Code of Conduct

Question & Answers

Please be aware of the new 2007 Edition of the Code of Conduct when browsing through the 2006-2005 questions & answers, as some of the guidelines may have been amendment in the new version and the response may not be compliant with the new 2007 Code.

1. Who can submit questions?
Due to the volume of questions received and in order to prioritize appropriately, responses will only be provided to member companies, health care professionals (HCPs), recognized health care associations (such as the CMA) and PAAB. In particular, we have received a large volume of "pre-clearance" requests from agencies, which will not be addressed going forward. If the agency is retained by a member company, they will be requested to forward their questions to the company's compliance representative for review. In the event that the member company needs additional guidance, the member company may then submit the question to Rx&D through their compliance representative.

2. How Should Questions be submitted?
To ensure a complete record of all questions and answers is available for the benefit of each member company, questions must be submitted in writing (by letter, fax or email). Questioners contacting Rx&D by phone will be requested to submit their inquiries in writing to maintain fairness and transparency. To help the IPC's analysis and to improve response times, written submissions should refer to the Code section requiring clarification or guidance, using the Code question form to be located shortly in the "Code of Conduct" section of the Rx&D website. Please do not submit samples, exhibits or supporting documentation with questions. Given the open nature of the process, member companies are advised not to include confidential or proprietary information with questions, or to pose questions requesting a confidential response.

3. What is the Process for Responses?
Once a question is submitted in accordance with these guidelines, Rx&D staff will draft a response. All draft responses will be consolidated and sent to an IPC core group for review at the end of each business week. At the IPC core group's discretion, certain questions may be circulated to the entire IPC for feedback. If approved by the IPC, Rx&D staff will then send the response to the questioner. If amendments are required, the response will not be sent until reviewed and approved by the IPC. The IPC's objective is to provide responses to all written enquiries from authorized questioners within two weeks of their receipt by Rx&D. Please note all questions (including follow up or supplementary questions) will be processed in order of their date of receipt. Rx&D staff will attempt to post all questions and responses on a monthly basis for the benefit of all member companies. Rx&D staff will remove names or terminology from questions and answers identifying the questioner. A more detailed description of the revised Q&A process is attached for your reference.

4. What is the Purpose of the Q&A Process?
The Q&A process is intended to provide supplementary advice and guidance to member companies, HCPs, recognized health care associations and PAAB regarding Code issues. It does not obviate the requirement for all member companies to familiarize themselves with the Code, and is not intended to fulfill a pre-clearance or review mechanism for questioners. Member companies must ultimately be solely and exclusively responsible for whether their activities, materials and conduct comply with the Code's requirements. 

Send questions via e-mail to code@canadapharma.org

Q&A's 2007

Q&A's 2006

Q&A's 2005