Bilateral Meeting Program with Compressed Gas Association (CGA) - Record of Decisions - April 20, 2010

Agenda

• Location: 250 Lanark Avenue, Graham Spry Building, Ottawa, Ontario
• Date: Tuesday April 20, 2010
• Time: 1:30 p.m. to 3:30 p.m.

Participants

• Health Canada
  • Kim Dix - A/Director, Compliance Coordination & Licensing Division (CCLD), Health Products and Food Branch Inspectorate (HPFBI) (meeting co-chair)
  • Stephanie Reid - A/Manager, Drug Good Manufacturing Practices (GMP) Inspection Unit
  • Joyce Pon - Bureau of Policy, Science and International Programs (BPSIP) , Therapeutics Products Directorate (TPD)
  • Thomas Hazle - Medical Device Compliance Unit, HPFBI
  • Sarah Chandler - Medical Devices Bureau, TPD (by phone)
  • Andrew Sun - Policy and Strategic Planning Division, HPFBI
  • Etienne Ouimette - Director, Strategic Horizontal Policy Division and HPFB Cost Recovery Initiative , HPFB (Item 5.3 only)
  • David Hennigar - HPFB Cost Recovery Initiative, HPFB (Item 5.3 only)
• Compressed Gas Association (CGA)
  • Joanne Lekkas - Linde Canada (Chair of CGA's Canadian Medical, Food, and Beverage Gases and Equipment Committee) (meeting co-chair)
  • Bill Beckett - Medigas
  • Ken Lum - Praxair Distribution
  • Alice Chen - VitalAire
  • Gordon Edwards - Praxair Canada
  • Karine Saint-Cyr - Air Liquide Canada
  • Patrick Litwin - VitalAire
  • Jim Wallace - Gas Pro

1. Welcome and Introductions

Kim Dix called the meeting order and welcomed the participants.

Joanne Lekkas thanked Health Canada for this opportunity to meet.

The meeting participants introduced themselves.

2. Review of Agenda

The agenda adopted.

3. Approval of the minutes of the meeting on October 29, 2009

The comments on the draft minutes of the previous meeting minutes were discussed, and the minutes were amended accordingly and approved.

4. Review of previous action items (from the October 29, 2009 meeting minutes)

1. Action items from the meeting on April 13, 2007
   • Item 4.1: (Approvals for gases in medical applications - drugs versus medical devices) - TPD to develop and to provide guidance to industry as to when a gas is considered a drug, a medical device, or a natural health product.
     • Update: (See discussion under 5.2 of this meeting.)
       Action item is on-going.
   • Item 4.1: (Approvals for gases in medical applications - drugs versus medical devices) - TPD to meet with CGA to discuss and to resolve the issues pertaining to compounding and approvals for gases in medical applications.
     • Update: (See discussion under 5.2 of this meeting.)
       Action item is on-going.
2. Action items from the meeting on November 14, 2007
   • Item 3: HPFBI will follow up with Brenda Lajeunesse regarding the posting on Health Canada's website of the minutes from the bilateral meetings held on October 13, 2006, April 13, 2007, and November 14, 2007.
     • Update: There have been challenges posting on the Health Canada (HC) website, and minutes of meetings are lower priority for web posting. HPFBI will follow up regarding this action item. The minutes from the previous bilateral meetings on October 28, 2008 and October 29, 2009 will also be posted on the website.
       Action item is on-going.
3. Action items from the meeting on October 28, 2008
   • Item 4.1: Approvals for gases in medical applications - TPD (BPSIP) and CGA will pursue further work regarding approvals for gases in medical applications.
     • Update: (See discussion under 5.2 of this meeting.)
       Action item is on-going.
   • Item 4.5: Transfilling of cylinders with medical gases - Chad Sheehy to follow up with regards to jurisdiction over transfilling by fire departments, ambulances, hospital homecare programmes, and airlines.
     • Update: Stephanie Reid reported that these activities are considered outside the scope of the regulations, as there is no further sale. She suggested that CGA members send details of any specific concern to her for review. Guide 31 will be reviewed this fiscal year (ending March 31, 2011).
       Action item is closed.
   • Item 5.1: Liquid nitrogen NF in open-top dewars - CGA to provide justification for removing the "small quantities" and "for professional use" limitations from the Q&A.
     • Update: CGA submitted a letter to Chad Sheehy (HPFBI) on May 1, 2009, regarding the medical gas GMP Q&A on liquid nitrogen NF in open-top dewars. Chad Sheehy sent a letter responding to CGA on June 11, 2009.
       Action item is completed.
     
     Action: HPFBI will update the Q&A posted on the Health Canada website to reflect the information in the letter from Chad Sheehy.
     • Update: HC will update the Q&As and post them.
       Action item is on-going.
   • Item 5.2: Ethylene oxide mixtures - The Inspectorate (GMP Unit) will update the Q&A on ethylene oxide mixtures to state that the provisions of that Q&A apply to all medical gas mixtures containing ethylene oxide, and not just mixtures of ethylene oxide and carbon dioxide.
     • Update: HC will update the Q&As and post them.
       Action item is on-going.
4. Action items from the meeting on October 29, 2009
   • Item 5.1: Expiry date requirements for medical gases - By the end of March 2010, Health Canada will provide CGA with a status report and a timeline for further discussions on the issue of expiry date requirements for medical gases.
     • Update: No meeting was held. (See also discussion under 5.1 of this meeting.)
       Action item is on-going.
   • Item 5.2: Approvals for gases in medical applications - By the end of March 2010, TPD and CGA will meet (outside of the bilateral meeting programme) for further discussions on the issue of the market authorisation process for gases in medical applications (drugs versus medical devices).
     • Update: Meeting was not held. (See also discussion under 5.2 of this meeting.)
       Action item is on-going.

