Transparency - Release of Product Monographs Directly to Requesters

Date: 2006-05-29

Contact: Policy Bureau Enquiries

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:

Therapeutic Products Directorate

Information Dissemination Unit
Office of Planning, Performance and Review Services
Therapeutic Products Directorate
Health Products and Food Branch
6^th Floor, Holland Cross, Tower B, A.L. 3106C
1600 Scott Street
Ottawa, ON K1A 0K9

E-mail: hc.prescription.drug.enquiries-renseignements.drogue.ordonnance.sc@canada.ca

Biologics and Genetic Therapies Directorate

Office of Regulatory Affairs
Biologics and Genetic Therapies Directorate
Health Products and Food Branch
1^st Floor, Laboratory Centre for Disease Control (LCDC), A.L.0601C
100 Eglantine Drive
Ottawa, ON K1A 0K9

E-mail: hc.bgtd.ora.sc@canada.ca

Any questions regarding the above Notice should be directed to:

Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Products and Food Branch
2nd Floor, Holland Cross, Tower B, A.L. 3102C1
1600 Scott Street
Ottawa, ON K1A 0K9 

E-mail: hc.policy.bureau.enquiries.sc@canada.ca