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Respiratory protection in the time of covid-19: ppes, mds and the latest developments in the national regulatory framework

The most used personal protection equipment (PPE) for respiratory protection is filtrating masks. These are usually bound to meet the requirements of the technical...

Update on the measures adopted by Di Renzo Regulatory Affairs in compliance with the provisions to contrast the spreading of the COVDI-19 epidemic

In compliance with the provisions of the President of the Ministry Council in order to contain the spreading of the...

What regulations say about drug shortage

Recent news say that Competent authorities for medicinal products in Europe and United States are preparing themselves to face one...

The lifecycle of vaccines, from development to post-marketing vigilance

The word “vaccine” is now very much recurring in the daily news; it is important, then, to understand the steps...

COVID-19 emergency: AIFA creates “Coronavirus crisis unit”

Discussions with the technical scientific Committee on investigational drugs and off-label use The crisis unit created by AIFA for the...

Devices like drugs, what will change with the UDI code

The application of the new Regulation EU 2017/745 o medical devices was postponed of one year, but some of the...

Between mdd and mdr: class i medical devices

Medical devices (MD) can be marketed only if complying with the relevant essential requirements described in annex I of Directive 93/42/EEC (MDD). In...

How to store narcotics and how to fill in the paper narcotic registry

Except for special cases, narcotic and psychotropic drugs should be stored in a cabinet or container that cannot be removed, and locked...

How to manage the incoming/outgoing narcotic information registry

Handling of narcotic and psychotropic substances, including medicines and relevant compositions containing such substances, can be recorded either on paper or...

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