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Mexico Adopts New Standards on Stability of Pharmaceuticals and Herbal Products

Mexico’s Ministry of Health has adopted a new regulation aimed at further enhancing the safety and efficacy of domestically-produced and imported pharmaceutical products and herbal remedies. NOM-073-SSA1-2015 establishes new stability requirements for pharmaceuticals, medicaments and herbal products for human use in order to better ascertain their useful life and expiration date, adopt more effective storage and transportation parameters and select the most adequate closure for a pharmaceutical container. It includes requirements regarding new pharmaceuticals and medicaments; known/generic pharmaceuticals, medicaments and herbal remedies; medicinal gases in metal containers; general considerations for stability studies; and compliance with international standards. Slated to enter into force on 4 December, the new requirements will replace those established under NOM-073-SSA1-2005 and point 9.8.6 of NOM-248-SSA1-2011.

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