5. Old items for further discussion

5.1 Expiry date requirements for medical gases

Prior to this bilateral meeting, Suranika Dias had sent three questions through Pat Litwin to CGA, regarding

HC clarified that there was no intention to revise the regulations to exempt medical gases from expiry date requirements. However, Guide 31 is up for review this fiscal year, and stakeholders will be given the chance to comment on any proposed changes. HC would appreciate any feedback from CGA on areas in the guidance that need clarification. These comments can be sent to the generic GMP e-mail account.

After a discussion between TPD, the Inspectorate, and CGA, it was agreed that a meeting between TPD and CGA to discuss this topic should be held. It was agreed to add Ken Lum to the list of contact people from CGA to continue discussions on this topic.

Action: Joyce Pon (TPD) will go back to BPS/TPD to identify TPD representatives for the meeting, and Joanne Lekkas will follow up with Joyce in a month to ensure a meeting is scheduled.

5.2 Market authorisation process for gases in medical applications

Joyce Pon stated that there was no plan to put Drugs and Medical Devices under one regulatory system. There was a discussion on the CGA concern that they receive orders for products but do not necessarily know what the end use will be. It could be for drugs, devices, both, or neither. It was agreed a separate meeting between TPD and CGA was required.

Action: Joyce Pon (TPD) will go back to BPS/TPD to identify TPD representatives for the meeting, and Joanne Lekkas will follow up with Joyce in a month to ensure a meeting is scheduled.

Joyce indicated that TPD considered it acceptable to have a DIN for a range of gas concentrations. Concern was raised by CGA that the annual notification for drugs did not have the detail of the approved ranges.

Action: Joyce Pon will go back to TPD to determine why the range is not on the annual notification.

5.3 Cost Recovery Initiative

Andrew Sun from HPFBI, Etienne Ouimette, and David Hennigar provided an update on the Cost Recovery Initiative. Etienne indicated that because the term "transfilling" was not in the regulations, they are assessing options to operationalize Option 1 that had been previously supported for medical gas companies (i.e. charge the packaging fee once (per year) even where the company has multiple sites performing transfilling activities). Once a sound option has been drafted, HC will come back to CGA to discuss.

Etienne described in detail the next steps and potential timing related to Health Canada's User Fees Proposal and subsequent amendments of fee regulations.

Action: Health Canada (Etienne Ouimette and Andrew Sun) to come back to the CGA to discuss a regulatory fee mitigation strategy for companies with multiple transfilling sites.

5.4 Unique Device Identifiers and Unique Product Identifiers

An update on Unique Device Identifiers (UDI) was provided by Thomas Hazle. Unique identification has been used in a variety of different product areas for many years such as for grocery produce, IT assets, etc. International governments have begun using them to track pharmaceuticals. A UDI system would ensure that a device could be tracked using the same bar code by anyone (manufacturers, regulators, etc.) who required the information. This system would facilitate information management and result in immediate access to desired information that pertains to a specific item and not just a group of items.

Health Canada has formed a Working Group that is to monitor domestic and international developments in UDI for medical devices. The purpose for this monitoring role is to remain up-to-date on UDI issues to enable Canada to position itself appropriately, and to develop lessons learned based on issues encountered by international partners.

Ultimately, the WG will be responsible for developing and recommending a policy position for the potential implementation of a UDI system for medical devices in Canada.

CGA voiced concerns about the incorporation of packaging location in the UDI. Andrew Sun encouraged CGA to provide any concerns or feedback about UDI to him through Amy Park.

6. New items

6.1 Product monographs

Issue brought forward by CGA: A CGA member company was cited after a Post-Market Reporting Compliance (PRMC) inspection with an observation that "no product monographs were available for any of the company's medical gases".

Health Canada agreed with CGA that product monographs are not required for medical gases (drugs) that when originally approved did not require product monographs. CGA members were encouraged to discuss observations with the inspector or supervisor if they have concerns. They can also contact Stephanie Reid at HC.

Based on this, the aforementioned PMRC observation would not be valid for medical gases.

6.2 Pre-fill odour checks on curbside-filled containers

Issue brought forward by CGA: During several recent HPFBI inspections at locations that performed curbside filling of Liquid Oxygen USP into homecare vessels, the inspector required that the homecare vessels' inspection include pre-fill odour checks.

Health Canada agreed with CGA that curbside-filled vessels do not require odour checks prior to filling. CGA members were encouraged to discuss requests of this nature with the inspector or supervisor if they have concerns. They can also contact Stephanie Reid at HC.

7. Next meeting and adjournment

The next meeting was tentatively scheduled for October 2010

The meeting was adjourned.