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Consultation on adoption of a European Union guideline in Australia

31 October 2016

This consultation closed on 16 December 2016

The EU guideline below has been recommended for adoption by the TGA. The guideline was open for comment on whether or not it should be adopted in Australia.

Note: This consultation is related to two concurrent consultations for guidance on biovigilance responsibilities and risk management plans for medicines and biologicals.

Guideline proposed for adoption

How to access a pdf or Word document

EMEA/149995/2008: Guideline on safety and efficacy follow-up - risk management of advanced therapy medicinal products (pdf,207kb)