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Maria Chaita

Hogan Lovells

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EC issues a new guidance concerning the safety features for Falsified Medicines

European Union - August 23 2017 The European Commission has published a guidance concerning “Safety Features for medicinal products for human use” (Guidance). The Guidance is in the...

Elisabethann Wright.

The European Commission opens a public consultation concerning EU legislation on Blood and, Tissues and Cells

European Union - August 21 2017 The European Commission has opened an online stakeholders’ consultation for the evaluation of the European (“EU”) legislation regarding blood and...

Elisabethann Wright.

EMA seeks to support the use of patient registries and to improve dialogue between various stakeholders

European Union - April 18 2017 In September 2015, the European Medicines Agency (EMA) launched the initiative for patient registries. The purpose of the initiative is to improve...

Elisabethann Wright.

European Commission publishes recommendations concerning the summary of product characteristics and patient information leaflet for medicinal products

European Union - April 14 2017 The European Commission (EC) has published a report (Report) recommending improvements in the summary of product characteristics (SmPC) and the...

Elisabethann Wright.

EMA’s initiative of expanding the use of early background summaries

European Union - April 14 2017 In an effort to help assessors evaluate initial marketing authorization applications, the European Medicines Agency (EMA) has taken the initiative to...

Elisabethann Wright.