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Adverse reactions, the role of regulatory agencies in the pharmacovigilance

The onset of unexpected adverse reaction and the measures to be taken to protect patients’ health have been very much debated lately....

Functions and benefits of production lot

All manufacturing activities provide for the attribution of a lot number for each batch of manufactured goods; this is even more...

AIFA clarifies the simplified procedure for generics classification in class C

Last 15 October, the Italian Medicine Agency had announced the introduction of a new simplified price and reimbursement procedure for...

Export of cosmetic products to China

The presence of products made in China and marketed in Europe and in Italy is often talked about. Several types of product...

MedDRA, the importance of harmonisation

In a world that is more and more globalised, managing international issues was made easier by legal and procedural harmonisation in every...

Orthotics and insoles: Are they medical devices? Do they need CE marking?

Some product groups can put manufacturers in a difficult position, as they are not always able to place their product...

How can I tell a PMC from other products?

In supermarkets’ shelves and other kinds of stores, we can find several products labelled as detergents, disinfectants, or that are attributed with...

The regulatory history of food supplements

According to the definition of Legislative Decree 169/2004, food supplements are “foodstuffs intended to complete ordinary diet and constituting a concentrated source...

Medical device regulation: first Eudamed module on line

On 1 December 2020 a further step was taken toward the implementation of the Regulations on medical devices 2017/745 EU and 2017/746...

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