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Posts by Di Renzo Regulatory Affairs

International meeting regulatory affairs

International meetings in March

8 March 2021 Presenting VirtuallyWebinar www.management-forum.co.uk 10 March 2021Regulatory Strategies for OrphanDrugsWebinarwww.management-forum.co.uk 10-11 March 2021Technical Documentation to Complywith the MDR...

Brexit medical product

Brexit, AIFA on non compliant MAs

Following the exit of the United Kingdom from the European Union, the Italian Medicine Agency has informed that for medicinal...

EFSA-regulation-trasparency

New EFSA regulation for transparency

The new Regulation EU 2019/1381, also known as “Transparency Regulation”, applicable as of 27 March 2021, will introduce important changes...

Paybak italy

The Italian Payback, why it is so important to contain pharmaceutical expenditure

The payback system is a mechanism introduced in Italy to collect financial resources to support pharmaceutical expenditure and contain the...

Medical Devices

IVDR, NB designation delayed

The application date of the IVD Regulation 2017/746 is still long to come but, in the meantime, progresses are being...

Environmental labelling for packaging: mandatory requirement in Italy

Since last September, in Europe, environmental labelling for packaging is mandatory for products intended for the final consumers. This new...

Updates on environmental packaging labelling

Law Decree 3 December 2020, no. 183 (the so called “Milleproroghe 2021”) was published in the Italian Official Journal on...

October 2020

October 2020

September 2020

Vita Food Europe 2020 September 1, 2020 September 3, 2020 Geneve Switzerland Vita Food Europe 2020 Geneve, Switzerland Vita food Europe...

Updated report on biosimilar expense and consumption

The Italian Agency Medicine has made available the updated reports on themonitoring of biosimilar expense and consumption for the period...