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Decision XXIII/2: Essential-use nominations for controlled substances for 2012

Noting with appreciation the work done by the Technology and Economic Assessment Panel and its Medical Technical Options Committee,

Mindful that, according to decision IV/25, the use of chlorofluorocarbons for metered‑dose inhalers does not qualify as an essential use if technically and economically feasible alternatives or substitutes are available that are acceptable from the standpoint of environment and health,

Noting the Panel’s conclusion that technically satisfactory alternatives to chlorofluorocarbon‑based metered-dose inhalers are available for some therapeutic formulations for treating asthma and chronic obstructive pulmonary disease,

Taking into account the Panel’s analysis and recommendations for essential-use exemptions for controlled substances for the manufacture of metered-dose inhalers used for asthma and chronic obstructive pulmonary disease,

Welcoming the continued progress in several parties operating under paragraph 1 of Article 5 in reducing their reliance on chlorofluorocarbon-based metered-dose inhalers as alternatives are developed, receive regulatory approval and are marketed for sale,

Welcoming the announcement by Bangladesh that it will not, in the future, submit essential‑use nominations for the use of chlorofluorocarbons in metered-dose inhalers,

  1. To authorize the levels of production and consumption for 2012 necessary to satisfy essential uses of chlorofluorocarbons for metered-dose inhalers for asthma and chronic obstructive pulmonary disease specified in the annex to the present decision;
  2. To request nominating parties to supply to the Medical Technical Options Committee information to enable assessment of essential-use nominations in accordance with the criteria set out in decision IV/25 and subsequent relevant decisions as set out in the handbook on essential‑use nominations;
  3. To encourage parties with essential-use exemptions in 2012 to consider sourcing required pharmaceutical-grade chlorofluorocarbons initially from stockpiles where they are available and accessible, provided that such stockpiles are used subject to the conditions established by the Meeting of the Parties in paragraph 2 of its decision VII/28;
  4. To encourage parties with stockpiles of pharmaceutical-grade chlorofluorocarbons potentially available for export to parties with essential-use exemptions in 2012 to notify the Secretariat of such quantities and of a contact point by 31 December 2011;
  5. To request the Secretariat to post on its website details of the potentially available stocks referred to in the preceding paragraph;
  6. That the parties listed in the annex to the present decision shall have full flexibility in sourcing the quantity of pharmaceutical-grade chlorofluorocarbons to the extent required for manufacturing metered-dose inhalers, as authorized in paragraph 1 above, from imports, from domestic producers or from existing stockpiles;
  7. To request parties to consider domestic regulations to ban the launch or sale of new chlorofluorocarbon-based metered-dose inhaler products, even if such products have been approved;
  8. To encourage parties to fast-track their administration processes for the registration of metered-dose inhaler products in order to speed up the transition to chlorofluorocarbon-free alternatives;
  9. To approve the authorization granted Mexico by the Secretariat, in consultation with the Technology and Economic Assessment Panel, for the emergency essential‑use of six metric tonnes of pharmaceutical-grade CFC-12 for the production of metered-dose inhalers, to cover the period 2011–2012;

Annex to decision XXIII/2

Essential-use authorizations for 2012 for chlorofluorocarbons for metered‑dose inhalers (in metric tonnes)

Parties 2012
Bangladesh 40.35
China 532.04
Pakistan 24.1
Russian Federation 212