Decision 51/34

March 2007
Metered-dose inhalers

The representative of Mexico, speaking as facilitator of the contact group established to consider MDI‑related issues, reported on the group’s deliberations. Following its consideration of the contact group’s conclusions and recommendations, the Executive Committee decided:

  1. That Article 5 Parties with plants manufacturing CFC-metered-dose inhalers (MDIs) should be advised of the timing on which to begin considering the need for essential use exemptions beyond the 2010 phase-out date and that the preparation of a nomination for essential use exemptions might begin in 2007 for submission to the Parties for their consideration in 2008;
  2. That the Executive Committee would need to consider further the availability of pharmaceutical grade CFC after 2010 in light of the Technology and Economic Assessment Panel reports to the 27th Meeting of the Open-ended Working Group and the Nineteenth Meeting of the Parties on campaign production of CFCs for MDIs in Article 5 and non-Article 5 Parties;
  3. That the Executive Committee might consider on a case-by-case basis the submission of requests for project preparation for the conversion of CFC-MDI production facilities on the understanding that they must include a comprehensive justification from the country concerned for the need to receive assistance and, as a minimum, should provide the following detailed information:
    1. Name of nationally owned CFC-MDI manufacturing facilities, the date when the CFC production lines were established and the production capacity of each production line;
    2. Type of CFC-MDI products manufactured, active ingredients used, annual production output (units/year);
    3. Growth patterns of CFC-MDI production over the past five years;
    4. Whether any of the CFC-MDI manufacturing plants were contemplating alternatives to CFC-MDIs and what those alternatives were;
    5. Each production facility’s plans for phasing out CFC consumption; and
    6. The number of non-CFC MDIs and dry-powder inhalers sold or distributed within the Party, by active ingredient, brand/manufacturer, and source;
  4. That the Executive Committee would consider on a case-by-case basis requests for transition strategies to non-CFC MDIs in Article 5 Parties that did not have MDI manufacturing facilities, in accordance with decision 45/54, when the need for a strategy had been fully demonstrated and documented through the submission of the following information for the previous three years:
    1. CFC and non-CFC MDIs and dry-powder inhalers: sold or distributed within the Party, by active ingredient, brand/manufacturer, and source;
    2. Non-CFC MDIs and dry-powder inhalers: date approved, authorized for marketing, and/or launched in the territory of the Party;
    3. CFC and non-CFC MDIs and dry-powder inhalers: estimated cost by active ingredient and source.