Transparency - Release of Product Monographs Directly to Requesters

Date: 2006-05-29

May 29, 2006

Notice

Our file number: 06-111774-698

The Health Products and Food Branch (HPFB) is notifying stakeholders that an interim measure for the direct release of Product Monographs (PMs) to requesters is being initiated immediately. This interim measure, as well as Health Canada's intent to post PMs on the internet, were both previously communicated in a Notice to Stakeholders (November 2002).

HPFB remains committed to the electronic posting of PMs to the internet and will consult with stakeholders prior to a final decision.

Previously, Product Monographs were released through the Access to Information Act process. As an interim measure, PMs will now be released directly to requesters through the appropriate Review Bureau/Centre in TPD/BGTD, following the issuance of the corresponding Notice of Compliance (NOC). The version released will reflect the latest Health Canada-authorized document and may not be identical to the version maintained by the product sponsor. PMs will only be released in the language in which they were submitted.

Releasing of PMs to requesters will take effect immediately.

Requests are to be made in writing (e-mail acceptable) as follows:

1. Requests from Industry sponsors should be directed to the relevant clinical review Bureau/Centre mailing or email address as follows:

Therapeutic Products Directorate

Director, Bureau of Metabolism, Oncology and Reproductive Sciences (BMORS)
2nd Floor, Finance Building, A.L. 0202D2
101 Tunney's Pasture Driveway,
Ottawa, ON
K1A 0K9.
E-mail: BMORS_Enquiries@hc-sc.gc.ca

Director, Bureau of Gastroenterology, Infection and Viral Diseases (BGIVD)
2nd Floor, Finance Building, A.L. 0202B1
101 Tunney's Pasture Driveway,
Ottawa, ON
K1A 0K9.
E-mail: BGIVD_Enquiries@hc-sc.gc.ca

Director, Bureau of Cardiology, Allergy and Neurological Sciences (BCANS)
2nd Floor, Finance Building, A.L. 0202A1.
101 Tunney's Pasture Driveway,
Ottawa, ON
K1A 0K9.
E-mail: BCANS_Enquiries@hc-sc.gc.ca

Director, Bureau of Pharmaceutical Sciences (BPS)
1st Floor, Finance Building, A.L. 0201D.
101 Tunney's Pasture Driveway,
Ottawa, ON
K1A 0K9.
E-mail: BPS_Enquiries@hc-sc.gc.ca

Biologics and Genetic Therapies Directorate

Regulatory Affairs Division
Centre for Policy and Regulatory Affairs
Biologics and Genetic Therapies Directorate
1st Floor, Health Canada Building, A.L.0701A.
200 Tunney's Pasture Driveway,
Ottawa, ON
K1A 0K9.
E-mail: BGTD_RAD_Enquiries@hc-sc.gc.ca

2. All other requests should be directed to the Submission and Information Policy Division (SIPD) who will forward requests to the relevant Bureau/Centre for processing.

Submission and Information Policy Division (SIPD)
1st Floor, Finance Building, A.L. 0201A1.
101 Tunney's Pasture Driveway,
Ottawa, ON
K1A 0K9.
Fax: (613) 941-0825
E-mail: sipdmail@hc-sc.gc.ca

Any comments regarding the above Notice should be directed to

Bureau of Policy, Science and International Programs,
Therapeutic Products Directorate,
1600 Scott Street,
Holland Cross, Tower 'B',
2nd Floor, A.L. 3102C5,
Ottawa, ON
K1A 1B6.

Fax: (613) 941-6458

Report a problem or mistake on this page
Please select all that apply:

Thank you for your help!

You will not receive a reply. For enquiries, contact us.

Date modified: