Monthly Archives: September 2016
Proposed updates to GVP Module VI and what this might mean for our clients
Good pharmacovigilance practices (GVP) are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU). GVP apply to marketing-authorisation holders, the European Medicines Agency and medicines regulatory authorities in EU Member States. The … Continue reading
Posted in Life Sciences Industry, Pharmacovigilance, TGA
Tagged European Medicines Agency, GVP, Medsafe, TGA
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Medicine labels: TGO 91 and TGO 92. What’s the impact?
Following years of consultation and review the TGA has issued two new labelling orders to replace the current Therapeutic Good Order No. 69 for specific medicine labelling requirements: Therapeutic Goods Order No. 91 – Standard for labels of prescription and … Continue reading
Posted in Life Sciences Industry, Regulatory Services, TGA
Tagged Regulatory Services, TGA, TGO
Comments Off on Medicine labels: TGO 91 and TGO 92. What’s the impact?