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The information above concerning the storage and recording of time/temperature conditions are applicable to other non-blood biologicals requiring refrigeration or frozen storage.
Yes. Medsafe, a unit of the Ministry of Health that regulates medicines used in New Zealand, makes sure that all medicines available in New Zealand go through the same quality and safety checks before they can become available. Because generic medicines have to have the same active ingredient in them as the original medicine, they have the same risks and benefits as the original brand medicines. PHARMAC only funds generic medicines that Medsafe has assessed as being safe, effective and of good quality.
Additionally, the DMEPA prospectively reviews proprietary names, labeling, packaging, and product design prior to drug approval to help prevent medication errors. The DMEPA also works closely with federal partners, patient safety organizations such as Institute for Safe Medication Practices (ISMP), standard setting organizations such as the United States Pharmacopeia (USP), and foreign regulators to address broader product safety issues.
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