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Decision XV/5. Promoting the closure of essential-use nominations for metered-dose
inhalers
Recognizing that Parties themselves have the ultimate competence, responsibility andaccountability for the protection of the health and safety of their citizens, and for their actions toprotect the ozone layer, Acknowledging the urgent need to accelerate the phase-out of CFC-containing metereddoseinhalers in Parties not operating under paragraph 1 of Article 5 and the importance of safe,effective and affordable metered-dose inhalers for public health and medical care, Bearing in mind the work of the Technology and Economic Assessment Panel drawing onthe database established by decision XIV/5, Aware in particular that CFC-free salbutamol metered-dose inhalers are available in mostParties not operating under paragraph 1 of Article 5, Mindful of the 2003 assessment of the Panel, which concludes that the development ofCFC-free metered-dose inhalers, their registration and launch into a market cannot alone lead toa full uptake in the market without appropriate domestic regulatory action,1. That the present decision shall not affect the operation of paragraph 10 of decisionVIII/9 relating to the authorization of a quantity of CFCs in an emergency situation ;2. To request that Parties not operating under paragraph 1 of Article 5, when submittingtheir nominations for essential-use exemptions for CFCs for metered-dose inhalers, specify, foreach nominated use, the active ingredients, the intended market for sale or distribution and thequantity of CFCs required;3. To request the Technology and Economic Assessment Panel and its Technical OptionsCommittee to make recommendations on nominations for essential-use exemptions for CFCs formetered-dose inhalers from Parties not operating under paragraph 1 of Article 5 with referenceto the active ingredient of the metered-dose inhalers in which the CFCs will be used and theintended market for sale or distribution and any national transition strategy covering thatintended market which has been submitted according to decision XII/2 or decision IX/19;4. That no quantity of CFCs for essential uses shall be authorized after thecommencement of the Seventeenth Meeting of the Parties if the nominating Party not operatingunder paragraph 1 of Article 5 has not submitted to the Ozone Secretariat, in time forconsideration by the Parties at the twenty-fifth meeting of the Open-ended Working Group, aplan of action regarding the phase-out of the domestic use of CFC-containing metered-doseinhalers where the sole active ingredient is salbutamol;5. That the plans of action referred to in paragraph 4 above must include:(a) A specific date by which time the Party will cease making nominations foressential-use exemptions for CFCs for metered-dose inhalers where the sole active ingredient issalbutamol and where the metered-dose inhalers are expected to be sold or distributed on themarket of any Party not operating under paragraph 1 of Article 5;(b) The specific measures and actions sufficient to deliver the phase-out;(c) Where appropriate, the actions or measures needed to ensure continuing access to orsupply of CFC-containing metered-dose inhalers by Parties operating under paragraph 1 o fArticle 5;6. To request each Party not operating under paragraph 1 of Article 5 to submit to theOzone Secretariat as soon as practicable for that Party specific dates by which time it will ceasemaking nominations for essential-use exemptions for CFCs for metered-dose inhalers where theactive ingredient is not solely salbutamol and where the metered-dose inhalers are expected tobe sold or distributed on the market of any Party not operating under paragraph 1 of Article 5;7. To request the Technology and Economic Assessment Panel to report, in time for thetwenty-fourth meeting of the Open-ended Working Group, on the potential impacts of thephase-out of CFCs in Parties not operating under paragraph 1 of Article 5 on the availability ofaffordable inhaled therapy in Parties operating under paragraph 1 of Article 5;8. To request the Ozone Secretariat to post on its web site all data submitted pursuant todecision XIV/5 that are designated non-confidential by the submitting Party;9. To request the Technology and Economic Assessment Panel to modify the Handbookon Essential Use Nominations to reflect the present decision;

Source: http://www.ciesin.columbia.edu/repository/entri/docs/cop/Montreal_COP015_Dec005.pdf

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