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Contact: Office of Business Transformation
Record of Decisions: Direct Sellers Association (DSA)
Location: 1600 Scott Street, Holland Cross, Tower B, 2nd Floor, Boardroom 2048, Ottawa, Ontario
Date: Tuesday, May 31, 2011
Start Time: 1:30 p.m.
End Time: 3:15 p.m.
Barbara J. Sabourin, Senior Executive Director, Therapeutic Products Directorate (TPD), Health Products and Food Branch (HPFB) welcomed everyone, and a roundtable of introductions followed.
Dr. Jacques Bouchard, Director, Bureau of Gastroenterology, Infection and Viral Diseases (BGIVD), TPD, provided the update on the status of the decision-making process involving the next set of PAACs.
Dr. Bouchard mentioned that Batch 2 PAACs and associated transition plans (Acne Therapy, Antidandruff Shampoos and Antiseptic Skin Cleansers) have been completed and are currently awaiting approval. Due to the election, the posting of Batch 2 of the PAACs had been delayed.
The Sunscreen PAAC has been submitted for approval. The sunscreen exposure survey may or may not be posted at the same time, depending on approvals and any technical difficulties experienced by Healthy Environments and Consumer Safety Branch (HECS) Publication. It will likely be published some time after the PAAC.
Krystle Gonzalez, Mary Kay Cosmetics Ltd., indicated that DSA members would be interested in receiving a copy of the survey.
The Pest Control Products (PCP) working group is currently working on the Batch 3 PAACs, which consists of tooth whiteners, tooth desensitizers and toothpaste (anti-caries).
It was suggested that HECS be invited to the next bilateral meeting.
Action: To invite HECS to the next bilateral meeting.
Update: A copy of the Sunscreen Usage Survey was sent to DSA on May 31, 2011.
Sarah Skuce, Drug Good Manufacturing Practices (GMP) Compliance Specialist, Health Products and Food Branch-Inspectorate (HPFB-I), addressed this item.
William Morkel, Dicentra Inc., mentioned that DSA member companies are facing increasing requests for informational studies covering the transportation of Category IV drugs, right to the end destination in Canada. DSA pointed out it has more complex distribution chains than the typical retail sales model. There is no single defined route of transportation within direct sales after initial importation, and it would be impractical to do full transportation studies for all scenarios. DSA's major concern is how to meet these requirements with all the possible contingencies that could occur. DSA made two suggestions:
Ms. Skuce indicated that, as currently stated in GUI-0069 (issued January 28, 2011), section 3.2.1 "Product Transportation and Products in Transit" - Drug products must be transported in a manner that ensures the products will be maintained within an acceptable temperature range as defined in the approved labelling and supported by stability data. Temperature excursions outside of their respective labelled storage conditions, for brief periods, may be acceptable provided stability data and scientific/technical justification exist, demonstrating that product quality is not affected.
The requirement for contractual agreements between all parties involved in the distribution of a drug product is aimed at ensuring products reaching consumers are safe, of good quality and maintain the efficacy as required by their market authorization. The fact that multiple parties can be involved in the final distribution of drug products is the exact reason that control over the movement and conditions in which product is transported is required to maintain quality and as detailed in GUI-0069 section 3.5.1 "Documentation".
If stability studies have been conducted and scientific justification exists to demonstrate a drug product may be stored or transported outside of the recommended label conditions while maintaining its quality, full transportation studies may not be required. However, the company must determine that the product will be maintained within the temperature range of the established stability data. The method for this determination is at the discretion of the company. Section 3.2.6 provides guidance on the various options available to a company in order to comply with the requirements of GUI-0069.
The requirement for warehouses to be equipped with calibrated monitoring systems again is to ensure the maintenance of safety, quality and efficacy of drug products being stored in the warehouse. If products are stored at the recommended label requirements, they maintain the approved specifications for market authorization. A company must be able to demonstrate that the equipment used to monitor temperature is reliable and working within specification in order to ensure product is maintained at the required temperature range.
Ms. Skuce indicated there was a need for additional guidance on the topic of quality agreements between the regulated party and transport companies that would apply to all products. She added that Health Canada was working on the draft guidance that should be ready within a year. It could be presented as an Annex to GUI-0069 or a formal guidance document.
Ms. Skuce suggested that companies document their practices for calibrating and any justification for deviations from the requirements outlined in the GMP Guidelines. She invited DSA to contact her for clarification if needed.
