18 de abril de 2016 / por SEGCIB / Guía
The new pharmacovigilance legislation, which came into effect in 2012, introduced a range of new tasks and streamlined existing responsibilities for regulators and the pharmaceutical industry in the European Union (EU). Más información: European Medicines Agency
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Implementation of the pharmacovigilance legislation
18 de abril de 2016 / por SEGCIB / Guía
The new pharmacovigilance legislation, which came into effect in 2012, introduced a range of new tasks and streamlined existing responsibilities for regulators and the pharmaceutical industry in the European Union (EU). Más información: European Medicines Agency
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Draft guideline on the sterilisation of the medicinal product, active substance, excipient and primary container
18 de abril de 2016 / por SEGCIB / Guía
This guideline provides guidance on the documentation expected for sterile products in the quality dossier for a marketing authorisation application or a variation application for a medicinal product, (called quality dossier throughout the guideline), and the selection of appropriate methods of sterilisation for sterile products. Although, terminal sterilisation using a reference condition of the European […]
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