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Notice to the pharmaceutical industry on process for addressing the backlog in evaluation of registration applications. Dossier is will be reviewed by work groups attending 2 different categories of document.
Recommendations for an application for a licence to manufacture, import or export medicines and medical devices. GWP guidelines apply.
Draft regulations to the Medicines Act have been published for a comment period of 3 months. Commentary is due by the 26th April 2017. The draft regulations include the complementary medicines regulations. Medical device-specific regulations (finalised) are published…