DSA member companies are noticing some inconsistencies in labelling requirements from reviewers at time of application. It was noted there is no current policy on "Convenience Packaging", so a lot of comments received by stakeholders could be reviewer-specific. Lisa Lange, Acting Director, Bureau of Policy, Science and International Programs (BPSIP), TPD, indicated that Health Canada was planning to revise the existing policy guidance on Kits. There will be targeted consultation in the fall to assist with issue identification. DSA will be engaged early in the process. Dr. Jacques Bouchard, Director, BGIVD, TPD, added that from the review side, the number of kits has increased, example: cough and cold, toothpaste and toothbrush, a drug and a cosmetic, etc.DSA was invited to contact Dr. Bouchard directly if companies have any questions.
╔tienne Ouimette, Acting Director, Strategic Horizontal Policy Division, Policy, Planning and International Affairs Directorate, (PPIAD), HPFB, provided the update on the possible legislative amendments and on the Red Tape Reduction Commission.
Modernizing the Food and Drugs Act and the Red Tape Reduction Commission were priorities of the former Government. The Branch needs to await the upcoming Speech from the Throne (on June 3, 2011) to determine its focus moving forward.
Lisa Lange, Acting Director, BPSIP, TPD, outlined the many initiatives that are currently active and which will require industry input in the near future. Where possible, the anticipated timing of the projects was provided to facilitate the coordination of member input by DSA.
With regards to the Scientific Advisory Committee, Dr. Jacques Bouchard, BGIVD, TPD, mentioned that Health Canada was recruiting. There was an extension and nominations are accepted until June 19. The proposed Terms of Reference are posted on the Health Canada website. DSA was encouraged to submit nominations.
Dr. Bouchard also provided an update on the status of the initiatives on Acetaminophen, Acetylsalicylic Acid (ASA), Ibuprofen, and product monograph.
Sarah Skuce, Drug Good Manufacturing Practices (GMP) Compliance Specialist, HPFB- Inspectorate, provided the update on the future initiatives that will impact DSA.
In terms of Active Pharmaceutical Ingredient (API) Regulation, Health Canada is working to establish regulatory requirements and a formal API GMP inspection program in Canada. Until regulatory revisions are complete, the Inspectorate plans to conduct voluntary visits to API facilities. These visits are designed to gather information and pilot a number of the tools and models that are being developed in preparation for implementation of the full inspection program. The Inspectorate is aiming to initiate these visits in the spring of 2011. The Inspectorate will also be sending out a survey to industry asking for information about sites and activities involving APIs. The information gained will help design an inspection program.
The regulatory requirements in respect of APIs will apply to all human drugs, including Category IV products. However, as has been done for the Category IV finished dosage forms (example-Annex 1 to GUI-0001), the Inspectorate, through the GMP Committee, will evaluate the appropriateness of the requirements in light of the nature of these products.
The GMP review team compiled a list of over 25 recommendations that cover a broad array of areas. The recommendations reflect a combination of efforts to improve effectiveness and efficiency. The GMP Review Stakeholder Consultation Summary Report was posted on January 26, 2011. A GMP Review Update Newsletterwas sent to industry including all Drug Establishing Licences (DEL) holders, 2009 GMP Review workshop attendees, 2010 GMP Roadshow attendees, and various stakeholders identified by TPD and Veterinary Drugs Directorate (VDD) via email on March 8, 2011. The implementation phase started in June 2010. DSA expressed interest in seeing the recommendations that pertain to DSA. Ms. Skuce will follow up on this request and will ensure that DSA is on the mailing list.
A significant amount of work to date has focussed on piloting a recommendation on making inspection scheduling more risk-based. Sites that are due for an inspection during the pilot period will be prioritized based on an analysis of risk factors. A communication package, including the GMP Update Report Form and Guidance to Industry on how to complete and submit the GMP Update Report Form, was sent to companies located in British Columbia, Alberta, Manitoba and Saskatchewan on March 16. The inspection phase is expected to start on target in April 2011 with an assessment to be done by the end of fiscal year 2011-2012.
The Inspectorate has launched a review of its compliance verification function, one of its core functions, in order to improve the effectiveness and efficiency of this area. The review currently applies to all product areas, but does not include border admissibility decisions or the investigation function. The scope includes both proactive and reactive activities. The review's recommendations will be aligned with the Inspectorate's risk framework. The objectives include:
The Inspectorate anticipates holding a consultation with stakeholders in the fall of 2011.
Updates: The GMP Review Newsletter was sent to DSA on June 1, 2011.
The Responses to comments GUI-0066 were sent to DSA on June 6, 2011.
Ross Creber, President, DSA, offered DSA's assistance in various projects.
Meeting adjourned at 3:15 p.m.
October 2011 - Date to be determined.
Original signed by Dr. Supriya Sharma for
Barbara J. Sabourin
Senior Executive Director
Therapeutic Products Directorate