disinfectant Drugs Manufacturers/Distributors/Importers

Contact: BGIVD Enquiries

Therapeutic Products Directorate Health Products and Food Branch
Finance Building
Address Locator 0202B1
Tunney's Pasture
Ottawa, Ontario
K1A 1B6

July 6, 2005

05-114918-504

To:  Disinfectant Drugs Manufacturers/Distributors/Importers

Dear Madam/Sir:

Subject:

Pre-Market Assessment of Disinfectants Formerly Regulated Under Schedule II to the Pest Control Products Regulations

The September 12, 2001 amendment to the Pest Control Products (PCP) Regulations includes the revocation of Sections 5 to 7 of Schedule II to these Regulations. Accordingly, disinfectants which had previously been regulated under those sections of the Schedule, and are referred to herewith as PCP Schedule II products, have since been administered by the Therapeutic Products Directorate (TPD). Following the publication of its letter of April 15, 2002, http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/disinfect-desinfect/disinf_desinf-eng.php, and subsequent correspondence with the Canadian Consumer Specialty Products Association, TPD now implements a process for the pre-market assessment and regulatory approval of PCP Schedule II products.

The review and approval process for Schedule II products will be as follows:

• Abbreviated reviews will apply to PCP Schedule II chlorine-releasing disinfectants which satisfy the Category IV Monograph for Hard Surface Disinfectants or for Toilet Bowl Disinfectant Cleaners, and carry bactericide, virucide, fungicide and/or germicide claims, as defined in Section 3.3.1 and Appendices VII and IX of the Disinfectant Drugs Guidelines.
• These short reviews will also apply to PCP Schedule II toilet bowl disinfectants which contain hydrogen chloride as the single medicinal ingredient with in-use solution concentrations greater than or equal to (≥) 9.5%, or phosphoric acid as part of a combination of medicinal ingredients and in accordance with Appendix IX, Section (III) (b) of the Disinfectant Drugs Guidelines.
• Full reviews will be performed on all other PCP Schedule II products including those which contain sulfuric acid and sodium bisulfate and those which carry a specific microbicidal claim, as defined in Section 3.3.2 and in accordance with Appendix II of the Disinfectant Drugs Guidelines.
• Warnings, precautionary statements and first aid information must be appropriate to the hazard.

If you have any questions, please contact Dr. André Craan, Disinfectants Unit, Bureau of Gastroenterology, Infection and Viral Diseases, at (613) 954-6731, fax (613) 941-1183, or by e-mail at BGIVD_Enquiries@hc-sc.gc.ca.

Sincerely,

Original signed by

Jacques Bouchard, PhD
Director
Bureau of Gastroenterology, Infection
and Viral Diseases

cc:
Omer Boudreau
Director General
Therapeutic Products Directorate

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