WebThe legal bases are Article 127 of Directive 2001/83/EC (medicinal product for human use) and Article 98 of the Regulation 2024/6 (veterinary medicinal products).As foreseen by the legislation, the Agency's certification scheme is based on World Health Organisation recommendations.. EMA issues such certificates on behalf of the European … WebThe batch certificates (Certificates of Analysis) of DURAN® PURE Screw Caps include dimensional values and results of visual inspection for the individual batch. In addition, compliance with pharmacopoeias and other international standards is confirmed. Extractables profiles assist in evaluation of the products and planning of extractables ...
DURAN® PURE - high-quality bottles and closures
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Certificates - Paul-Ehrlich-Institut - PEI
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